上市进程提速，有望成为全球首个获批用于胃癌围手术期治疗的抗PD-1单抗
首个获CDE突破性疗法认定及首个被纳入优先审评的胃癌围手术期治疗药物
全球首个胃癌围手术期以免疫单药取代术后辅助化疗的治疗方案，显著降低复发风险，提升治愈机会
12月12日，复宏汉霖（2696.HK）宣布公司自研创新型抗PD-1单抗H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入优先审评审批程序。此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。
复宏汉霖执行董事、首席执行官
朱俊博士表示
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此次获受理并被纳入优先审评，标志着H药胃癌围手术期适应症正式进入上市‘快车道’。作为全球首个在胃癌围手术期以免疫单药取代术后辅助化疗的创新方案，该疗法将显著改善患者的生活质量与生存获益。期待这一创新治疗策略尽早惠及广大胃癌患者，为他们带来治愈希望。
”胃癌是全球范围内的高发恶性肿瘤，其发病率和死亡率均位居所有癌种的第五位[1]。2022年，中国胃癌新发病例约35.9万例，死亡病例约26万例，分别位居所有恶性肿瘤第五位和第三位[2]，成为重大公共卫生挑战。当前，根治性手术是治疗胃癌的主要手段，但仍面临切除率低、术后复发风险高等难题。因此，优化围手术期治疗策略成为改善预后的关键[3-5]。目前，化疗或放化疗是胃癌围手术期的主流治疗策略[6-8]，但由于其疗效有限，且常伴患者耐受性不佳等问题，导致患者的复发率仍处于较高水平。近年来，免疫治疗在晚期胃癌中取得突破，但其在围手术期的应用有限，且中国目前尚无在该治疗领域获批的免疫疗法，存在大量未被满足的临床需求。因此，探索能够有效降低复发、提升治愈率的新治疗方案尤为迫切。
H药是全球唯一胃癌围手术期III期注册研究取得阳性结果的抗PD-1单抗，本次上市申请主要基于该项关键性研究ASTRUM-006的积极结果。ASTRUM-006研究是一项随机、双盲、多中心的III期临床研究，旨在评估汉斯状联合化疗对比安慰剂联合化疗新辅助/辅助治疗胃癌的有效性和安全性。期中分析结果显示：该研究达到预设的优效性标准。与安慰剂联合化疗相比，汉斯状联合化疗显著改善无事件生存期（EFS），病理完全缓解（pCR）率相较对照组大幅提升，患者复发风险明显降低，且整体安全性可控。该研究开创了术后“免化疗”辅助治疗新模式，不仅显著提升了疗效，更改善了患者生活质量，标志着胃癌治疗理念从“单一疗效追求”向“疗效与生活质量并重”的关键转变。此前，H药已被CDE纳入突破性治疗品种名单，是首个在胃癌围手术期治疗领域获此认定的药物。因符合优先审评范围，CDE同意将其纳入优先审评审批程序。根据相关规定，对正式纳入优先审评审批程序的药品上市许可申请，审评时限将由常规程序的200个工作日大幅缩短为130个工作日。
作为复宏汉霖的核心抗肿瘤药物，汉斯状凭借其差异化的机制，在多种实体瘤的治疗中展现出独特优势。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[9]，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[10-12]，增强下游AKT蛋白活性[13]，促进T细胞持续活化。目前，H药已获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC) 适应症，并在包括中国、英国、德国、新加坡、印度等40多个国家获批上市，覆盖全球近半数人口。H药在胃癌围手术期治疗中取得突破的同时，斯鲁利单抗联合化疗一线治疗转移性结肠癌的III期临床研究也已完成患者入组，有望明年公布数据。
消化道肿瘤是公司重点深耕的核心战略领域，公司正积极围绕胃癌、食管癌、结直肠癌等关键癌种纵深布局，并以H药、HLX22（新表位抗HER2单抗）、HLX43（PD-L1 ADC）等创新产品为驱动，构建全面的消化道肿瘤治疗版图。未来，复宏汉霖将继续秉承“以患者为中心”的理念，持续推进该突破性治疗方案的上市进程，使其加速惠及胃癌患者，改善临床结局。
【参考文献】
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[5] 高梓茗，等. 新辅助治疗与转化治疗——探索适合中国胃癌患者的围手术期治疗模式[J]. 中华医学信息导报，2021, 36(3): 17-17.
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关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，5个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药 汉斯状的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）、自主研发的中美欧三地获批单抗生物类似药汉曲优（曲妥珠单抗，美国商品名：HERCESSI，欧洲商品名：Zercepac）、国内首个生物类似药汉利康（利妥昔单抗）、地舒单抗生物类似药Bildyos和Bilprevda，以及帕妥珠单抗POHERDY。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer
The regulatory approval process for serplulimab has accelerated, making it poised to become the world’s first anti-PD-1 monoclonal antibody approved for perioperative treatment of gastric cancer.
