Jiangsu Hengrui Pharmaceuticals' New Drug Injection for Carirelizumab Monoclonal Antibody Combined with Apatinib Mesylate Tablets for a New Indication has been Accepted for Market Approval Application.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, the company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received a "Notice of Acceptance" issued by the National Medical Products Administration for the new indication application for the market approval of the innovative drug Carilizumab injection combined with Apatinib mesylate tablets. The application for this indication is based on a randomized, open-label, multicenter phase III clinical trial (SHR-1210-III-336 study) evaluating the effectiveness and safety of the combination of Carilizumab and Apatinib with TACE compared to TACE alone in patients with unresectable hepatocellular carcinoma. The study was led by Academician Fan Jia and Professor Qin Shukui from Zhongshan Hospital affiliated with Fudan University, with 34 centers nationwide participating and a total of 423 patients enrolled. The primary efficacy endpoint of the study was progression-free survival (PFS) evaluated by the blind independent imaging review committee (BIRC); secondary efficacy endpoints included overall survival (OS), PFS evaluated by researchers, BIRC and researchers assessed objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). Mid-term analysis results of the study showed that compared to TACE alone, the combination of Carilizumab with Apatinib and TACE group achieved a significant clinically meaningful improvement in BIRC-evaluated PFS, and there was an observed trend of OS benefit. This combination therapy is expected to become a new clinical treatment option for patients with unresectable hepatocellular carcinoma.