Dr. Reddy’s Laboratories has launched Toripalimab, a next-generation PD-1 inhibitor, in India under the brand name Zytorvi. Toripalimab is approved for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). With this launch, India becomes the third country worldwide, after China and the United States, to access this innovative immuno-oncology drug.
Toripalimab is approved by leading global regulatory bodies, including the USFDA, EMA, and MHRA, for its efficacy in RM-NPC. It is indicated as a first-line treatment for metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. Additionally, it is approved as monotherapy for patients with recurrent unresectable or metastatic NPC who experience disease progression after platinum-based chemotherapy.
Dr. Reddy’s obtained exclusive rights to develop and commercialize Toripalimab in India, South Africa, Brazil, and other regions through a 2023 licensing agreement with Shanghai Junshi Biosciences. The agreement also allows for potential expansion into markets such as Australia and New Zealand.
Nasopharyngeal carcinoma is a rare form of head and neck cancer with a poor prognosis in advanced stages. According to GLOBOCAN 2022, over 120,000 new NPC cases were diagnosed globally in 2022, with 6,519 cases reported in India, making it one of the top five countries in terms of disease burden.
M.V. Ramana, CEO of Branded Markets (India and Emerging Markets) at Dr. Reddy’s, emphasized the milestone, stating, “Toripalimab meets a significant unmet need for NPC patients in India, offering superior outcomes compared to the standard of care.”
Dr. Reddy’s Laboratories operates across global generics, pharmaceutical services, active ingredients (PSAI), and proprietary products, reinforcing its commitment to delivering innovative solutions for unmet medical needs.