HLX-43

H药胃癌围手术期III期临床研究达到主要终点EFS，支持提前申报上市 全球首个胃癌围术期（术前/术后）以免疫单药取代术后辅助化疗的治疗方案 该方案明显改善无事件生存期（EFS），病理完全缓解（pCR）率是对照组的3倍多，复发风险显著降低，提升治愈机会 2025年10月9日，复宏汉霖（2696.HK）宣布公司自研创新型PD-1抑制剂H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）联合化疗新辅助/单药辅助治疗胃癌的III期临床研究（ASTRUM-006）期中分析达到了主要研究终点无事件生存期（EFS），成为全球首个胃癌围术期（术前/术后）以免疫单药取代术后辅助化疗的治疗方案，实现了该领域的重大突破。 ASTRUM-006是一项针对早期胃癌患者的随机、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/单药辅助治疗早期胃癌患者的临床有效性及安全性。根据独立数据监察委员会（Independent Data Monitoring Committee, IDMC）的期中分析结果显示：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EFS，病理完全缓解（pCR）率是对照组3倍多，患者复发风险明显降低。同时，该治疗方案安全性良好，未发现新的安全性信号。基于这一积极结果，建议提前申报上市。 ASTRUM-006研究主要研究者 北京大学肿瘤医院季加孚教授表示 手术是胃癌治疗的核心环节，而围术期治疗直接影响患者的长期预后。本次研究首次证实了术后以免疫单药替代辅助化疗的可行性，不仅为巩固手术疗效、降低复发风险开辟了新路径，也为临床实践带来全新思路。 ASTRUM-006研究主要研究者 北京大学肿瘤医院沈琳教授表示 本次研究的积极结果，证实了斯鲁利单抗在胃癌围术期的卓越潜力。尤其在辅助治疗阶段创新探索了‘单免疫去化疗’方案，切实改善了患者生存质量，为优化临床策略提供了新方向。 复宏汉霖执行董事、首席执行官朱俊博士表示 消化道肿瘤是复宏汉霖深耕的核心领域。此次H药在胃癌围术期III期研究中达到主要终点，标志着公司在该领域取得关键突破。我们将积极推动成果转化，早日惠及患者，并持续加快更多创新疗法的深度探索与广泛应用。 引领革新，拓展胃癌围术期新路径 胃癌是全球重大公共卫生挑战，根据GLOBOCAN最新统计，2022年全球胃癌新发病例约96.9万例、死亡病例约66万例，其发病率和死亡率在所有癌症中均高居第五位[1] 。目前根治性手术是治疗胃癌的主要手段，而围手术期治疗（新辅助/辅助）策略的优化则成为改善患者长期生存的关键[2]。 近年来，免疫治疗正系统性重塑胃癌的治疗格局。在晚期胃癌中，免疫联合化疗已成为一线标准方案。针对围术期治疗，全球范围内也有多项III期临床研究正在开展，旨在验证免疫联合化疗在此阶段的疗效和安全性。然而，该领域面临双重挑战：在研发方面，目前尚无免疫疗法获批该适应症，且仅少数免疫联合III期研究明确达到主要终点；在临床实践中，患者常因术后恢复缓慢或对化疗耐受性不佳而难以完成辅助化疗，影响长期生存获益。因此，临床亟需兼具卓越疗效与良好耐受性的新一代治疗方案。 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[3]，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[4-6]，增强下游AKT蛋白活性[7]，促进T细胞持续活化。ASTRUM-006研究创新性地在辅助治疗阶段采用“去化疗”的汉斯状®单药治疗策略。该方案在确保疗效的同时，有效规避了传统化疗相关毒性，极大提升了患者生活质量，为临床实践提供了全新选择。ASTRUM-006研究的成功，标志着胃癌围术期治疗实现了从“单纯强化治疗”到“高效低毒”精准模式的关键性跨越。 多维探索，深耕消化道肿瘤前沿 消化道肿瘤是复宏汉霖战略聚焦和深度布局的核心治疗领域之一。公司围绕食管癌、胃癌、结直肠癌等高发消化道癌种，构建了从免疫治疗到靶向药物、从成熟靶点到创新分子类型的多元化产品组合，形成了覆盖不同分子分型与疾病阶段的差异化治疗体系。 在食管癌领域，汉斯状®已于2023年9月在中国获批用于一线治疗食管鳞状细胞癌（ESCC），凭借卓越的疗效与安全性获得临床广泛认可，迅速成为该领域的重要治疗选择。针对胃癌这一关键市场，复宏汉霖展现出强大的研发纵深与协同优势。除汉斯状®在胃癌新辅助/辅助治疗方面取得的积极结果外，公司自主研发的差异化新表位HER2单抗HLX22正通过国际多中心III期头对头临床研究，挑战HER2阳性晚期胃癌的一线治疗标准。在结直肠癌领域，公司正积极推进汉斯状®联合方案一线治疗转移性结直肠癌（mCRC）的国际多中心III期临床研究，同时通过布局PD-L1抗体偶联药物（ADC）HLX43等新一代疗法，针对晚期胃/胃食管交界部腺癌等开展临床研究，持续拓展消化道肿瘤的治疗边界。 未来，复宏汉霖将依托产品管线的多层次创新疗法矩阵，以及丰富的全球多中心临床试验数据，持续深化在消化道肿瘤领域的领先优势，致力于将更多优质治疗方案推向全球，惠及更广泛的患者群体。 【参考文献】 [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2024;74(3):229-263. [2] 高梓茗，徐惠绵. 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. [3] 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. [4] Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433. [5] 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. [6] 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. [7] 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. 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9款产品，4个上市申请分别获中国药监局、美国FDA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）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。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。 Phase 3 Clinical Trial of HANSIZHUANG Plus Chemotherapy Meets Primary Endpoint in Neoadjuvant/Adjuvant Gastric Cancer, Greenlighting Early NDA Submission The phase 3 clinical trial of HANSIZHUANG for perioperative gastric cancer treatment met its EFS primary endpoint, supporting an early New Drug Application (NDA) submission World-first regimen in gastric cancer that replaces adjuvant chemotherapy with mono-immunotherapy in the perioperative setting The ASTRUM-006 study demonstrated a significant improvement in event-free survival (EFS) and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, unlocking the potential for a cure Shanghai, China, October 9, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody, HANSIZHUANG (serplulimab, Hetronifly® in Europe), in combination with chemotherapy for the