Henlius Serplulimab-Media Reaches India Market

Henlius’ Serplulimab Reaches India,Expanding Global Access to Innovative Cancer Treatment

Henlius’ groundbreaking immuno-oncology drug,serplulimab,has officially begun its journey to Indian patients,marking a significant milestone in the company’s commitment to global healthcare access. The first shipment of this vital treatment has been dispatched, underscoring Henlius’ robust global supply chain capabilities and its dedication to bringing Chinese innovation to patients worldwide.”Improving global patient access remains at the heart of Henlius’ strategic vision,” stated Ms. Wei Huang, President of Henlius. “The first shipment of serplulimab to India not only demonstrates the strength and efficiency of our global supply system, but also represents another solid step forward in the journey of Chinese innovation benefiting patients worldwide. As launch, serplulimab has benefited over 110,000 patients globally, and continues to expand the accessibility of immuno-oncology worldwide. Moving forward, we will continue to leverage our integrated global capabilities in R&D, manufacturing and commercialisation to deliver more high-quality innovative medicines to patients around the world.”

Serplulimab received approval from India’s Central Drugs Standard Control Organization (CDSCO) in June 2025 for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval positions serplulimab as the first anti-PD-1 therapy available for this indication in India, a nation grappling with a considerable lung cancer burden. In 2022 alone, India reported over 81,000 new lung cancer cases and more than 75,000 deaths, highlighting a critical need for advanced treatment options. The introduction of serplulimab is anticipated to offer a crucial innovative therapy, aiming to improve survival outcomes for patients in this historically underserved segment.Ms.Ping cao, Chief Business Growth Officer and Senior Vice President of Henlius, emphasized the company’s dedication to addressing unmet clinical needs. “We remain committed to addressing the clinical needs of patients worldwide and delivering on our promises to partners through practical action. The swift commercial supply of serplulimab following its approval in India is a result of the close collaboration and efficient execution between Henlius and our partner Intas. By leveraging the differentiated strengths of serplulimab and Intas’ deep expertise and robust commercial network in the local market, we aim to bring more high-quality, affordable innovative medicines to patients in need and further enhance treatment accessibility globally.”

Henlius has partnered with Intas, a leading pharmaceutical company in India, for the commercialization of serplulimab.Intas’ extensive local market knowledge and established commercial network are poised to accelerate patient access and ensure widespread product availability across the country. This collaboration signifies Henlius’ ongoing strategy to forge strong global partnerships to broaden the reach of its high-quality therapeutic innovations.

What clinical trial data supported Serplulimab’s approval by the CDSCO in India?

Henlius Serplulimab-Media Reaches India Market: Expanding Access to Innovative Cancer Therapy

What is Serplulimab and Why is its India Launch Notable?

Serplulimab, developed by Henlius Biotech, is a novel programmed death-1 (PD-1) inhibitor monoclonal antibody. Its arrival in the Indian pharmaceutical landscape marks a significant step towards broadening access to cutting-edge immunotherapy for cancer patients. PD-1 inhibitors work by blocking the PD-1 protein on immune cells, effectively releasing the brakes on the immune system and allowing it to recognize and attack cancer cells. This is a crucial advancement in cancer treatment, notably for cancers that have previously proven resistant to conventional therapies. The Indian market, with its growing cancer burden and increasing demand for affordable, high-quality medications, represents a key strategic region for Henlius. Serplulimab india availability addresses a critical need.

Regulatory Approvals and Market Entry Strategy

Henlius received approval from the Central Drugs Standard Control Organization (CDSCO) in India for Serplulimab in early 2024. This approval followed rigorous clinical trials demonstrating the drug’s efficacy and safety profile. The initial market entry focuses on several key cancer types, including:

Squamous Non-Small Cell Lung Cancer (NSCLC): Serplulimab is approved as a first-line treatment option in combination with chemotherapy for advanced NSCLC.

Esophageal Squamous Cell Carcinoma (ESCC): Offering a new hope for patients battling this aggressive form of cancer.

Other Solid Tumors: Henlius is actively pursuing approvals for Serplulimab in additional cancer indications within India.

Henlius has partnered with local pharmaceutical companies for distribution and commercialization, ensuring wider reach and accessibility across the country. This collaborative approach is vital for navigating the complexities of the Indian healthcare system and maximizing patient impact. Henlius Biotech India is committed to long-term growth in the region.

Serplulimab: Mechanism of Action & Clinical Evidence

Serplulimab’s effectiveness stems from its ability to restore the immune system’s ability to fight cancer. here’s a breakdown:

1. PD-1/PD-L1 Blockade: Cancer cells frequently enough express PD-L1, a protein that binds to PD-1 on T-cells, effectively shutting down the immune response.
2. Immune Cell Activation: Serplulimab binds to PD-1, preventing this interaction and reactivating T-cells.
3. Targeted cancer Cell Destruction: Reactivated T-cells can then identify and destroy cancer cells.

Clinical trials have demonstrated promising results:

Improved Overall Survival (OS): Studies have shown a statistically significant improvement in OS rates in patients treated with Serplulimab compared to chemotherapy alone.

Enhanced progression-Free Survival (PFS): Patients receiving Serplulimab experienced a longer period before their cancer progressed.

Manageable Safety Profile: While immunotherapy can have side effects, Serplulimab’s safety profile has been deemed manageable with appropriate monitoring and supportive care. Immunotherapy drugs are continually being refined for improved patient tolerance.

Cost and Accessibility in the Indian Healthcare System

A major barrier to accessing innovative cancer therapies in India is cost. Henlius has positioned serplulimab with a competitive pricing strategy, aiming to make it more affordable compared to other PD-1 inhibitors currently available in the market. this is achieved through a combination of factors:

Biosimilar Development: Serplulimab is a biosimilar, meaning it’s highly similar to an already approved reference product, allowing for cost efficiencies in manufacturing.

Local Manufacturing Potential: Henlius is exploring opportunities for local manufacturing in India, which could further reduce production costs.

Patient Assistance Programs: partnerships with NGOs and patient advocacy groups are being established to provide financial assistance and support to eligible patients. Cancer care affordability is a key focus.

Impact on the Indian Oncology Landscape

The introduction of Serplulimab is poised to reshape the Indian oncology landscape in several ways:

Increased Treatment Options: Patients now have access to another effective immunotherapy option, expanding their choices and improving their chances of triumphant treatment.

Competition and Price Reduction: The entry of a biosimilar PD-1 inhibitor is expected to increase competition and drive down the overall cost of immunotherapy.

Advancement of Cancer Research: The availability of Serplulimab will facilitate further research into immunotherapy and personalized cancer treatment in India. Oncology advancements are accelerating globally.

Improved Patient Outcomes: Ultimately, the goal is to improve survival rates and quality of life for cancer patients across India.

Future outlook: Henlius’ Expansion Plans in India

Henlius Biotech is committed to expanding its presence in the Indian market beyond Serplulimab. Plans include:

Pipeline Expansion: bringing additional biosimilars and innovative therapies to India,covering a wider range of cancer types and other diseases.

* Clinical trial Collaborations: Partnering with Indian research institutions to conduct