Shanghai, China, May 23, 2026
Henlius Biotech has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of serplulimab (Hetronifly® in Europe) in combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). The milestone represents another major step in Henlius’ expanding global oncology strategy and further strengthens the company’s growing presence in the European immuno-oncology market.
The recommendation follows previous European approvals for serplulimab in extensive-stage small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer (nsqNSCLC), and esophageal squamous cell carcinoma (ESCC). If formally approved by the European Commission later this year, serplulimab will further expand its first-line lung cancer treatment coverage across Europe, giving physicians and patients access to an additional anti-PD-1 immunotherapy option for one of the world’s deadliest cancers.
Phase 3 ASTRUM-004 Trial Supports European Expansion
The CHMP positive opinion was primarily based on data from the pivotal ASTRUM-004 Phase 3 clinical trial, an international, randomized, double-blind multicenter study evaluating serplulimab in combination with chemotherapy for previously untreated advanced sqNSCLC patients. The trial compared serplulimab plus chemotherapy against placebo combined with chemotherapy and demonstrated significant improvements across key clinical endpoints.
According to Henlius, patients receiving serplulimab achieved meaningful improvements in both overall survival (OS) and progression-free survival (PFS) while maintaining a manageable safety profile. Researchers described the results as highly encouraging for patients with squamous non-small cell lung cancer, a disease subtype historically associated with limited targeted treatment options and poor long-term prognosis.
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The final analysis data from the ASTRUM-004 study was previously presented during the 2023 World Conference on Lung Cancer (WCLC) and later published in the leading oncology journal Cancer Cell, where the study was also featured on the journal cover. The publication significantly increased international scientific recognition of serplulimab’s clinical potential within the global oncology community.
Based on the same Phase 3 findings, serplulimab already received approval from China’s National Medical Products Administration (NMPA) in 2022 for first-line sqNSCLC treatment in combination with chemotherapy.
Henlius Strengthens Global Immuno-Oncology Strategy
Non-small cell lung cancer accounts for approximately 85% of all lung cancer cases globally, with squamous NSCLC representing a major subtype associated with substantial unmet clinical needs. Henlius stated that the latest European milestone significantly strengthens serplulimab’s integrated lung cancer portfolio by expanding treatment coverage across multiple high-incidence tumor categories.
Since receiving its first European Union approval in February 2025, serplulimab has continued expanding commercially across Europe through Henlius’ partnership with Accord Healthcare. The company confirmed that the medicine has already launched in 16 European countries and secured reimbursement or public healthcare access in multiple key markets including Germany, Italy, Spain, Sweden, Austria, Denmark, and Ireland.
Serplulimab has now been approved in more than 40 countries and regions worldwide, supporting Henlius’ ambition to become a globally recognized biopharmaceutical company focused on innovative oncology biologics. Industry analysts believe the latest CHMP recommendation may significantly increase the therapy’s commercial potential within Europe’s competitive immunotherapy market while strengthening Henlius’ international regulatory credibility.
The company also confirmed that additional clinical development, bridging studies, and regulatory activities are ongoing in the United States, Japan, and other international markets as part of a broader strategy to expand global patient access to advanced anti-PD-1 cancer therapies. Experts believe the continued expansion of serplulimab across lung cancer indications could position the therapy as one of the most important emerging immuno-oncology assets originating from China’s biotechnology sector.
As global demand for targeted immunotherapies continues rising, Henlius’ expanding oncology pipeline reflects the growing influence of Asian biopharmaceutical innovation within international cancer treatment markets.
Source: Henlius press release
