Tag: NMPA
GSK seeks to extend shingles vaccine Shingrix to younger at-risk adults in China
GSK plc (LSE/NYSE: GSK) has reached a pivotal milestone in the prevention of shingles (herpes zoster) in China, with the Center for Drug Evaluation (CDE) ... Read More
Avistone Biotechnology receives NMPA approval for Vebreltinib in China
Avistone Biotechnology Co. Ltd., a precision oncology therapeutics company, has announced the conditional approval from the National Medical Products Administration (NMPA) of China for commercializing ... Read More
China’s NMPA expands AstraZeneca’s Forxiga use as heart failure treatment
China's National Medical Products Administration (NMPA) has approved AstraZeneca's Forxiga (dapagliflozin) for diminishing the risk of cardiovascular fatalities and hospitalizations in adults diagnosed with symptomatic ... Read More
AceLink Therapeutics kickstarts Phase 2 Fabry disease clinical trials in China
In a pivotal move, AceLink Therapeutics, Inc., a frontrunner in the biopharmaceutical sector, has inaugurated its first clinical trial site in China. The Phase 2, ... Read More
AstraZeneca, Daiichi Sankyo’s Enhertu approved for breast cancer in China
The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in ... Read More
Gufic Biosciences secures NMPA approval to market Prilocaine (API) in China
Gufic Biosciences has received approval from the National Medical Products Administration (NMPA) in China for its product, Prilocaine (API), an amide-type local anesthetic. The approval ... Read More
Amgen gets breakthrough therapy status for sotorasib in China
Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National ... Read More
Chinese regulator accepts NDA of BeiGene’s pamiparib in ovarian cancer
BeiGene said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of ... Read More
Genetron Health’s semiconductor-based NGS system gets Chinese approval
Genetron Health has been granted approval by China’s National Medical Products Administration (NMPA) for GENETRON S5, its semiconductor-based next-generation sequencing system (NGS system). With the ... Read More