Junshi Biosciences' Application for Toripalimab-Bevacizumab Combo in Advanced Hepatocellular Carcinoma Accepted

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), a prominent biopharmaceutical company, announced on July 17, 2024, that the National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) for toripalimab (TUOYI®, JS001) combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).

HCC, the main type of liver cancer, represents a significant global health challenge, making up about 90% of liver cancer cases. According to the 2022 GLOBOCAN Report, there were 866,000 new liver cancer cases and 759,000 deaths globally. Particularly in China, liver cancer accounted for 368,000 new cases and 317,000 deaths, representing 42.4% and 41.7% of the global totals, respectively. The insidious nature of HCC means that around 70%-80% of Chinese patients are diagnosed at an advanced stage, resulting in a poor prognosis with a median overall survival (OS) of roughly 10 months and a 5-year survival rate of about 12%. Recent advancements in combination therapies, especially those involving immunotherapy, are changing the treatment landscape for advanced liver cancer.

The sNDA submission is based on the HEPATORCH study (NCT04723004), a phase III clinical trial assessing the efficacy and safety of toripalimab combined with bevacizumab versus the standard treatment with sorafenib. Conducted across 57 centers in China, the study was led by Professor Jia FAN of Zhongshan Hospital affiliated with Fudan University. The primary endpoints of progression-free survival (PFS) and overall survival (OS) were met in June 2024, showing significant improvements over sorafenib. The combination therapy also improved secondary endpoints such as objective response rate and time to progression, with a safety profile consistent with known risks.

Professor Jia FAN highlighted the potential of the new combination therapy to offer significant survival benefits for advanced HCC patients, reaffirming the efficacy of combining immunosuppressants with anti-angiogenesis drugs. He expressed anticipation for regulatory approval to provide new treatment options for advanced HCC patients in China.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, celebrated the submission of the sNDA for toripalimab’s 11th indication. Since its marketing approval in 2018, toripalimab has addressed unmet needs for cancer patients in China and internationally. It has been approved for 10 indications across seven cancer types, many of which are exclusive. This sNDA marks its first liver cancer indication. Dr. ZOU emphasized the company's commitment to accelerating regulatory approval to benefit more patients.

Toripalimab, an anti-PD-1 monoclonal antibody, works by blocking PD-1 interactions with its ligands, PD-L1 and PD-L2, enhancing the immune system's ability to target tumor cells. Junshi Biosciences has conducted over forty clinical studies on toripalimab across various regions, including China, the United States, Southeast Asia, and Europe, covering a wide range of tumor types.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing. It currently has eight approved indications for various cancers. The first six indications have been included in the National Reimbursement Drug List (NRDL). In April 2024, the Department of Health in Hong Kong accepted the NDA for toripalimab combined with cisplatin and gemcitabine for treating metastatic or recurrent nasopharyngeal carcinoma (NPC), and as a single agent for recurrent, unresectable, or metastatic NPC.

In the United States, the FDA approved toripalimab for similar indications in October 2023. The FDA has also granted toripalimab multiple Breakthrough Therapy, Fast Track, and Orphan Drug designations for various cancers. In Europe, the EMA and MHRA have accepted marketing authorization applications for specific indications. The drug has also received regulatory traction in Australia and Singapore.

Founded in 2012, Junshi Biosciences is dedicated to innovative therapeutic development, with a diverse pipeline of over 50 drug candidates. The company prioritizes providing accessible and effective treatments, evidenced by its contributions during the COVID-19 pandemic. With operations in the US and China, Junshi Biosciences continues to expand its global footprint in the biopharmaceutical industry.