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ZLAB

Zai Lab Limited American Depositary Shares NASDAQ Global Market
$176.77
Open: $152.74 High: $155.98 Low: $151.305 Close: $155.58
Range: 2021-05-06 - 2021-05-07
Volume: 516,137
Market: Closed
Powered by Finage Stock APIDelayed data
ZLAB
Zai Lab Limited American Depositary Shares 4560 Jinke Road Pudong , 201210 http://www.zailaboratory.com
Zai Lab Ltd is a biopharmaceutical company. The company is engaged in discovering or licensing, developing and commercializing proprietary therapeutics in the fields of oncology, autoimmune and infectious diseases.
  • CEO: Ying Du
  • Employees: 88
  • Sector: Healthcare
  • Industry: Biotechnology
ZLAB News
Latest news about the ZLAB
  • Entasis Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

    – ATTACK Phase 3 topline data readout remains on track for second half of 2021 – – Strengthened balance sheet with $20M financing – WALTHAM, Mass., May 05, 2021 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced today its first quarter 2021 financial results and provided a business update. “Through the dedication of our employees and partners, we have maintained momentum in our Phase 3 registrational trials addressing multidrug-resistant Acinetobacter infections and uncomplicated gonorrhea,” commented Manos Perros, President and Chief Executive Officer of Entasis Therapeutics. “We are especially encouraged by the progress achieved in ATTACK, our Phase 3 trial for multidrug-resistant Acinetobacter infections where we now have a clear line of sight to enrolling 120 evaluable patients with carbapenem-resistant infections. Given this progress, we remain confident ATTACK is on-track to complete enrollment in the coming weeks and for topline data readout during the second half of 2021. While advancing SUL-DUR remains our top-priority, we are also excited by the progression of our pipeline, including the Phase 3 trial for zoliflodacin, which we believe has the potential to provide a solution for the millions of annual cases of gonorrhea around the world. We are also pleased to recently announce the closing of the first tranche of a $20 million private placement transaction. The second tranche of the financing will occur upon shareholder approval, which is anticipated in June 2021. As a result of the first tranche of the offering, we now anticipate that our cash runway will be sufficient to fund our operations into the second quarter of 2022. 2021 is poised to be a transformative year for Entasis as we conclude our Phase 3 ATTACK registration trial and initiate preparations to become a commercial stage company.” First Quarter 2021 and Recent Highlights Business HighlightsThe Company, along with our partner Zai Lab (Nasdaq: ZLAB), has enrolled 108 patients with confirmed carbapenem-resistant Acinetobacter infections in the ATTACK trial. The Company estimates that the ATTACK trial is approximately 90% enrolled and expects to complete enrollment in the coming weeks and remains on-track for top-line data readout in the second half of 2021. The Company recently announced that it had entered into a private placement agreement to sell Entasis common stock and warrant securities to a subsidiary of Innoviva, Inc. (Nasdaq: INVA) ("Innoviva"), Entasis’ largest shareholder. The gross proceeds to the Company from the transaction after both closings are expected to be approximately $20 million, before deducting estimated offering expenses payable by the Company. The closing of the first tranche of the financing, consisting of approximately $7.5 million, occurred on May 3, 2021. The closing of the second tranche, consisting of approximately $12.5 million, is expected to occur in early June, assuming approval of the financing at a special meeting of stockholders. The Company intends to use the net proceeds for the continued support of the ongoing ATTACK trial, NDA filing preparation as well as working capital and other general corporate purposes. SUL-DUR As of May 1, 2021, 167 patients have been enrolled in the ATTACK trial across approximately 90 clinical trial sites in 17 countries, including China. ATTACK is our single Phase 3 registrational trial that will evaluate SUL-DUR in patients with confirmed carbapenem-resistant Acinetobacter pneumonia and/or bloodstream infections. Entasis currently estimates the trial is approximately 90% enrolled, as microbiological analyses have confirmed 108 carbapenem-resistant evaluable patients out of the target of 120 evaluable patients necessary for completion of the trial, with another 16 enrolled patients pending confirmation. The Company expects to complete enrollment in the ATTACK trial in the coming weeks with a top-line data readout in the second half of 2021. Zoliflodacin The Company continues to support the Global Antibiotic Research and Development Partnership (GARDP), and the Phase 3 registration trial of zoliflodacin for the treatment of uncomplicated gonorrhea. The trial, designed to assess the safety and efficacy of oral zoliflodacin versus the current standard of care combination of intramuscular ceftriaxone plus oral azithromycin, is actively enrolling patients with uncomplicated gonorrhea, including infections potentially caused by multidrug-resistant strains of N. gonorrhoeae. In Q1, GARDP activated additional clinical trial sites in the US, Thailand, and South Africa, and plans to activate up to 16 additional clinical trial sites across these countries and the Netherlands during the first half of 2021. Due to the unique challenges to site activation and enrollment precipitated by the COVID-19 pandemic, the Company remains unable to provide guidance for completion of the trial. The Company will continue to monitor and consult with GARDP and will provide updates on guidance when appropriate. First Quarter 2021 Financial Results The Company reported a net loss of $10.7 million for the three months ended March 31, 2021, compared to a net loss of $15.3 million for the three months ended March 31, 2020. The decrease in net loss was primarily related to a decrease in operating expenses during the first quarter of 2021 versus the prior year. Research and development expenses were $9.4 million during the three months ended March 31, 2021, compared to $11.6 million during the three months ended March 31, 2020. The decrease of $2.3 million was primarily due to a decrease of $3.4 million in expenses related to our SUL-DUR product candidate attributable to decreases in clinical trial costs, manufacturing costs, spending related to commercial readiness and NDA support. These decreases were offset by increases in expenses related to our ETX0462 product candidate, other preclinical expenses and personnel expenses associated with higher headcount. General and administrative expenses were $3.3 million for the three months ended March 31, 2021, compared to $3.8 million during the three months ended March 31, 2020. The decrease of $0.5 million was driven primarily by decreases in legal expenses and personnel related expenses, and was offset by an increase in insurance related costs. As of March 31, 2021, cash and cash equivalents were $44.9 million, compared to $53.2 million as of December 31, 2020. Based on our current operating plan, we believe that our existing cash and cash equivalents, including amounts received from the first tranche of the most recent private offering, will be sufficient to fund our operating expenses and capital expenditure requirements into the second quarter of 2022. About EntasisEntasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including sulbactam-durlobactam (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacteriaceae infections) and ETX0462 (targeting Pseudomonas infections). For more information, visit www.entasistx.com. Entasis Forward-looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected and changes in expected or existing competition, changes in the regulatory environment, failure of Entasis’ collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Many of these factors are beyond Entasis’ control. These and other risks and uncertainties are described more fully in the Entasis’ filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Company Contact Kyle Dow Entasis Therapeutics (781) 810-0114 kyle.dow@entasistx.com Investor Relations ContactsJames SaliernoThe Ruth Group(646) 536-7028jsalierno@theruthgroup.com Media ContactAnnika ParrishThe Ruth Group(720)-412-9042 aparrish@theruthgroup.com Entasis Therapeutics Holdings Inc.Condensed Consolidated Statements of OperationsUnaudited(in thousands, except share and per share data) Three Months Ended March 31, 2021 2020 Operating expenses: Research and development $9,370 $11,623 General and administrative 3,307 3,780 Total operating expenses 12,677 15,403 Loss from operations (12,677) (15,403)Other income: Grant income 1,972 13 Interest income 4 124 Total other income 1,976 137 Net loss $(10,701) $(15,266)Net loss per share—basic and diluted $(0.29) $(1.15)Weighted average common stock outstanding—basic and diluted 37,078,478 13,291,563 Entasis Therapeutics Holdings Inc. Condensed Consolidated Balance Sheets Unaudited (in thousands) March 31, December 31, 2021 2020 Cash and cash equivalents $44,937 $53,247 Other assets 7,888 8,311 Total assets $52,825 $61,558 Total liabilities $8,568 $9,269 Total stockholders' equity 44,257 52,289 Total liabilities and stockholders’ equity $52,825 $61,558

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  • Deciphera Pharmaceuticals, Inc. (DCPH) Q1 2021 Earnings Call Transcript

    At this time, I would like to hand the conference over to Jen Robinson, Vice President of Investor Relations. With me this afternoon to discuss the financial results and provide a general corporate update are Steve Hoerter, President and Chief Executive Officer; Dan Martin, Chief Commercial Officer; Matt Sherman, Chief Medical Officer; and Tucker Kelly, Chief Financial Officer.

