Junshi Biosciences' Toripalimab Approved for Marketing in India and Hong Kong SAR

Shanghai Junshi Biosciences Co., Ltd. and its subsidiary, TopAlliance Biosciences Inc., have announced the approval of their drug toripalimab for marketing in India and Hong Kong SAR for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The approval covers two specific indications: toripalimab combined with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced NPC, and toripalimab as a monotherapy for adults with recurrent unresectable or metastatic NPC after progression following platinum-containing chemotherapy. Dr. Reddy’s Laboratories Ltd. will be responsible for the import and commercialization of Zytorvi® in India.

Dr. Jianjun Zou, General Manager and CEO of Junshi Biosciences, expressed excitement over the approval, highlighting toripalimab's broad international reach and clinical performance. He emphasized the company's commitment to its international strategy and collaboration with partners to deliver high-quality innovative drugs globally.

NPC is a malignant tumor originating in the nasopharynx epithelium, with over 120,000 new cases reported worldwide in 2022. Surgery is typically not an option for this type of cancer due to its location. Toripalimab now stands as the sole approved treatment for NPC in India and Hong Kong SAR.

The approval is supported by data from two significant clinical studies: JUPITER-02 and POLARIS-02. The JUPITER-02 study, a comprehensive Phase 3 trial, evaluated the efficacy of toripalimab combined with gemcitabine and cisplatin as a first-line treatment for NPC. This study, the largest of its kind in NPC immunotherapy, demonstrated a survival benefit and showed that the toripalimab combination reduced disease progression risk by 48% and death risk by 37%. The median progression-free survival in the toripalimab group was extended by 13.2 months compared to chemotherapy alone. These results were presented at the 2021 ASCO annual meeting and published in Nature Medicine and the Journal of the American Medical Association (JAMA). An additional five-year survival rate of 52.0% was reported at ASCO 2024.

The POLARIS-02 study, published in the Journal of Clinical Oncology in January 2021, showed that toripalimab exhibited durable antitumor activity in patients with recurrent or metastatic NPC who had failed previous chemotherapy. The study reported an overall response rate of 20.5%, a duration of response of 12.8 months, and a median overall survival of 17.4 months, all while maintaining a manageable safety profile.

Toripalimab has been approved in over 30 countries and regions, including mainland China, the US, the EU, and India, with marketing applications under review in several other countries. The drug is an anti-PD-1 monoclonal antibody designed to block interactions between PD-1 and its ligands, PD-L1 and PD-L2, thereby enhancing the immune system's ability to combat tumor cells.

Junshi Biosciences, founded in December 2012, focuses on the discovery, development, and commercialization of innovative therapeutics. The company has a diverse R&D pipeline with over 50 drug candidates across various therapeutic areas. Four of its innovations, including toripalimab, have reached Chinese or international markets. During the COVID-19 pandemic, Junshi Biosciences contributed to the development of therapies like etesevimab and MINDEWEI® for COVID-19 prevention and treatment.

The company aims to provide world-class, affordable, and innovative drugs to patients globally, with approximately 2,500 employees across the United States and China. Junshi Biosciences remains dedicated to its mission of global healthcare innovation.