Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Affamed, Apellis, Biosyngen, BMS, Carsgen, CSL, Daiichi Sankyo, H. Lundbeck, Hanchorbio, Huidagene, Hutchmed, Innocare, Otsuka.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Acadia, Amgen, Astellas, Daewoong, Direct, Everest Medicines, Keyuan Xinhua, LG Chem, Neuren, Sandoz, Shanghai Pharma, Sygnature Discovery, Twist, Zydus.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Arch, Axcella, Beigene, Cantex, Gritstone, Immutep, Junshi, Relief, Shionogi.
China’s Hasten Biopharmaceutical Co. Ltd. will look for bolt-on acquisitions to deepen its pipeline following a funding round of $315 million that was co-led by Asia’s largest health care-dedicated investment firm, CBC Group of Singapore, and Abu Dhabi sovereign wealth fund, Mubadala Investment Co.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing to support phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases such as osteoarthritis, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
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