Serplulimab is the first drug to receive Breakthrough Therapy Designation from the CDE for perioperative gastric cancer treatment, and the first to be granted Priority Review for this indication.
As the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy, it significantly reduces the risk of recurrence and increases the potential for cure.
Dr. Jason Zhu, Executive Director, and Chief Executive Officer of Henlius, said: “The NDA acceptance and priority review of serplulimab marks its formal entry onto a fast regulatory track for perioperative gastric cancer. As the world’s first innovative regimen in this setting to replace postoperative adjuvant chemotherapy with immunotherapy monotherapy, this approach will significantly improve patients’ quality of life and survival outcomes. We look forward to bringing this novel strategy to patients as soon as possible, offering them renewed hope for a cure.”
Gastric cancer is a major global health burden, ranking as the fifth most common cancer and the fifth leading cause of cancer-related death worldwide [1]. In China, it is particularly prevalent, with approximately 359,000 new cases and 260,000 deaths estimated in 2022, making it the fifth most frequently diagnosed cancer and the third leading cause of cancer mortality [2]. Radical surgery is the primary curative approach but is often limited by low rates of curative resection and high risks of postoperative recurrence. Therefore, optimizing perioperative therapeutic strategies is critical for improving patient outcomes [3-5]. Currently, perioperative chemotherapy or chemoradiotherapy constitutes the standard of care [6-8]. However, the efficacy of these regimens is constrained, and they are frequently associated with significant toxicity, contributing to persistently high recurrence rates. Although immunotherapy has transformed the treatment landscape for advanced gastric cancer, its application in the perioperative setting remains investigational, with no such therapies yet approved for this use in China. This gap underscores a significant unmet clinical need. Consequently, the development of novel treatment strategies capable of effectively reducing recurrence and enhancing cure rates is of paramount importance.HANSIZHUANG is the world’s first and only anti-PD-1 monoclonal antibody with positive results from a phase 3 registrational trial in the perioperative treatment of gastric cancer. The NDA is primarily supported by the encouraging outcomes of the pivotal ASTRUM-006 study. ASTRUM-006 is a randomized, double-blind, multicenter, phase 3 clinical trial designed to evaluate the efficacy and safety of HANSIZHUANG combined with chemotherapy versus placebo combined with chemotherapy in the neoadjuvant/adjuvant treatment of gastric cancer. The interim analysis showed the study met its pre-specified primary endpoint of superiority. Compared to the control arm, the serplulimab-based regimen demonstrated a statistically significant and clinically meaningful improvement in Event-Free Survival (EFS) and a substantially higher pathological complete response (pCR) rate, significantly reducing the risk of disease recurrence, with a manageable safety profile. This study pioneers a novel, “chemotherapy-free” adjuvant treatment model following surgery, which not only significantly enhances efficacy but also improves patients’ quality of life. It marks a pivotal shift in the treatment paradigm for gastric cancer—from a sole focus on efficacy to a balanced emphasis on both efficacy and quality of life. Previously, HANSIZHUANG was granted BTD by the CDE for perioperative treatment of gastric cancer, becoming the first drug to receive this designation in this indication. Given that it meets the criteria for priority review, the CDE has agreed to include it in the Priority Review and Approval Procedure. Under relevant regulations, the regulatory review timeline for its NDA is set to be substantially shortened from the standard 200 working days to approximately 130 working days.
As a core oncology asset for Henlius, HANSIZHUANG demonstrates unique advantages in treating various solid tumors via its differentiated mechanism. The drug not only induces stronger PD-1 internalization—reducing PD-1 receptor presence on T cells for rapid and potent immune activation[9]—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling [10-12], enhancing downstream AKT activity [13], and promoting sustained T-cell activation. To date, HANSIZHUANG has received marketing approvals for the treatment of multiple indications, including squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). The drug has been launched in over 40 countries and regions, including China, the United Kingdom, Germany, Singapore, and India, reaching nearly half of the global population. Alongside this advance in gastric cancer, patient enrollment has been completed for a phase 3 trial evaluating serplulimab plus chemotherapy as first-line therapy for metastatic colorectal cancer, with data anticipated in the coming year.Gastrointestinal (GI) cancers are a core strategic focus area for the company. Henlius is actively deepening our pipeline around key malignancies such as gastric, esophageal, and colorectal cancers. This effort is driven by a portfolio of innovative products, including HANSIZHUANG, HLX22 (a novel epitope-targeting anti-HER2 monoclonal antibody), and HLX43 (a PD-L1-targeting antibody-drug conjugate). Our goal is to build a comprehensive and leading treatment landscape for GI cancers. Remaining committed to our patient-first mission, Henlius will advance this breakthrough therapy toward market approval, aiming to accelerate patient access and improve clinical outcomes in gastric cancer.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 10 products have been approved for marketing across multiple countries and regions, and 5 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos and Bilprevda, and pertuzumab Poherdy. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
To learn more about Henlius, visit and connect with us on LinkedIn at
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