- 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)
- 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 the
U.S., making India the third country in the world to receive access
to this New Biological Entity (NBE)
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.
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 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.
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 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.
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 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.
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. Lyon,
France:International Agency for Research on Cancer. Available from:
https://gco.iarc.who.int/today. 5 Mailankody, Sharada, et al.
"Epidemiology of rare cancers in India and South Asian
countries–remembering the forgotten." The Lancet Regional
Health-Southeast Asia 12 (2023). 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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