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  • Zai Lab to Announce First Quarter 2021 Financial Results on May 10, 2021

    Company to Host Conference Call and Webcast on May 10, 2021 at 8:00 a.m. ETSHANGHAI and SAN FRANCISCO, April 26, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that it will report financial results for the first quarter ended March 31, 2021, and provide a corporate update before the opening of the U.S. equity markets on May 10, 2021. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast on May 10, 2021 at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration Link:http://apac.directeventreg.com/registration/event/2374839 Conference ID: 2374839 All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call. A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://ir.zailaboratory.com. About Zai Lab Zai Lab (NASDAQ:ZLAB, HKEX:9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide.For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. For more information, please contact: ZAI LAB CONTACTS: Zai LabBilly Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006, ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Pete Rahmer / Mike ZanoniEndurance Advisors, on behalf of Zai Lab415-515-9763 / 610-442-8570prahmer@enduranceadvisors.com / mzanoni@enduranceadvisors.com Zai Lab Limited Source: Zai Lab Limited

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  • Zai Lab Announces Closing of Public Offering of American Depositary Shares and Full Exercise of Greenshoe Option

    SHANGHAI and SAN FRANCISCO, April 23, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 4,776,000 American depositary shares (“ADSs”), each representing one ordinary share of the Company, at a price of US$150.00 per ADS (the “ADS Offering”). Zai Lab had also granted the underwriters a 30-day option to purchase up to an additional 716,400 ADSs at the public offering price, less underwriting discounts and commissions. The underwriters fully exercised their option to purchase these additional ADSs. The ADS Offering closed on April 23, 2021. The expected total global offering gross proceeds to Zai Lab, including both the ADS Offering and the previously announced underwritten offering of 224,000 ordinary shares (the “Ordinary Shares Offering), are approximately US$857.5 million. The gross proceeds to Zai Lab from the ADS Offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately US$823.9 million. The closing of the Ordinary Shares Offering is expected on or about April 28, 2021, and will be settled in Hong Kong dollars at a price of HK$1,164.20 per ordinary share. J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and GuggenheimSecurities, LLC acted as joint book-running managers for the ADS offering. The ADSs were offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission (“SEC”) on April 19, 2021. The ADS Offering was made only by means of a prospectus supplement and an accompanying prospectus included in Form-S-3ASR. The registration statement on Form S-3ASR and the prospectus supplement are available at the SEC’s website at: http://www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at prospectus-eq_fi@jpmchase.com, (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing Prospectus-ny@ny.email.gs.com, (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at prospectus_department@jefferies.com, (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at syndicate@svbleerink.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs, ordinary shares or any other securities, nor shall there be any sale of ADSs or ordinary shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Zai Lab Zai Lab (NASDAQ:ZLAB, HKEX:9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. Zai Lab Forward-Looking Statements This press release contains references to statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements containing words such as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions that Zai Lab believes are reasonable as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results of operations, financial condition and liquidity, and the development of the industry in which Zai Lab operates may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab’s ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. ZAI LAB CONTACTS: Zai Lab Billy Cho, CFO+86 21 6163 7322billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D. Burns McClellan, on behalf of Zai Lab212-213-0006, ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike ZanoniEndurance Advisors, on behalf of Zai Lab610-442-8570, mzanoni@enduranceadvisors.com

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  • Analysts Expect Breakeven For Zai Lab Limited (NASDAQ:ZLAB) Before Long

    With the business potentially at an important milestone, we thought we'd take a closer look at Zai Lab Limited's...

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  • Zai Lab Announces Pricing of Public Offering of American Depositary Shares and Ordinary Shares

    SHANGHAI and SAN FRANCISCO, April 20, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 4,776,000 American depositary shares (“ADSs”), each representing one ordinary share of the Company, at a price of US$150.00 per ADS, and 224,000 ordinary shares, at a price of HK$1164.20 per ordinary share, which will be settled in Hong Kong dollars, based upon each ADS representing one ordinary share and an exchange rate of HK$7.7613 to US$1.00, the spot rate of exchange at the time of pricing. The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately US$750 million. Subject to customary closing conditions, the underwriters expect to deliver the ADSs against payment to the purchasers on or about April 23, 2021, on a “T+2” basis, and to deliver the ordinary shares against payment therefor through the facilities of the Central Clearing and Settlement System on or about April 28, 2021, on a “T+5” basis. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 716,400 ADSs at the public offering price, less underwriting discounts and commissions, which purchase will be settled only in ADSs. J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs. The ADSs and ordinary shares are offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission (“SEC”) on April 19, 2021. The offering is being made only by means of a prospectus supplement and an accompanying prospectus included in Form-S-3ASR. The registration statement on Form S-3ASR and the prospectus supplement are available at the SEC’s website at: http://www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at prospectus-eq_fi@jpmchase.com, (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing Prospectus-ny@ny.email.gs.com, (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at prospectus_department@jefferies.com, (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at syndicate@svbleerink.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs, ordinary shares or any other securities, nor shall there be any sale of ADSs or ordinary shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Zai Lab Zai Lab (NASDAQ:ZLAB, HKEX:9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. Zai Lab Forward-Looking Statements This press release contains references to statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements containing words such as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions that Zai Lab believes are reasonable as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results of operations, financial condition and liquidity, and the development of the industry in which Zai Lab operates may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab’s ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. ZAI LAB CONTACTS: Zai Lab Billy Cho, CFO+86 21 6163 7322billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D. Burns McClellan, on behalf of Zai Lab212-213-0006, ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike ZanoniEndurance Advisors, on behalf of Zai Lab610-442-8570, mzanoni@enduranceadvisors.com

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  • Amgen's Bemarituzumab Scores Breakthrough Therapy Tag For Gastric, GEJ Cancers

    The FDA has granted Breakthrough Therapy Designation to Amgen Inc's (NASDAQ: AMGN) bemarituzumab for patients with gastric and gastroesophageal (GEJ) adenocarcinoma. The designation covers bemarituzumab as first-line treatment of fibroblast growth factor receptor 2b, overexpressing and human epidermal growth factor receptor 2-negative, metastatic and locally advanced GEJ adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin). Following sotorasib, bemarituzumab is the second asset in Amgen's oncology portfolio to receive Breakthrough Therapy Designation in the past six months. The designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medications. Bemarituzumab is a targeted antibody that is designed to block fibroblast growth factors from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Zai Lab Ltd (NASDAQ: ZLAB) was granted an exclusive license to develop and commercialize bemarituzumab in Greater China. Price Action: AMGN shares closed 0.1% higher at $255.9 on Monday. See more from BenzingaClick here for options trades from BenzingaEvotec To Build Another Biologics Manufacturing Facility In Europe, With First In USEmergent BioSolutions Stock Falls After FDA Initiates Inspection Of Bayview Facility© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Zai Lab Announces Proposed Public Offering of American Depositary Shares

    SHANGHAI and SAN FRANCISCO, April 19, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of $750,000,000 of American depositary shares (“ADSs”), each representing one ordinary share of the Company. All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase additional ADSs. Investors have an option to receive ordinary shares of the Company (“Shares”) in lieu of ADSs in this offering only, and such option will not be available to purchasers of the additional ADSs. J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. The offering will be made pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission (“SEC”) on April 19, 2021. A preliminary prospectus supplement related to the proposed ADS offering is being filed with the SEC. Copies of the registration statement on Form S-3ASR, the preliminary prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at prospectus-eq_fi@jpmchase.com, (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing Prospectus-ny@ny.email.gs.com, (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at prospectus_department@jefferies.com, (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at syndicate@svbleerink.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs, Shares or any other securities, nor shall there be any sale of ADSs or Shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Zai Lab Zai Lab (NASDAQ:ZLAB, HKEX:9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. Zai Lab Forward-Looking Statements This press release contains references to statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements containing words such as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions that Zai Lab believes are reasonable as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results of operations, financial condition and liquidity, and the development of the industry in which Zai Lab operates may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab’s ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. ZAI LAB CONTACTS: Zai LabBilly Cho,CFO+86 21 6163 7322billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006, ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike ZanoniEndurance Advisors, on behalf of Zai Lab610-442-8570, mzanoni@enduranceadvisors.com

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  • Is ZLAB Stock A Buy or Sell?

