In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor. Read More
Connect Biopharma Holdings Ltd. has been seeking a partner for its atopic dermatitis candidate rademikibart, and it appears to have found the perfect partner in Simcere Pharmaceutical Group, which gains exclusive rights to develop, manufacture and commercialize rademikibart in China in a deal worth $120 million plus royalties. Read More
Clinical trial updates for the period of January to October 2023 saw an increase of 4.6% compared to the same time period last year. Comparatively, clinical data from January to September 2023 was up 1.79% compared to the same period last year. Read More
Asep Medical Holdings Inc. is expanding operations into China with a joint venture (JV) with Chinese medical diagnostics firm Sansure Biotech Inc., ramping up the race to commercialize sepsis diagnostics in Asia. Read More
Some autoimmune diseases are different in women and men. A group of researchers from the Chinese Academy of Sciences (CAS) has found a strong female bias in the response of a neurotransmitter receptor that is involved in many neurological processes. Read More
Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics. Read More
The Korean Research Institute of Bioscience and Biotechnology has synthesized peptides reported to be useful for the treatment of inflammatory disorders. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Chengdu, Innovent, Kazia, Micurx. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Connect Biopharma, GSK, Myricx Bio, Wuxi Biologics, Simcere Pharmaceutical, SK Bioscience, Sosei Group. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Biostar, Takeda, Sumitomo. Read More