Henlius (02696.HK) Serplulimab Approved by EU Commission for First-Line sqNSCLC

Shanghai Henlius Biotech, Inc. (2696.HK) announced on June 25, 2026, that the Board is pleased to announce that recently, the European Commission ("EC") has approved the Company's independently developed serplulimab injection (China trade name: Hansizhuang®; EU trade name: HETRONIFLY®) for a new indication: serplulimab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). This approval means the new indication is approved in all EU member states as well as Iceland, Liechtenstein and Norway (each being European Economic Area (EEA) countries).

This EC approval is primarily based on a randomized, double-blind, international multi-center Phase 3 clinical study. The study results showed that serplulimab combined with carboplatin and nab-paclitaxel for first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) demonstrated significant clinical benefit, meeting the pre-specified primary endpoint, with good safety and tolerability. In December 2023, the Group received several GMP certificates from the Dutch Health and Youth Care Inspectorate, confirming that serplulimab-related production lines meet EU GMP standards. In addition, in May 2026, serplulimab received a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP), recommending approval for this new indication.

Serplulimab is an innovative anti-PD-1 monoclonal antibody independently developed by the Company. In China, approved indications include first-line combination therapy for 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 (nsNSCLC), and gastric cancer neoadjuvant/adjuvant therapy. In the EU, approved indications include first-line combination therapy for sqNSCLC, ES-SCLC, ESCC and nsNSCLC. Serplulimab has also been approved in the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has received orphan drug designation from drug regulatory authorities in the US, Switzerland, and South Korea.

According to IQVIA MIDASTM data, global sales of PD-1-targeted monoclonal antibody drugs in 2025 were approximately USD50.871 billion.

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