    Is Zai Lab Limited (NASDAQ:ZLAB) a good place to invest some of your money right now? We can gain invaluable insight to help us answer that question by studying the investment trends of top investors, who employ world-class Ivy League graduates, who are given immense resources and industry contacts to put their financial expertise to […]

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  • Zai Lab Partner Novocure Announces Update on Phase 3 Pivotal LUNAR Trial of Tumor Treating Fields in Non-Small Cell Lung Cancer

    Pre-specified interim analysis concluded with favorable recommendation to continue the LUNAR trial DMC stated accrual to 534 patients is likely unnecessary and possibly unethical for patients randomized to control arm and recommended a shortened trial SHANGHAI and SAN FRANCISCO and ST. HELIER, Jersey, April 13, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) today announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in stage 4 non-small cell lung cancer (NSCLC) following platinum failure. Following a routine review of the study by an independent data monitoring committee (DMC), Novocure was informed that the pre-specified interim analysis for the LUNAR trial would be accelerated given the length of accrual and the number of events observed, to date. The interim analysis included data from 210 patients accrued to the LUNAR trial through February 2021. After review of the interim analysis report, the DMC concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity. The DMC also stated that it is likely unnecessary and possibly unethical for patients randomized to the control arm to continue accrual to 534 patients with 18 months follow-up. The DMC recommended a reduced sample size of approximately 276 patients with 12 months follow-up which it believes will provide sufficient overall power for both primary and secondary endpoints. The DMC recommended no other changes to the design of the trial. Novocure remains blinded to all data. The primary endpoint of the LUNAR trial is superior overall survival when patients are treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. The final analysis will also include an analysis of overall survival in the immune checkpoint inhibitor and docetaxel treatment subgroups. Novocure has notified the U.S. Food and Drug Administration (FDA) of the DMC recommendations and of its intent to submit an Investigational Device Exemption (IDE) supplement incorporating the recommended protocol adjustments. “We are very pleased with the DMC recommendations, which we believe support the potential for TTFields to make a significant difference in treatment outcomes for patients with non-small cell lung cancer, whether used together with immune checkpoint inhibitors or docetaxel,” said William Doyle, Novocure’s Executive Chairman. “The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields’ broad potential across a range of hard-to-treat cancers.” “Combination therapy is a cornerstone of cancer care, and we believe using TTFields together with other cancer treatments, including immunotherapies, may lead to better outcomes for some patients,” continued Mr. Doyle. “We are very encouraged that, consistent with our expectations, the DMC concluded that TTFields exhibited no systemic toxicity. We will continue to develop TTFields as a limited toxicity backbone therapy upon which other standard-of-care and emerging cancer treatments can be added.” Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. and approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. TTFields is intended principally for use together with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful. “The completion of the LUNAR interim analysis is an important milestone for Novocure,” said Asaf Danziger, Novocure’s CEO. “We are grateful to the DMC members for their diligence, guidance and support, and are looking forward to working closely with the FDA on amendments to the protocol given the DMC’s recommendations. Pending regulatory approval, the recommended protocol adjustments could accelerate trial completion by more than a year. We look forward to sharing final data from the LUNAR trial as quickly as possible.” About NSCLC in ChinaLung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases. Lung cancer has the highest total incidence of any cancer in China. According to the World Health Organization, the incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths. In China, the five-year survival rate of lung cancer is estimated to be about 20%. About LUNARLUNAR is a phase 3 pivotal trial testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. TTFields is intended principally for use in combination with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful. About Tumor Treating FieldsTumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected. Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death. TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields' broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields. Use of Tumor Treating Fields for the treatment of NSCLC is investigational only. About Zai LabZai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. Our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact human health worldwide. For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. About NovocureNovocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, TTFields. TTFields are electric fields that disrupt cancer cell division. Novocure’s commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing clinical trials investigating TTFields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer. Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure. Zai Lab Forward-Looking StatementsThis press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects and plans for developing and commercializing Tumor Treating Fields in Greater China and other statements containing words such as “anticipates”, “believes”, “expects”, “plans”, “can be” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab’s ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. Novocure Forward-Looking StatementsIn addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding LUNAR progress and timelines, interpretation of the LUNAR interim analysis, anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 25, 2021, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. ZAI LAB CONTACTS:Zai LabBilly Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006 ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike ZanoniEndurance Advisors, on behalf of Zai Lab610-442-8570mzanoni@enduranceadvisors.com Media and Investor Contact:Ashley Cordova(212)767-7558media@novocure.cominvestorinfo@novocure.com Zai Lab Limited

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  • Goldman Sachs Says These 3 Stocks Are Ready to Rip Higher

    Current market conditions are pushing investors into stocks – and the result is record-high valuations. The S&P 500 has hit a new all-time high, and the NASDAQ, which peaked in February, remains within 3% of its record level and is headed back up. While this is obviously good for investors’ portfolios, there is some concern that we may be looking at a stock bubble. Weighing in from Goldman Sachs, however, strategist Petter Openheimer believes those worries are overblown. He recently led a comprehensive study of asset bubbles over the past three centuries – and comes to the conclusion that stocks, while high, are justifiably so. He notes that interest rates are historically low, keeping down returns in other assets and making stocks the best option for strong returns. In addition, Openheimer notes that some high-profile stock sectors – he uses Big Tech as his example – are bringing in the profits needed to underpin the stock values. “While the technology companies of today have become very large, they're also extremely profitable. They've seen roughly three times the average sales growth of the rest of the market, and roughly twice the average net income growth over the last few years.... being large and seeing strong price appreciation is not the equivalent of being a bubble, I think, because these have actually been very profitable parts of the market,” Openheimer noted. With that in mind, Openheimer’s colleagues among Goldman’s stock analysts have been scouring the market, finding the stocks that are primed to see gains in today’s environment. We’ve opened up the TipRanks database to get the details on three of these Goldman picks. Let's take a closer look. Oscar Health (OSCR) The first Goldman Sachs pick we’ll look at is Oscar Health, a disruptive company in the health insurance industry. Oscar has a tech focus and provides a new type of health insurance: telemedicine, technological healthcare interfaces, and a transparent claims pricing system all combine to make the famously opaque health insurance industry easier for patients to navigate. The company was founded in 2012, and now serves over 520,000 customers in 18 states. Early in March of this year, Oscar held its IPO. The company offered over 37 million shares at $39 each, $1 above the $36 to $38 initial guidance, and raised over $1.4 billion. Investors will get their first look under the hood of Oscar in the 1Q21 earnings release, which has been scheduled for this coming May 13. Covering the stock for Goldman Sachs, analyst Robert Jones believes OSCR presents a compelling risk reward. "OSCR, in our view, represents an opportunity to buy into a differentiated offering that is levered to attractive secular themes in healthcare (increased consumerization, proliferation of tech-enabled health offerings, etc) and capable of growing at a 40%+ organic top-line rate. We also see meaningful upside optionality in currently nascent opportunities in small group and MA end-markets, as well as tech platform monetization. While we have appreciation for competitive risks in the IFP end-market and the company’s multi year timeline to profitability, we think these are appropriately accounted for in the current trading multiple," Jones commented. To this end, Jones puts a Buy rating on OSCR, to go along with his generally optimistic outlook. His price target, at $44, implies an upside of ~76% for the next 12 months. (To watch Jones’s track record, click here) In its short time on the public markets, Oscar has received 6 analyst reviews, including 5 Buys against a single Hold, making the consensus view a Strong Buy. The shares are priced at $25.06 and the average target of $37.83 suggests room for 51% growth in 2021. (See OSCR stock analysis on TipRanks) Zai Lab, Ltd. (ZLAB) Some biotech companies operate with a precision approach, developing targeted treatments for specific conditions; others take a shotgun approach, creating and testing a wide range of therapeutic agents against an equally wide range of conditions, from cancers to autoimmune diseases to infectious agents. Zai Lab, based in China, is clearly in the latter category. The company’s pipeline includes no fewer than 21 agents under development as treatment for conditions varying from ovarian and gastric cancers to glioblastomas and mesothelioma to autoimmune skin conditions like psoriasis. The pipeline projects are at all stages, from pre-clinical research to Phase 3/Pivotal clinical trials to approval for treatment. Zai Lab’s chief products are niraparib, Optune and ripretinib: Under the trade name Zejula, niraparib has been approved in China since December 2019 as a maintenance therapy for adults with ovarian and fallopian tube cancers. It was approved by the US FDA for similar use in April of 2020. Optune is Zai Lab’s trade name for tumor treating fields (TTFields), a new treatment regime that uses electric fields, tuned to particular frequencies, to inhibit the cell division that causes tumor growth. Optune has been approved for use, and marketing, in mainland China, Hong Kong, Japan, the US, the EU, and Switzerland. The treatment is used to target glioblastoma tumors in the brain. Looking forward, Zai Lab expects that the recent Chinese approval of ripretinib (trade name Qinlock) as a treatment for gastrointestinal stromal tumors (GIST) will open up new opportunities to expand the patient base. Ripretinib is the company’s third approved product in China in a span of 15 months. Zai Lab will be submitting regulatory filings to expand the use of TTFields to mesothelioma later this year. In his coverage of Zai Lab for Goldman, Ziyi Chen sees the company’s continued success with the regulators as a primary factor supporting the stock value. “We see the [Qinlock] approval as a further validation to Zai Lab’s robust clinical development and regulatory communication capability (approval 8.4 months from NDA acceptance and 22 months from in-licensing), confirming one of our thesis points from our initiation…. In addition, we believe Qinlock will be eligible for this year’s NRDL price negotiation (last year’s cutoff Aug 17, 2020) although no official guidance has been given by the company,” Chen wrote. In line with these comments Chen rates ZLAB shares as a Buy and gives the stock a $205 price target. At current levels, his target implies a robust 64% one-year upside. (To watch Chen’s track record, click here) With three reviews on record, all to Buy, the Strong Buy consensus rating ZLAB is unanimous. The stock is selling for $129, and its $207.29 average price target, slightly more bullish than the Goldman Sachs target set by Chen, suggests ~61% growth this year. (See ZLAB stock analysis on TipRanks) Coupang (CPNG) When an online sales site hits it big, to say, “It’s the next Amazon,” usually, that’s all hype. But Coupang, by all appearances, is the real deal. The South Korean e-commerce company, founded in 2010, showed over US$5.9 billion in sales in 2019, doubled that to $12 billion in 2020, and is on its way toward dominating the South Korean online retail market. Coupang sells an enormous range of products on its site, from household furnishings and kitchen utensils to childcare items to pet supplies and automotive needs – and that is only a small selection of their categories. The company boasts a Rocket Delivery network, guaranteeing same-day or next-day delivery on more than 5 million items in stock, and claims a 99.6% 24-hour delivery rate. A major e-commerce player, posting numbers like that, would be ripe for an IPO – and Coupang went public on Wall Street this past March. The company offered 130 million shares at $35 each, and raised $4.55 billion. Among the bulls is Goldman Sachs analyst Eric Cha, who initiated coverage of Coupang with a Buy rating and a $62 price target. Investors stand to pocket ~35% gain should the analyst's thesis play out. Backing his stance, Cha writes: “Coupang has disrupted Korea’s e-commerce market with its 1P-based service, dubbed 'Rocket Delivery.' The vast assortment of low-priced 1P products delivered free of charge the next day (or within hours) to Coupang Wow members will be difficult for competitors to match and seems to be driving mind-share as well as GMV. We expect the company to continue to place priority on GMV growth by expanding to new service offerings (i.e., Fresh and Eats) as well as new categories.” Not everyone is as enthusiastic about Coupang as Cha, as TipRanks analytics reveal CPNG as a Hold. In fact, out of 5 analysts polled in the last 3 months, Cha seems to be the sole bull. Meanwhile, the 12-month average price target stands at $50.60, which implies ~9% upside from current levels. (See CPNG stock analysis on TipRanks) To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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  • China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)

