SHANGHAI, China, March 21, 2025 — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (\u201cNMPA\u201d) has approved the supplemental new drug application (\u201csNDA\u201d) for the company\u2019s product, toripalimab, in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (\u201cHCC\u201d) patients.<\/p>\n\n\n\n
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 (\u201cOS\u201d) of only approximately 10 months and a five-year survival rate of approximately 12%.<\/p>\n\n\n\n
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\u2019s 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.<\/p>\n\n\n\n
In September 2024, the results of the HEPATORCH study made its debut at the 27th<\/sup> 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 (\u201cPFS,\u201d based on independent radiographic review) and OS, both achieved positive results.<\/p>\n\n\n\n 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 (\u201cORR\u201d) 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.<\/p>\n\n\n\n Academician Jia FAN from Zhongshan Hospital affiliated with Fudan University said, \u201cThe combination of immunotherapy and anti-angiogenic therapy has become the foundation of first-line treatment for advanced liver cancer. The HEPATORCH study has fully demonstrated the clinical efficacy of toripalimab in liver cancer patients in China, achieving an ORR of 25.3%, a median PFS of 5.8 months, and a median OS of 20.0 months. The \u2018TB\u2019 regimen combining toripalimab with bevacizumab will benefit many advanced liver cancer patients in China.\u201d<\/p>\n\n\n\n Dr. Jianjun ZOU, Junshi Biosciences\u2019 General Manager and CEO said, \u201cBuilding on the success of our previously approved 10 indications\u2014the \u2018Perfect 10,\u2019 toripalimab has reached another breakthrough achievement with the official approval of its 11th<\/sup> indication, and we are extremely elated! China has suffered the brunt of liver cancer, and Chinese patients have long faced the challenge of limited treatment options. Junshi Biosciences consistently prioritizes the clinical needs of liver cancer treatment around the world, advancing clinical research through combination strategies tailored to patients across the different stages of disease progression. Our goal is to provide more precise and diverse treatment options for liver cancer patients. Moving forward, we remain dedicated to liver cancer innovation and integrating even greater \u2018Chinese Wisdom\u2019 into the fight against this disease.\u201d<\/p>\n\n\n\n <\/p>\n\n\n\n About Toripalimab<\/strong><\/p>\n\n\n\n Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system\u2019s ability to attack and kill tumor cells.<\/p>\n\n\n\n More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.<\/p>\n\n\n\n In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI\u00ae). Currently, there are eleven approved indications for toripalimab in the Chinese mainland:<\/p>\n\n\n\n