Zai Lab Limited develops and commercializes therapies to treat oncology, autoimmune disorders, and infectious diseases primarily in Greater China. The company's commercial products include Zejula for the treatment of breast cancer and non-small cell lung cancer; Optune, a device that delivers tumor treating fields; and Qinlock to treat gastrointestinal stromal tumors. It also develops Odronextamab to treat follicular lymphoma, diffuse large B-cell lymphoma, and other lymphomas; Repotrectinib, a tyrosine kinase inhibitor (TKI) to target ROS1 and TRK A/B/C in TKI-naïve- or -pretreated cancer patients; Margetuximab for the treatment of breast and gastroesophageal cancers; and Bemarituzumab to treat gastric and gastroesophageal junction cancer. In addition, the company develops CLN-081 for the treatment of patients with EGFR exon 20 insertion NSCLC; TPX-0022, an orally bioavailable multi-targeted kinase inhibitor; Tebotelimab, a tetravalent IgG4 monoclonal antibody; Retifanlimab that inhibits interactions between PD-1 and its ligands; ZL-2309, an orally active, selective, and ATP-competitive cell division cycle 7 (CDC7) kinase inhibitor; ZL-1201, a humanized IgG4 monoclonal antibody; Efgartigimod to reduce disease-causing immunoglobulin G antibodies; ZL-1102, a human nanobody targeting interleukin-17; and Sulbactam/durlobactam for the treatment of serious infections caused by Acinetobacter. It has development, license, and collaboration agreements with GlaxoSmithKline; Paratek Bermuda, Ltd.; Five Prime Therapeutics, Inc.; Entasis Therapeutics Holdings, Inc.; Crescendo Biologics Ltd.; Novocure Limited; MacroGenics Inc.; Deciphera Pharmaceuticals, LLC; Incyte Corporation; Regeneron Ireland Designated Activity Company; Turning Point Therapeutics Inc; Cullinan Pearl Corp.; Takeda Pharmaceutical Company Limited; Schrödinger, Inc.; and argenx BV. The company was incorporated in 2013 and is headquartered in Shanghai, China.
IPO Year: 2017
Exchange: NASDAQ
Website: zailaboratory.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
12/14/2023 | $47.50 | Overweight | Morgan Stanley |
8/10/2023 | $70.00 | Overweight | Cantor Fitzgerald |
3/2/2022 | $194.00 → $102.00 | Outperform | SVB Leerink |
1/21/2022 | $64.00 | Outperform | Macquarie |
12/15/2021 | $189.00 → $136.00 | Overweight | JP Morgan |
11/11/2021 | $222.00 → $217.00 | Buy | Citigroup |
11/10/2021 | $200.00 → $194.00 | Outperform | SVB Leerink |
10/12/2021 | Market Perform | Bernstein |
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Poster session will highlight potential of ZL-1218 to modulate tumor microenvironment and regulate anticancer immune response in advanced solid tumors Trial update demonstrates the advancement of company's robust, internal global oncology pipeline Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that data from a Phase 1 study of ZL-1218, the company's anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain. The preliminary results from the ongoing dose-escalation clinical trial (NCT05859464) will highlight the potential of ZL-1218 to reduce regulatory T
Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that members of the Company's senior management team will participate in the following investor conferences in September 2024: Morgan Stanley 22nd Annual Global Healthcare Conference Location: New York, New York Cantor Fitzgerald Global Healthcare Conference Fireside Chat: Thursday, September 19, 2024, 8:00 a.m. ET in Track 2 Location: New York, New York About Zai Lab Zai Lab (NASDAQ:ZLAB, HKEX: 9688))) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical con
– Net product revenue of $100.1 million for the second quarter of 2024, representing 45% y-o-y growth; 47% y-o-y growth at constant exchange rate (CER) – VYVGART® (efgartigimod alfa injection) sales of $23.2 million for the second quarter of 2024; raising full-year VYVGART revenue guidance to exceed $80.0 million – Expansion of Zai Lab's global oncology pipeline with a next generation ROR1 antibody-drug conjugate (ADC) program – Three product approvals in China including XACDURO® for HABP/VABP, efgartigimod SC for gMG, and AUGTYRO™ for ROS1+ NSCLC; expect at least four regulatory submissions to the NMPA within next 12 months including KarXT for schizophrenia – Strong balance sheet w
First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study July 16, 2024 6:30am CET Amsterdam, the Netherlands— argenx SE ((Euronext &, NASDAQ:ARGX) and Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myastheni
First and only NMPA-approved subcutaneous (SC) injectable providing additional flexibility and optionality for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) and argenx ((Euronext &, NASDAQ:ARGX) today announced that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acet
Manuscript represents the first publication from China's gynecology oncology field to be published in Cell Publication highlights first-time learnings about the landscape of ovarian cancer microenvironment stratified by HRD and how a PARP inhibitor perturbs it Data suggest combination of niraparib and ZL-1218, an investigational CCR8 antibody, may decrease tumor burden, offering synergistic potential for improving efficacy in treatment of HRD tumors Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that data published in the journal Cell demonstrate that neoadjuvant monotherapy with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib results in a high response rate a
