Junshi Biosciences Announces Toripalimab’s Approval in Australia

SHANGHAI, Jan. 17, 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, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced that toripalimab, the anti-PD-1 monoclonal antibody self-developed by the company, has obtained the marketing authorization issued by the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”). The New Chemical Entity (the “NCE”) application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (“NPC”) and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy has been approved by TGA. Toripalimab has become the first and only immuno-onocology treatment for NPC in Australia.