CSPC Pharmaceutical Group Pertuzumab Injection Marketing Application Accepted by NMPA

Reuters
Nov 12
CSPC Pharmaceutical Group Pertuzumab Injection Marketing Application Accepted by NMPA

CSPC Pharmaceutical Group Ltd. has announced that its marketing authorisation application for Pertuzumab Injection has been accepted by the National Medical Products Administration (NMPA) of China. Developed by its subsidiary CSPC Megalith Biopharmaceutical Co., Ltd., the biosimilar product is intended for the treatment of HER2-positive breast cancer. The application is primarily supported by results from a Phase III equivalence clinical trial, which demonstrated that the product is highly similar to the reference drug in terms of efficacy, safety, and tolerability. The application is currently under regulatory review. No grant or funding from multiple organizations was mentioned in the announcement.

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