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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Zai Lab Q2 and Full-Year 2024 Report Shows Sales Growth and Loss Reduction
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) released its Q2 and full-year 2024 financial report. The company recorded USD 108.5 million in product net sales in Q4 and USD 397.6 million for the full year of 2024, marking a 65% and 50% year-on-year (YOY) increase at constant exchange…
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Zai Lab’s ZL-1310 Granted Orphan Drug Designation by FDA for SCLC
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its ZL-1310, a potential first-in-class DLL3-targeted antibody drug conjugate (ADC) for the treatment of small cell lung cancer (SCLC). This designation underscores the drug’s…
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Zai Lab’s KarXT NDA Accepted by NMPA for Schizophrenia Treatment
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that a New Drug Application (NDA) filing for its KarXT (xanomeline and trospium chloride) in adult schizophrenia has been accepted for review by the National Medical Products Administration (NMPA). This milestone underscores Zai Lab’s commitment to advancing innovative treatments…
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Zai Lab Secures Rights to Vertex’s Povetacicept in Key Asian Markets
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced an exclusive collaboration and license agreement with US-headquartered Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX). Through this agreement, Zai Lab has obtained the development and commercialization rights to Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region,…
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Zai Lab and MediLink Therapeutics Partner to Develop LRRC15 ADC Drug ZL-6201 for Solid Tumors
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On January 10, Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced a new strategic cooperation and global licensing agreement with MediLink Therapeutics. The partnership aims to utilize MediLink’s TMALIN® antibody-drug conjugate (ADC) platform to develop a novel LRRC15 ADC drug, ZL-6201, targeting solid tumors. The antibody for this product was…
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MediLink and Zai Lab Collaborate on LRRC15-Targeted ADC Drug ZL-6201
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Chinese biotechs MediLink Therapeutics (Suzhou) Co., Ltd and Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) have entered into a collaboration and license agreement. MediLink’s TMALIN antibody drug conjugate (ADC) platform will be utilized to develop ZL-6201, a novel LRRC15-targeted ADC drug discovered by Zai Lab, for the treatment of solid…
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argenx’s Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
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Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can…
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Zai Lab Ltd Partners with Pfizer for Commercialization of Xacduro in China
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China-based biotechnology company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced a strategic collaboration agreement with global pharmaceutical giant Pfizer (NYSE: PFE). The partnership grants Pfizer’s affiliated companies the exclusive rights to commercialize Xacduro (durlobactam, sulbactam) in mainland China. This collaboration, set to be in effect through November 2028,…
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Zai Lab Ltd Announces Secondary Public Offering Worth $230 Million
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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…
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Zai Lab Ltd Reports 46% YOY Revenue Growth in Q3 2024 Driven by Vygart, Zejula, and Nuzyra
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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…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
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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…
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Zai Lab Reports Positive Phase III Results for KarXT, Showcasing Efficacy in Psychiatric Conditions
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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…
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Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
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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…
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FDA Approves Cobenfy as Novel Schizophrenia Treatment with First-in-Decades Mechanism
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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…
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Zai Lab’s Q2 2024 Revenues Soar 47% YOY, Driven by Vyvgart and Zejula Sales
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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…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo (efgartigimod alfa SC) in gMG
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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…
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Zai Lab’s Partner Argenx Receives FDA Approval for CIDP Treatment Vygart Hytrulo
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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).…
