• First prescriptions in Europe and India: From regulatory approval to clinical accessibility, demonstrating the global execution and vitality of Chinese biopharma innovation

• Benefiting patients rapidly: Within just 12 days of launch in India, more than 150 patients have already received treatment with serplulimab, reflecting strong market recognition of its clinical value and differentiated advantages

• Expanding global footprint: Serplulimab has been approved in over 40 countries and regions, benefiting more than 120,000 patients. Henlius’ mission to deliver high-quality biologics to patients around the world is being realized at an accelerated pace

Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab was recently prescribed for the first time in both Europe and India. This milestone marks that this Chinese innovative biologic is now in clinical use in Europe as well as the world’s most populous country[1], further accelerating the global accessibility of innovative biologics.

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said:“The first prescriptions in Europe and India demonstrate that serplulimab has rapidly achieved clinical rollout across diverse overseas markets. We remain committed to addressing global patient needs, strengthening efficient collaborations with our partners, and delivering more high-quality, affordable innovative medicines to patients worldwide—ensuring Chinese innovation benefits the world.”

Alex Falgas, Global SVP - BD Portfolio & Strategy of Intas said: “The first prescriptions of Hetronifly^® in Europe and India mark a proud and significant milestone for Accord and Intas, showcasing our ability to swiftly bring innovative therapies to patients. By combining our strong expertise in oncology, market access, and patient reach, we have transformed Henlius’ scientific innovation into real-world treatment options across two critical regions. This accomplishment reinforces Accord and Intas’ position as trusted global partners in expanding access to high-quality, life-changing medicines which will have a real impact on patients’ lives.”

First Prescriptions in Europe and India: A Key Step Toward Clinical Accessibility

In the first half of 2025, serplulimab received approvals from both the European Commission (EC) and the Central Drugs Standard Control Organization (CDSCO) of India for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), becoming the first anti-PD-1 monoclonal antibody approved for this indication in these regions.

Recently, the first prescriptions of serplulimab were issued in Germany and India, marking its official entry into clinical use. The successful rollout in both regions was made possible through Henlius’ efficient collaboration with partner Intas and its subsidiary Accord Healthcare. Intas and Accord Healthcare are responsible for market access, pricing, and distribution in India and Europe respectively, while Henlius provides end-to-end production and cross-border supply support.

According to the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS), serplulimab received a score of 4 for the treatment of ES-SCLC—the highest among evaluated therapies for this indication—demonstrating its significant clinical benefit in prolonging survival and improving quality of life. The score is based on results from the ASTRUM-005 study, an international multi-centre Phase 3 study. The final analysis of the study was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Long-term follow-up data (median follow-up: 42.4 months) showed a 4-year overall survival (OS) rate of 21.9% in the serplulimab arm versus 7.2% in the control arm, with a manageable safety profile.

Global Strategy: Expanding the Accessibility of Innovative Biologics

As a key asset in Henlius’ globalization strategy, serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of ES-SCLC. It has been approved in over 40 countries and regions, including China, the U.K., Germany, India, Indonesia, and Singapore, benefiting more than 120,000 patients worldwide. It has received orphan drug designations for small cell lung cancer from the U.S. Food and Drug Administration (FDA), the EC, the Swiss Agency for Therapeutic Products (Swissmedic), and the Korean Ministry of Food and Drug Safety (MFDS) for ES-SCLC.

Henlius is actively advancing the registration and clinical development of serplulimab in additional markets. In the U.S. and Japan, independent bridging studies comparing serplulimab to the current first-line standard of care, are underway to support respective regulatory filings.

The first prescriptions in Europe and India mark the completion of a full-cycle success—research, approval, launch, and clinical use—of Henlius’ first self-developed and -manufactured innovative biologic in major pharmaceutical markets. These achievements set a replicable precedent for the company’s other innovative assets as they advance toward international markets. Henlius is working closely with its partners to expand market access and prescription coverage in more countries and regions, accelerating its mission to deliver high-quality biologics to patients around the world.

Reference

[1] UNFPA (United Nations Population Fund), 2025. “The Real Fertility Crisis: The pursuit of reproductive agency in a changing world.” ¬State of World Population 2025. New York: UNFPA. ISBN: 9789211542837