Company to Host Conference Call and Webcast on August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that it will report financial results for the second quarter of 2024 and recent corporate updates, after the closing of the U.S. equity markets on Tuesday, August 6, 2024. The Company will host a live conference call and webcast on Wednesday, August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT). Conference Call and Webcast Information 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: Registrati
Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) announced today that following a distinguished career, Harald Reinhart, M.D., President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases (NSAiID) of Zai Lab, will retire at the end of June, after which he will serve as a senior advisor for the Company. Rafael Amado, M.D., President, Head of Global Oncology Research and Development of Zai Lab, will expand his role and assume responsibility for all of the Company's Global R&D upon Dr. Reinhart's retirement. "Harald has devoted nearly 50 years to treating patients, first as a physician and later discovering and developing innovative therapies to bring to patients in
SHANGHAI, June 4, 2024 /PRNewswire/ -- The 2024 Forbes Midas List, a distinguished industry list of the world's best venture capital investors, has been unveiled. Nisa Leung, Managing Partner at Qiming Venture Partners, has become a Forbes Midas Lister for the sixth consecutive year, ranking 40th this year. The Forbes Midas List celebrates honorees' extraordinary investment insights and accomplishments. Nisa and her team have shown a strong commitment to identifying startups that enhance the healthcare system while addressing global unmet medical needs. Over the past decade, Nisa and her team have overseen over 220 healthcare companies, including Gan & Lee Pharmaceuticals (SHSE:603087), Sin
This is the first compound in Zai's portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai's global capabilities Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that the first patient has been dosed in a global Phase 2 clinical trial (NCT06380907) evaluating the efficacy and safety of the company's internally developed anti-IL-17 investigational therapy, ZL-1102, for the treatment of chronic plaque psoriasis (CPP). ZL-1102 is a novel human VH antibody fragment (Humabody®) targeting the IL-17 cytokine. Emph
– Net product revenue of $100.1 million for the second quarter of 2024, representing 45% y-o-y growth; 47% y-o-y growth at constant exchange rate (CER) – VYVGART® (efgartigimod alfa injection) sales of $23.2 million for the second quarter of 2024; raising full-year VYVGART revenue guidance to exceed $80.0 million – Expansion of Zai Lab's global oncology pipeline with a next generation ROR1 antibody-drug conjugate (ADC) program – Three product approvals in China including XACDURO® for HABP/VABP, efgartigimod SC for gMG, and AUGTYRO™ for ROS1+ NSCLC; expect at least four regulatory submissions to the NMPA within next 12 months including KarXT for schizophrenia – Strong balance sheet w
Company to Host Conference Call and Webcast on August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that it will report financial results for the second quarter of 2024 and recent corporate updates, after the closing of the U.S. equity markets on Tuesday, August 6, 2024. The Company will host a live conference call and webcast on Wednesday, August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT). Conference Call and Webcast Information 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: Registrati
Net product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate (CER) VYVGART® (efgartigimod alfa injection) sales of $13.2 million for the first quarter of 2024, driven by increased patient access; an estimated 2,700 new patients were treated with VYVGART in the first quarter of 2024 Regulatory reviews ongoing for sulbactam-durlobactam for ABC, efgartigimod SC for gMG, and repotrectinib for ROS1+ NSCLC; sBLA submitted for efgartigimod SC in CIDP Strong balance sheet with a cash position1 of $750.8 million as of March 31, 2024, compared to $806.5 million as of December 31, 2023 Company to host confere
- Company to Host Conference Call and Webcast on May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that it will report financial results for the first quarter of 2024 and recent corporate updates, after the closing of the U.S. equity markets on Wednesday, May 8, 2024. The Company will host a live conference call and webcast on Thursday, May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT). Conference Call and Webcast Information 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:
Total product revenue of $266.7 million for Full-Year 2023, representing 25% y-o-y growth; 31% y-o-y growth at constant exchange rate (CER) VYVGART® (efgartigimod alfa injection) was launched in September 2023 in China and we estimate that nearly 1,000 patients were treated through the fourth quarter before its listing on China's National Reimbursement Drug List (NRDL) We estimate that nearly 1,000 new patients were treated with VYVGART in January 2024 alone; expect VYVGART product sales to exceed $70.0 million in 2024 Regulatory reviews ongoing for sulbactam-durlobactam, efgartigimod SC and repotrectinib; up to four new regulatory submissions expected in 2024 Strong balanc
- Company to Host Conference Call and Webcast on February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT) Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that it will report financial results for the year ended December 31, 2023 and recent corporate updates, after the closing of the U.S. equity markets on Tuesday, February 27, 2024. The Company will host a live conference call and webcast on Wednesday, February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT). Conference Call and Webcast Information 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 follow
