Xian Janssen Pharmaceutical Ltd. obtained marketing approval in China for Spravato (esketamine hydrochloride nasal spray) in combination with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Unlike existing antidepressants on the market, which can take weeks to take effect, the newly approved nasal spray shows effects right away. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer. Read More
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. Read More
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Arch, Axcella, Beigene, Cantex, Gritstone, Immutep, Junshi, Relief, Shionogi. Read More
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. Read More
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. Read More
