In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rovadicitinib, branded as Anxu, for first-line treatment of adults with intermediate- or high-risk primary myelofibrosis, as well as post polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
CF Pharmtech Inc. has announced approval from China’s National Medical Products Administration (NMPA) of an IND application filed by subsidiary Changfeng Suyue Pharmaceutical (Guangzhou) Co. Ltd. for ICF-004.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Changchun Genescience Pharmaceutical Co. Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to start clinical trials with Gensci-136 for injection, a dual APRIL/BAFF antagonist in development for the treatment of immunoglobulin A nephropathy.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.