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Committee Recommendation: Dr. Reddy’s Granted Permission for Import and Marketing of Toripalimab in India

NextEdge Admin

16 Apr 2024

2 min 36 sec

Dr. Reddy’s presented the proposal for grant of permission to import and market Toripalimab 240 mg solution for infusion to use in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma and 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 with local Phase III clinical trial waiver. The proposed drug Toripalimab has been granted an orphan drug designation for the treatment of nasopharyngeal cancer by the US FDA & EMA and approved in China & USA for the proposed indications based on Phase II & Phase III trials conducted. After detailed deliberation, the CDSCO committee recommended grant of permission to import and market the drug with waiver of local Phase III clinical trial with condition to conduct Phase IV clinical trial in India. The firm should submit Phase IV clinical trial protocol within 3 months from grant of marketing authorization.

Toripalimab (Tuoyi™) is a selective, recombinant, humanized monoclonal antibody against programmed death protein 1 (PD-1) developed by Shanghai Junshi Bioscience Co., Ltd. Toripalimab is able to bind to PD-1 and block the interaction with its ligands.

In 2023 Shanghai Junshi Biosciences and Dr. Reddy’s Laboratories have partnered for the development and commercialisation of the anti-PD-1 monoclonal antibody, toripalimab, in 21 countries. Under the terms of the license and commercialisation deal, Dr. Reddy’s will get licence for the development and commercialisation of toripalimab in India, Panama, Peru, Colombia, South Africa, Brazil, Argentina, Chile, Uruguay, and Mexico.