    China NMPA approval follows 2020 U.S. FDA approval for the treatment of patients with fourth-line GIST QINLOCK demonstrated a significant improvement in progression-free survival and a clinically meaningful benefit in overall survival compared to placebo in the pivotal Phase 3 INVICTUS study QINLOCK approval is the third innovative oncology product approval Zai Lab received in the last 15 months SHANGHAI, SAN FRANCISCO and WALTHAM, Mass., March 31, 2021 (GLOBE NEWSWIRE) -- Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, and Deciphera Pharmaceuticals (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced that the China National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for QINLOCK® (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. QINLOCK targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST. “Treatment of GIST remains an important unmet medical need in China,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “Approximately 30,000 GIST patients are newly diagnosed each year in China, twice as many as in the U.S. and Europe combined. NMPA’s approval of QINLOCK establishes a new standard of care for treating patients with fourth-line GIST in China. We appreciate the NMPA’s rapid and thorough assessment of QINLOCK. We look forward to working closely with our partner, Deciphera, to introduce this new treatment option to benefit many more patients who are suffering from advanced GIST in Greater China.” “We congratulate Zai on gaining this important approval,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “QINLOCK is a new standard of care for patients with fourth-line GIST, and we’re excited to work with our partner Zai as they deliver this innovative medicine to patients in China.” “The approval of QINLOCK in China is a significant milestone for the GIST community,” said Dr. Shukui Qin, Chief Physician of Cancer Center, Nanjing Jinling Hospital, Senior Vice President of the Chinese Society of Clinical Oncology. “Many GIST patients, who initially responded to traditional tyrosine kinase inhibitors, ultimately developed tumor progression due to secondary mutations. QINLOCK may potentially alter the treatment landscape for patients in China with GIST.” “Based on the pivotal Phase 3 INVICTUS study, QINLOCK demonstrated compelling clinical benefit in progression-free and overall survival, and was shown to have a favorable safety profile in treating advanced GIST patients,” said Dr. Lin Shen, Vice President of Clinical Oncology at Beijing Cancer Hospital. “We look forward to making this innovative therapy available to patients as soon as possible.” Deciphera and Zai Lab are also exploring the use of QINLOCK to treat patients with second-line GIST. Deciphera has completed target enrollment in the Phase 3 INTRIGUE study of QINLOCK in patients with second-line GIST, with top-line results anticipated in the second half of 2021. About QINLOCK (ripretinib) QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In March 2021, the NMPA approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the Hong Kong Department of Health approved QINLOCK in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. In May 2020, the U.S. FDA approved QINLOCK for the treatment of adult patients with advanced GIST who received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China (mainland China, Hong Kong, Macau and Taiwan). About the INVICTUS Phase 3 Study INVICTUS is a Phase 3 randomized, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK or placebo once daily. The primary efficacy endpoint is progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). QINLOCK also demonstrated a median OS of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36). Important Safety Information There are no contraindications for QINLOCK. The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. About Deciphera Pharmaceuticals Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumors. For more information, visit www.deciphera.com or follow us on LinkedIn and Twitter (@Deciphera). Zai Lab Forward-Looking Statements This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing QINLOCK in Greater China and other statements containing words such as “potentially”, “anticipates,” “believes,” “expects,” “plan” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab’s ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. Deciphera Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations regarding top-line data from our Phase 3 INTRIGUE study in second-line GIST, the possible benefits of QINLOCK in GIST patients, and expanding the geographic reach of QINLOCK. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations, our ability to successfully demonstrate the efficacy and safety of our drug candidates and in additional indications for our existing drug, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, our ability to manage our reliance on sole-source third parties such as our third party drug substance and drug product contract manufacturers, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, our ability to build and scale our operations to support growth in additional geographies, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized, our ability to comply with healthcare regulations and laws, our ability to obtain, maintain and enforce our intellectual property rights, any or all of which may affect the initiation, timing and progress of clinical studies and the timing of and our ability to obtain additional regulatory approvals, and other risks identified in our Securities and Exchange Commission (SEC) filings, including our Annual Report on Form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC. For more information, please contact: ZAI LAB CONTACTS: Zai LabBilly Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006 ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike ZanoniEndurance Advisors, on behalf of Zai Lab610-442-8570mzanoni@enduranceadvisors.com DECIPHERA CONTACTS: Investors: Jen RobinsonDeciphera Pharmaceuticals, Inc. 781-906-1112jrobinson@deciphera.com Media: David RosenArgot Partners, on behalf of Deciphera212-600-1902David.Rosen@argotpartners.com Zai Lab Limited

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  • 7 Biotech Stocks With Catalysts That Go Far Beyond Covid-19 Vaccines

