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- Serplulimab has been launched in 12 EU countries and included in reimbursement schemes in Germany, Italy, Spain and other Member States
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- Approved in over 40 countries and regions worldwide, covering nearly half of the global population
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- Henlius continues to advance the systematic global rollout of innovative immunotherapies with partners
This February, Henlius (2696.HK) marks the one-year anniversary of the European Union approval of its self-developed anti-PD-1 monoclonal antibody serplulimab (trade name in Europe: Hetronifly®).
In February 2025, the European Commission (EC) granted marketing authorization for serplulimab in combination with carboplatin and etoposide as a first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). As the first anti-PD-1 monoclonal antibody approved globally for first-line treatment of ES-SCLC, serplulimab has since advanced steadily across the European market.
Over the past year, Henlius, together with its EU regional partner Accord Healthcare Ltd (“Accord”), a subsidiary of Intas, has continued to drive market access and commercialization efforts. To date, Hetronifly® has been launched in 12 EU countries and has been reimbursed in Austria, Denmark, Germany, Ireland, Italy, Spain, Sweden, entering mainstream healthcare systems and supporting improved outcomes for eligible patients.
Reimbursement decisions in the EU are typically subject to stringent health technology assessment (HTA) processes, evaluating clinical efficacy, safety, patient benefit and cost-effectiveness. According to IQVIA, the average reimbursement approval lead time cross EU Member States is 578 days1.
Achieving reimbursement coverage across multiple Member States within one year of EU approval reflects recognition of the clinical value and real-world applicability of serplulimab within mature European healthcare systems. It also marks a key step in transitioning from regulatory approval to broader patient accessibility across the region.
Strong Clinical Foundation and International Recognition
The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including China, Poland, Türkiye, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians.
Based on the clinical outcomes demonstrated in ASTRUM-005, serplulimab has received Orphan Drug Designations (ODDs) by the US FDA, the European Commission, Swissmedic, Korea MFDS and Mexico COFEPRIS, supporting regulatory and development pathways in small cell lung cancer.
In addition, clinical data of serplulimab in ES-SCLC were incorporated into the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS), where it achieved the highest score among evaluated therapies for this indication. The data have also been presented through oral presentations and dedicated sessions at international academic conferences including ESMO and the World Conference on Lung Cancer (WCLC).
Parallel Global Development and Expanding Indication Footprint
Serplulimab demonstrates unique advantages in treating various solid tumours via its differentiated mechanism of action. The drug not only induces stronger PD-1 internalization, reducing PD-1 receptor presence on T cells for rapid and potent immune activation 2—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signalling 3-5, enhancing downstream AKT activity 6, and promoting sustained T-cell activation. Focused on lung cancers and gastrointestinal cancers, serplulimab has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), ESCC, and non-squamous non-small cell lung cancer (nsNSCLC).
Up to date, it has been approved in over 40 countries and regions including China, the U.K., the EU, Singapore, India, Switzerland and Peru, covering nearly half of the global population. Henlius continues to advance regulatory submissions globally, and additional EU approvals for new indications are anticipated before the end of 2026.
The progress achieved in the EU market over the past year lays a solid foundation for the commercialisation of Henlius’ broader innovative pipeline in Europe and other mature markets. It also provides practical experience for the value realization pathway of innovative immunotherapies developed in China within global healthcare systems.
Henlius remains committed to its patient-centred R&D and globalization strategy. The company will continue working closely with global partners and local healthcare stakeholders to expand access to innovative biologics across more countries and regions, bringing high-quality therapies to a broader patient population.
References
1. EFPIA Patients W.A.I.T. Indicator 2024 Survey, IQVIA, published in Apr.2025
2.ssafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972.
3. Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.
4. Patsoukis N, et al. Interaction of SHP-2 SH2 domains with PD-1 ITSM induces PD-1 dimerization and SHP-2 activation. Commun Biol. 2020;3(1):128.
5. Fenwick C, et al. Tumor suppression of novel anti-PD-1 antibodies mediated through CD28 costimulatory pathway. J Exp Med. 2019;216(7):1525-1541.
6. Primavera E, et al. Computer-Aided Identification of Kinase-Targeted Small Molecules for Cancer: A Review on AKT Protein. Pharmaceuticals (Basel). 2023;16(7):993.