• 全球首个且唯一*获批胃癌围术期适应症的抗PD-1单抗，填补临床治疗空白

• 全球首个胃癌围术期术后“去化疗”方案，以免疫单药取代辅助化疗，显著降低复发风险，治愈可及

• 注册研究ASTRUM-006登顶《柳叶刀》主刊并重磅亮相ASCO 2026，已被纳入CSCO指南

复宏汉霖执行董事、首席执行官朱俊博士表示：

H药胃癌围术期III期临床研究ASTRUM-006主要研究者、北京大学肿瘤医院沈琳教授表示：

胃癌是全球高发恶性肿瘤，发病率和死亡率均位居前列。尤其在中国，胃癌负担尤为突出，2024年新发病例约34.2万例、死亡约24.9万例，分别居恶性肿瘤第六位和第四位¹。目前，根治性手术是胃癌患者的核心治疗手段，但术后复发转移风险仍较高。当前围术期治疗方案以化疗或放化疗为主，在肿瘤退缩效果方面存在一定局限，且毒副作用较为明显。近年来，免疫治疗正系统性重塑胃癌的治疗格局，免疫联合化疗已成为晚期胃癌一线标准方案，相关应用也逐步向围术期场景拓展探索。然而，现有探索多依赖全程免疫联合化疗模式，化疗相关毒性问题仍未有效解决。另一方面，目前国内尚无胃癌围术期免疫治疗获批药物，临床迫切需要兼顾疗效、安全性与治疗依从性的全新治疗策略。

此次H药获批胃癌围手术期适应症主要基于一项随机、双盲、安慰剂对照的多中心III期临床研究（ASTRUM-006）。该研究共入组了588例PD-L1表达阳性（CPS≥5）且满足手术条件的局部进展期胃/胃食管结合部腺癌患者。研究数据显示，截至2025年8月19日，在 PD-L1 CPS≥5 人群中，与化疗对照组相比，斯鲁利单抗联合化疗新辅助治疗序贯斯鲁利单抗单药辅助治疗的方案显著延长无事件生存期（EFS），BICR评估的疾病进展、复发、新发其他恶性肿瘤或死亡风险大幅降低33%。斯鲁利单抗组的病理完全缓解（pCR）率达到21.6%，是对照组的3倍以上，展现出卓越的肿瘤退缩能力，同时，根治性（R0）切除率为96.7%，展现出极高的手术根治质量。安全性与耐受性评价结果显示，斯鲁利单抗组与对照组≥3 级治疗相关不良事件（TRAEs）发生率分别为46.6%和58.5%，因TRAEs导致永久停药的发生率分别为6.5%和10.5%，整体安全可控、患者耐受性良好。

此项研究的突破性成果已于2026年在美国临床肿瘤学会（ASCO）年会上以口头报告形式重磅发布，并同期发表于全球四大顶级医学期刊之一的《柳叶刀》（The Lancet，影响因子：88.5），成为全球首个登上《柳叶刀》主刊的胃癌围术期免疫治疗临床研究。此外，汉斯状^®胃癌围术期方案已于同年4月被纳入《CSCO胃癌诊疗指南（2026版）》。从权威诊疗指南的推荐到国际学术殿堂的背书，充分彰显了全球肿瘤学术界对该围术期“去化疗”创新方案的高度认可。

作为复宏汉霖自主研发的创新型人源化抗PD-1单抗，H药拥有独特的差异化药理机制。临床前研究证明，该药物不仅具备更强的PD-1内吞作用，可减少T细胞表面PD-1受体²，实现快速、强效的免疫激活；还能减少PD-1对共刺激分子CD28的募集，从而更大程度保留CD28信号传导^3-5，增强下游AKT蛋白活性⁶，促进T细胞持续活化。这一差异化机制为胃癌围术期治疗中的抗肿瘤效应提供了有力的药理学支持。

依托独特的机制优势， H药已在全球范围内**获批鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞癌（ESCC）和非鳞状非小细胞肺癌（nsqNSCLC）的一线治疗，以及胃癌围术期治疗等多个适应症，并已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等50个国家和地区获批上市，覆盖全球近半数人口。复宏汉霖携手Accord、Abbott等全球合作伙伴，持续推进H药海外市场准入与商业化落地。自2025年2月首次获得欧盟批准以来，H药已在16个欧盟国家实现上市销售，并在奥地利、丹麦、德国、爱尔兰、意大利、西班牙和瑞典等10个国家纳入医保或公共支付体系，进入当地主流医疗保障体系。

与此同时，复宏汉霖正围绕肺癌和消化道肿瘤等高发癌种持续推进H药的全球临床开发计划。从全球首个获批用于小细胞肺癌一线治疗的抗PD-1单抗，到全球首个且唯一*获批胃癌围术期适应症的抗PD-1单抗，H药正逐步构建覆盖更广泛癌种的全球临床价值体系。截至目前，复宏汉霖已针对H药在全球开展超过10项肿瘤免疫联合治疗研究，累计入组患者超过5,700例，并在美国和日本同步开展ES-SCLC的桥接试验并已完成全部受试者入组。在消化道肿瘤领域，H药联合贝伐珠单抗及化疗一线治疗转移性结直肠癌（mCRC）的III期国际多中心临床研究（ASTRUM-015）已完成全球患者入组，有望填补免疫治疗在MSS mCRC领域的临床空白。

此次胃癌围术期适应症的成功获批，是复宏汉霖聚焦未满足临床需求、深耕实体瘤治疗的重要里程碑。未来，公司将持续拓展H药的肿瘤治疗适应症版图，深化围术期精准治疗布局，同时加速推进全球化注册与商业化进程，以高品质、可及性的创新生物药，惠及国内外肿瘤患者。

*截至2026年6月9日

**不同国家或地区的获批适应症请以当地药品监管部门发布的公告为准

Henlius’ Serplulimab Approved for Perioperative Gastric Cancer, Pioneering a Chemotherapy-Sparring Adjuvant Approach

• 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.