Dr. Reddy's Zytorvi Secures DCGI Approval for Advanced Esophageal Cancer Treatment

Key numbers

Market Cap	₹1,03,708.5 CrPharmaceuticals
Net Profit Growth	101.1%Quarter-on-Quarter
P/E TTM	32.2xSector PE 44.8x
Promoter Holding	26.6%Steady Ownership

Key highlights

• DCGI approves Zytorvi in combination with chemotherapy for first-line treatment of adult patients with advanced ESCC
• Clinical data from Phase 3 JUPITER-06 trial shows Zytorvi reduced the risk of disease or death by 42%
• Median overall survival improved to 17.7 months with Zytorvi compared to 12.9 months with chemotherapy alone
• Approval allows for treatment regardless of PD-L1 biomarker status, expanding the eligible patient pool in India
• ESCC accounts for approximately 80% of all esophageal cancer cases in the Indian market

Expanding Immunotherapy Access in India

The Central Drugs Standard Control Organisation (CDSCO), under the DCGI, has authorized Dr. Reddy's to market Zytorvi for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma. This regulatory milestone follows a 2023 licensing and commercialization agreement with Junshi Biosciences covering 21 countries.

Significantly, the approved indication in India does not require patient selection based on PD-L1 expression, enabling physicians to consider the treatment for appropriate patients regardless of their specific biomarker status. This second indication builds on the drug's existing approval for nasopharyngeal carcinoma, which was launched in the Indian market in November 2024.

Clinical Efficacy and Financial Performance

• Phase 3 JUPITER-06 trial results demonstrated a 42% reduction in the risk of disease progression or death.
• Median overall survival reached 17.7 months in the toripalimab arm versus 12.9 months in the chemotherapy control arm.
• Dr. Reddy's reported revenue of ₹8,099.8 Crore for the quarter ended June 30, 2026.
• The company achieved a net profit of ₹444.3 Crore in the same period, reflecting a 101.1% growth over the previous quarter.
• Operating profit margins stood at 10.62% as the company continues to invest in its oncology and biosimilar pipeline.

Strategic Expansion in Oncology Portfolio

The approval for Zytorvi aligns with Dr. Reddy's broader strategy of securing high-value regulatory clearances in major markets. Recent milestones include the August 26, 2026, CDSCO approval for an Abatacept biosimilar in India and the August 1, 2026, USFDA approval for a Rituximab biosimilar.

As of June 30, 2026, the company maintains a robust pipeline with 79 drug filings pending USFDA approval, including 76 Abbreviated New Drug Applications (ANDAs). This momentum in regulatory approvals supports management guidance for double-digit revenue growth and sustained EBITDA margins, as articulated in previous fiscal outlooks.

Management on Clinical Impact

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.

Addressing High Mortality Cancer Needs

In 2024, esophageal cancer was identified as the fourth leading cause of cancer-related deaths in India, representing roughly 8.1% of all cancer fatalities. Esophageal squamous cell carcinoma is the predominant subtype in the region, accounting for 80% of cases. By securing this second indication for Zytorvi, Dr.

Reddy's aims to address a critical therapeutic gap in the Indian oncology landscape. The drug works as a next-generation humanised IgG4 monoclonal antibody directed against PD-1, blocking interactions with PD-L1 and PD-L2 to support T-cell activity against cancer cells.

What to watch next

• Board meeting scheduled for October 23, 2026, to approve Q2 FY27 financial results.
• Potential clearance of 79 pending drug filings currently under review by the USFDA.
• Commercial rollout and clinical adoption of Zytorvi for the ESCC indication in Indian hospitals.

Dr Reddys Laboratories · financial snapshot

Share price	₹1242.5
Market capitalisation	₹1.04L Cr
Revenue (annual)	₹33,700.20 Cr
Net profit (annual)	₹4,196.00 Cr
Revenue (latest quarter)	₹8,099.80 Cr+7.33% vs previous quarter
Net profit (latest quarter)	₹444.30 Cr+101.13% vs previous quarter
P/E (TTM)	32.19×Sector 44.82×
Promoter holding	26.64%+0.01% QoQ
FII holding	20.67%Current quarter

Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.