    It has been a year since we officially recognized the novel coronavirus as a serious threat. And while it seems like it has been far longer for us to manage our “new normal,” the fact that we’re seeing numbers drop and there are more than a dozen vaccines available around the world, goes to show the power of technology. The initial Covid-19 vaccines that were launched in the U.S. were the first of their type ever approved. They use messenger RNA (mRNA), the building block of DNA, to help our bodies develop immunity to the virus. This takes a significant amount of technological know-how. Also, the fact that the vaccines only took a year to develop is incredibly fast. Usually it takes years to sort out the virus, potential vectors to stop it, etc. The runway was significantly shortened by the technology currently available.InvestorPlace - Stock Market News, Stock Advice & Trading Tips 7 of the Best Value Stocks on the Market Today However, when looking for biotech stocks to buy, those which are producing Covid-19 vaccines aren’t the only ones you should be paying attention to. As such, these seven stocks are worth considering beyond Covid-19 vaccines: Denali Therapeutics (NASDAQ:DNLI) Moderna (NASDAQ:MRNA) Mirati Therapeutics (NASDAQ:MRTX) Zai Lab Ltd (NASDAQ:ZLAB) Novavax (NASDAQ:NVAX) Seagen (NASDAQ:SGEN) Fate Therapeutics (NASDAQ:FATE) The work that these second-tier biotechs are doing now will continue to grab headlines in a post-coronavirus world. Biotech Stocks: Denali Therapeutics (DNLI) Source: Shutterstock I have been a big fan of this clinical-stage biotech stock for quite a while for a couple reasons. First, DNLI has been a strong performer during the past 12 months, which represents a well-managed company in a focused sector that doesn’t have significant, focused competitors. Second, its key market is neurodegenerative diseases like Parkinson’s, ALS, dementia and Alzheimer’s. With drugs in the pipeline for all of these challenges and more, DNLI is addressing one of the biggest demands in the developed world — the graying of the population. DNLI has some very promising drugs making their way through trials now. In August of last year a major biotech agreed to partner with DNLI on two programs using DNLI’s unique blood-brain barrier crossing TV platform. That’s a big confirmation regarding the company’s proprietary technology. The stock has come off its December highs, but it’s still up 290% in the past 12 months. However, given its potential, those old highs are certainly achievable as its drugs pass through trials. But be prepared for volatility. Moderna (MRNA) Source: Shutterstock Certainly if you haven’t heard the name by now, the ticker symbol should give you an idea of what the company focuses on. It’s all about mRNA and the possibilities of using it for vaccines as well as other medicines. But its vaccine work is what has launched it, now that it has one of the few vaccines that is getting into Americans’ arms. MRNA research has been going on for decades, but it’s very difficult to manipulate and until technology reached its current state it was very expensive to develop on a scale large enough for trials, much less broad distribution. But that has all changed now. 7 Healthcare Stocks to Buy and Hold for the Long Term And the fact that this biotech stock went from around $19 a share 12 months ago to $132 today (and up to $189), means MRNA is in a much better place to become a leading player in mRNA research and development. Mirati Therapeutics (MRTX) Source: Shutterstock This clinical stage biotech stock has a novel approach to treating cell growth and cell division using what are called KRAS inhibitors. This company is all about cancer drugs. And some of its drugs in the pipeline show best-in-class efficacy, outperforming KRAS inhibitors made by some of the biggest pharmaceutical companies on the planet. With a market cap around $9 billion, however, this is a David in a David and Goliath battle. However, it’s the perfect size to be swallowed by a bigger, diversified pharmaceutical firm as a plug and play opportunity. Like other biotech stocks, it has been on a wild ride this past year, with a 52-week range between $66 and $249. It’s around $188 now and is likely to consolidate around here. Its 12-month performance of 161% is still impressive, but there’s plenty of headroom if it goes it alone or a big pharma steps in with an offer. Zai Lab Ltd (ZLAB) Source: Shutterstock If you’re looking for a way to play China’s growing demand for world-class medicines, this should be one of the biotech stocks you consider. It has a foot in China and the U.S., which means it can create value in both markets. One of its recent deals is to license a drug made by a U.S. big pharma for use in China. This is a win-win for both sides. China gets a U.S. drug in a key strategic area and the U.S. company gets a revenue source in China without having to access the country on its own. Of course, ZLAB also has its own drugs, four of them are already approved in the U.S. market. Currently it has 15 drug candidates in oncology, autoimmune and infectious disease trials. When approved they have easy access to both U.S. and Chinese markets. 10 Stocks That Just Might be Good Investments Its current $11 billion market cap has been boosted significantly after the ZLAB’s 201% run in the past 12 months. But there’s a lot of promise here, especially as a conduit into the Chinese market. Novavax (NVAX) Source: Ascannio/Shutterstock.com Less than two years ago, this vaccine maker was having to face the reality of being delisted from Nasdaq because its stock had traded under $1 for 30 days in a row. It was selling office space and cutting jobs. It had great ideas, but trying to develop them on a shoestring was hitting the biotech “valley of death” when scientists take a great idea from the lab and try to commercialize it. That requires a whole different level of management skills and often inflicts mortal wounds on promising biotech stocks. But then Covid-19 rolled into the U.S. and NVAX got a $2 billion shot in the arm (I couldn’t resist) from the U.S. government to move forward with its research and development. It now has a market cap nearing $13 billion and the stock is trading at $177 a share. NVAX is up 1,757% in the past 12 months, but it’s nearly 50% off its 52-week highs. And its vaccine, while not approved in the first round, demonstrated powerful resistance to Covid-19 — that’s especially true for the Brazil and U.K. variants. In late January its Phase 3 trials in the U.K. were released, and it’s considered by experts to be one of the best vaccines out there. Seagen (SGEN) Source: nine muses / Shutterstock.com If you’ve heard of onco-immunotherapy, then you have a pretty good idea what SGEN does. If you haven’t, then a quick description is using your own immune system to help fight cancer. Given the fact that this was practically science fiction a decade ago, at least on a commercial level, it’s a significant step forward in cancer treatment. There are a number of biotech stocks that are in this field, but SGEN is one of the leaders, having been at this since 1997. SGEN uses antibody-drug conjugates (ADCs), which attach small molecule drugs to naturally occurring antibodies to target tumor cells. The antibodies are absorbed and dissipate, but the drug goes to work on the tumor and destroys its ability to grow. The tumor dies. This approach means unlike traditional chemotherapy, it’s highly targeted, so it doesn’t compromise the patient’s immune system, yet is highly effective. 7 Penny Stocks That Wall Street Thinks Are Undervalued SGEN stock is up 56% in the past 12 months. It has a $27 billion market cap, so it’s an established player in a very hot sector, which makes it a great growth story on its own or a buy-out target at a big premium. Fate Therapeutics (FATE) Source: Shutterstock Another immunotherapy biotech, FATE targets cancers and other immune disorders using a proprietary induced pluripotent stem cell (iPSC) technology that sets it apart from similar biotech stocks. IPSC allows FATE to create an unlimited cell source for differentiation into specialized cell types and development of “off-the-shelf” cellular therapies. Basically FATE can create master lines of iPSCs and then apply them to the particular diagnoses. The company has been around since 2007, and is on the leading edge of immunotherapies, so it may take some time to gain real traction. It has a number of drugs in preclinical and Phase 1 trials, and a hematology drug in Phase 2 trials. But given the fervor in tech-driven stocks, FATE is up 364% in the past 12 months, yet has a market cap of $8 billion. All that cash will help keep those trials moving and certainly help its burn rate. On the date of publication, Louis Navellier has a position in NVAX in this article. Louis Navellier did not have (either directly or indirectly) any other positions in the securities mentioned in this article. The InvestorPlace Research Staff member primarily responsible for this article did not hold (either directly or indirectly) any positions in the securities mentioned in this article. Louis Navellier had an unconventional start, as a grad student who accidentally built a market-beating stock system — with returns rivaling even Warren Buffett. In his latest feat, Louis discovered the “Master Key” to profiting from the biggest tech revolution of this (or any) generation. More From InvestorPlace Why Everyone Is Investing in 5G All WRONG It doesn’t matter if you have $500 in savings or $5 million. Do this now. Top Stock Picker Reveals His Next Potential 500% Winner Stock Prodigy Who Found NIO at $2… Says Buy THIS Now The post 7 Biotech Stocks With Catalysts That Go Far Beyond Covid-19 Vaccines appeared first on InvestorPlace.

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  • Why Amgen's $1.9 Billion Takeover Might Only Whet Its Appetite In 2021

    Amgen said Thursday it will spend $1.9 billion to buy Five Prime Therapeutics, a small biotech company with a promising stomach cancer drug. The news sent FPRX stock rocketing.

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  • Analysts Are More Bearish On Zai Lab Limited (NASDAQ:ZLAB) Than They Used To Be

    The analysts covering Zai Lab Limited ( NASDAQ:ZLAB ) delivered a dose of negativity to shareholders today, by making a...

