Shanghai Junshi Biosciences Co., Ltd, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for the company’s product, toripalimab, in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (“HCC”) patients.

Globally, liver cancer is a common malignant tumor of the digestive system, and the main pathological type is HCC (accounting for about 90%). According to data released by the GLOBOCAN for 2022, the annual number of new cases and deaths of liver cancer worldwide was 866,000 and 759,000, respectively. China has a high incidence of liver cancer. In 2022, the number of new liver cancer cases reached 368,000 (accounting for 42.4% of global cases), ranking fourth among domestic malignant tumors, with 317,000 deaths (accounting for 41.7% of global cases), ranking second among domestic malignant tumors. Due to its insidious onset, about 70%-80% of liver cancer patients in China are already at the intermediate or advanced stage at first diagnosis, with a median overall survival (“OS”) of only approximately 10 months and a five-year survival rate of approximately 12%.

The supplemental NDA approval is based on data from the HEPATORCH study (NCT04723004), which is a multinational multi-center, randomized, open-label, active-controlled phase 3 clinical study. Professor Jia FAN, an academician of the Chinese Academy of Sciences, from Zhongshan Hospital affiliated to Fudan University, served as the principal investigator. HEPATORCH was launched in 57 clinical centers in the Chinese mainland, China’s Taiwan and Singapore, and a total of 326 patients were enrolled. The study aimed to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic HCC compared to the standard treatment with sorafenib.

In September 2024, the results of the HEPATORCH study made its debut at the 27^th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. The results of the study showed that the primary endpoints, progression-free survival (“PFS,” based on independent radiographic review) and OS, both achieved positive results.

HEPATORCH demonstrated that compared with sorafenib, toripalimab in combination with bevacizumab could significantly extend the PFS and OS of patients, with a median PFS of 5.8 months vs. 4.0 months, reduce the risk of disease progression or death by 31% (hazard ratio [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), with a median OS of 20.0 months vs. 14.5 months, and reduce the risk of death by 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). The objective response rate (“ORR”) of the toripalimab and bevacizumab group was significantly higher than that of the sorafenib group. The ORR of the two groups were 25.3% and 6.1%, respectively. Furthermore, the combination therapy has a good safety profile in patients with advanced HCC. The toxicity spectrum is consistent with the known toxicity spectrum of the standard monotherapy, and no new safety signal was identified.