• The world’s first and only* anti-PD-1 monoclonal antibody approved for a perioperative gastric cancer indication, filling a major clinical treatment gap

• The world’s first postoperative “chemo-sparring” perioperative regimen for gastric cancer, replacing adjuvant chemotherapy with immunotherapy monotherapy, significantly reducing the risk of recurrence and bringing curative treatment within reach

• The pivotal ASTRUM-006 study was published in The Lancet and featured prominently at ASCO 2026, and has already been incorporated into the CSCO guidelines

Shanghai, June 9, 2026 — Henlius (2696.HK) announced that the New Drug Application (NDA) for a new indication of its self-developed anti-PD-1 monoclonal antibody(mAb) HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly^®) , in combination with Oxaliplatin and S-1 for neoadjuvant treatment of resectable gastric cancer with tumour PD-L1 expression CPS ≥ 5, followed by adjuvant monotherapy after surgery, has been officially approved by the China National Medical Products Administration (NMPA) under the priority review pathway.

With this approval, serplulimab becomes the first and only* anti-PD-1 mAb in the world approved for perioperative treatment of gastric cancer, filling a long-standing clinical gap in this setting. More importantly, this groundbreaking regimen enables a postoperative “chemo-sparring” approach, replacing conventional adjuvant chemotherapy with immunotherapy monotherapy. While significantly improving efficacy, it also effectively avoids chemotherapy-related toxicities, greatly enhancing treatment compliance and tolerability for patients with locally advanced gastric cancer, and ushering perioperative gastric cancer treatment into a new era of precise, efficient, and curative care.

Dr. Jason Zhu, Executive Director and CEO of Henlius, stated:“The approval of serplulimab for perioperative gastric cancer marks another major milestone for Henlius as we continue to drive innovation based on 'first principles' and deepen our presence in gastrointestinal oncology. Centered on patient needs, this new post-operative chemotherapy-free regimen not only underscores our strong expertise in tumor immunotherapy, but also brings new hope for cure to patients undergoing perioperative treatment for gastric cancer. Looking ahead, we will continue to unlock the clinical potential of our innovative pipeline and accelerate our Globalization 2.0 strategy, with the goal of delivering high-quality innovative biologic medicines to benefit patients in China and around the world.”

Professor Lin Shen from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, stated:“Gastric cancer remains a highly prevalent malignancy in China, and traditional high-intensity perioperative chemotherapy often results in poor patient compliance due to toxicity. The serplulimab-based perioperative regimen has successfully achieved a postoperative ‘chemo-sparring’ approach. This innovative strategy of enhancing efficacy while reducing toxicity significantly improves outcomes while also addressing safety and tolerability. The approval of this indication for serplulimab effectively addresses a long-standing unmet clinical need, offering gastric cancer patients a higher-quality chance for cure and further promoting the development of perioperative gastric cancer treatment in China toward greater precision, efficiency, and standardization.”

Addressing a Critical Unmet Need and Setting a New Benchmark in Perioperative Treatment for Gastric Cancer

Gastric cancer remains one of the most common malignancies worldwide, ranking among the leading causes of cancer incidence and mortality. The disease burden is particularly significant in China, where an estimated 342,000 new cases and 249,000 deaths were reported in 2024, ranking sixth and fourth among all malignant tumors, respectively.¹At present, curative surgery remains the cornerstone of treatment for gastric cancer. However, the risk of postoperative recurrence and metastasis remains high. Current perioperative treatment strategies are primarily based on chemotherapy or chemoradiotherapy, both of which have limitations in tumor regression and are often associated with substantial toxicity. In recent years, immunotherapy has been reshaping the treatment landscape of gastric cancer, with immunotherapy plus chemotherapy becoming a standard first-line treatment for advanced disease, and its application increasingly being explored in the perioperative setting. However, most existing approaches still rely on immunotherapy combined with chemotherapy throughout the treatment course, leaving chemotherapy-related toxicity insufficiently addressed. Meanwhile, there has been no approved perioperative immunotherapy for gastric cancer in China, underscoring an urgent clinical need for a new treatment strategy that can balance efficacy, safety, and patient adherence.

The approval of serplulimab for perioperative gastric cancer was primarily based on ASTRUM-006, a randomized, double-blind, placebo-controlled, multicenter Phase 3 study enrolling 588 patients with PD-L1-positive (CPS ≥5), resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma. As of August 19, 2025, in the PD-L1 CPS ≥5 population, the regimen of neoadjuvant serplulimab plus chemotherapy followed by adjuvant serplulimab monotherapy significantly prolonged event-free survival (EFS) versus the chemotherapy control group, reducing the risk of disease progression, recurrence, other new malignancies, or death by 33%, as assessed by blinded independent central review (BICR). The serplulimab group also achieved a pathological complete response (pCR) rate of 21.6%, more than three times that of the control group, and an R0 resection rate of 96.7%, demonstrating strong tumor regression and a high quality of curative surgery. Safety and tolerability were manageable overall, with grade ≥3 treatment-related adverse events (TRAEs) reported in 46.6% of patients in the serplulimab group and 58.5% in the placebo group, and permanent discontinuation due to TRAEs occurring in 6.5% and 10.5% of patients, respectively.

