Junshi Biosciences Announces the sNDA Approval of Toripalimab for the 1st-line Treatment of Melanoma

About this update from Shanghai Junshi Biosciences Co., Ltd. Class A

[{"type":"image","alt":"Junshi Biosciences","displaySize":"","headline":null,"caption":"Junshi Biosciences","className":"","disableSlideshowImg":false,"size":{"original":{"width":150,"height":56,"url":"https://media.zenfs.com/en/globenewswire.com/971d658a30455dfc9bd856efb4c84acc"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/4euD1KvxSTvPpofaq76LRQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTc4O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/971d658a30455dfc9bd856efb4c84acc","width":150,"height":56}},"lazy":false},{"type":"text","content":"SHANGHAI, April 25, 2025 (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 supplemental new drug application (“NDA”) for toripalimab (trade name: TUOYI®) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration (“NMPA”). This marks the approval of toripalimab’s 12th indication in the Chinese mainland.","length":589,"tagName":"p"},{"type":"text","content":"Melanoma is the most malignant type of skin cancer. According to GLOBOCAN 2022 statistics, approximately 332,000 new melanoma cases and 59,000 deaths were recorded globally that year. Though melanoma is relatively uncommon in China, its mortality rate is high (approximately 5,000 deaths amongst approximately 9,000 new cases in 2022) and its incidence rate is rising year by year. Since 2018, anti-PD-1 monoclonal antibodies have been approved for the second-line or later treatment of advanced melanoma in China and are widely used clinically. However, the first-line standard treatment for advanced melanoma is still dominated by traditional chemotherapy or targeted therapy (limited to patients with BRAF V600 mutation). Until now, no domestic anti-PD-1 monoclonal antibody had been approved for advanced melanoma in China, creating an urgent clinical need for first-line immunotherapy options.","length":898,"tagName":"p","attribs":{}},{"type":"text","content":"The supplemental NDA approval is based on data from the MELATORCH study (NCT03430297). MELATORCH is a multicenter, randomized, open-label, positive-controlled Phase 3 clinical study, and is also the first pivotal registrational clin...

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