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  • Zai Lab Announces Financial Results for Second-half and Full-year 2020

    -- Company to Host Conference Call and Webcast Today at 8:00 a.m. ET SHANGHAI and SAN FRANCISCO, March 01, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today reported financial results for the second half and full year of 2020, along with corporate updates. “2020 was another year of great accomplishment for Zai Lab,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “We successfully launched ZEJULA for both second-line and first-line ovarian cancer and Optune for glioblastoma in China. We submitted NDAs and were granted priority reviews by China’s National Medical Products Administration (NMPA) for both QINLOCK for advanced gastrointestinal stromal tumors (GIST) and NUZYRA for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in China. We continued to expand our pipeline by forming new strategic partnerships with four companies for five compounds that we believe can address significant unmet medical needs. We and our partners continued to execute in clinical development, and we now have 21 product candidates, including 17 in clinical development, 11 in late-stage development and five that have been approved in the United States. Our pipeline of internally developed products with global rights grew to seven, including three in global clinical development. “Looking ahead to 2021, we expect to receive approval for and launch QINLOCK and NUZYRA in China, bringing our total number of commercial products to four. In addition, ZEJULA for second-line ovarian cancer has been included in the National Reimbursement Drug List (NRDL), and we expect this will drive strong volume growth for the product this year and beyond. We also plan to submit regulatory filings for Tumor Treating Fields in mesothelioma and for MARGENZA in HER2-positive breast cancer in China in 2021. We expect to hold regulatory discussions with the NMPA regarding a potential accelerated regulatory pathway for efgartigimod, which has already been filed by our partner argenx for generalized myasthenia gravis in the United States. And we expect to obtain new clinical data for many products and product candidates. “We are focused on building disease strongholds in China in three therapeutic areas — oncology, autoimmune disorders and infectious diseases. Within oncology, we have focused on five cancer franchises that account for over half of all new cancer patients in China. These cancer franchises include lung cancer and gastric cancer, where we have a world-class portfolio of product candidates, as well as women’s cancer, brain cancer and hematology. We plan to continue to expand this product pipeline both vertically within these areas of focus and horizontally into new therapeutic areas of significant unmet medical need. “Over the next three years, our mission is to become a leading global biopharmaceutical company. In addition to seeking to deliver a steady stream of approvals and launches in China from our existing pipeline and forming new strategic collaborations and transformative partnerships, we aim to discover and develop innovative medicines. To accomplish our mission, we will continue to build upon our current scale, which currently consists of nearly 1,200 employees across eight operational locations around the world. While the challenges of COVID-19 continue for all of us, we at Zai Lab remain committed to extending our track record of execution in pursuit of our overall goal of improving human health globally.” Recent Product Highlights and Anticipated Milestones Oncology ZEJULA® (niraparib) ZEJULA is an oral, once-daily small-molecule poly ADP-ribose polymerase (PARP) 1/2 inhibitor. It is the only PARP inhibitor approved in the United States, the European Union and China as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status. Second-half 2020 Accomplishments In December 2020, we announced that ZEJULA was included in the NRDL released by China’s National Healthcare Security Administration.In September 2020, the NMPA approved the supplemental New Drug Application (sNDA) for ZEJULA as a maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.In September 2020, we announced detailed positive results from the NORA study, the Phase 3 randomized, double-blind, placebo-controlled study of ZEJULA as a maintenance therapy in patients in China with recurrent ovarian cancer. The NORA study demonstrated a significant progression-free survival (PFS) benefit for ZEJULA, regardless of biomarker status, with an improved safety profile when given in an individualized starting dose regimen.Since its commercial launch in January 2020 in China, ZEJULA has been listed in 67 commercial health insurance plans and 44 supplemental insurance plans initiated by provincial or municipal governments. Anticipated 2021 Zai Milestones Complete enrollment of the Phase 1b study of ZEJULA in combination with tebotelimab (PD-1 x LAG-3) in gastric cancer.Announce topline results of the China Phase 3 PRIME study of ZEJULA in patients with first-line ovarian cancer in the second half. Submit the sNDA for late-line ovarian cancer treatment in the second half.Continue to explore additional indications and combination opportunities. Tumor Treating Fields Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cell death. Second-half 2020 Accomplishments In August 2020, we launched Optune LuaTM for the treatment of malignant pleural mesothelioma (MPM) in Hong Kong. Since its launch in June 2020, Optune® has been listed in 10 supplemental insurance plans and is the first innovative medical device supported by commercial health insurance in China. Anticipated 2021 Zai Milestones Submit a Marketing Authorization Application (MAA) for MPM. Join the global Phase 3 pivotal LUNAR trial in non-small cell lung cancer (NSCLC), the Phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer, the Phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer and the Phase 3 pivotal METIS trial in brain metastases from non-small cell lung cancer.Complete enrollment of the Phase 2 pilot trial in first-line gastric adenocarcinoma. Anticipated 2021 Partner Milestones Obtain final data from the Phase 2 HEPANOVA trial in advanced liver cancer in the first half. Complete the interim analysis of the Phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer in the second half. Complete the interim analysis of the Phase 3 pivotal LUNAR trial in NSCLC in the second half. QINLOCK® (ripretinib) QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. Second-half 2020 and 2021 Accomplishments In March 2021, the Hong Kong Department of Health approved QINLOCK in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. In December 2020, we announced dosing of the first patient with QINLOCK in Greater China for the second-line GIST registrational bridging study. In August 2020, the NMPA granted priority review for the New Drug Application (NDA) for QINLOCK for the treatment of fourth-line GIST.In July 2020, the NMPA accepted the NDA submission of QINLOCK for the treatment of fourth-line GIST. Anticipated 2021 Zai Milestone Potential NMPA approval and commercial launch of QINLOCK for the treatment of fourth-line GIST in the first half. Anticipated 2021 Partner Milestone Obtain topline data from the INTRIGUE Phase 3 study of QINLOCK in patients with second-line GIST in the second half. Odronextamab Odronextamab is a bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20). Anticipated 2021 Zai Milestone Enroll the first patient in Greater China in the global Phase 2 potentially pivotal program in the first half, subject to feedback from the U.S. Food and Drug Administration (FDA). Anticipated 2021 Partner Milestones Complete enrollment of the Phase 2 potentially pivotal program in B-cell non-Hodgkin lymphoma (B-NHL).Initiate confirmatory OLYMPIA Phase 3 trials in combination with chemotherapy in follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) and explore other combination opportunities.Initiate development of a subcutaneous formulation. Repotrectinib Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-naïve or TKI-pretreated patients. Anticipated 2021 Zai Milestone Enroll the first patient in Greater China in the global TRIDENT-1 Phase 2 registrational study in the first half. Anticipated 2021 Partner Milestones Plan to discuss the regulatory path of repotrectinib in patients with TKI-naïve ROS1-positive NSCLC with the FDA in the first half.Initiate a Phase 2 combination study in KRAS-mutant NSCLC.Provide clinical data updates from cohorts of the ongoing TRIDENT-1 study in the second half. MARGENZA™ (Margetuximab) MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2). Second-half 2020 Accomplishments In December 2020, our partner MacroGenics announced that the FDA approved MARGENZA, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. In October 2020, we announced dosing of the first patient in Greater China in the global MAHOGANY study evaluating margetuximab as an investigational agent in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer or gastroesophageal junction (GEJ) cancer. Anticipated 2021 Zai Milestone Submit an NDA for pretreated metastatic HER2-positive breast cancer. Anticipated 2021 Partner Milestones Obtain initial data from Module A of the MAHOGANY study.Complete the final overall survival (OS) analysis of the SOPHIA study, a randomized, open-label Phase 3 study evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have previously been treated with HER2-targeted therapies. Bemarituzumab Bemarituzumab is a first-in-class antibody that is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. Second-half 2020 Accomplishment In November 2020, our partner Five Prime Therapeutics announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 2 FIGHT trial. All three efficacy endpoints in the FIGHT trial – PFS, OS and objective response rate (ORR) – achieved pre-specified statistical significance in the bemarituzumab arm compared to the placebo arm. The trial results were later presented at the 2021 ASCO Gastrointestinal Cancers Virtual Annual Symposium (ASCO GI) in January 2021. Anticipated 2021 Zai Milestone Initiate a pivotal Phase 3 trial in gastric cancer with our partner Five Prime Therapeutics. Anticipated 2021 Partner Milestone Initiate a pivotal Phase 3 trial in gastric cancer and clinical development in other FGFR2b+ cancers. CLN-081 CLN-081 is an orally available, small-molecule, next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertions. Anticipated 2021 Zai Milestone Enroll the first patient in Greater China in the global potentially pivotal study in the second half. Anticipated 2021 Partner Milestone Provide a clinical data update from the Phase 1/2a global study. TPX-0022 TPX-0022 is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases. Anticipated 2021 Partner Milestone Provide updated data from the Phase 1 SHIELD-1 study and initiate the Phase 2 portion of the SHIELD-1 study pending FDA feedback in the second half. Tebotelimab Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Second-half 2020 Accomplishments In November 2020, our partner MacroGenics presented Phase 1 clinical data for tebotelimab in combination with margetuximab in advanced HER2-positive neoplasms at the Society for Immunotherapy of Cancer (SITC) annual meeting.In December 2020, our partner MacroGenics presented Phase 1 cohort data in relapsed or refractory DLBCL at the ASH Annual Meeting and Exposition. Anticipated 2021 Zai Milestones Make go/no-go decision on tebotelimab in combination with brivanib for hepatocellular carcinoma based on the Phase 1/2 proof-of-concept trial. Anticipated 2021 Partner Milestone Provide a clinical update, including future development plans. Retifanlimab Retifanlimab is an investigational monoclonal antibody that inhibits PD-1. Second-half 2020 Accomplishments In October 2020, we announced dosing of the first patient in Greater China in the global Phase 3 study evaluating retifanlimab in combination with platinum-based chemotherapy in patients with first-line metastatic NSCLC.In October 2020, we announced dosing of the first patient in Greater China in the global potentially registrational study of retifanlimab in patients with previously treated microsatellite-instability-high endometrial cancer. 