Zhitong Finance App News, Hengrui Pharmaceutical (01276) announced that recently, the company's subsidiary Suzhou Shengdia Biomedical Co., Ltd. received the “Notice of Acceptance” issued by the State Drug Administration. The company's application for marketing licensing of Ruikang trastuzumab for injectable drugs was accepted and included in the priority review process.
The company's injectable recontrastuzumab has been approved for three domestic indications, namely: to treat adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activation mutations and who have previously received at least one systematic treatment; for locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs; and for HER2-positive adult breast cancer patients who have failed treatment with oxaliplatin, fluorouracil, and irinotecan.
This new indication is based on a multicenter, randomized, open, positive-controlled phase III clinical trial (SHR-A1811-307). The study aims to evaluate the efficacy and safety of Recon trastuzumab with or without pertuzumab compared with docetaxel combined with trastuzumab and pertuzumab (THP) regimens in patients with HER2-positive breast cancer who have not received systemic antineoplastic treatment during the relapse/metastasis phase. Professor Jiang Zefei of the Fifth Medical Center of the Chinese People's Liberation Army General Hospital and Professor Yin Yongmei of the Jiangsu Provincial People's Hospital co-acted as the main researchers, and 75 research centers across the country collaborated to conduct the study. The primary study endpoint was progression-free survival (PFS) based on the RECIST v1.1 assessment by the Blind Independent Center Review (BICR). The study results showed that compared to the control group, recontrastuzumab with or without pertuzumab can significantly prolong the PFS of HER2-positive breast cancer patients who have not received systemic antineoplastic treatment during the relapse/ metastasis phase and reduce the risk of disease progression or death.