Drug Approval | February 21, 2025
GSK's Nucala application for COPD accepted for review in China
Around 100 million people live with COPD in China, accounting for almost 25% of all COPD cases globally
Around 100 million people live with COPD in China, accounting for almost 25% of all COPD cases globally
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
In 2020, CORXEL acquired the rights to develop and commercialize aficamten in Greater China
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Approval based on a separate phase III trial among Chinese patients reinforcing mepolizumab’s efficacy and safety data
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
Tislelizumab is now approved in nine indications in China
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