Dr Reddy’s launches toripalimab in India as first immuno-oncology drug for nasopharyngeal carcinoma

Dr. Reddy’s Laboratories Ltd. announced a significant milestone in its oncology portfolio with the launch of Toripalimab in India. This innovative immuno-oncology drug is the first of its kind approved for the treatment of recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). The move positions India as the third country globally, following China and the United States, to gain access to this advanced therapeutic option.

Toripalimab, marketed under the brand name Zytorvi, is a next-generation anti-PD-1 monoclonal antibody. The drug has received approval from regulatory authorities, including the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and India’s Drug Controller General of India (DCGI), for its efficacy in addressing RM-NPC. Notably, clinical trials have shown that a combination of Toripalimab with chemotherapy, specifically gemcitabine and cisplatin, can reduce the risk of disease progression or death by an impressive 48%.

This launch follows Dr. Reddy’s strategic collaboration with Shanghai Junshi Biosciences Co. Ltd., established in 2023. Under the agreement, the Indian pharmaceutical giant secured exclusive rights to develop and market Toripalimab across 21 countries, including India, South Africa, and regions in Latin America. The agreement also allows potential expansion into Australia and New Zealand.

A Game-Changer for Nasopharyngeal Carcinoma Patients in India

Nasopharyngeal carcinoma (NPC) is a rare yet aggressive cancer originating in the nasopharynx’s epithelial cells. India ranks among the top five countries globally in terms of NPC burden, with over 6,500 new cases reported in 2022, according to GLOBOCAN statistics. This burden is disproportionately high in the northeastern states, particularly Nagaland, where incidence rates reach 19.4 per 100,000 people.

Prior to Toripalimab, treatment for RM-NPC in India was limited to chemotherapy. The introduction of this immunotherapy offers an advanced line of defence by enhancing the immune system’s ability to target and destroy tumour cells.

Dr. Reddy’s Broader Oncology Ambitions

M.V. Ramana, CEO of Branded Markets at Dr. Reddy’s, highlighted the company’s commitment to addressing unmet healthcare needs in oncology, especially in emerging markets. He noted that the availability of Toripalimab reflects Dr. Reddy’s dedication to providing innovative and affordable medicines globally.

The company’s oncology portfolio already includes prominent offerings such as Reditux, Versavo, Lenangio, and Hervycta, and this latest addition signals a broader push towards innovation through partnerships. By launching Toripalimab in India within the same year as its U.S. debut, Dr. Reddy’s has demonstrated its agility in delivering cutting-edge treatments to underserved regions.

Innovative Mechanism of Action

Toripalimab is designed to block PD-1 interactions with its ligands PD-L1 and PD-L2, enhancing T-cell activation and promoting the immune system’s ability to combat tumours. This mechanism has positioned the drug as a next-generation therapy, offering superior outcomes regardless of PD-L1 expression status in patients.

Looking Ahead

As Dr. Reddy’s strives to serve over 1.5 billion patients by 2030, the launch of Toripalimab underscores its vision to bridge gaps in access to advanced cancer care. The introduction of such innovative therapies not only strengthens its oncology pipeline but also sets a benchmark for timely delivery of new medicines in emerging markets.