The European Commission (EC) has formally approved two new indications for serplulimab for the first-line treatment of non-squamous non-small cell lung carcinoma (nsqNSCLC) and esophageal squamous cell carcinoma (ESCC)

• Serplulimab’s approved indications in Europe have expanded to three, spanning key treatment areas across lung and gastrointestinal cancers and further advancing its global regulatory footprint

• Serplulimab has been approved in over 40 countries and regions worldwide, launched in 16 EU countries, and included in reimbursement schemes across 10 European markets

Shanghai, China – May 10, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (European trade name: Hetronifly^®), has received formal approval from the European Commission (EC) for two new indications: in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma (nsqNSCLC) without EGFR, ALK, or ROS1 positive mutations ineligible to local therapy, and with unresectable locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC), whose tumours express PD-L1 with a CPS ≥ 5.

This approval marks a further expansion of serplulimab’s indication portfolio in Europe. Previously, serplulimab had already been approved in the European Union as the world’s first anti-PD-1 monoclonal antibody for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). With these latest approvals, serplulimab’s approved indications in Europe have expanded to three, spanning multiple key treatment settings across lung and gastrointestinal cancers and further strengthening Henlius’ integrated global regulatory and commercialisation strategy.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The continued expansion of serplulimab’s indication portfolio in Europe not only further broadens its treatment footprint across major high-incidence cancers globally, but also reflects our firm commitment to advancing our Globalisation 2.0 strategy. We remain focused on unlocking the clinical value of this core innovative asset to benefit more patients worldwide. Looking ahead, we will continue leveraging growing clinical evidence, an increasingly integrated global network, and close partner collaboration to accelerate access to high-quality innovative therapies across broader international markets.”

Strong Clinical Evidence Underpins Approval of Two New Indications

The EC approvals are primarily based on results from the ASTRUM-002 and ASTRUM-007 studies. These two phase 3 clinical trials previously supported the approval of serplulimab in China for first-line treatment of nsqNSCLC and ESCC, respectively, with findings presented at major international academic conferences and published in leading peer-reviewed journals.

ASTRUM-002, led by Professor Yuankai Shi from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, evaluated serplulimab in combination with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone in patients with advanced nsqNSCLC and no EGFR, ALK, or ROS1 positive mutations. The study demonstrated a statistically significant improvement in progression-free survival (PFS), meeting its primary endpoint with a favourable safety profile. Final results of ASTRUM-002 were presented as a late-breaking abstract at the European Society for Medical Oncology Annual Meeting (ESMO), showing a median overall survival (mOS, key secondary outcome of the study) for the serplulimab plus chemotherapy group which reached 26.8 months, successfully surpassing the two-year mark.

ASTRUM-007, led by Professor Jing Huang from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, evaluated serplulimab in combination with chemotherapy (cisplatin and 5-FU) versus placebo plus chemotherapy in previously untreated patients with PD-L1-positive advanced ESCC. The study demonstrated significant improvements in both overall survival (OS) and progression-free survival (PFS), with a favourable safety profile. The results were published in Nature Medicine.

European Regulatory Success Continues to Translate into Systematic Patient Access

Since serplulimab first received EC approval in February 2025 for first-line treatment of ES-SCLC, Henlius, together with its European regional partner Accord Healthcare Ltd (“Accord”), a subsidiary of Intas, has continued advancing market access and commercialisation across Europe.

To date, serplulimab in ES-SCLC, which scores 4 out of 5 on the European Society for Medical Oncology’s (ESMO) magnitude of clinical benefit scale (MCBS), has been commercially launched in 16 EU countries and has been reimbursed in in 10 countries, including Austria, Denmark, Germany, France, Ireland, Italy, Spain, and 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 days. ¹

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.

Globalisation 2.0 Continues to Deepen, Advancing Innovation for More Patients Worldwide

Serplulimab demonstrates unique advantages in treating various solid tumours via its differentiated mechanism of action. The drug not only induces stronger PD-1 internalisation, 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 and gastrointestinal cancers, serplulimab has been approved in China for squamous NSCLC (sqNSCLC), ES-SCLC, ESCC, and nsqNSCLC, and has now been approved in over 40 countries and regions worldwide, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the global population.

Henlius continues to advance an extensive global clinical program for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,700 patients enrolled. Bridging studies in ES-SCLC in both the United States and Japan have completed full patient enrollment.

In gastrointestinal cancers, ASTRUM-006, the phase 3 study is evaluating serplulimab in perioperative gastric cancer, including neoadjuvant combination therapy and adjuvant monotherapy, representing a novel treatment approach. ⁷ As the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy, its New Drug Application (NDA) has been accepted by the National Medical Products Administration (NMPA) and granted Priority Review. The indication is expected to be approved in China in 2026. In colorectal cancer, ASTRUM-015, the global phase 3 study evaluating serplulimab in combination with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.⁸

The formal approval of these two new indications in Europe not only further validates serplulimab’s global clinical value across lung and gastrointestinal cancers, but also marks another meaningful step forward in Henlius’ Globalisation 2.0 strategy for innovative product internationalisation.

From regulatory approvals to reimbursement access, and from multi-regional launches to systematic commercialisation, Henlius continues to drive a more integrated, higher-quality, and broader-reaching model for global immuno-oncology development. Looking ahead, Henlius will remain focused on unmet clinical needs worldwide, leveraging its integrated capabilities across R&D, regulatory affairs, manufacturing, and commercialisation to accelerate the global reach of high-quality innovative biologics and benefit more patients around the world.