Serplulimab, marketed as Hetronifly®, has achieved significant regulatory milestones, becoming the first and only anti-PD-1 monoclonal antibody approved in the UK for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) that has not been previously treated and has spread within the lungs or to other parts of the body. This UK approval, granted by the Medicines and Healthcare products Regulatory Agency (MHRA), coincided with an announcement in India, bringing the total number of countries and regions where the medicine is approved to over 40, including Europe, China, Indonesia, and Singapore. Intas Pharmaceuticals and its subsidiary Accord Healthcare are leading the commercialization efforts in Europe and India, with Accord Healthcare specifically spearheading commercialization in the UK and India on behalf of Intas and its commercial partner, Henlius.

Small cell lung cancer (SCLC) is a particularly aggressive subtype, accounting for approximately 15% to 20% of all lung cancer cases. It is known for its high malignancy, early metastasis, rapid progression, and often poor prognosis, with limited treatment options. The introduction of serplulimab provides a crucial new therapeutic avenue for patients facing this challenging disease, a sentiment echoed by Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK's MHRA, who emphasized its importance as an option for patients with limited choices.

The development of serplulimab was originally undertaken by Henlius Biotech. In 2023, Henlius forged a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights for the development and commercialization of the medicine in over 50 countries across Europe and India. Paul Tredwell, Executive Vice-President EMENA at Accord Healthcare, welcomed the approval, stating that it reflects their commitment to providing novel specialty medicines for difficult-to-treat conditions. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, highlighted that these approvals represent continued progress in their globalization strategy and a dedication to patient-centric innovation.

Serplulimab has received significant recognition from regulatory bodies and clinical organizations. In December 2022, it was granted orphan drug designation by the European Commission (EC) for SCLC, a designation that was recently reviewed and renewed. It also holds an orphan drug designation from the FDA for the same condition. Furthermore, the European Society for Medical Oncology (ESMO) has rated serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) for ES-SCLC, underscoring its clinical significance.

The approvals are primarily underpinned by the robust data from the global phase 3 clinical study, ASTRUM-005. This study enrolled 585 patients across 128 trial sites worldwide. The final analysis results of ASTRUM-005, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated a median follow-up of 42.4 months and a remarkable 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These findings further solidify the long-term survival benefit of this immunotherapy-based regimen for ES-SCLC patients. Additionally, a bridging head-to-head trial is currently underway in the United States, comparing serplulimab to atezolizumab, the standard of care anti-PD-L1 mAb, for the first-line treatment of ES-SCLC.

Beyond ES-SCLC, serplulimab has received approvals in China from the National Medicinal Products Administration (NMPA) for other indications, including squamous non-small cell lung cancer (sqNSCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). Its efficacy has been further validated by the publication of results from four pivotal trials in prestigious journals such as the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell, and British Journal of Cancer. It is also recommended in several definitive clinical guidelines in China, providing valuable references for tumor diagnosis and treatment.

With over 110,000 patients having received serplulimab to date, the drug is making a significant impact globally. Lung cancer remains the leading cause of cancer-related death worldwide, with over 2.48 million new cases reported in 2022. The high malignancy and poor prognosis associated with SCLC highlight the urgent need for effective treatments like serplulimab, which now offers new hope to patients across multiple regions.