安科生物(300009.SZ):注射用曲妥珠单抗新增规格的补充申请获批
Core Viewpoint - Anke Biopharma has received approval from the National Medical Products Administration for a supplemental application for its injection of Trastuzumab (brand name: Ansaiting), adding a new specification of 60mg/bottle [1] Company Summary - Anke Biopharma's Ansaiting is a monoclonal biosimilar drug developed independently according to the "Guidelines for the Research and Evaluation of Biosimilars" [1] - The drug is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer [1]