Thursday, July 18, 2024 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a prominent innovation-driven biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review the supplemental new drug application (sNDA) for toripalimab (trade name: TUOYI®, product code: JS001) in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). Liver cancer, particularly hepatocellular carcinoma (HCC), is a major malignant tumor affecting the digestive system worldwide, accounting for approximately 90% of cases.
The 2022 GLOBOCAN Report documented 866,000 new liver cancer cases and 759,000 deaths globally, with China bearing a significant burden of this disease. In 2022, China reported 368,000 new liver cancer cases, representing 42.4% of the global incidence, and 317,000 deaths, accounting for 41.
7% of global liver cancer fatalities. Liver cancer ranks fourth in new cases and second in deaths among domestic malignancies in China. Due to its asymptomatic nature, 70%-80% of liver cancer patients in China are diagnosed at intermediate or advanced stages, with a median overall survival (OS) of about 10 months and a 5-year survival rate of approximately 12%.
Recent advancements in combination therapies involving immunotherapy drugs have revolutionized the treatment landscape for advanced liver cancer, making radical cures more achievable. The sNDA submission is based on the HEPATORCH study (NCT04723004), a multicenter, randomized, open-label, active-controlled phase III clinical trial designed to assess the efficacy and safety of toripalimab combined with bevacizumab for the first-line treatment of unresectable or metastatic HCC, compared to the standard sorafenib treatment. Led by Principal Investigator Professor Jia FAN, President of Zhongshan Hospital affiliated with Fudan University and an academician of the Chinese Academy of Sciences, the HEPATORCH study was conducted across 57 centers in China.
In June 2024, the HEPATORCH study’s primary endpoints of progression-free survival (PFS, based on independent radiological review) and overall survival (OS) met the pre-defined efficacy criteria. The study demonstrated that toripalimab in combination with bevacizumab significantly improved PFS and OS in patients with advanced HCC compared to sorafenib, while also enhancing secondary endpoints such as objective response rate and time to progression. The safety profile of toripalimab was consistent with known risks, with no new safety concerns identified.
Detailed results will be presented at an upcoming international academic conference..