2021 Partner Accomplishment In January 2021, our partner Incyte announced that FDA had accepted for Priority Review its Biologics License Application (BLA) for retifanlimab in patients with pretreated advanced squamous cell anal cancer (SCAC), with a PDUFA date of July 25, 2021. Autoimmune Diseases Efgartigimod Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Anticipated 2021 Zai Milestones Discuss with the NMPA the potential accelerated regulatory pathway for efgartigimod in generalized myasthenia gravis (gMG).Continue to explore and advance additional indications in coordination with argenx. Anticipated 2021 Partner Milestones Potential FDA approval and global commercial launch of efgartigimod for the treatment of patients with gMG.Continue enrollment of the registrational ADHERE trial in chronic inflammatory demyelinating polyneuropathy (CIDP).Initiate clinical trials in fifth and sixth indications. Infectious Disease NUZYRA® (Omadacycline) NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI. Anticipated 2021 Zai Milestone Potential NMPA approval and commercial launch of NUZYRA for the treatment of CABP and ABSSSI. Sulbactam-Durlobactam (SUL-DUR) Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains. Anticipated 2021 Zai Milestone Complete enrollment of patients in Greater China in the global Phase 3 ATTACK trial. Internal Programs with Global Rights ZL-2309 (CDC7) ZL-2309 is an orally active, selective and ATP-competitive cell division cycle 7 (CDC7) kinase inhibitor. Anticipated 2021 Zai Milestone Initiate a biomarker-driven POC study in selected tumors. ZL-1201 (CD47) ZL-1201 is a humanized, IgG4 monoclonal antibody, engineered to reduce effector function, that specifically targets CD47. Its therapeutic potential will be assessed in both solid tumors and hematological malignancies, in both monotherapy and combination opportunities. In June 2020, first-in-human dosing was achieved in the Phase 1 study. ZL-1102 (IL-17) ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP). In July 2020, first-in-human dosing was achieved in the Phase 1 study. Business Development Second-half 2020 and Early 2021 Accomplishments In January 2021, we expanded the collaboration with Turning Point Therapeutics with an exclusive license agreement for the development and commercialization of TPX-0022 in Greater China.In January 2021, we announced an exclusive license agreement with argenx for the development and commercialization of efgartigimod in Greater China.In December 2020, we announced an exclusive license agreement for the development, manufacturing and commercialization of CLN-081 in Greater China.In July 2020, we announced an exclusive license agreement with Turning Point Therapeutics for the development and commercialization of repotrectinib in Greater China. Anticipated 2021 Zai Milestone Continue to pursue bolt-on and transformational business development opportunities. Corporate Updates Zai Lab continues to build its presence and capabilities in the United States in discovery, clinical development, business development and legal teams. The research center in the San Francisco Bay Area and the Cambridge office have been expanded. Zai Lab continues to enhance R&D and other operational capabilities with a new campus under development in Suzhou, China.Zai Lab continues to expand and hire talented professionals. As of January 31, 2021, Zai Lab employed 1,194 full-time employees, including 450 and 592 employees engaged in R&D and commercial activities, respectively. Zai Lab appointed several executives with extensive global experience, including Alan Sandler, M.D., as President and Head of Global Development, Oncology; Ty Edmondson as Chief Legal Officer; and Ann Beasley as Chief Compliance Officer. In September 2020, Zai Lab achieved a secondary listing on the Main Board of the Stock Exchange of Hong Kong, with total proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately HK$6.83 billion ($881 million). Zai Lab has been added to the Hang Seng Composite MidCap Index as of December 7, 2020. Full-Year 2020 Financial Results Revenues for the full year of 2020 were $49.0 million, compared to $13.0 million in 2019. Revenues for the period were comprised of $32.1 million in sales of ZEJULA, compared to $6.6 million in 2019; and $16.4 million in sales of Optune, compared to $6.4 million in 2019.R&D expenses were $222.7 million for 2020, compared to $142.2 million for 2019. The increase in R&D expenses was primarily attributable to the upfront and milestone payments for licensing agreements, ongoing and newly initiated late-stage clinical trials, payroll and payroll-related expenses from increased R&D headcount and expansion of research efforts to support internal development programs. Selling, General & Administrative expenses were $111.3 million for 2020, compared to $70.2 million for 2019. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and related costs as Zai Lab continued to expand its commercial operations in China.For the full year of 2020, Zai Lab reported a net loss of $268.9 million, or a loss per share attributable to common stockholders of $3.46, compared to a net loss of $195.1 million, or a loss per share attributable to common stockholders of $3.03, for the full year of 2019.As of December 31, 2020, cash and cash equivalents, short-term investments and restricted cash totaled $1,187.5 million compared to $276.4 million as of December 31, 2019. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast on March 1, 2021 at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration Link:http://apac.directeventreg.com/registration/event/3008148 Conference ID:3008148 All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, a Direct Event passcode and a unique access PIN, which can be used to join the conference call. A replay will be available shortly after the call and can be accessed by visiting the Company’s website at http://ir.zailaboratory.com. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding our ability to advance our product pipeline and further demonstrate our commercial and discovery capabilities, expected milestones for our approved products and product candidates and other statements containing words such as “anticipates,” “believes,” “expects,” “plan” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to obtain additional future funding, (2) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (4) Zai Lab’s ability to generate revenue from its product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release. Patients should refer to the Prescribing Information for ZEJULA, Optune, QINLOCK, MARGENZA, and NUZYRA for important safety information. For more information, please contact: ZAI LAB CONTACTS: Zai LabBilly Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006 ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike ZanoniEndurance Advisors, on behalf of Zai Lab610-442-8570mzanoni@enduranceadvisors.com Zai Lab Limited Zai Lab Limited Audited consolidated balance sheet statements (In thousands of U.S. dollars ("$") except for number of shares and per share data) As of December 31, 2019 2020 $ $ Assets Current assets: Cash and cash equivalents 75,932 442,116 Short-term investments 200,000 744,676 Accounts receivable (net of allowance of nil and $1 as of December 31, 2019 and 2020, respectively) 3,791 5,165 Inventories 6,005 13,144 Prepayments and other current assets 6,736 10,935 Total current assets 292,464 1,216,036 Restricted cash, non-current 510 743 Investments in equity investees 2,398 1,279 Prepayments for equipment 440 274 Property and equipment, net 21,353 29,162 Operating lease right-of-use assets 15,071 17,701 Land use rights, net 7,655 7,908 Intangible assets, net 1,148 1,532 Long term deposits 377 862 Value added tax recoverable 13,737 22,141 Total assets 355,153 1,297,638 Liabilities and shareholders' equity Current liabilities: Short-term borrowings 6,450 — Accounts payable 22,660 62,641 Current operating lease liabilities 4,351 5,206 Other current liabilities 13,174 30,196 Total current liabilities 46,635 98,043 Deferred income 2,881 16,858 Non-current operating lease liabilities 10,977 13,392 Total liabilities 60,493 128,293 Shareholders' equity Ordinary shares (par value of $0.00006 per share; 500,000,000 shares authorized, 68,237,247 and 87,811,026 shares issued and outstanding as of December 31, 2019 and 2020, respectively) 4 5 Additional paid-in capital 734,734 1,897,467 Accumulated deficit (444,698) (713,603) Accumulated other comprehensive income (loss) 4,620 (14,524) Total shareholders' equity 294,660 1,169,345 Total liabilities and shareholders' equity 355,153 1,297,638 Zai Lab Limited Audited consolidated statements of operations (In thousands of U.S. dollars ("$") except for number of shares and per share data) Year ended December 31, 2018 2019 2020 $ $ $ Revenue 129 12,985 48,958 Expenses: Cost of sales (43) (3,749) (16,736) Research and development (120,278) (142,221) (222,711) Selling, general and administrative (21,576) (70,211) (111,312) Loss from operations (141,768) (203,196) (301,801) Interest income 3,261 8,232 5,120 Interest expense (40) (293) (181) Other income, net 59 938 29,076 Loss before income tax and share of loss from equity method investment (138,488) (194,319) (267,786) Income tax expense — — — Share of loss from equity method investment (587) (752) (1,119) Net loss (139,075) (195,071) (268,905) Net loss attributable to ordinary shareholders (139,075) (195,071) (268,905) Loss per share - basic and diluted (2.64) (3.03) (3.46) Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 52,609,810 64,369,490 77,667,743 Zai Lab Limited Audited consolidated statements of comprehensive loss (In thousands of U.S. dollars ("$") except for number of shares and per share data) Year ended December 31, 2018 2019 2020 $ $ $ Net loss (139,075) (195,071) (268,905) Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments 2,212 1,958 (19,144) Comprehensive loss (136,863) (193,113) (288,049)

