Tag: NMPA

GSK seeks to extend shingles vaccine Shingrix to younger at-risk adults in China

businessnewstoday- February 7, 2024

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

businessnewstoday- November 19, 2023

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

businessnewstoday- August 20, 2023

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

businessnewstoday- August 12, 2023

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

businessnewstoday- July 15, 2023

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

businessnewstoday- June 16, 2023

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

pharmanewsdaily- January 31, 2021

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

pharmanewsdaily- July 19, 2020

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

pharmanewsdaily- December 30, 2019

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