CSPC pertuzumab injection application accepted by China’s NMPA

CSPC Pharmaceutical Group Limited announced that its marketing authorization application for Pertuzumab Injection has been accepted by China's National Medical Products Administration (NMPA). The product, developed by CSPC Megalith Biopharmaceutical Co., a subsidiary of CSPC, is a recombinant humanized anti-HER2 monoclonal antibody injection. It is designated as a Class 3.3 therapeutic biological product and is intended for the treatment of HER2-positive breast cancer.

The application is supported by a Phase III equivalence clinical trial that enrolled patients with early-stage or locally advanced HER2-positive breast cancer. Trial results indicated that the product, when used as a neoadjuvant treatment, demonstrated efficacy equivalent to the reference drug, along with a comparable safety and tolerability profile. The product works by binding to the HER2 receptor, blocking dimerization and inducing apoptosis.

Developed following biosimilar research guidelines, the Pertuzumab Injection has undergone comprehensive pharmaceutical, non-clinical, human pharmacokinetic, and clinical efficacy and safety studies. These studies affirm its high similarity to the reference drug in terms of quality, safety, and efficacy, with no clinically significant differences.