Dr. Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
- Only immuno-oncology drug approved by various regulatory authorities around the world such as the USFDA, DCGI, EMA, MHRA, NMPA and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC)
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Combination of Toripalimab and standard of care chemotherapy has shown a
48% reduction in risk of progression or death -
Launched in
India in the same year as its launch in theU.S. , makingIndia the third country in the world to receive access to this New Biological Entity (NBE)
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). 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
The standard of care for RM-NPC in
M.V. Ramana, Chief Executive Officer, Branded Markets (
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
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
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. In
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalisation (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumour cells6.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein.
1 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
2 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).
3 Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80.
4 Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today.
5 Mailankody, Sharada, et al. "Epidemiology of rare cancers in
6 Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80.
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INVESTOR RELATIONS
RICHA PERIWAL
richaperiwal@drreddys.com
MEDIA RELATIONS
USHA IYER
USHAIYER@DRREDDYS.COM
Source: Dr. Reddy’s Laboratories Ltd.