Junshi Biosciences Gets Approval of sNDA for Toripalimab and Bevacizumab Combination Therapy

Junshi Biosciences Gets Approval of sNDA for Toripalimab and Bevacizumab Combination Therapy

By, Admin 19 July 2024

Junshi Biosciences Announces Approval of sNDA for Toripalimab and Bevacizumab Combination Therapy for Advanced Hepatocellular Carcinoma

Overview 

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a biopharmaceutical company committed to developing and commercializing innovative therapies, has announced that the National Medical Products Administration (NMPA) has accepted for review the supplemental new drug application (sNDA) for toripalimab (TUOYI®, JS001) in combination with bevacizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC).

Hepatocellular Carcinoma

  • HCC accounts for about 90% of liver cancer cases worldwide. According to the 2022 GLOBOCAN Report, there were 866,000 new cases and 759,000 deaths from liver cancer globally. 
  • China had 368,000 new liver cancer cases (42.4% of global cases) and 317,000 deaths (41.7% of global cases), ranking fourth in new cases and second in deaths among domestic malignant tumors. 
  • Due to its subtle onset, about 70%-80% of liver cancer patients in China are diagnosed at an intermediate or advanced stage, with a median overall survival (OS) of about 10 months and a 5-year survival rate of approximately 12%. 
  • Recently, combination therapies based on immunotherapy have improved the treatment landscape for advanced liver cancer, increasing the possibility of a radical cure after downstaging.

Study Behind sNDA 

  • The sNDA is based on the HEPATORCH study (NCT04723004), a phase III clinical trial evaluating the efficacy and safety of toripalimab with bevacizumab versus sorafenib for first-line treatment of unresectable or metastatic HCC. 
  • Conducted across 57 centers in China, the HEPATORCH study was led by Professor Jia FAN, President of Zhongshan Hospital affiliated with Fudan University and an academician of the Chinese Academy of Sciences.

HEPATORCH Study Results

  • In June 2024, the HEPATORCH study met its primary endpoints of progression-free survival (PFS) and overall survival (OS). 
  • Results showed that toripalimab combined with bevacizumab significantly improved PFS and OS compared to sorafenib, along with 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 signals identified. Detailed results will be presented at a future international conference.

Professor Jia FAN emphasized the significant survival benefits shown by the HEPATORCH study for first-line treatment of advanced HCC with toripalimab and bevacizumab, highlighting the potential for this combination therapy to offer new treatment options for advanced HCC patients in China.

Words from CEO: Junshi Biosciences

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, expressed excitement about the sNDA submission for toripalimab’s 11th indication, underscoring the antibody's broad-spectrum effectiveness in battling cancer. He pledged to expedite the approval process to benefit more advanced liver cancer patients.

About Toripalimab

  • Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2, enhancing the immune system's ability to attack tumor cells. 
  • Over forty company-sponsored clinical studies have been conducted globally, covering more than fifteen indications.

In Hong Kong, the Department of Health accepted the NDA for toripalimab combined with cisplatin and gemcitabine for first-line NPC treatment and as a monotherapy for recurrent, unresectable, or metastatic NPC in April 2024.

FDA Approval for Toripalimab & Combo

In the United States, the FDA approved toripalimab combined with cisplatin and gemcitabine for first-line NPC treatment and as a monotherapy for recurrent, unresectable, or metastatic NPC in October 2023. Toripalimab received Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA for various indications.

Marketing Authorization Applications

In Europe, the EMA and MHRA accepted marketing authorization applications for toripalimab in combination with cisplatin and gemcitabine for NPC and with paclitaxel and cisplatin for ESCC.

TGA acceptance- In Australia, the TGA accepted the NCE application and granted Orphan Drug designation for NPC.

HAS acceptance- In Singapore, the HSA accepted the NDA application and granted priority review for toripalimab.

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