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Innovent Biologics Doses First Patient in Phase 3 Study of IBI302 for Neovascular AMD
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302). This recombinant fully human anti-VEGF and anti-complement bispecific fusion protein aims to address unmet needs in nAMD…
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NHSA Issues Guidelines to Strengthen Medical Insurance Payment Management
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The National Healthcare Security Administration (NHSA) has released a set of guiding opinions aimed at enhancing the management of medical insurance payment qualification for relevant personnel in designated medical institutions. The new policies are designed to implement supervision over medical service behavior and expenses covered by medical insurance, strengthen the…
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Sino Medical Sciences’ HT Supreme Stent System Included in French Reimbursement List
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading medical device company based in China, announced that its HT Supreme drug-eluting stent system has been included in the reimbursement drug list (RDL) in France, effective as of October 4, 2023. This inclusion marks a significant milestone for the company’s efforts…
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HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
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Innovent Biologics Withdraws Parsaclisib Filing in China, Halts Development
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Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release. Background on Parsaclisib and…
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Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
