Core Viewpoint - The application for the marketing authorization of the drug "Patuzumab Injection" developed by the subsidiary of the company, Shijiazhuang Yiling Pharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration of China for the treatment of HER2-positive breast cancer [1] Group 1: Product Information - The product is a recombinant humanized anti-HER2 monoclonal antibody injection, administered once every three weeks [1] - It works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The product also mediates antibody-dependent cell-mediated cytotoxicity [1] Group 2: Clinical Trial and Efficacy - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that the product is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1] - The safety and tolerability of the product are good and comparable to the reference drug [1] Group 3: Development and Research Compliance - The development of the product follows the guidelines for biosimilar drug research, confirming its high similarity in quality, safety, and efficacy to the reference drug through a series of rigorous studies [1] - The studies include pharmaceutical, non-clinical, human pharmacokinetics, clinical efficacy, and safety assessments, ensuring there are no clinically meaningful differences [1]
石药集团(01093)：帕妥珠单抗注射液的上市申请获国家药品监督管理局受理