- Serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of ES-SCLC and has reached over 110,000 patients
- It has been approved in nearly 40 countries including China, Europe, India and multiple Southeast Asian countries
- Commercialisation in Europe and India is led by Intas and its subsidiary Accord Healthcare
Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly®) has been approved in both the United Kingdom and India for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Commercialisation in the UK and India will be led by Henlius’ partner Intas and its subsidiary Accord Healthcare.
The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC.
Lung cancer remains the leading cause of cancer-related death globally[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. Hetronifly® is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of SCLC. Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), commented: “As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis.” [2]
In India, lung cancer ranks fourth in both incidence and mortality among cancers. In 2022, over 81,000 new cases and more than 75,000 deaths were reported[1]. According to the State of World Population 2025 report by the United Nations Population Fund (UNFPA), India’s population is projected to reach 1.46 billion, reaffirming its position as the most populous country in the world[3]. The growing demand for healthcare resources highlights the urgent need to improve access to innovative therapies.
The approvals of Hetronifly® in the UK and India—representing a mature, mainstream biologics market and emerging market, respectively—underscore a significant milestone in expanding the therapy’s global reach. Leveraging the local expertise and commercial networks of Intas and Accord Healthcare, Hetronifly® is expected to accelerate market penetration and address unmet medical needs in both regions, bringing tangible clinical benefits to more patients.
Regarding the UK approval, Paul Tredwell, Executive Vice-President, EMENA, Accord Healthcare said: “At Accord, we are dedicated to supporting patients with cancer. The MHRA’s approval of Hetronifly® provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions.”
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy, but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world.”
As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in nearly 40 countries and regions including China, Indonesia, Singapore, Germany, the UK and India, reaching over 110,000 patients worldwide. Its potential in SCLC has been widely recognised, with orphan drug designations granted by the US FDA, the European Commission, and Swissmedic for SCLC; Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group (ILAP); and orphan drug designation from South Korea’s MFDS for ES-SCLC.
Henlius is currently conducting head-to-head bridging trials in the US and Japan comparing serplulimab with atezolizumab—the current standard of care for ES-SCLC—to further support global regulatory filings. Looking ahead, the company will continue to collaborate with global partners to enhance accessibility and bring more life-changing therapies to patients worldwide.
