HENGRUI PHARMA (01276) announced that recently, the company and its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. received the "Acceptance Notice" from the National Medical Products Administration (NMPA) for the marketing authorization application of a new indication for their innovative drug, Camrelizumab for Injection, in combination with Apatinib Mesylate Tablets. This application for the new indication is based on a randomized, controlled, open-label, multicenter Phase III clinical trial (Study SHR-1210-III-336) evaluating the efficacy and safety of Camrelizumab and Apatinib combined with TACE versus TACE alone in patients with unresectable hepatocellular carcinoma (HCC). The study was led by principal investigators Academician Jia Fan from Zhongshan Hospital, Fudan University, and Professor Shu-kui Qin, with participation from 34 centers nationwide, enrolling a total of 423 patients. The primary efficacy endpoint was Progression-Free Survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC); secondary efficacy endpoints included Overall Survival (OS), PFS assessed by investigators, Objective Response Rate (ORR), Disease Control Rate (DCR), and Duration of Response (DoR) as assessed by both BIRC and investigators. Interim analysis results from the study indicated that, compared to TACE treatment alone, the Camrelizumab plus Apatinib and TACE group demonstrated a statistically significant and clinically meaningful improvement in BIRC-assessed PFS, and a trend towards OS benefit has already been observed. This combination therapy is expected to become a new clinical treatment option for patients with unresectable hepatocellular carcinoma.