Dr Reddy’s has commercialisation pact with Shanghai Junshi Biosciences
Hyderabad-headquartered Dr Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) has obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and across Latin America https://fieo.org/.
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 (RM-NPC) https://www.nseindia.com/.
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 https://www.bseindia.com/.
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. 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.
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr Reddy’s, said on 28 Nov, “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 burden3. 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.”
NPC is a malignant tumour that arises from the epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Fiinews.com