Total product revenue of $69.2 million for the third quarter of 2023, representing 22% y-o-y growth; 27% y-o-y growth at constant exchange rate (CER)VYVGART® (efgartigimod alfa injection) achieved $4.9 million sales since its commercial launch in September in ChinaStrong balance sheet with a cash position of $822.2 million as of September 30, 2023, compared to $876.4 million as of June 30, 2023Company to host conference call and webcast on November 8, 2023, at 8:00 a.m. ET SHANGHAI, China and CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced financial results for the third quarter of 2023, along with recent product highlights a
SHANGHAI, China and CAMBRIDGE, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that it will report financial results for the third quarter of 2023 and recent corporate updates, after the closing of the U.S. equity markets on November 7, 2023. The Company will host a live conference call and webcast on November 8, 2023, at 8:00 a.m. ET. Conference Call and Webcast Information 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: https://register.vevent.com/register/BI87a7a83f6a64412
Total product revenue of $68.9 million for the second quarter of 2023, representing 45% y-o-y growth; 53% y-o-y growth at constant exchange rateVYVGART® (efgartigimod alfa injection) approved in China as first-and-only neonatal Fc receptor (FcRn) blocker for generalized myasthenia gravis (gMG); preparations for launch underway; subcutaneous efgartigimod for gMG under Biologics License Application (BLA) reviewPrimary endpoint met in ADHERE trial of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)Strong balance sheet with a cash position of $876.4 million as of June 30, 2023, compared to $931.4 million as of Ma
SHANGHAI, China and CAMBRIDGE, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that it will report financial results for the second quarter of 2023 and recent corporate updates, after the closing of the U.S. equity markets on August 7, 2023. The Company will host a live conference call and webcast on August 8, 2023, at 8:00 a.m. ET. Conference Call and Webcast Information 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: https://register.vevent.com/register/BIb7d99f107c3347f29e1
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Morgan Stanley initiated coverage of Zai Lab with a rating of Overweight and set a new price target of $47.50
Cantor Fitzgerald initiated coverage of Zai Lab with a rating of Overweight and set a new price target of $70.00
SVB Leerink reiterated coverage of Zai Lab with a rating of Outperform and set a new price target of $102.00 from $194.00 previously
Macquarie initiated coverage of Zai Lab with a rating of Outperform and set a new price target of $64.00
JP Morgan reiterated coverage of Zai Lab with a rating of Overweight and set a new price target of $136.00 from $189.00 previously
Citigroup reiterated coverage of Zai Lab with a rating of Buy and set a new price target of $217.00 from $222.00 previously
SVB Leerink reiterated coverage of Zai Lab with a rating of Outperform and set a new price target of $194.00 from $200.00 previously
Bernstein initiated coverage of Zai Lab with a rating of Market Perform
SVB Leerink reiterated coverage of Zai Lab with a rating of Outperform and set a new price target of $202.00 from $192.00 previously
SVB Leerink reiterated coverage of Zai Lab with a rating of Outperform and set a new price target of $192.00 from $183.00 previously
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Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) announced today that following a distinguished career, Harald Reinhart, M.D., President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases (NSAiID) of Zai Lab, will retire at the end of June, after which he will serve as a senior advisor for the Company. Rafael Amado, M.D., President, Head of Global Oncology Research and Development of Zai Lab, will expand his role and assume responsibility for all of the Company's Global R&D upon Dr. Reinhart's retirement. "Harald has devoted nearly 50 years to treating patients, first as a physician and later discovering and developing innovative therapies to bring to patients in
SHANGHAI and CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced that Michel Vounatsos has been appointed to its Board of Directors, effective January 7, 2023. Mr. Vounatsos brings to the Board extensive global leadership and management experience in the biopharmaceutical industry, including more than 25 years of service at leading companies. His expertise includes significant commercial experience in China and worldwide in the areas of primary care and neuroscience. "We are delighted to welcome Michel Vounatsos to the Zai Lab Board of Directors," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "Michel has a wealt
SHANGHAI and CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced the appointment of Rafael G. Amado, M.D. as President, Head of Global Oncology Research and Development, effective December 30, 2022. Dr. Amado brings to Zai Lab deep expertise in the field of oncology and significant global biopharmaceutical R&D leadership. "We are pleased to welcome Rafael to our executive leadership team," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "Rafael's experience leading worldwide discovery and clinical development for a number of oncolog
