Toripalimab is a New Biological Entity (NBE). It 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 for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma.
Earlier in 2023, Dr Reddy’s had 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.
Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. This combination has shown a 48% reduction in risk of progression or death.
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.
“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,” said MV Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr Reddy’s.
Shares of Dr Reddy’s Laboratories Ltd. settled 0.55% lower at ₹1,201.95 apiece on the NSE on Wednesday. The stock is up 3% on a year-to-date basis.