The landmark results of ASTRUM-006 were presented at the 2026 ASCO Annual Meeting and simultaneously published in The Lancet, making it the first perioperative immunotherapy trial in gastric cancer worldwide to appear in the journal’s main edition. In addition, the perioperative regimen for gastric cancer of serplulimab was included in the CSCO Clinical Guidelines for Gastric Cancer (2026 Edition), underscoring strong recognition from the global oncology community for this innovative chemo-sparring perioperative approach.

Differentiated Mechanism Drives Broad Strategic Expansion, as Serplulimab Continues to Advance Innovation in Cancer Immunotherapy

As an innovative anti-PD-1 mAb independently developed by Henlius, serplulimab is distinguished by a differentiated mechanism. Preclinical studies have proven that serplulimab not only induces stronger PD-1 internalization—reducing PD-1 receptor presence on T cells for rapid and potent immune activation²—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling,^3-5 enhancing downstream AKT activity,⁶ and promoting sustained T-cell activation. Together, these mechanistic advantages provide compelling pharmacological rationale for its antitumor activity in the perioperative treatment of gastric cancer.

Based on this differentiated mechanism, serplulimab has been approved for the first-line treatment of 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 (nsqNSCLC) and perioperative treatment of gastric cancer.**Up to date, it has been approved in 50 countries and regions including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the global population. Henlius, together with its regional partners including Accord and Abbott, has continued to advance market access and commercialisation efforts for serplulimab in overseas markets. Since receiving its first approval in the European Union in February 2025, 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.

Henlius is advancing the global development of serplulimab across major cancers, with a focus on lung and gastrointestinal tumors. As the world’s first anti-PD-1 mAb approved for first-line small cell lung cancer and the world’s first and only* anti-PD-1 mAb approved for perioperative gastric cancer, serplulimab continues to expand its global clinical value. Henlius has launched more than 10 studies of serplulimab-based combination immunotherapies, with over 5,700 patients enrolled. Bridging studies in ES-SCLC in the United States and Japan have completed enrollment. In gastrointestinal cancer, the Phase 3 global study ASTRUM-015 evaluating serplulimab plus bevacizumab and chemotherapy for first-line metastatic colorectal cancer (mCRC) has completed enrollment and may help address the unmet need for immunotherapy in microsatellite stable (MSS) mCRC.

The approval of serplulimab for perioperative gastric cancer marks another important milestone in Henlius’ efforts to address unmet needs in solid tumors.  Looking ahead, the Company will continue to expand serplulimab’s oncology indications, strengthen its presence in precision perioperative treatment, and accelerate global registration and commercialization to bring high-quality, accessible innovative biologics to patients worldwide.

*As of June 9, 2026.

**Approved indications may differ across countries and regions. Please refer to the approval announcements issued by the relevant local regulatory authorities.

About Serplulimab

Serplulimab is a recombinant humanized anti-PD-1 mAb injection (trade name: Hetronifly^® in Europe). It is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and for perioperative gastric cancer. Up to date, it has been approved in 50 countries and regions including China, the U.K., EU, Singapore, India, Switzerland, and Peru.

In March 2022, serplulimab was officially approved  in China and is currently indicated for the treatment of 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 (nsqNSCLC), and gastric cancer (GC). With the approval of the gastric cancer indication, serplulimab has become the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy

Henlius continues to advance an extensive global clinical programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,700 patients enrolled, with over 30% of patients enrolled in two pivotal international studies being Caucasian, making it one of the anti-PD-1 mAbs with the most extensive international clinical data. Bridging studies for ES-SCLC are being conducted in the United States and Japan.

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.⁷

Three pivotal clinical studies of serplulimab have been published in leading journals including The Lancet, The Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer. In addition, serplulimab has been included in several authoritative clinical guidelines, such as the CSCO Guidelines for SCLC, NSCLC, ESCC, GC, Clinical Application of Immune Checkpoint Inhibitors, and Chinese Guidelines for Radiotherapy in Esophageal Cancer, providing important references for oncology clinical practice. Internationally, serplulimab for the treatment of SCLC has been granted Orphan Drug Designations (ODDs) by regulatory authorities of multiples countries, including the U.S. FDA.

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