Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.

CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYH-2061 injection for the treatment of IgA nephropathy and other complement-mediated diseases.

Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.

Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.

Samsung Bioepis Co. Ltd. announced Oct. 21 the signing of a license deal to codevelop, manufacture and commercialize two of Phrontline Biopharma Suzhou Co. Ltd.’s novel bispecific dual-payload antibody-drug conjugate (ADC) candidates.

Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders. The payment comprises $30 million up front and some near-term milestones, plus an $8 million milestone for getting a phase I study underway. Leads Biolabs is in line to bring in another $962 million in milestones and royalties.

Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders. The payment comprises $30 million up front and some near-term milestones, plus an $8 million milestone for getting a phase I study underway. Leads Biolabs is in line to bring in another $962 million in milestones and royalties.

Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders.

China’s National Medical Products Administration (NMPA) recently met with a delegation from Singapore’s Health Sciences Authority (HSA) to discuss cooperation in the two agencies’ regulation of medical products, part of a series of efforts by NMPA to expand its use of regulatory reliance.

Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.