新诺威子公司帕妥珠单抗注射液上市申请获得受理

Core Viewpoint - The announcement indicates that the company's subsidiary, Giant Biopharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the marketing application of Pertuzumab injection, marking a significant step in the company's oncology product pipeline [1] Group 1: Product Details - Pertuzumab injection is a recombinant humanized anti-HER2 monoclonal antibody administered every three weeks [1] - The product 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 application is based on a Phase III equivalence clinical trial involving patients with early or locally advanced HER2-positive breast cancer, demonstrating that the product is equivalent to the reference drug for neoadjuvant treatment [1] Group 2: Clinical Trial Results - Clinical trial results indicate that the safety and tolerability of the product are good and similar to the reference drug [1]