Dr. Reddy’s Laboratories Ltd. and its subsidiaries have announced the launch of Toripalimab in India, the first and only immuno-oncology medication approved to treat nasopharyngeal cancer.
Toripalimab is a new biological entity (NBE). It is the only immuno-oncology drug approved by multiple regulatory authorities worldwide, including the United States Food and Drug Administration (USFDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicines Agency (EMA), and others, for the treatment of adults with recurrent or metastatic nasopharyngeal cancer.
Dr Reddy’s already signed a license and commercialisation deal for Toripalimab with Shanghai Junshi Biosciences Co. Ltd in 2023.
Dr Reddy’s got exclusive rights to develop and commercialize Toripalimab in 21 countries, including India, South Africa, Brazil, and several Latin American countries.
Additionally, the arrangement authorizes Dr. Reddy’s to broaden the scope of the license to include Australia, New Zealand, and nine other nations.
Toripalimab is used as a first-line treatment for adults with metastatic or recurrent locally advanced NPC, in conjunction with gemcitabine and cisplatin. This combination has resulted in a 48% reduction in the probability of progression or death.
Toripalimab is also licensed as a monotherapy for the treatment of people with recurrent unresectable or metastatic NPC with disease progression during or following platinum-containing chemotherapy.
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