Sun Pharmaceutical Industries Limited , India's largest pharmaceutical company, has announced the commercial availability of UNLOXCYT™ (cosibelimab-ipdl) in the United States for treating advanced cutaneous squamous cell carcinoma (aCSCC). This milestone represents a significant advancement from the company's earlier plans to launch the treatment in the second half of FY '26.

UNLOXCYT Commercial Launch

UNLOXCYT is now available for healthcare professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The treatment is distributed through a limited network of authorized specialty distributors and one contracted specialty pharmacy.

Clinical Efficacy and Safety Profile

The FDA recently approved an updated label for UNLOXCYT reflecting long-term follow-up data from the pivotal CK-301-101 clinical trial. The treatment demonstrates significant clinical benefits:

The safety profile shows manageable adverse reactions, with the most common being fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism. Notably, no patients developed Grade 3 or 4 pneumonitis, with only 0.90% experiencing Grade 2 pneumonitis.

Strong Q1 Financial Performance

Sun Pharma's robust financial foundation supports this launch, with impressive results for the quarter ending June 30:

Market Segment Performance

The company's diversified portfolio shows strong performance across key markets:

India Formulations

Sales grew 13.90% to ₹47,211.00 million, representing 34.20% of total consolidated sales. Sun Pharma maintained its No. 1 ranking in the Indian pharmaceutical market with an 8.30% market share.

US Formulations

US sales reached $473.00 million, contributing 29.30% to total consolidated sales, providing a strong foundation for the UNLOXCYT launch.

Global Innovative Medicines

This segment achieved $311.00 million in sales, up 16.90% year-over-year, representing 19.30% of Q1 sales. UNLOXCYT will further strengthen this high-growth portfolio.

Management Perspective

Richard Ascroft, CEO of Sun Pharma North America, emphasized the treatment's significance: "UNLOXCYT is an evolution in checkpoint inhibition, combining durable efficacy with a proven tolerability profile for a group of aCSCC patients who traditionally would struggle to strike that therapeutic balance."

Dilip Shanghvi, Chairman and Managing Director, highlighted the company's strong quarterly performance: "Sun had a strong performance during the quarter, where the overall growth reflects steady progress across all our markets."

Market Impact and Future Outlook

With an estimated 40,000 US patients progressing to advanced CSCC annually, resulting in nearly 15,000 deaths, UNLOXCYT addresses a significant unmet medical need. The treatment's availability through the UNLOXCYT SUPPORT™ program ensures comprehensive patient access and affordability support.

Sun Pharma's successful launch of UNLOXCYT, combined with its strong financial performance and robust R&D pipeline of six novel entities in clinical stages, positions the company for continued growth in the competitive oncology market.

Sun Pharmaceutical Industries Limited , India's largest pharmaceutical company, has reported robust financial results for the first quarter of fiscal year 2026, demonstrating steady progress across all markets and significant growth in its Innovative Medicines business.

Financial Highlights

Sun Pharma's gross sales for Q1 FY26 reached ₹137,861.00 million, marking a 10.1% increase year-over-year. The company's adjusted net profit rose by 5.7% to ₹29,961.00 million, excluding exceptional items. However, the reported net profit stood at ₹22,786.00 million, compared to ₹28,356.00 million in Q1 FY25, due to certain exceptional charges.

Market Performance

India Formulations

Sun Pharma continued to strengthen its leadership position in the Indian pharmaceutical market. Sales in India grew by 13.9% to ₹47,211.00 million, accounting for 34.2% of total consolidated sales. The company's market share increased from 8.0% to 8.3%, maintaining its No. 1 ranking. Sun Pharma launched 5 new products in the Indian market during the quarter.

US Formulations

US formulation sales reached $473.00 million, representing a 1.4% growth and contributing 29.3% to total consolidated sales.

Global Innovative Medicines

The company's Global Innovative Medicines business, previously known as Specialty business, showed impressive growth of 16.9%, reaching $311.00 million. This segment now accounts for 19.3% of Q1 FY26 sales, highlighting Sun Pharma's successful expansion into innovative drug development.

Emerging Markets and Rest of World

Emerging Markets formulation sales grew by 5.1% to $298.00 million, while Rest of World markets saw a significant increase of 15.5%, reaching $219.00 million.

R&D and Product Pipeline

Sun Pharma continued its focus on research and development, investing ₹9,029.00 million (6.5% of sales) in R&D during Q1 FY26. The company's innovative R&D pipeline includes six novel entities in clinical stages. In the US market, Sun Pharma has 542 approved ANDAs and 119 pending approvals, along with 57 approved NDAs and 13 pending approvals.

Launch of Leqselvi in the US

A significant milestone for Sun Pharma this quarter was the US launch of Leqselvi, a JAK inhibitor for severe alopecia areata. This launch not only expands the company's dermatology portfolio but also adds a new growth engine to its Innovative Medicines business.

Leadership Transition

Sun Pharma announced an important leadership change during its 33rd Annual General Meeting. Dilip Shanghvi, the company's founder, will transition from his role as Managing Director. Kirti Ganorkar, a long-standing member of Sun Pharma's leadership team, will take over as the new Managing Director, subject to shareholder approval.

Outlook

Dilip Shanghvi, Chairman and Managing Director, commented on the results: "Sun had a strong performance during the quarter, where the overall growth reflects steady progress across all our markets. India continues to show strong momentum, contributing meaningfully to our performance."

Looking ahead, Sun Pharma expects mid to high single-digit topline growth for FY26, with continued growth trajectory in its Global Specialty business. The company plans to maintain its R&D spend in the range of 6-8% of sales, with an increased focus on Specialty products.

As Sun Pharmaceutical Industries Limited continues to expand its global footprint and innovative product portfolio, it remains committed to delivering long-term value and touching more lives globally.