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权威认可！全球首个胃癌围术期“免化疗”方案，H药获中国药监局突破性疗法认定

11月20日

来源：复宏汉霖

首个获CDE突破性疗法认定的胃癌围手术期治疗药物，有望加速惠及胃癌患者。
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方案，其III期研究达到主要终点，显著降低复发风险，提升治愈机会。
全球范围内尚无免疫疗法获批胃癌围手术期适应症，H药有望填补该领域治疗空白。

2025年11月20日，复宏汉霖（2696.HK）宣布，创新型PD-1抑制剂H药汉斯状^®（斯鲁利单抗，欧洲商品名：Hetronifly^®）被国家药品监督管理局（NMPA）药品审评中心（CDE）正式纳入突破性治疗品种名单，联合化疗用于新辅助/辅助治疗胃癌，成为首个获CDE突破性疗法认定的胃癌围手术期治疗药物。此前，H药针对该适应症的III期临床研究达到了主要终点，作为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，有望为患者带来生存获益与生活质量提升的双重突破。

根据《药品注册管理办法》和《国家药品监督管理局关于发布<突破性治疗药物审评工作程序（试行）>等三个文件的公告》（2020年第82号），突破性治疗药物程序适用范围为“防治严重危及生命或严重影响生活质量的疾病、对于尚无有效治疗手段的，该药物可以提供有效防治手段或与现有治疗手段相比具有更明显的临床优势”。对于纳入突破性治疗药物程序的药物，在符合相关条件的情况下，可以在申请药品上市许可时提出附条件批准申请和优先审评审批申请。

胃癌是全球高发恶性肿瘤，发病率和死亡率均位居所有癌种的第五位^[^1]。在我国，2022年胃癌新发与死亡病例分别高达35.9万例和26万例，位居恶性肿瘤第五位和第三位^[2]，疾病负担沉重。目前根治性手术是治疗胃癌的主要手段，然而临床上面临手术切除率低，根治性切除比例少，以及II期以上患者术后复发率高等多重挑战。因此，提高手术切除率、探索手术以外的有效治疗策略，成为胃癌治疗研究的关键方向^[3]。在此背景下，新辅助/辅助治疗在胃癌治疗中的作用日益凸显^[4]。新辅助治疗旨在降低肿瘤分期，提高肿瘤完全切除率，并争取最大程度的病理缓解；辅助治疗则致力于清除术后微小残留病灶、以降低复发风险。目前，化疗或放化疗是胃癌围手术期主流治疗策略^[5-7]，但患者的复发率仍处于较高水平，此外，许多患者因术后身体恢复缓慢或对化疗药物耐受性差，导致术后辅助治疗中断，直接影响最终的生存获益。

H药联合化疗新辅助/辅助治疗胃癌的III期临床研究（ASTRUM-006）是我国首个取得阳性结果的胃癌围手术期III期注册临床研究，旨在评估H药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。期中分析结果显示：H药联合化疗可显著延长患者的无事件生存期（EFS），病理完全缓解（pCR）率达对照组的3倍以上，患者复发风险明显降低，且整体安全性可控。该研究开创了“免化疗”辅助治疗新模式，不仅有效提升了患者的治愈机会，更通过避免化疗相关毒性，在疗效与安全性之间实现了更优平衡，从而极大改善了患者的治疗依从性与生活质量。目前，全球范围内尚无免疫疗法获批用于胃癌围手术期治疗，ASTRUM-006研究作为由中国企业发起，中国研究者主导的多中心临床研究，充分展现了我国在肿瘤治疗领域的创新实力与引领能力。此次获得突破性疗法认定，标志着H药在胃癌围手术期治疗中的潜力与临床价值获得权威认可，有望加速其审评与上市进程，填补该领域免疫治疗的空白。

未来，复宏汉霖将全力推进这一创新方案的上市，致力于将该临床突破成果转化为患者切实的生存获益，以更优的治疗选择点亮生命新希望。

【参考文献】

[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.

[2] Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53.

[3] 江良县,周申康,刘帅等. 新辅助化疗联合腹腔镜手术治疗进展期胃癌效果及患者生活质量情况观察[J]世界华人消化杂志,2018, 26(13):782-789.

[4] Knight G, Earle CC, Cosby R, et al. Neoadjuvant or adjuvant therapy for resectable gastriccancer: a systematic review and practice guideline for North America. Gastric Cancer ,2013, 16(1):28-40.

[5] Lordick F, Carneiro F, Cascinu S, et al. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020.

[6] National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): gastric cancer (Version 3.2025).

