Junshi Biosciences Announces Phase 3 Study of Toripalimab Combined with Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma Meets Primary Endpoint

SHANGHAI, June 11, 2024 (GLOBE NEWSWIRE) — 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 primary endpoints of progression-free survival (“PFS,” based on independent radiographic review) and overall survival (“OS”) of a multi-center, randomized, open-label, active-controlled phase III clinical study (the “HEPATORCH study,” NCT04723004) of the company’s product, toripalimab (trade name: TUOYI^®, product code: JS001), in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (“HCC”) has met the pre-defined efficacy boundary. Junshi Biosciences plans to submit a supplemental new drug application (“NDA”) for this indication to the regulatory authorities in the near future.

Liver cancer is a common malignant tumor of the digestive system worldwide, and the predominant pathological type is HCC (accounting for about 90%). According to the GLOBOCAN Report for 2022, there were 866,000 new cases and 759,000 deaths from liver cancer globally that year. China in particular suffers greatly from liver cancer. The number of new liver cancer cases reached 368,000 (accounting for 42.4% of global cases) in 2022, ranking fourth in new cases among domestic malignant tumors; the numbr of deaths reached 317,000 (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 upon first diagnosis, with a median OS of approximately only 10 months and a 5-year survival rate of approximately 12%. In recent years, with the continuous emergence of the combination therapies based on the immunotherapeutic drugs, the treatment pattern of advanced liver cancer has changed, and radical cure after down-stage transformation is gradually becoming a possibility.

The HEPATORCH study is a multi-center, randomized, open-label, active-controlled phase 3 clinical study, aiming 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 of sorafenib. According to the analysis results of this study, toripalimab in combination with bevacizumab for the first-line treatment of patients with advanced HCC could significantly prolong the PFS and OS of the patients compared with sorafenib while improving the secondary endpoints such as objective response rate and time to progression. The safety profile of toripalimab was consistent with the known risks, and no new safety signals were identified. Further details will be presented at a subsequent international academic conference.

Principal investigator Professor Jia FAN, Academician of Chinese Academy of Sciences and President of Zhongshan Hospital, said, “Currently, the combination of immune checkpoint inhibitors and anti-angiogenesis targeted therapies has become a vital first-line treatment for advanced liver cancer. The HEPATORCH phase 3 clinical study evaluating toripalimab combined with bevacizumab achieved its primary endpoint, potentially offering a new treatment option with better survival benefits for advanced liver cancer patients. Toripalimab has already been approved for marketing in the US. As the first innovative biological drug independently developed and produced in China to receive FDA approval, toripalimab has received international recognition for its quality. We look forward to a day when more advanced liver cancer patients can benefit from domestically developed innovative drugs!”

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said “The incidence and mortality rates of hepatocellular carcinoma in China have remained consistently high, posing a serious threat to public health. Junshi Biosciences is committed to putting patients first, with the mission of ‘providing patients with world-class, trustworthy, and affordable and innovative drugs’. In this study, toripalimab demonstrated its powerful synergy as a cornerstone of immuno-oncology, significantly improving survival rates for patients with advanced HCC. Moving forward, we will actively communicate with regulatory authorities to expedite the approval of relevant indications, and we hope our efforts will benefit more patients with advanced liver cancer.”

About Toripalimab

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 for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

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, Southeast Asia, and Europe. 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.

In mainland China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). Currently, there are eight approved indications for toripalimab in mainland China:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”);
6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”);
7. in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
8. in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC).

The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In April 2024, the Drug Office at the Department of Health in the Government of the Hong Kong Special Administration Region (DO) accepted the NDA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

In the United States, the US FDA has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (“TGA”) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.

In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (“HSA”) in January 2024. The HSA has also granted priority review designation for the NDA.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI^®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs”, Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com.

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