Dr. Reddy’s Laboratories Ltd has announced the launch of Toripalimab in India, marking a significant advancement in the treatment of nasopharyngeal carcinoma (NPC). Toripalimab, a New Biological Entity (NBE), is the first and only immuno-oncology drug approved by regulatory agencies worldwide, including the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). It is approved for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
In 2023, Dr. Reddy’s entered into a licensing and commercialization agreement with Shanghai Junshi Biosciences Co. Ltd. for Toripalimab. As part of this agreement, Dr. Reddy’s secured exclusive rights to develop and market Toripalimab in 21 countries, including India, South Africa, Brazil, and several countries in Latin America. The agreement also allows Dr. Reddy’s to expand its license to include Australia, New Zealand, and nine other countries. With India’s launch, the country becomes the third globally—after China and the United States—to gain access to this next-generation PD-1 inhibitor, branded as Zytorvi® in India.
Prior to Toripalimab’s launch, chemotherapy with drugs like gemcitabine and cisplatin was the standard treatment for RM-NPC in India. Toripalimab is indicated as a first-line treatment for adults with metastatic or recurrent locally advanced NPC when used in combination with gemcitabine and cisplatin. This combination has demonstrated a 48% reduction in the risk of progression or death. Toripalimab is also approved as a monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC who have progressed after platinum-based chemotherapy.
M.V. Ramana, Chief Executive Officer of Branded Markets (India and Emerging Markets) at Dr. Reddy’s, commented on the launch: “The introduction of Toripalimab is a major milestone for patients in India diagnosed with nasopharyngeal carcinoma (NPC). NPC, a rare form of head and neck cancer, has a poor prognosis when diagnosed in advanced stages, and India is among the top five countries globally in terms of NPC disease burden. Toripalimab, as a next-generation PD-1 inhibitor, has demonstrated superior outcomes compared to the standard treatment, addressing a significant unmet need for patients in India.”
He continued, “Oncology is a key therapeutic focus for Dr. Reddy’s, and we strive to create a comprehensive ecosystem of care. Our approach includes providing access to current standard-of-care cancer medications across multiple countries, innovation in formulations, and strategic collaborations for novel molecules. We are committed to improving cancer care in India and emerging markets, as demonstrated by our portfolio of treatments like Reditux™, Versavo®, Lenangio™, and Hervycta™. Through collaborations, we aim to bring the latest innovative treatments to underserved patients in these regions.”
Nasopharyngeal carcinoma is a malignant tumor that originates in the nasopharynx. According to GLOBOCAN 2022 statistics, there were over 120,000 newly diagnosed cases of NPC worldwide in 2022. In India, there were 6,519 new cases of NPC in the same year. The highest rates of NPC are found in India’s northeastern states, with Kohima in Nagaland recording an incidence rate of 19.4 per 100,000 people.
Toripalimab is a monoclonal antibody that targets PD-1, a protein on immune cells. By blocking interactions between PD-1 and its ligands, PD-L1 and PD-L2, Toripalimab enhances the immune system’s ability to recognize and destroy cancer cells. This mechanism has shown promising results in treating patients with RM-NPC and improving survival rates.
Dr. Reddy’s continues to focus on expanding its oncology portfolio and increasing access to cutting-edge treatments for cancer patients in India and other emerging markets. With the launch of Toripalimab, the company reaffirms its commitment to addressing critical unmet medical needs and advancing patient care in oncology.