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  • 15 Fastest Growing Biotech Companies in the US

    In this article we talk about 15 fastest growing biotech companies in the US. You can skip our detailed analysis of the biotech industry and go to 5 Fastest Growing Biotech Companies in the US. Biotechnology is one of the most consequential domains of the healthcare industry. Biotechnology uses biology and the functions of living […]

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  • Zai Lab to Announce Full-Year 2020 Financial Results on March 1, 2021

    Company to Host Conference Call and Webcast on March 1, 2021 at 8:00 a.m. ETSHANGHAI and SAN FRANCISCO, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that it will report financial results for the full year ended December 31, 2020, and provide a corporate update before the opening of the U.S. equity markets on March 1, 2021. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast on March 1, 2021 at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration Link:http://apac.directeventreg.com/registration/event/3008148 Conference ID:3008148 All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call. A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://ir.zailaboratory.com. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and drug candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. For more information, please contact: ZAI LAB CONTACTS: Zai LabBilly Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006 ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Pete Rahmer / Mike ZanoniEndurance Advisors, on behalf of Zai Lab415-515-9763 / 610-442-8570prahmer@enduranceadvisors.com / mzanoni@enduranceadvisors.com Zai Lab Limited Source: Zai Lab Limited

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  • Zai Lab Announces Upcoming Presentations in February Investor Conferences

    SHANGHAI and SAN FRANCISCO, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that senior management from Zai Lab will be presenting in the following upcoming virtual investor conferences in February. Details are as follows: Guggenheim Healthcare Talks 2021 Oncology DayFireside chat: Thursday, February 11, 2021 at 12:00 p.m. ET 2021 SVB Leerink Global Healthcare ConferencePresentation: Friday, February 26, 2021 at 8:00 a.m. ET A live webcast of the 2021 SVB Leerink Global Healthcare Conference presentation will be available under “Events & Presentations” in the “Investor Relations” section of Zai Lab’s website. An archived replay will be available for 90 days following the event. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and drug candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide. For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. For more information, please contact: ZAI LAB CONTACTS: Zai LabBilly Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf of Zai Lab212-213-0006 ext. 315 / 364rimai@burnsmc.com / rflamm@burnsmc.com Investors: Pete Rahmer / Mike ZanoniEndurance Advisors, on behalf of Zai Lab415-515-9763 / 610-442-8570prahmer@enduranceadvisors.com / mzanoni@enduranceadvisors.com Zai Lab Limited Source: Zai Lab Limited

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  • Turning Point and Zai Lab Broaden Collaboration

    Zai Lab Secures Exclusive Right to Develop and Commercialize TPX-0022, Turning Point’s MET/SRC/CSF1R Inhibitor, in Greater China Turning Point to Receive $25 Million Upfront, with Up to Approximately $336 Million in Potential Milestone Payments and RoyaltiesSAN DIEGO and SHANGHAI and SAN FRANCISCO, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced an expansion of their collaboration.Under the terms of the new agreement, Zai Lab will obtain exclusive rights to develop and commercialize TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Turning Point will receive a $25 million upfront payment, with up to approximately $336 million in potential development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-teen- to low-twenty-percent royalties based on annual net sales of TPX-0022 in Greater China. In addition, Turning Point will have the right of first negotiation to develop and commercialize an oncology drug candidate discovered by Zai Lab.This agreement builds on Zai Lab and Turning Point’s existing relationship under the exclusive licensing agreement announced by the companies in July 2020, under which Zai Lab gained the exclusive right to develop and commercialize Turning Point’s lead drug candidate, repotrectinib, in Greater China.“The higher incidence of MET-driven cancers – particularly in gastric and lung cancer – in Asian countries led us to initiate the development of TPX-0022 in Greater China following our encouraging initial data from the Phase 1 SHIELD-1 study,” said Athena Countouriotis, M.D., president and chief executive officer of Turning Point. “We have great confidence in Zai Lab as our partner to advance this important drug candidate in a key region of the world. Zai Lab also has a promising discovery pipeline and we are pleased to receive the right of first negotiation for a drug candidate from Zai’s discovery pipeline.”Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab, said, “Turning Point has assembled a formidable pipeline of next-generation oncology target therapies, and we are very pleased to broaden our global collaboration and strategic partnership. We believe TPX-0022 is a promising drug candidate that is also highly synergistic with our portfolio in gastric and lung cancer.”Jin Li, M.D., Professor, Chairman of Chinese Society of Clinical Oncology Foundation and Director of Department of Oncology, Tongji University Shanghai East Hospital said, “The initial safety and efficacy data for TPX-0022 are promising, and its novel mechanism to target MET, SRC and CSF1R encourages us to investigate its therapeutic potential further. We are particularly interested in the early but promising findings in patients with MET-driven gastric cancer and look forward to advancing the study of TPX-0022 in this area of high unmet need in China.”Initial data from the SHIELD-1 study reported in a late-breaker oral presentation at the EORTC-NCI-AACR symposium highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally tolerable safety profile.About TPX-0022 TPX-0022 is an orally bioavailable multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases. TPX-0022 has completed IND-enabling studies and cleared its IND. During the second half of 2019, Turning Point initiated the SHIELD-1 Phase 1 clinical trial of TPX-0022 for the treatment of advanced or metastatic solid tumors with abnormal MET/HGF or CSF1R/SCF1R signaling.MET is a receptor tyrosine kinase that binds with high affinity to hepatocyte growth factor (HGF). MET alterations, including point mutations, amplifications, fusions, exon 14 skipping, and the generation of HGF-MET autocrine loops have been reported in many cancers. MET amplification has been detected in up to 20 percent of non-small cell lung cancer patients with EGFR mutations who acquired resistance to Iressa (gefitinib), Tarceva (erlotinib) or Tagrisso (osimertinib) treatment. SRC is a kinase involved in the MET signaling pathway. Inhibition of SRC has the potential to reduce or abolish the upregulation of HGF. Targeting CSF1R leads to the modulation of tumor-associated macrophages (TAMs), a type of immune cell that suppresses the T-cell mediated anti-tumor immune response, which is a promising therapeutic strategy for TPX-0022 as a single agent or in combination with standard of care chemotherapy and immunotherapy in various solid tumors.About Turning Point Therapeutics Inc. Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study called TRIDENT-1 in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is in a Phase 1 study called SHIELD-1 in patients with advanced or metastatic solid tumors harboring genetic alterations in MET; RET-inhibitor TPX-0046, which is in a Phase 1/2 study of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and ALK-inhibitor TPX-0131, which is in IND-enabling studies. Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.For more information, visit www.tptherapeutics.com.About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and drug candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide.For additional information about the company, please visit www.zailaboratory.com or follow us on Linkedin at https://www.linkedin.com/company/zai-lab/mycompany/ and Twitter at www.twitter.com/ZaiLab_Global.Turning Point Therapeutics Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidates repotrectinib and TPX-0022, the results, conduct, progress and timing of Turning Point Therapeutics’ SHIELD-1 clinical study of TPX-0022, including the potential to advance the development of TPX-0022 in Greater China, the potential to further expand the relationship with Zai Lab and the potential to receive milestone and royalty payments from Zai Lab. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point’s business and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Zai Lab Forward Looking Statements This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for commercializing repotrectinib and TPX-0022 in Greater China. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to obtain additional future funding, (2) Zai Lab’s results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s drug candidates, (4) Zai Lab’s ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release.For more information, please contact:CONTACTS:Turning Point TherapeuticsJim Mazzola Senior Vice President, Communication and Investor Relations 858-342-8272 jim.mazzola@tptherapeutics.comZai Lab Billy Cho CFO +86 137 6151 2501 billy.cho@zailaboratory.com Media: Ryo Imai / Robert Flamm, Ph.D. Burns McClellan, on behalf of Zai Lab 212-213-0006 ext. 315 / 364 rimai@burnsmc.com / rflamm@burnsmc.com Investors: Mike Zanoni Endurance Advisors, on behalf of Zai Lab 610-442-8570 mzanoni@enduranceadvisors.com

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