Turning Point Therapeutics Inc. has picked up near-global rights to develop and commercialize an antibody drug conjugate (ADC) targeting Claudin18.2 from Lanova Medicines Ltd. for $25 million up front. The deal excludes greater China and South Korea. Read More
Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs. Read More
China’s Jiangsu Hengrui Pharmaceuticals Co. Ltd. is launching a new biotech company called Luzsana Biotechnology that will develop and commercialize Hengrui assets in the U.S., Europe and Japan. A wholly owned subsidiary of Hengrui, Luzsana, which means “healing light,” will develop innovative products from Hengrui’s pipeline. Read More
Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors. Read More
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure. Many Athersys investors appeared to read the results as bad news for Athersys' ongoing pivotal phase III stroke study, Masters-2. Read More
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress. The WHO’s director general, Tedros Adhanom Ghebreyesus, emphatically agreed on May 18, saying he was taken aback by data showing COVID-19 cases rose in four out of the six WHO regions just in the past week. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Anji, Athersys, Belief Biomed, China Oncology Focus, Cstone, Healios, Imugene, Prota, Recce, Regencell, Sorrento, Synairgen, Urovant Sciences. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Akari, Almac Discovery, Anticancer, Aptamer, Aslan, Brim, Delsitech, Hitgen, Immunocore, Immunome, Kallyope, Kyowa Kirin, Luca Science, Medison, Model Medicines, Ora, Pinotbio, Quoin, Sosei, St. Jude Children’s Research Hospital, Tonix, Vaxart. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Biontech, Cansino, Incannex Healthcare, Inmagene, Junshi, Pfizer, Simcere, Valneva, Zenas. Read More
