Jiangsu Hengrui Pharmaceuticals (01276) recently received acceptance of its application for market approval for the new indication of injection rituximab in combination with trastuzumab, and has been included in the priority review process.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., recently received a "Notice of Acceptance" issued by the National Medical Products Administration. The company's injection of Rucanjutanuzumab (SHR-A1811) for the new indication for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs has been accepted by the National Medical Products Administration for marketing approval and has been included in the priority review program. It is reported that the SHR-A1811--301 study is a randomized, open-label, positive drug-controlled, multicenter designed Phase III clinical trial, aimed at comparing the efficacy and safety of SHR-A1811 with pyrotinib combined with capecitabine in HER2-positive breast cancer patients who have previously been treated with one or more anti-HER2 drugs. This study is jointly conducted by Professor Song Erwei and Professor Yao Herui of Sun Yat-sen Memorial Hospital of Sun Yat-sen University, with 54 centers nationwide participating. The main endpoint is the progression-free survival (PFS) assessed by the blind independent imaging review committee (BIRC) based on RECIST v1.1. Secondary endpoints include PFS assessed by investigators based on RECIST v1.1, overall survival (OS), objective response rate (ORR), duration of response (DoR), etc. In July 2025, the Independent Data Monitoring Committee (IDMC) reviewed the data and confirmed that in the prespecified interim analysis, the primary study endpoint PFS assessed by BIRC reached the prespecified superior efficacy criteria. The results indicate that compared to the control group, Rucanjutanuzumab can significantly reduce the risk of disease progression/death in patients and has good safety. The injection of Rucanjutanuzumab was approved for marketing in China in May 2025 and is indicated for the treatment of unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with HER2 (ERBB2) activating mutations who have previously received at least one systemic treatment.