The European Commission (EC) has approved a new indication for serplulimab (trade name: Hetronifly® in Europe) for squamous non-small cell lung cancer (sqNSCLC)
Following approvals in ES-SCLC, nsqNSCLC, and ESCC, serplulimab further expands its portfolio in the European market, deepening its presence in major high-incidence tumour types
Serplulimab has been approved in 50 countries and regions worldwide and recently gained approval in China for a perioperative gastric cancer indication, continuing to validate its differentiated clinical value across multiple treatment settings.
June 25, 2026, Shanghai — Shanghai Henlius Biotech, Inc. (2696.HK) announced that serplulimab (trade name: Hetronifly® in Europe), the company’s self-developed anti-PD-1 mAb, has been approved by the European Commission (EC) for combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). Previously, serplulimab had already been approved in the European Union for extensive-stage small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer (nsqNSCLC), and esophageal squamous cell carcinoma (ESCC). This approval marks further expansion of serplulimab’s indications across EU Member States and European Economic Area (EEA) countries, enabling broader coverage of first-line treatment of core subtypes of lung cancer and providing new treatment options for more patients. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “From lung cancer to gastrointestinal cancers, serplulimab continues to expand its clinical reach, bringing innovative treatment options to patients worldwide. The European Commission’s approval of serplulimab for squamous non-small cell lung cancer not only further strengthens the product’s foundation for growth in the European market, but also underscores the consistent execution of our global clinical development strategy. Moving forward, we remain committed to addressing significant unmet medical needs by accelerating the development, regulatory approval and commercialisation of innovative therapies worldwide, so that more patients can benefit from scientific innovation.” Pivotal Phase 3 Trial ASTRUM-004 Establishes Evidence Base Supporting Global Regulatory Advancement in sqNSCLC The positive CHMP opinion was primarily based on ASTRUM-004, a randomised, double-blind, international multicentre phase 3 clinical trial. Led by Dr. Caicun Zhou of Shanghai East Hospital, Tongji University School of Medicine, the study was designed to evaluate the efficacy and safety of serplulimab versus placebo, each in combination with chemotherapy, in patients with previously untreated advanced sqNSCLC. Study results demonstrated that, compared with the standard-of-care regimen, serplulimab plus chemotherapy significantly improved survival outcomes in patients with previously untreated locally advanced or metastatic sqNSCLC, showing positive results across key endpoints including overall survival (OS) and progression-free survival (PFS), with a manageable safety profile. The final analysis results of the overall population from the ASTRUM-004 trial were first shared in an oral presentation at the 2023 World Conference on Lung Cancer (WCLC). On January 5, 2024, the study was published online in Cancer Cell, a leading international oncology journal, and was featured on the journal cover, highlighting the study’s significance within the global clinical oncology community and its potential impact on the treatment landscape of sqNSCLC. Based on the results of ASTRUM-004, serplulimab received approval from China’s National Medical Products Administration (NMPA) in 2022 in combination with chemotherapy for the first-line treatment of sqNSCLC. Expanding from ES-SCLC to Coverage of Core Subtypes of NSCLC: Serplulimab Further Strengthens Its First-Line Lung Cancer Portfolio in Europe Lung cancer remains one of the most significant contributors to the global cancer burden. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, among which squamous non-small cell lung cancer (sqNSCLC) represents a major subtype. While immunotherapy has markedly improved outcomes for patients with sqNSCLC in recent years, unmet needs remain in achieving greater long-term survival benefits. With the EC’s approval of the sqNSCLC indication, serplulimab further expands its coverage across multiple key lung cancer subtypes in the European market, ranging from SCLC to NSCLC, further strengthening its integrated immunotherapy portfolio in lung cancer. Since receiving its first approval in the European Union in February 2025, Henlius, together with its regional partner Accord, has continued to advance market access and commercialisation efforts for serplulimab across Europe. To date, serplulimab has been commercially launched in 16 European countries and has been included in reimbursement or public healthcare coverage systems in over 10 countries, including the United Kingdom, Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, thereby gaining access to mainstream healthcare systems in these markets. Supported by its continuously expanding indication portfolio, serplulimab is steadily enhancing its clinical value, commercial potential, and long-term accessibility in the European market. From Differentiated Indication Expansion to Unlocking Blockbuster Potential, Serplulimab Continues to Expand Its Global Value Proposition As a core product underpinning Henlius’ globalisation strategy, serplulimab has been approved in 50 countries and regions worldwide, covering nearly half of the global population. The product continues to advance multiple international clinical trials and regulatory filings across major high-incidence cancers, including lung cancer and gastrointestinal cancers. From becoming the world's first anti-PD-1 mAb launched for first-line treatment of ES-SCLC, to recently gaining approval in China for perioperative treatment of gastric cancer as the first and only[1] anti-PD-1 mAb approved for this indication worldwide, serplulimab is steadily building a differentiated global clinical value proposition across major high-burden cancers through its forward-looking clinical development strategy. Meanwhile, the company is simultaneously advancing bridging studies and regulatory plans in the United States, Japan, and additional international markets, further strengthening the foundation for its global commercialisation strategy. Looking ahead, Henlius will continue to leverage its integrated global capabilities across R&D, regulatory affairs, manufacturing and commercialisation to advance innovative therapies with first-in-class and best-in-class potential, drive further breakthroughs in major global markets, and bring high-quality biologic medicines to more patients worldwide. *As of June 25, 2026 About Serplulimab Serplulimab is a recombinant humanized anti-PD-1 mAb injection (trade name: Hetronifly® in Europe). It is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and for perioperative gastric cancer. Up to date, it has been approved in 50 countries and regions including China, the U.K., EU, Singapore, India, Switzerland, and Peru. In March 2022, serplulimab was officially approved in China and is currently indicated for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC), and gastric cancer (GC). With the approval of the gastric cancer indication, serplulimab has become the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy. Henlius continues to advance an extensive global clinical programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,700 patients enrolled, with over 30% of patients enrolled in two pivotal international studies being Caucasian, making it one of the anti-PD-1 mAbs with the most extensive international clinical data. Bridging studies for ES-SCLC are being conducted in the United States and Japan. In colorectal cancer, ASTRUM-015, the global phase 3 study evaluating serplulimab in combination with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.1 Three pivotal clinical studies of serplulimab have been published in leading journals including The Lancet, The Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer. In addition, serplulimab has been included in several authoritative clinical guidelines, such as the CSCO Guidelines for SCLC, NSCLC, ESCC, GC, Clinical Application of Immune Checkpoint Inhibitors, and Chinese Guidelines for Radiotherapy in Esophageal Cancer, providing important references for oncology clinical practice. Internationally, serplulimab for the treatment of SCLC has been granted Orphan Drug Designations (ODDs) by regulatory authorities of multiples countries, including the U.S. FDA. References Wang ZX, Peng J, Liang X, et al. First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. Med. 2024;5(9):1150-1163.e3. doi:10.1016/j.medj.2024.05.009
