Accord Healthcare receives approval for Hetronifly® (Serplulimab), from the Medicines and Healthcare Regulatory Agency (MHRA) for first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

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• Intas and its subsidiary Accord Healthcare lead commercialisation in Europe and India.
• In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed.
• ESMO has scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC.
• Serplulimab is the only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC and has now reached over 110,000 patients.
• It has been approved in nearly 40 countries, including China, Europe, India and multiple Southeast Asian countries.

LONDON, June 24, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) is delighted to announce that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly®, has been approved by the MHRA to treat adults in the UK with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated and has spread within the lungs or to other parts of the body. 

This approval comes in the same week as the announcement in India, bringing the total number of countries and regions in which the medicine is approved to over 40 — including Europe, China, Indonesia, and Singapore. Accord Healthcare will lead commercialisation in both the UK and India on behalf of its parent company, Intas, and its commercial partner, Henlius.

Lung cancer remains the leading cause of cancer-related death globally. 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^[1].

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] 

Henlius Biotech originally developed Serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise the medicine in over 50 countries across Europe and India.

Welcoming the news, 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."

In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed. 

ESMO has also scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC. 

About Serplulimab

Serplulimab (recombinant humanised anti-PD-1 monoclonal antibody injection)) is an anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries.  Serplulimab has been approved by the National Medicinal Products Administration (NMPA) in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare serplulimab to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, serplulimab was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

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.

About Lung Cancer

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.^[1]

Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis.

Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in an extensive stage.

Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.^[3]

References

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834
2. MHRA approves the UK's first anti-PD-1 monoclonal antibody for the treatment of an aggressive form of lung cancer. https://www.gov.uk/government/news/mhra-approves-uks-first-anti-pd-1-monoclonal-antibody-for-treatment-of-aggressive-form-of-lung-cancer last accessed June 2025
3. Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207

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