New Norway: The application for the marketing authorization of the injection of patuzumab monoclonal antibody has been accepted.
In the latest announcement by Sinopharm, its holding subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. has received the "Acceptance Letter" issued by the National Medical Products Administration for the approval of the listing application of Pertuzumab injection. Pertuzumab injection is a recombinant humanized anti-HER2 monoclonal antibody injection, which needs to be used every 3 weeks by patients. This product blocks the dimerization of HER2 with ligands between HER2 and other HER family members by specifically binding to the extracellular dimerization domain II of HER2, thereby blocking the cell cycle and inducing apoptosis. The product can also mediate antibody-dependent cell-mediated cytotoxicity. This application is mainly based on a Phase III clinical trial, with patients enrolled being early or locally advanced HER2-positive breast cancer patients. The clinical trial results show that this product is equivalent to the reference drug in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer. At the same time, the safety and tolerability of the product are good and similar to the reference drug.
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