neoadjuvant/adjuvant monotherapy treatment of gastric cancer, has met the primary endpoint of Event-Free Survival (EFS) in an interim analysis of its phase 3 clinical study (ASTRUM-006). This outcome represents a breakthrough, making it the world-first regimen to replace adjuvant chemotherapy with mono-immunotherapy in the perioperative treatment of gastric cancer. ASTRUM-006 is a randomized, double-blind, multi-centre phase 3 clinical study among patients with early-stage gastric cancer, aiming to compare the efficacy and safety of HANSIZHUANG or placebo in combination with chemotherapy as a neoadjuvant/adjuvant monotherapy treatment for patients with early-stage gastric cancer. According to the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), the trial met its predefined efficacy criteria. Compared with placebo plus chemotherapy, HANSIZHUANG plus chemotherapy significantly prolonged EFS and achieved a more than threefold higher pathological complete response (pCR) rate compared with the control arm, with a significant reduction in the risk of recurrence. Furthermore, the combination regimen demonstrated a favorable safety profile, with no new safety signals identified. Based on this positive outcome, the IDMC has recommended an early NDA submission. Professor Jiafu Ji from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, commented: “Surgery is the cornerstone of gastric cancer treatment, and perioperative therapy is critical to long-term survival. This study is the first to confirm the feasibility of replacing adjuvant chemotherapy with mono-immunotherapy in the postoperative setting. It not only opens a new path to consolidate surgical outcomes and reduce recurrence risk, but also paves the way for innovation in clinical practice.” Professor Lin Shen from Beijing Cancer Hospital, a leading principal investigator of the ASTRUM-006 study, stated: “The positive results from this study confirm the significant potential of serplulimab in the perioperative setting for gastric cancer. The innovative exploration of a 'chemotherapy-free, mono-immunotherapy' regimen during the adjuvant phase tangibly improves patients' quality of life, offering a new approach for optimizing clinical strategies.” Dr. Jason Zhu, Executive Director, and Chief Executive Officer of Henlius, said: “Gastrointestinal (GI) cancer is a core therapeutic area of dedicated focus for Henlius. The successful achievement of the primary endpoint in the phase 3 perioperative study of HANSIZHUANG in gastric cancer marks a pivotal breakthrough for the company. We are committed to actively advancing the translation of these findings into clinical practice, with the goal of bringing benefits to patients at the earliest opportunity. Concurrently, we will continue to accelerate the in-depth exploration and broad application of more innovative therapies.” Pioneering New Pathways in Gastric Cancer Perioperative Care Gastric cancer represents a major global public health challenge. According to the latest GLOBOCAN statistics, there were approximately 969,000 new cases and 660,000 deaths worldwide in 2022, ranking it fifth in both incidence and mortality among all cancers. [1] While radical surgery remains the primary treatment modality, optimizing perioperative (neoadjuvant/adjuvant) strategies has become pivotal to improving long-term patient survival. [2] In recent years, immunotherapy is fundamentally reshaping the treatment landscape for gastric cancer. While the combination of immunotherapy and chemotherapy has become the first-line standard for advanced disease, its potential in the perioperative setting is now a major focus of clinical investigation, with multiple trials underway to evaluate its efficacy and