Zhi Tong Cai Jing·2026-01-29 09:28Core Viewpoint - Heng Rui Medicine (01276) has received a notice from the National Medical Products Administration regarding the acceptance of its application for the marketing license of the innovative drug injection of Camrelizumab combined with Apatinib for a new indication [1] Group 1: Clinical Trial Details - The application for the new indication is based on a randomized, controlled, open-label, multicenter Phase III clinical trial (SHR-1210-III-336 study) evaluating the efficacy and safety of Camrelizumab and Apatinib combined with TACE compared to TACE alone in patients with unresectable hepatocellular carcinoma [1] - The study was led by Academician Fan Jia and Professor Qin Shukui from Zhongshan Hospital, Fudan University, with participation from 34 centers nationwide, enrolling a total of 423 patients [1] Group 2: Study Outcomes - The primary efficacy endpoint was progression-free survival (PFS) assessed by a blinded independent radiological review committee (BIRC); secondary endpoints included overall survival (OS), investigator-assessed PFS, BIRC and investigator-assessed objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) [1] - Interim analysis results indicated that the PFS assessed by BIRC showed a significant clinical improvement in the Camrelizumab combined with Apatinib and TACE group compared to the TACE alone treatment, with a trend observed for OS benefit [1] - This combination therapy is expected to become a new clinical treatment option for patients with unresectable hepatocellular carcinoma [1]