· The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of 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 is expected to further expand its lung cancer treatment portfolio in Europe, deepening its presence in major high-incidence tumour types

· Focused on lung cancer and gastrointestinal cancers, serplulimab has been approved in more than 40 countries and regions worldwide

May 23, 2026, Shanghai — Henlius Biotech, Inc. (2696.HK) announced that serplulimab (trade name: Hetronifly^® in Europe), the company’s self-developed anti-PD-1 mAb, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending its approval in combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).

The positive CHMP opinion marks a potential further expansion of serplulimab’s indication portfolio in Europe. 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). Under the EU regulatory framework, the CHMP positive opinion will be submitted to the European Commission (EC) for final review. If approved, serplulimab’s indications across EU Member States and European Economic Area (EEA) countries will be further expanded, enabling broader coverage of first-line lung cancer treatment and providing new treatment options for more patients.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU. We firmly believe that the value of innovative medicines lies not only in scientific breakthroughs themselves, but also in continuously expanding treatment coverage across different healthcare systems to ultimately reach more patients in need. Moving forward, we will continue to advance our global clinical development, regulatory, and commercialisation efforts, while working closely with our partners to improve access to innovative therapies worldwide.”

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 Primary Coverage of NSCLC: Serplulimab Poised to Further Strengthen 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 with substantial unmet clinical needs. With the positive CHMP opinion for the sqNSCLC indication, serplulimab is expected to further expand its coverage across multiple key lung cancer subtypes in the European market, ranging from SCLC to NSCLC, further strengthening its integrated lung cancer portfolio.

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 10 countries, including 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 more than 40 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 approved for the first-line treatment of ES-SCLC, to continuously expanding into NSCLC and gastrointestinal cancer indications, serplulimab is progressively building a broader global clinical value portfolio across multiple tumour types. 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 focus on major unmet clinical needs worldwide and leverage its integrated global capabilities spanning R&D, regulatory affairs, manufacturing, and commercialisation to accelerate breakthroughs in international mature markets and expand access to high-quality innovative biologics for patients worldwide.