BSECompany Update7h ago · 20 Oct 2026, 05:33 pm

Press Release

Sun Pharmaceutical Industries Ltd · 524715

✦ AI Summary▲ PositiveProduct Launch

Sun Pharmaceutical Industries Ltd announced that its drug UNLOXCYT (cosibelimab-ipdl) has received a Category 2A Preferred Designation in the Updated NCCN Guidelines for Locally Advanced Cutaneous Squamous Cell Carcinoma (laCSCC) patients who are not candidates for curative surgery or curative radiation.

Analysis Scores

Earnings Impact2/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment9/10

✦ Ask a Question

Ask anything about this announcement — AI will answer based on the filing content.

0/500

Full Announcement

Sun Pharmaceutical Industries Ltd - 524715 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

Attachments (1)

📄

9a434af1-62a4-4822-a754-fa547098def0.pdf

pdf

Download →
View document text
Sun Pharmaceutical Industries Limited Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai – 400 063, Maharashtra, INDIA. Tel.: (91-22) 4324 4324 Fax: (91-22) 4324 4343 Website: www.sunpharma.com Email: secretarial@sunpharma.com CIN: L24230GJ1993PLC019050 20 October 2026 National Stock Exchange of India Limited BSE Limited Scrip Symbol: SUNPHARMA Scrip Code: 524715 Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – Press Release Enclosed herewith is a copy of the press release titled “Sun Pharma Announces UNLOXCYT® (cosibelimab- ipdl) Has Received a Category 2A Preferred Designation in the Updated NCCN Guidelines for Locally Advanced Cutaneous Squamous Cell Carcinoma (laCSCC) Patients Who Are Not Candidates for Curative Surgery or Curative Radiation” which shall be released after this intimation. For Sun Pharmaceutical Industries Limited (Anoop Deshpande) Company Secretary and Compliance Officer ICSI Membership No.: A23983 Registered Office: SPARC, Tandalja, Vadodara – 390 012, Gujarat, INDIA. Reaching People. Touching Lives. Sun Pharmaceutical Industries Limited Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai – 400 063, Maharashtra, INDIA. Tel.: (91-22) 4324 4324 Fax: (91-22) 4324 4343 Website: www.sunpharma.com Email: secretarial@sunpharma.com CIN: L24230GJ1993PLC019050 FOR IMMEDIATE RELEASE Sun Pharma Announces UNLOXCYT® (cosibelimab-ipdl) Has Received a Category 2A Preferred Designation in the Updated NCCN Guidelines for Locally Advanced Cutaneous Squamous Cell Carcinoma (laCSCC) Patients Who Are Not Candidates for Curative Surgery or Curative Radiation MUMBAI, INDIA and PRINCETON, NJ (October 20, 2026) – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, (together with its subsidiaries and/or affiliated companies, “Sun Pharma”) today announced that UNLOXCYT® (cosibelimab-ipdl) has been elevated to a National Comprehensive Cancer Network® (NCCN®) Category 2A recommended option for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or curative radiation. This is an addition to the Category 2A designation in metastatic cutaneous squamous cell carcinoma (mCSCC), which was assigned to UNLOXCYT in 2025. UNLOXCYT was approved by the U.S. Food and Drug Administration (FDA) in 2024 and is indicated for the treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. UNLOXCYT is the first and only FDA- approved PD-L1-blocking antibody for advanced CSCC (aCSCC). The evidence submitted to NCCN in support of the change was based on the pivotal registration study, in which 55% of patients achieved an objective response, including 26% who achieved a complete response. Responses were durable: at a median follow-up of 24.1 months; median duration of response had not been reached (range: 8.3 to 31.3+ months). In addition, fewer than 1% of patients experienced a high-grade (Grade 3-5) immune-mediated adverse reaction (imARs)—an important consideration in this patient population. There were no grade 4 or 5 imARs. “The NCCN Guidelines play an important role in helping physicians evaluate appropriate treatment options for patients across different disease settings,” said Ahmad Naim, MD, Senior Vice President, North American Chief Medical Officer, Sun Pharma. “The elevation of UNLOXCYT to a Category 2A recommendation for patients with laCSCC marks an important milestone, validating the growing body of clinical evidence supporting UNLOXCYT and reflecting increasing confidence among oncology experts in its role as a treatment option for patients with this challenging disease.” NCCN is an alliance of 34 leading cancer centers in the U.S. Its Clinical Practice Guidelines in Oncology, referred to as the NCCN Guidelines, provide recommendations for the prevention, diagnosis, evaluation, and treatment of different types of cancer. The NCCN Guidelines are among the most influential clinical guidelines in cancer care, offering evidence-based, expert- developed recommendations intended to help clinicians make treatment decisions for patients with cancer. One such expert clinician is Dr. Francis Worden, Clinical Professor of Internal Medicine at the University of Michigan Rogel Cancer Center, whose institution is one of the 34 NCCN member cancer centers in the alliance. Dr. Worden said, “This guideline update reflects the strength of the published evidence supporting the use of UNLOXCYT as first line treatment for laCSCC. In the pivotal study, patients experienced durable and clinically meaningful responses. UNLOXCYT also demonstrated a low incidence of high-grade imARs—an important consideration when selecting immune checkpoint inhibitor therapy for a patient population that is mainly elderly and is often afflicted with other health issues. These clinical outcomes may be explained by the mechanism of action that restores adaptive immunity, engages innate immunity through antibody-dependent cellular cytotoxicity (ADCC), and preserves PD-L2 signaling that may be linked to the presence of some immune tolerance in non-tumor tissues.” NCCN Guidelines also have a meaningful impact on patient access because they inform payer coverage policies, prior-authorization criteria, institutional formularies, and clinical pathways. “For patients with laCSCC—many of whom are older, medically complex, and vulnerable to treatment-related complications—access to a therapy that offers durable responses together with a low rate of high-grade imARs is especially important. NCCN recognition helps ensure that appropriate patients can receive this treatment up front without unnecessary access barriers,” said Mark Gimbert, Senior Vice President, Head of Market and Patient Access, North America, Sun Pharma. About Cutaneous Squamous Cell Carcinoma Cutaneous squamous cell carcinoma (CSCC) is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths. Important risk factors for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear. About Sun Pharma in Cutaneous Oncology For more than two decades, Sun Pharma has built on its established leadership in dermatology to advance care for people impacted by skin cancer. Working in collaboration with the broader skin cancer community, the company is focused on addressing needs across the disease continuum—from precancerous conditions to advanced skin cancers. With a dedicated cutaneous oncology team and a growing focus in specialty medicines, Sun Pharma applies scientific rigor, real-world insight, and partnership to support meaningful progress in care and improve continuity for patients, caregivers, and clinicians. Please see the INDICATIONS and IMPORTANT SAFETY INFORMATION below. INDICATIONS AND USAGE UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. IMPORTANT SAFETY INFORMATION WARNING AND PRECAUTIONS Severe and Fatal Immune-mediated Adverse Reactions: Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, including, but not limited to, immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, and dermatologic adverse [Showing first 8,000 characters — download PDF for full document]