-
Zai Lab Ltd Announces Secondary Public Offering Worth $230 Million
•
Zai Lab Ltd (ZLAB; NASDAQ: ZLAB; HKG: 9688), a leading biopharmaceutical company, is set to raise capital through a secondary public offering of American Depositary Shares (ADSs) valued at USD 230 million. The offering consists of 7,843,137 ADSs, with each ADS representing ten ordinary shares of the company, priced at…
-
Zai Lab Ltd Reports 46% YOY Revenue Growth in Q3 2024 Driven by Vygart, Zejula, and Nuzyra
•
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has released its Q3 2024 financial report, showcasing robust growth and providing updates on recent product highlights and corporate developments. Revenue Growth and Product PerformanceDuring Q3, Zai Lab reported product net revenues of USD 101.8 million, a 46% year-on-year (YOY) increase…
-
Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
•
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be…
-
Zai Lab Reports Positive Phase III Results for KarXT, Showcasing Efficacy in Psychiatric Conditions
•
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced encouraging topline results from its Phase III multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) within China. In line with prior global studies, this registrational bridging trial successfully met its primary endpoint, showing a…
-
Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
•
Novocure (NASDAQ: NVCR), a Swiss firm renowned for its pioneering Tumor Treating Fields (TTFields) cancer therapy, has received marketing approval from the US Food and Drug Administration (FDA) for its Optune Lua device. This portable device is now cleared for use in combination with PD-1/PD-L1 inhibitors or docetaxel to treat…
-
FDA Approves Cobenfy as Novel Schizophrenia Treatment with First-in-Decades Mechanism
•
The U.S. Food and Drug Administration (FDA) has granted official approval to Cobenfy (KarXT, xanomeline and trospium chloride) as an oral treatment for schizophrenia, marking it as the first therapy with a novel mechanism of action in this indication in several decades within the U.S. KarXT, an oral M1/M4 type…
-
Zai Lab’s Q2 2024 Revenues Soar 47% YOY, Driven by Vyvgart and Zejula Sales
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a leading biopharmaceutical company based in China, has released its financial report for the second quarter of 2024, highlighting recent product milestones and corporate developments. The company reported net revenues of USD 100.1 million for Q2’24, marking a 47% increase year-on-year (YOY) at…
-
Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo (efgartigimod alfa SC) in gMG
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced that China’s National Medical Products Administration (NMPA) has granted Biologic License Application (BLA) approval for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). Vygart Hytrulo is indicated for use in combination with conventional therapy…
-
Zai Lab’s Partner Argenx Receives FDA Approval for CIDP Treatment Vygart Hytrulo
•
Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).…
-
Zai Lab’s Global R&D Leadership Transition: Dr. Harald Reinhart to Retire, Dr. Rafael Amado Expands Role
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a leading biopharmaceutical company based in China, has announced the upcoming retirement of Harald Reinhart, M.D., who serves as the President and Head of Global Development for Neuroscience, Autoimmune, and Infectious Diseases (NSAiID). Dr. Reinhart’s tenure will conclude on June 30th, 2024. In…
-
Zai Lab and Innoviva Win China Approval for SUL-DUR to Treat Hospital-Acquired Pneumonia
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP)…
-
Zai Lab Advances Vygart Hytrulo for CIDP with sBLA Filing in China
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced the filing of a supplemental Biologics License Application (sBLA) in China for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). The sBLA seeks to expand Vygart’s indication to include the treatment of chronic inflammatory demyelinating polyneuropathy…
-
Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
-
Zai Lab’s Q1 2024 Revenue Rises 43% YOY on Strong Product Launch and NRDL Inclusion
•
Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) has announced its financial results for the first quarter of 2024, with product revenues increasing to USD 87.1 million from USD 62.8 million in the same period of 2023, reflecting a 43% year-on-year (YOY) growth in constant exchange rate terms. The company’s research…
-
Zai Lab Ltd Appoints New Greater China CCO as Liang Yi Exits
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the appointment of Zhu Tong as the new Greater China Chief Commercial Officer (CCO), succeeding Liang Yi, who is departing from his role as both CCO and President of Greater China. Liang’s departure will become official on April 30. Zhu Tong’s…
-
Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
•
Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products…
-
Zai Lab and Novocure Report Positive Phase III Results for TTFields in NSCLC Brain Metastases
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, and Novocure (Nasdaq: NVCR), a UK-based oncology innovator, have announced positive results from the Phase III METIS trial. The trial evaluated the efficacy of the Tumor Treating Fields (TTFields) therapeutic device in combination with supportive care for…
-
Zai Lab Ltd Reports 31% YOY Growth in Product Revenues and Strategic Pipeline Expansion
•
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has released its financial results for 2023, along with updates on product highlights and corporate developments. The company reported total product revenues of USD 266.7 million for the year, marking a 31% year-on-year growth at constant exchange rates. This…
-
BMS to Acquire Karuna Therapeutics for $14 Billion, Expanding Psychosis Treatment Portfolio
•
Bristol Myers Squibb (BMS; NYSE: BMY), a leading US pharmaceutical company, has announced its intention to acquire Karuna Therapeutics, Inc. (NASDAQ: KRTX) for a total consideration of USD 14 billion. This acquisition will bolster BMS’s product pipeline with the inclusion of the antipsychotic drug KarXT (xanomeline-trospium), which is currently awaiting…
-
BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
-
China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
•
The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
-
CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
•
The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy VSA001, Sperogenix Therapeutics’ vamorolone, and Zai Lab’s (HKG: 9688) efgartigimod are on track for breakthrough therapy designation (BTD) status awards in China. VSA001 for Familial Chylomicronemia Syndrome (FCS)VSA001 is designed to reduce triglyceride levels in…
-
Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
•
Zai Lab Ltd (Nasdaq: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
