• The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued two positive opinions recommending new indications for serplulimab in 30 EEA countries

• As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), serplulimab has been launched in 12 EU countries and included in reimbursement schemes in 7

• Serplulimab has been approved in over 40 countries and regions worldwide, covering nearly half of the global population

Shanghai, China – March 30, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly^®), has received two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP recommends approval of serplulimab 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) and with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (whose tumours express PD-L1 with a CPS ≥ 5.).

Serplulimab has previously been approved in the European Union (EU) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Under EU regulatory procedures, the CHMP’s positive opinion will be submitted to the European Commission (EC) for final decision. If approved by the EC, the indications of serplulimab in the EU Member States and the European Economic Area (EEA) will be further expanded.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinions strongly validate the clinical value and robust scientific evidence of serplulimab, marking another significant milestone in expanding our global oncology footprint. Lung cancer and gastrointestinal tumours pose severe threats to human health, representing substantial and urgent unmet medical needs in Europe and globally. If approved, these two new indications will provide local patients with new treatment options and survival benefits. Moving forward, we will continuously advance the global development and regulatory submissions of our innovative therapies, working alongside our partners to accelerate the delivery of clinical benefits to more patients.”

Robust Clinical Evidence with Recognized Efficacy and Safety

The CHMP opinions 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.

Both studies are randomized, double-blind, multicentre Phase 3 trials designed to evaluate the efficacy and safety of serplulimab in the respective patient populations. Results have been presented at international academic conferences and published in 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. 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) for the serplulimab plus chemotherapy group 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.

Steady Commercialization and Enhanced Accessibility in Europe

As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC, serplulimab has made steady progress in the European market since receiving EC approval in February 2025.

Henlius, together with its EU regional partner Accord Healthcare Ltd (“Accord”), a subsidiary of Intas, has continued to drive market access and commercialization efforts in Europe. To date, Hetronifly^® has been launched in 12 EU countries and has been reimbursed in Austria, Denmark, Germany, Ireland, Italy, Spain and Sweden so far, 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.

Differentiated Mechanism and Global R&D Advancement

Serplulimab demonstrates unique advantages in treating various solid tumours via its differentiated mechanism of action. The drug not only induces stronger PD-1 internalization, 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.

Serplulimab has been approved in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, ESCC, and nsqNSCLC. Up to date, it has been approved in over 40 countries and regions 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 programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,100 patients enrolled. Bridging studies for ES-SCLC are being conducted in the United States and Japan.

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

Looking ahead, Henlius will continue to advance global registration and clinical development of serplulimab, further expanding its potential across tumour types and bringing innovative treatment options to patients worldwide.

References

1.EFPIA Patients W.A.I.T. Indicator 2024 Survey, IQVIA, published in Apr.2025

2.Issafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972.

3.Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.

4.Patsoukis N, et al. Interaction of SHP-2 SH2 domains with PD-1 ITSM induces PD-1 dimerization and SHP-2 activation. Commun Biol. 2020;3(1):128.

5.Fenwick C, et al. Tumor suppression of novel anti-PD-1 antibodies mediated through CD28 costimulatory pathway. J Exp Med. 2019;216(7):1525-1541.

6.Primavera E, et al. Computer-Aided Identification of Kinase-Targeted Small Molecules for Cancer: A Review on AKT Protein. Pharmaceuticals (Basel). 2023;16(7):993.

7.China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer. Henlius. December 12, 2025. Accessed December,232025. https://www.henlius.com/en/NewsDetails-5670-26.html

8.Wang ZX, Peng J, Liang X, et al. First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. Med. 2024;5(9):1150-1163.e3. doi:10.1016/j.medj.2024.05.009