The drug application for the injection of Rituximab monoclonal antibody by Jiangsu Hengrui Pharmaceuticals (01276) has been accepted and included in the priority review program.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. received a "Notice of Acceptance" issued by the National Medical Products Administration. The company's application for marketing approval of the injectable drug rituximab trastuzumab emtansine has been accepted for review and has been included in the priority review program. The injectable drug rituximab trastuzumab emtansine has already been approved for two indications in China, namely: for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have received at least one prior systemic therapy; and for the treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies. The application for this new indication is based on a randomized, open-label, positive drug-controlled, multicenter Phase III clinical trial. The study aims to evaluate the efficacy and safety of rituximab trastuzumab emtansine (developed under the code name SHR-A1811) compared to chemotherapy selected by researchers (paclitaxel, albumin-bound paclitaxel, eribulin, capecitabine, gemcitabine) in patients with HER2 low-expressing recurrent/metastatic breast cancer who have not received or have received first-line chemotherapy in the metastatic stage. The study is led by Academician Xu Binghe of the Cancer Hospital of the Chinese Academy of Medical Sciences, with 73 centers nationwide participating. The primary endpoint of the study is progression-free survival (PFS) in the population who have not received prior chemotherapy in the metastatic stage (i.e., those who have received 0 line chemotherapy) and PFS in the overall population (i.e., those who have received 1 line chemotherapy) evaluated by an Independent Review Committee (IRC) based on RECIST v1.1 criteria; key secondary endpoints include PFS in the population who have received first-line chemotherapy in the metastatic stage (i.e., those who have received 1 line chemotherapy), overall survival (OS) in the overall population, and OS in the population who have not received prior chemotherapy in the metastatic stage. The study results show that rituximab trastuzumab emtansine can significantly prolong PFS in patients with HER2 low-expressing advanced breast cancer who have not received or have received first-line chemotherapy in the metastatic stage compared to chemotherapy selected by researchers, reducing the risk of disease progression or death. The OS data is currently immature, but a trend towards survival benefit has been observed.