[7] Japanese Gastric Cancer Association. Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer. 2023 Jan;26(1):1-25.

Henlius' Serplulimab (anti-PD-1 mAb) Granted Breakthrough Therapy Designation by China NMPA for Neo-/Adjuvant Treatment for Gastric Cancer

The first CDE-designated Breakthrough Therapy for perioperative gastric cancer, promising accelerated patient access.
The world's first gastric cancer perioperative regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting has met primary endpoints in its phase 3 clinical trial, significantly reducing recurrence risk and improving cure rates.
No immunotherapy has been approved globally for gastric cancer perioperative treatment – HANSIZHUANG is poised to address this unmet medical need.

Shanghai, China, November 20, 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 neo-/adjuvant treatment for gastric cancer, has been officially granted the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks the first gastric cancer perioperative drug to receive the CDE’s BTD. Previously, the phase 3 clinical trial of this therapy met its primary endpoints. As the world's first perioperative gastric cancer treatment regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting, it demonstrates potential to deliver dual breakthroughs in survival benefits and quality of life for patients.

In accordance with the relative measures of Administration of Drug Registration and the Announcement of the NMPA on the Release of Three Documents including the Working Procedures for Review of Breakthrough Therapeutics (Trial) (No. 82 of 2020), the BTD procedure is designed to expedite the development and review of therapies that are intended for treatment of a seriously debilitating or life-threatening condition for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options. According to the CDE, drug candidates with BTD may be eligible for conditional approval and priority review when submitting a New Drug Application (NDA).

Gastric cancer is a highly prevalent malignant tumor worldwide, ranking fifth in both incidence and mortality among all cancers^[1]. In China, the number of new cases and deaths from gastric cancer reached 359,000 and 260,000 respectively in 2022, ranking fifth and third among all malignant tumors ^[2], reflecting a substantial disease burden. Currently, radical surgery remains the primary treatment for gastric cancer. However, clinical practice faces multiple challenges, including low rates of surgical resection, a limited proportion of radical resections, and high postoperative recurrence rates in patients with stage 2 or higher disease. Therefore, improving resection rates and exploring effective non-surgical treatment strategies have become key research directions in gastric cancer management ^[3]. Against this backdrop, the role of neoadjuvant/adjuvant therapy has become increasingly prominent ^[4]. Neoadjuvant therapy aims to downstage tumors, increase the rate of complete resection, and achieve maximal pathological response. Adjuvant therapy, on the other hand, focuses on eliminating minimal residual disease after surgery to reduce the risk of recurrence. Currently, chemotherapy or chemoradiotherapy represents the mainstream perioperative treatment strategy for gastric cancer ^[5-7]. Nevertheless, recurrence rates remain high. Additionally, many patients experience interruptions in adjuvant therapy due to slow postoperative recovery or poor tolerance to chemotherapy, which directly affects their long-term survival outcomes.

The ASTRUM-006 trial—a phase 3 study evaluating HANSIZHUANG combined with chemotherapy as neo-/adjuvant treatment for gastric cancer—is the first perioperative Phase 3 registration study in China to report positive results, It aims to assess the clinical efficacy and safety of HANSIZHUANG plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant, followed by HANSIZHUANG monotherapy as adjuvant therapy, in patients with early-stage gastric cancer. Interim analysis results demonstrated that the combination of HANSIZHUANG and chemotherapy significantly extended event-free survival (EFS) and achieved a pathological complete response (pCR) rate more than three times that of the control group, significantly reducing the risk of recurrence with an overall manageable safety profile. The study pioneers a novel "chemotherapy-free" adjuvant treatment model. This approach not only enhances the potential for cure but also achieves a superior balance between efficacy and safety by avoiding chemotherapy-related toxicities, thereby substantially improving patient treatment adherence and quality of life. Currently, no immunotherapy is approved globally for the perioperative treatment of gastric cancer. As a multicenter clinical trial initiated by a Chinese company and led by Chinese investigators, ASTRUM-006 fully demonstrates China's innovative capacity and leadership in the field of oncology. The recent granting of BTD authoritatively recognizes HANSIZHUANG’s potential and clinical value in the perioperative setting of gastric cancer, which is expected to accelerate its regulatory review and market approval, potentially filling the current gap in immunotherapy for this indication.

Going forward, Henlius will fast-track this innovative therapy to market, bridging a clinical breakthrough into tangible survival benefits. We are committed to bringing new hope to patients through a superior treatment option.

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 3 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, 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 https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

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排版编辑：肿瘤资讯-as

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