The European Commission approved Henlius’ serplulimab for first-line advanced nsqNSCLC and PD-L1-positive ESCC based on phase 3 ASTRUM-002 and ASTRUM-007 trial data
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Shanghai-based Shanghai Henlius Biotech announced that the European Commission has approved two new indications for its anti-PD-1 monoclonal antibody serplulimab, marketed in Europe as Hetronifly®, expanding the therapy’s footprint in lung and gastrointestinal cancers.
The approvals cover serplulimab in combination with chemotherapy for the first-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (nsqNSCLC) without EGFR, ALK, or ROS1 mutations who are not eligible for local therapy.
The European Commission also approved the therapy for patients with unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC) whose tumours express PD-L1 with a combined positive score (CPS) of at least 5.
Serplulimab had previously received European approval for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), making it the first anti-PD-1 monoclonal antibody approved globally for that indication. With the latest decisions, the drug now holds three approved indications in Europe.
Henlius Chief Executive Officer Dr. Jason Zhu said the approvals further expand serplulimab’s reach across major high-incidence cancers and support the company’s “Globalisation 2.0” strategy focused on accelerating international access to innovative therapies.
The European approvals were primarily supported by data from the phase 3 ASTRUM-002 and ASTRUM-007 studies. In ASTRUM-002 (NCT03952403), serplulimab combined with carboplatin and pemetrexed demonstrated statistically significant progression-free survival improvement versus chemotherapy alone in advanced nsqNSCLC patients without EGFR, ALK, or ROS1 mutations. Final study data presented at the European Society for Medical Oncology Annual Meeting showed median overall survival reached 26.8 months in the serplulimab combination arm.
ASTRUM-007 (NCT03958890) evaluated serplulimab with cisplatin and 5-FU in previously untreated PD-L1-positive advanced ESCC patients. The study reported significant improvements in overall survival and progression-free survival compared with placebo plus chemotherapy, while maintaining a favourable safety profile. Results from the trial were published in Nature Medicine.
Henlius and its European partner Accord Healthcare have continued expanding access to serplulimab across Europe following the therapy’s initial EU approval in February 2025 for ES-SCLC. According to the company, the treatment has been commercially launched in 16 European Union countries and reimbursed in 10 countries, including Germany, France, Italy, Spain, Sweden, and Ireland.
The company also highlighted serplulimab’s broader global development program, which includes more than 10 ongoing combination immunotherapy studies and enrollment of over 5,700 patients worldwide. Serplulimab has now been approved in more than 40 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.