CSPC's pertuzumab injection accepted for HER2-positive breast cancer market application

CSPC Innovation Pharmaceutical Co., Ltd. announced that its controlled subsidiary, CSPC Megastone Biopharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration (NMPA) for the marketing authorization application of its pertuzumab injection. The drug is classified as a therapeutic biological product (Class 3.3) and is intended for the treatment of HER2-positive breast cancer.

The pertuzumab injection is a recombinant humanized anti-HER2 monoclonal antibody, administered every three weeks. It functions by specifically binding to the extracellular dimerization domain II of HER2, blocking dimerization between HER2 and other HER family members. This mechanism inhibits cell cycle progression, induces apoptosis, and mediates antibody-dependent cell-mediated cytotoxicity. The application is supported by a Phase III equivalence clinical trial involving patients with early or locally advanced HER2-positive breast cancer. Results indicated that the product is equivalent to the original reference drug for neoadjuvant treatment, demonstrating comparable safety and tolerability.

The company highlighted that, in accordance with national regulations, the drug still requires NMPA review and approval before it can be listed and sold. Drug development involves high investment, significant risks, and long cycles, posing potential risks such as delays in approval, market launch, or lower-than-expected sales. The company commits to timely disclosure of future research and development progress and advises investors to be aware of the associated investment risks.