CSPC PHARMA (01093) announced that the marketing application for Pertuzumab Injection, developed by its subsidiary CSPC JUSHI BIOPHARMACEUTICAL CO., LTD., has been accepted by China's National Medical Products Administration (NMPA). The product was submitted as a therapeutic biological product under Category 3.3, with its indication being HER2-positive breast cancer.

Pertuzumab Injection is a recombinant humanized anti-HER2 monoclonal antibody solution, administered once every three weeks. It works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization between HER2 and other HER family members, thereby inhibiting the cell cycle and inducing apoptosis. The product also mediates antibody-dependent cell-mediated cytotoxicity.

The application is primarily based on a Phase III equivalence clinical trial involving patients with early or locally advanced HER2-positive breast cancer. Clinical trial results demonstrated that the product, when used as neoadjuvant therapy, showed equivalence to the reference innovator drug. Additionally, the product exhibited favorable safety and tolerability profiles comparable to the reference drug.

The development of Pertuzumab Injection followed biosimilar research guidelines, with comprehensive studies in pharmaceutical properties, non-clinical data, human pharmacokinetics, clinical efficacy, and safety. These studies scientifically and rigorously confirmed its high similarity to the reference drug in quality, safety, and efficacy, with no clinically meaningful differences.