Regulatory snapshots for biopharma and med tech in Asia-Pacific, including global submissions and approvals, and other regulatory decisions and designations: Akeso, Astrazeneca, Daiichi Sankyo, Everest Medicines, Kelun-Biotech, Neurophet.
Biopharma and med-tech happenings in Asia-Pacific, including deals and partnerships, and other news in brief: 48Hour Discovery, Advancell, Arctic Vision, Biodexa, Biomica, Eisai, Eli Lilly, Everest Medicines, Evogene, Golden Age Health, Henlius, Lishan, MDCO Technology, Micot, Newsoara, Otsuka, Phase Scientific, Tenacia, Vtv, Zonsen Peplib.
Amgen Inc. quit a development deal with Kyowa Kirin Co. Ltd., returning global rights for rocatinlimab, Kyowa Kirin’s T-cell rebalancing therapy being investigated for moderate to severe atopic dermatitis.
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
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-CEO-Elevar-1-30.webp?height=488&t=1769801176&width=650 "Kim Dong-gun (DG), CEO, Elevar")
