Junshi Biosciences’ Toripalimab-Bevacizumab Combination Gains NMPA Approval For First-Line Advanced Liver Cancer Treatment

Shanghai Junshi Biosciences Co., Ltd. is a company focused on researching, developing and commercialising innovative cancer therapies; the company has announced that they have secured approval from China's National Medical Products Administration (NMPA).  The approval is considering the supplemental new drug application (sNDA) of toripalimab in combination with bevacizumab. This approval allows its use as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most dominant type of liver cancer. According to 2022 GLOBOCAN data, liver cancer remains a significant global health burden, with China alone accounting for 42.4% of new cases and 41.7% of deaths worldwide. Due to delayed diagnoses, the survival rate of HCC patients in China remains low, highlighting the urgent need for effective treatment options.

Academician Jia FAN from Zhongshan Hospital, affiliated with Fudan University, commented, “The 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 ‘TB’ regimen combining toripalimab with bevacizumab will benefit many advanced liver cancer patients in China.”

The approval is backed by findings from the HEPATORCH trial (NCT04723004), a Phase 3 study conducted across 57 clinical centres in China, Taiwan, and Singapore, enrolling 326 patients. The study was led by Professor Jia Fan of Zhongshan Hospital, Fudan University, and compared toripalimab plus bevacizumab with sorafenib, a widely used first-line therapy. Results showed significant improvements in progression-free survival (PFS) and overall survival (OS), with patients on the combination therapy experiencing a 31% lower risk of disease progression and a 24% reduction in death risk. Also, the new regimen's objective response rate (ORR) was 25.3%, significantly surpassing sorafenib’s 6.1%, highlighting its superior efficacy.

Dr Jianjun ZOU, Junshi Biosciences’ General Manager and CEO said, “Building on the success of our previously approved 10 indications—the ‘Perfect 10,’ toripalimab has reached another breakthrough achievement with the official approval of its 11th 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 prioritises the clinical needs of liver cancer treatment worldwide, advancing clinical research through combination strategies tailored to patients across the different stages of disease progression. We aim 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 ‘Chinese Wisdom’ into the fight against this disease.”

The combination therapy also demonstrated a favourable safety profile, with side effects in line with existing PD-1 inhibitors and VEGF-targeting treatments. No new safety issues were observed, supporting its clinical viability as an improved treatment option for advanced HCC. This approval represents a significant advancement in liver cancer therapy, providing an effective immunotherapy-based alternative for patients with limited options. Junshi Biosciences continues strengthening its position in oncology drug development by securing this regulatory milestone and advancing next-generation treatments for patients with difficult-to-treat cancers.