Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of SHR-A1811, an injection for treating locally advanced or metastatic HER2-positive breast cancer in adults who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [2]. Group 1 - The company has received regulatory acceptance for a new indication of SHR-A1811 [2]. - The new indication targets adult patients with locally advanced or metastatic HER2-positive breast cancer who have undergone prior anti-HER2 treatment [2]. - The application is part of a priority review process by the National Medical Products Administration [2].
恒瑞医药:关于药品上市许可申请获受理并纳入优先审评程序的提示性公告