NSEPress Release21 Oct 2026 · 21 Oct 2026, 09:44 am
Press Release
Dr. Reddy's Laboratories Limited · DRREDDY
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Dr. Reddy's Laboratories Ltd. has received approval from the Central Drugs Standard Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI) for Zytorvi (toripalimab) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
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Dr. Reddy's Laboratories Limited has informed the Exchange regarding a press release dated October 21, 2026, titled "Dr. Reddy s Receives DCGI Approval for Zytorvi® (toripalimab) in Advanced Esophageal Squamous Cell Carcinoma, Its Second Approved Indication in India.".
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Dr. Reddy's Laboratories Ltd.
8-2-337, Road No. 3, Banjara Hills
Hyderabad – 500 034, Telangana, India
CIN: L85195TG1984PLC004507
Tel: + 91 40 4900 2900
Fax: + 91 40 4900 2999
Email: mail@drreddys.com
Web: www.drreddys.com
October 21, 2026
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Dear Sir/Madam,
Ref: Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements)
Regulations, 2015
Please find enclosed a Press Release viz. “Dr. Reddy’s Receives DCGI Approval for Zytorvi®
(toripalimab) in Advanced Esophageal Squamous Cell Carcinoma, Its Second Approved Indication in
India”
This is for your information and records.
Thanking you,
Yours faithfully,
For Dr. Reddy’s Laboratories Limited
K Randhir Singh
Company Secretary, Compliance Officer & Head-CSR
Press Release
DR. REDDY'S LABORATORIES LTD.
8-2-337, Road No. 3, Banjara Hills, CONTACT
Hyderabad - 500034. Telangana, India.
CIN: L85195TG1984PLC004507 INVESTOR RELATIONS MEDIA RELATIONS
Tel: + 91 40 4900 2900
Fax: + 91 40 4900 2999
AISHWARYA SITHARAM SANTOSH VYAS
Email: mail@drreddys.com
AISHWARYASITHARAM@DRREDDYS.COM SANTOSHVYAS@DRREDDYS.COM
Web: www.drreddys.com
Dr. Reddy’s Receives DCGI Approval for Zytorvi® (toripalimab) in
Advanced Esophageal Squamous Cell Carcinoma, Its Second Approved
Indication in India
The approval expands the use of Zytorvi® beyond its initially approved indication in
nasopharyngeal carcinoma (NPC)
Hyderabad, India; October 21, 2026: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s,”) today announced
that the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India
(DCGI), has approved Zytorvi® (toripalimab) in combination with cisplatin and paclitaxel for the first-line
treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell
carcinoma (ESCC).1
Dr. Reddy’s entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for
toripalimab across 21 countries. Globally, Toripalimab is approved by regulatory authorities including the U.S.
Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the UK Medicines and
Healthcare products Regulatory Agency (MHRA).2 Notably, the EMA approval is for first-line treatment of ESCC
irrespective of PD-L1 expression.3 The approved indication in India similarly does not require patient selection
based on PD-L1 expression, enabling appropriate patients to be considered for treatment regardless of their
biomarker status.1,3
In 2024, esophageal cancer was the fourth leading cause of cancer-related death in India, accounting for
approximately 8.1% of all cancer deaths4. ESCC, the predominant subtype, accounts for approximately 80%
of all esophageal cancer cases in India. Through Zytorvi®, Dr. Reddy’s Laboratories Ltd. aims to expand access
to first-line immunotherapy for appropriate patients with advanced ESCC in India.
The approval is supported by the results from the Phase 3 JUPITER-06 trial. In the study, toripalimab in
combination with paclitaxel and cisplatin reduced the risk of disease or death by 42% compared with
chemotherapy alone.7 At the final overall-survival analysis, median overall survival was 17.7 months with
toripalimab plus chemotherapy compared with 12.9 months with chemotherapy alone. Clinical benefit was
observed across PD-L1-expression subgroups.8
M.V. Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said:
“Following the approval of Zytorvi® in nasopharyngeal carcinoma, this second indication marks an important
step in extending the reach of immunotherapy to patients with advanced esophageal squamous cell carcinoma.
It gives physicians an additional first-line treatment option for appropriate patients. As we continue to build our
oncology portfolio, our focus remains on bringing meaningful advances and expanding access to innovative
treatment options.”
About esophageal squamous cell carcinoma
Esophageal cancer begins in the tissues of the esophagus, the muscular tube that carries food and liquids from
the throat to the stomach. ESCC develops from the squamous cells lining the esophagus.
Risk factors associated with ESCC include smoked and smokeless tobacco, alcohol consumption, areca-nut
use, consumption of very hot beverages, poor diet and certain environmental and socioeconomic factors. Risk
Press Release
varies between individuals, and the presence of one or more risk factors does not mean that a person will
necessarily develop cancer.
Progressive difficulty in swallowing, pain or discomfort when swallowing, unexplained weight loss, persistent
chest discomfort and regurgitation may be associated with esophageal cancer. These symptoms may also be
caused by other conditions and require evaluation by a qualified healthcare professional.5,6
About Zytorvi® (toripalimab)
Zytorvi® contains toripalimab, a next-generation humanised IgG4 monoclonal antibody9 directed against
programmed death receptor-1, or PD-1. By binding to PD-1, toripalimab blocks its interaction with PD-L1 and
PD-L2, supporting T-cell activity against cancer cells.3
In 2023, Dr. Reddy’s entered into a licence and commercialisation agreement with Shanghai Junshi Biosciences
Co., Ltd. for toripalimab. Under this agreement, Dr. Reddy’s holds exclusive rights to develop and commercialise
toripalimab in 21 countries, including India, South Africa, Brazil and several countries in Latin America, Australia,
New Zealand and nine other countries.2 Dr. Reddy’s launched Zytorvi® in India in November 2024 for recurrent
or metastatic nasopharyngeal carcinoma, making India the third country in the world, after China and the United
States, to receive access to the medicine.2
Toripalimab is approved by regulatory authorities including the U.S. Food and Drug Administration (USFDA),
the EMA and the UK Medicines and Healthcare products Regulatory Agency (MHRA).2 The European
Commission authorised toripalimab for first-line ESCC in September 2024.3
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. Ac
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