SHANGHAI and CAMBRIDGE, Mass., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced the appointment of Dr. Peter Huang as its Chief Scientific Officer (CSO), effective immediately. Dr. Huang brings an extensive scientific background and strong leadership and research and development experience, including over 16 years working within the biopharmaceutical industry, to Zai Lab. "We are excited to welcome Peter to our global leadership team," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "Peter has a strong track record in leading internal discovery re
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., March 15, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced the appointment of Josh Smiley as its Chief Operating Officer (COO). Mr. Smiley brings over 26 years of experience working within the biopharmaceutical industry, including experience leading finance, corporate strategy, business development, venture capital and the Global Business Services operations at Eli Lilly and Co (Lilly). "We are very pleased to welcome Josh at this exciting time, when we have so many potential breakthrough therapies in our pipeline," said
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, announced today that it has appointed Richard Gaynor, M.D., to its Board of Directors. Dr. Gaynor will also serve as Chair of the Research and Development Committee. Dr. Gaynor is the President and Chief of Research and Development of BioNTech US. Prior to this, he was President, Research and Development, at Neon Therapeutics, beginning in 2016. Previously, Dr. Gaynor spent 15 years in senior roles at Lilly Oncology, including as Senior Vice President, Clinical Development and Medi
SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Oct. 18, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that it has appointed Scott Morrison to its Board of Directors. Mr. Morrison will also serve as a member of the Audit Committee. Mr. Morrison has served public and private companies in the life sciences industry since 1980. He was a Partner with Ernst & Young LLP (EY) from 1996 to 2015, serving as its U.S. Life Sciences Leader from 2002 to 2015. During his tenure at EY, he worked on hundreds of public and private financings, M&A transactions, and corporate collaborati
First and only NMPA-approved subcutaneous (SC) injectable providing additional flexibility and optionality for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study
Manuscript represents the first publication from China's gynecology oncology field to be published in CellPublication highlights first-time learnings about the landscape of ovarian cancer microenvironment stratified by HRD and how a PARP inhibitor perturbs itData suggest combination of niraparib and ZL-1218, an investigational CCR8 antibody, may decrease tumor burden, offering synergistic potential for improving efficacy in treatment of HRD tumorsZai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))))) today announced that data published in the journal Celldemonstrate that neoadjuvant monotherapy with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib results in a high response rate and reshap
JP Morgan analyst Anupam Rama maintains Zai Lab (NASDAQ:ZLAB) with a Overweight and lowers the price target from $43 to $38.
Cantor Fitzgerald analyst Louise Chen reiterates Zai Lab (NASDAQ:ZLAB) with a Overweight.
Cantor Fitzgerald analyst Louise Chen reiterates Zai Lab (NASDAQ:ZLAB) with a Overweight.
Shares of Core & Main Inc (NYSE:CNM) fell sharply during Tuesday's session after the company reported mixed first-quarter financial results. Core & Main posted quarterly earnings of 49 cents per share, missing market expectations of 52 cents per share. The company's quarterly sales came in at $1.74 billion versus estimates of $1.72 billion, according to data from Benzinga Pro. Core & Main shares dipped 11.4% to $49.77 on Tuesday. Here are some other stocks moving in today’s mid-day session. Gainers MicroAlgo Inc (NASDAQ:MLGO) shares jumped 284% to 5.99 after the company announced that it will jointly establish a micro-consciousness quantum research center with WiMi. Sobr S
U.S. stocks were mixed, with the Dow Jones index gaining around 20 points on Tuesday. Shares of Saia Inc (NASDAQ:SAIA) rose sharply during today's pre-market trading session after the company reported an 18% increase in LTL shipments per workday in April. Saia shares jumped 12.3% to $452.00 on Tuesday. Here are some other big stocks recording gains in today’s session. Annexon, Inc. (NASDAQ:ANNX) surged 40% to $6.44 after the company’s Phase 3 trial of ANX005 met its primary endpoint. Core Scientific Inc (NASDAQ:CORZ) shares climbed 29% to $6.28. Core Scientific announced the signing of a series of 12-year contracts with CoreWeave, the AI Hyperscaler. Terawulf Inc (NASDAQ:W
This is the first compound in Zai's portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai's global capabilities Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response
Drug-resistant Acinetobacter baumannii is a growing global health threat and high priority pathogen needing new antibiotics, according to World Health Organization China NMPA approval based on comprehensive clinical data demonstrating robust activity of SUL-DUR against carbapenem-resistant bacterial strains In China, it is estimated there are approximately 300,000 cases of Acinetobacter infections and approximately 74% of them are carbapenem-resistant
The approval is based on the pivotal TRIDENT-1 trial, in which AUGTYRO achieved a high response rate and durable responses, including robust intracranial responses