Toripalimab is the only immuno-oncology drug approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others.

In 2023, Dr. Reddy’s entered into a license and commercialisation agreement with Shanghai Junshi Biosciences Co. Ltd for Toripalimab.

Under this agreement, Dr. Reddy’s obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America.

Additionally, the agreement allows Dr. Reddy’s to expand the scope of the license to cover Australia, New Zealand and nine other countries.

With this launch by Dr. Reddy’s, India becomes the third country in the world after China and the United States to receive access to this next generation PD-1 inhibitor. Dr. Reddy’s will market it under the brand name Zytorvi in India.

The standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin.

Additionally, Toripalimab has also been approved as monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 20224.

M.V. Ramana, chief executive officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said: 'The launch of Toripalimab is a significant milestone for patients diagnosed with nasopharyngeal carcinoma (NPC) in India.

NPC is a rare form of head and neck cancer. However, the prognosis of the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden.

As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for RM-NPC versus standard of care, thereby meeting a significant unmet need for patients with NPC in India.'

Dr Reddy's Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.

The company’s consolidated net profit declined 15.3% to Rs 1255.70 crore despite of 16.5% jump in revenue from operations to Rs 8016.10 crore in Q2 FY25 over Q2 FY24.

The scrip shed 0.17% to currently trade at Rs 1198.45 on the BSE.