HETRONIFLY® (SERPLULIMAB) FORMALLY ENTERS ROUTINE USE IN THE NHS FOLLOWING NICE RECOMMENDATION, BECOMING THE FIRST ANTI-PD-1 IMMUNOTHERAPY FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER IN ENGLAND and WALES
· Extensive-stage small cell lung cancer (ES-SCLC) is a highly aggressive type of cancer with 4,500 new cases each year in England and Wales, almost equivalent to the incidence of ovarian, stomach and liver cancers.1-6
· Small cell lung cancer cases represent approximately 15% of UK lung cancer diagnoses each year with one of the worst prognoses, an average median overall survival of only 2-4 months in the natural course.1,3
· Over one in five patients treated with serplulimab in the ASTRUM-005 study were alive at four years.7
Accord Healthcare UK (Accord) and Shanghai Henlius Biotech, Inc. (2696.HK) recently announced that HETRONIFLY® (serplulimab) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine use within the National Health Service (NHS) in England and Wales. According to publicly available UK pricing information, serplulimab has now been listed on the NHS.
With NICE’s recommendation now implemented and the product listed on the NHS, serplulimab has become the first anti-PD-1 monoclonal antibody recommended by NICE and available through the NHS in England and Wales for the treatment of ES-SCLC,8 supported by clinical trial data demonstrating a median overall survival of 15.8 months versus 11.1 months for placebo, with approximately 22% of patients still alive four years after starting treatment.7,9
Every year, around 4,500 people in England and Wales are diagnosed with ES-SCLC.1,2,3 Small-cell lung cancer accounts for approximately 15% of all lung cancer cases, with two-thirds of people receiving a diagnosis once it has reached an extensive stage.1 With a five-year mortality rate above 90% and most patients living less than a year after diagnosis with chemotherapy, even small extensions in survival could be meaningful to those affected and their loved ones.10,11
“This approval represents an important and long-overdue breakthrough for people living with extensive-stage small cell lung cancer and the families who support them,” said Paula Chadwick, Chief Executive of Roy Castle Lung Cancer Foundation.
“For decades, progress in treating small cell lung cancer has lagged far behind the advances seen in non-small cell lung cancer, where patients now benefit from a growing range of targeted and immunotherapy treatments. By contrast, people diagnosed with small cell lung cancer have faced limited options and devastating outcomes for far too long.”
“This aggressive disease progresses rapidly. That is why every additional month, every milestone and every precious moment gained through new treatment options matters so deeply. For families affected by this disease, that time is truly priceless.”
Serplulimab is a type of immunotherapy that helps the body’s own immune system recognise and attack cancer cells.12 The treatment became the first anti-PD-1 inhibitor in the United Kingdom approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for those living with ES-SCLC.13
“Even with current standards of care, median survival for extensive-stage small cell lung cancer in England and Wales is approximately 12 months, with the majority of patients relapsing rapidly. The decision from NICE to recommend serplulimab is a step forward in expanding potential treatment options for patients facing this challenging cancer,” said Dr Giuseppe Banna, Consultant Medical Oncologist for Lung and Urology Tumours, Department of Oncology of Portsmouth Hospitals University NHS Trust.
“I am grateful to NICE for enabling eligible patients to have the option of accessing this treatment. Whilst extensive-stage small cell lung cancer will remain a difficult prospect for the clinical community to manage, this decision creates new possibilities and will allow us to provide patients with another immunotherapy through the NHS.”
The decision was supported by positive data from the global phase 3 ASTRUM-005 clinical study. The safety profile of serplulimab was consistent with previous studies, with most common grade 3 adverse events including neutropenia (65.3%), leukopenia (33.7%), thrombocytopenia (23.1%), anaemia (19.8%), hyponatraemia (10%) and lymphopenia (5.1%).14
"The inclusion of HETRONIFLY® in the NHS following NICE recommendation is a strong validation of Henlius' commitment to bringing innovative immunotherapies to patients worldwide. We are proud to partner with Accord to make HETRONIFLY® available to the NHS," added Darius Panaligan, Chief Commercial Officer, International Markets of Henlius. "Our focus now is supporting timely access for eligible patients who can benefit from this treatment."
“At Accord Healthcare, we’re absolutely committed to supporting people living with lung cancer,” added Paul Tredwell, CEO of Accord Healthcare. “This recommendation means ES-SCLC patients will potentially have access to a treatment that has been shown to improve survival.”
“We will continue working with the NHS and oncology community to make sure those who could benefit from this treatment are able to access it as quickly as possible.”
Serplulimab is an anti-PD-1 monoclonal antibody which is effective by blocking the PD-1 receptor on immune cells which guides the immune system to identify and attack lung cancer cells.12 The treatment became the UK’s first anti-PD-1 inhibitor for those living with ES-SCLC to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA).13 The European Society of Medical Oncology (ESMO) assigned the treatment a score of four out of five in its Magnitude of Clinical Benefit Scale in ES-SCLC.15
In the study, serplulimab, in combination with chemotherapy, demonstrated significantly longer overall survival (OS) when compared with chemotherapy alone, with median OS of 15.8 months versus 11.1 months with placebo, with over 20% of patients alive at 4 years.7,9
The safety profile of serplulimab was consistent with previous studies, with most common grade 3 adverse events including neutropenia (65.3%), leukopenia (33.7%), thrombocytopenia (23.1%), anaemia (19.8%), hyponatraemia (10%) and lymphopenia (5.1%).14
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.16
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 extensive stage.1,17
Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.11
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.
Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and for perioperative gastric cancer. Up to date, it has been approved in 50 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb dulpatatug (HLX22) — are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.
To learn more about Henlius, visit http://www.hqglc.com/en/index.html and connect with us on LinkedIn at http://www.linkedin.com/company/henlius/.
Headquartered in the United Kingdom, Accord Healthcare is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies, selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide.
The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord is driven to think differently and deliver more for the benefit of patients worldwide.
Accord has particular heritage and expertise in oncology. We have over 54 oncology-related treatments across its portfolio and further molecules in our pipeline, including several due for regulatory review over the next five years. As one of the largest suppliers of chemotherapy products in Europe, one in three oncology injectables are Accord products. We particularly focus on prevalent tumour types, including breast and prostate cancer, in additional to haematological and cancer supportive care.
Accord is also investing in the future of cancer care with a new research and development facility under construction in the United Kingdom, to focus on biologics and vaccines, and further enable us to address patient needs at every step of their cancer treatment journey.
1. Zhang X, et al. Front. Immunol. 2022;13:1059331. Accessed May 2026.
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3. Mao Y, et al. Lung Cancer Manag. 2024;13(1):LMT64. Accessed May 2026.
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12. National Cancer Institute. Serplulimab. Available at: http://www.cancer.gov/publications/dictionaries/cancer-drug/def/serplulimab. Accessed May 2026
13. Medicines and Healthcare products Regulatory Agency (MHRA). Serplulimab approval. Available at: http://www.gov.uk/government/news/mhra-approves-uks-first-anti-pd-1-monoclonal-antibody-for-treatment-of-aggressive-form-of-lung-cancer. Accessed May 2026.
14. Serplulimab: Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc. Accessed May 2026.
15. European Society for Medical Oncology (ESMO). ESMO-MCBS scorecard. Available at: http://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards/?scorecard=470. Accessed May 2026.
16. Bray F, et al. CA: A Cancer Journal for Clinicians. 2024;74(3):229–263. Accessed May 2026.
17. Cancer Research UK. Types of lung cancer. Available at: http://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types/types. Accessed May 2026.
