Full Press Release Details
National Stock Exchange of India Ltd. (Stock Code: DRREDDY-EQ)
BSE Limited (Stock Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Please find enclosed a Press Release on "Dr.
Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma."
This is for your information and record.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR
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| DR. REDDY'S LABORATORIES LTD. | I nvestor relationS | MEDIA RELATIONS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | RICHA PERIWAL richaperiwal@drreddys.com | USHA IYER ushaiyer@drreddys.com |
Dr. Reddy's launches
Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
Hyderabad, India; November 28, 2024 -
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred
to as "Dr. Reddy's"), announced the launch of Toripalimab in India.
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 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 inhibitor1. Dr.
Reddy's will market it under the brand name Zytorvi in India.
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 death2.
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: "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. Our portfolio of standard of care small molecules and biosimilars across cancer types in India and other emerging markets has included
Reditux , Versavo , Lenangio , and Hervycta .
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."
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 India, there were 6,519 newly diagnosed cases of NPC in 20224. The highest age-adjusted rates for NPC were found
in the north-eastern states in India, with Kohima in Nagaland having an incidence of 19.4/100,000 population5.
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 Hyderabad,
India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of Good
Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars
and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
Our major markets include - USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep
science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter
of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high
in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
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