Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022.
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
Guangzhou Fermion Technology Co. Ltd. has announced IND clearance by China’s National Medical Products Administration (NMPA) for FZ-008-145 to treat pain.
Innovent Biologics Inc. said its glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, met the primary endpoints and all key secondary endpoints in its first phase III trial in Chinese adults who were overweight or obese. The company plans to submit the first mazdutide NDA for weight management to China's NMPA shortly.
Jiangxi Jemincare Group Co. Ltd. has reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co. Ltd., recently received approvals for clinical trials of five of its drugs in the fields of cancer, kidney and infectious diseases.
China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022.
China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022.
CSPC Pharmaceutical Group Ltd.’s SYH-2053 injection has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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.
RSS
