Toripalimab Launches in India

Dr. Reddy’s Laboratories Ltd. has launched Toripalimab in India, an immuno-oncology drug and PD-1 inhibitor that’s also considered a new biological entity (NBE).¹ It’s approved by various regulatory authorities, including the FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and other agencies for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).

Last year, the company entered into a license and commercialization agreement with Shanghai Junshi Biosciences Co. Ltd for the drug. Per the deal, Dr. Reddy’s is able to both develop and commercialize Toripalimab in 21 countries including India, South Africa, Brazil and multiple Latin American countries. Dr. Reddy’s can now also increase the coverage of the license to include New Zealand and Australia, along with nine additional countries.

India is now the third country in the world after China and the United States to receive access to this PD-1 inhibitor.² In India, it will be sold under the brand name Zytorvi.

Prior to Toripalimab, RM-NPC was often treated in India before Toripalimab with chemotherapy (gemcitabine and cisplatin). Toripalimab was approved with the indication of treating adults with metastatic or recurrent locally advanced NPC alongside gemcitabine and cisplatin. Doing so has demonstrated 48% decrease in the change of progression or death.³ Further, Toripalimab was previously approved as a 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 diagnosedwith nasopharyngeal carcinoma (NPC) in India. NPC is a rare form of head and neck cancer,” explained M.V. Ramana, CEO, branded markets (India and emerging markets), Dr. Reddy’s. "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.⁴ 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.

"This launch is also a major milestone for us as a company. Oncology has been a top focus therapy area for us. Our offerings aim to build an end-to-end ecosystem of care—access to current standard of care cancer medicines across multiple countries globally, innovation in formulations, strategic collaborations for novel innovative molecules particularly in India and other emerging markets, beyond-the-pill support such as nutrition and digital tools. … Additionally, under our innovation agenda, access to novel molecules through collaborations is a key pillar, since access to meaningful innovation and the latest standard of care remains a challenge for patients in emerging markets. Thanks to the relentless efforts of our cross-functional teams, we have been able to launch Toripalimab in India in the same year as its launch in the U.S. We will continue to work hard to serve our patients and stakeholders to remain their partner of choice, and progress towards our goal of serving over 1.5 billion patients by 2030.”

References

1. Dr. Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma. Business Wire. November 28, 2024. Accessed December 3, 2024. https://www.businesswire.com/news/home/20241128406821/en/Dr.-Reddys-launches-Toripalimab-in-India-the-first-and-only-immuno-oncology-drug-approved-for-the-treatment-of-nasopharyngeal-carcinoma

2. Ravindranathan S, Wang X, et al. Characteristics of toripalimab: a next generation anti-PD-1 antibody with potent T cell activation and enhanced clinical efficacy irrespective of PD-L-1 status. J Immunother Cancer 2023;11(Suppl 1):A1–A1731

3. Mai, HQ., Chen, QY., Chen, D. et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med 27, 1536–1543 (2021).

4. Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80.