safety in this context. However, the field faces a dual challenge. On one hand, no immunotherapy has yet been formally approved for this specific indication, and only a limited number of phase 3 studies have successfully met their primary endpoints. On the other hand, in clinical practice, factors such as slow postoperative recovery and poor chemotherapy tolerance often prevent patients from completing adjuvant chemotherapy, thereby compromising their long-term survival outcomes. This significant unmet medical need underscores the urgent demand for novel treatment strategies that deliver both superior efficacy and improved tolerability. 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 [3]—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling [4-6], enhancing downstream AKT activity [7], and promoting sustained T-cell activation. The ASTRUM-006 study innovatively employed a “chemotherapy-free” serplulimab monotherapy strategy in the adjuvant setting. This approach maintained therapeutic efficacy while effectively circumventing toxicity related to conventional chemotherapy, significantly improved patients’ quality of life, and provided a new clinical option. The success of this trial marks a pivotal shift in perioperative gastric cancer care—from a conventional intensity-driven paradigm toward a more refined “high-efficacy, low-toxicity” treatment model. Delving into the Frontiers of GI Oncology GI cancer is a strategically core therapeutic area for Henlius, with dedicated focus and extensive development. The company has built a diversified product portfolio spanning from immunotherapy to targeted agents, and from established targets to novel molecular modalities, addressing high-incidence GI cancers such as esophageal, gastric, and colorectal cancers. This portfolio forms a differentiated treatment system covering various molecular subtypes and disease stages. In esophageal cancer, HANSIZHUANG received approval in China in September 2023 for the first-line treatment of esophageal squamous cell carcinoma (ESCC). Its efficacy and safety profile have earned it broad clinical recognition, rapidly establishing it as a key therapeutic option in this field. In the gastric cancer segment, Henlius demonstrates strong R&D depth and synergistic advantages. Beyond the positive outcomes achieved with HANSIZHUANG in the neoadjuvant/adjuvant setting, the company's internally developed, differentiated novel epitope HER2 mAb, HLX22, is challenging the current first-line standard of care for HER2-positive advanced gastric cancer through an international multi-centre, head-to-head phase 3 trial. In colorectal cancer, Henlius is actively advancing an international multi-centre phase 3 clinical study evaluating HANSIZHUANG-based combinations in the first-line treatment of metastatic CRC (mCRC). Concurrently, the company continues to push the boundaries of GI cancer treatment by developing next-generation therapies, such as the PD-L1-targeting ADC HLX43, now in clinical studies for advanced gastric/gastroesophageal junction adenocarcinoma and other tumors. Looking ahead, Henlius will leverage its robust pipeline of innovative therapies and extensive global multi-centre clinical trial data to solidify its leadership in GI oncology. The company is dedicated to bringing a growing portfolio of high-quality therapeutic options to patients worldwide, addressing significant unmet needs across the globe. 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, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. 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, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式 媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容 点击下方按钮·分享 ·收藏 ·点赞 ·在看