关键进展！复宏汉霖H药美国桥接试验完成全部受试者入组

2025年10月22日，复宏汉霖（2696.HK）宣布，公司自主研发的创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）在既往未经治疗的广泛期小细胞肺癌（ES-SCLC）美国患者中开展的对比一线标准治疗阿替利珠单抗（PD-L1免疫抑制剂）的桥接临床试验（ASTRIDE研究）已顺利完成招募计划要求的全部200例患者入组，将为后续向美国食品药品监督管理局（FDA）递交生物制品许可申请（BLA）奠定坚实基础。

ASTRIDE研究是一项随机、对照、开放标签的临床研究，旨在比较斯鲁利单抗联合化疗与阿替利珠单抗联合化疗在美国ES-SCLC患者中的疗效与安全性。研究结果将作为关键临床数据支持H药在美国市场的注册申报。本研究由复宏汉霖美国临床、注册团队自主管理、独立执行，并在超过100家美国肿瘤中心开展，是美国入组规模最大的ES-SCLC临床试验之一。此外，H药也是目前唯一一款在美国开展桥接临床试验的抗PD-1单抗。这一研究的顺利推进，充分彰显了复宏汉霖在国际临床研究设计、执行及监管沟通等全链条能力上的领先水平，也标志着中国创新药全球化步入更高阶段。

ASTRIDE研究的牵头主要研究者，加州大学戴维斯分校综合癌症中心（UCDCCC）名誉教授兼实验治疗中心联合主任David R. Gandara医学博士表示

非常高兴看到斯鲁利单抗桥接研究顺利完成全部入组。这项研究的完成，也让我们离为美国广泛期小细胞肺癌患者提供全新的治疗选择更近一步。

复宏汉霖全球产品开发部副总裁李靖表示

ASTRIDE研究全部患者入组的完成，不仅代表H药在美国临床运营上取得重要里程碑，也标志着复宏汉霖在美国本土产品开发体系的全面落地，为未来更多创新管线的国际多中心研究奠定了坚实基础。

复宏汉霖美国首席医学官Ely Benaim博士表示

ASTRIDE研究由复宏汉霖美国团队独立执行，充分体现了我们对美国临床体系的深度融入。我们将继续与研究者保持紧密合作，推进H药在美注册申报进程，尽早为更多患者带来这一具有突破性的创新疗法。

此前，复宏汉霖已针对H药用于一线治疗ES-SCLC开展一项随机、双盲、安慰剂对照的国际多中心III期临床研究（ASTRUM-005）。该研究结果于2022年美国临床肿瘤学会（ASCO）年会以口头报告方式首次发布，并于全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA）在线发表，成为全球首个登上JAMA主刊的小细胞肺癌免疫治疗临床研究。2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布研究结束分析结果，截至2024年12月31日（中位随访时间42.4个月），斯鲁利单抗组的4年总生存期（OS）率达21.9%，对照组为7.2%，且安全性可控，进一步夯实了H药能为ES-SCLC患者带来显著的长期生存获益。

基于ASTRUM-005研究的优异结果，H药获得了美国FDA与欧洲欧盟委员会（EC）的孤儿药资格认定（ODD），并已陆续在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市用于一线治疗ES-SCLC。此外，H药在小细胞肺癌领域的临床数据被纳入欧洲肿瘤内科学会（ESMO）临床获益评估体系（MCBS），评分优于同类产品，并多次在ESMO和世界肺癌大会（WCLC）等国际学术会议上作口头报告和专题讨论。复宏汉霖在全球范围内积极推进H药的获批上市进程。在小细胞肺癌领域，公司也在开展一项H药联合化疗同步放疗用于治疗局限期小细胞肺癌（LS-SCLC）患者的国际多中心III期临床研究（ASTRUM-020），该研究已于2025年1月完成所有受试者入组。

作为首批在美国境内独立开展创新型肿瘤免疫治疗研究的中国药企之一，复宏汉霖始终以科学证据为核心，通过符合国际标准的临床实践与本土化开发，推动精准治疗策略的落地，为全球患者提供更加可负担、可及且贴合临床需求的创新治疗选择。

关于H药 汉斯状®

H药 汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液，欧洲商品名：Hetronifly®），是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，目前已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市。

2022年3月，H药正式在中国获批上市，目前可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）及非鳞状非小细胞肺癌（nsqNSCLC）。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展10余项肿瘤免疫联合疗法临床试验。截至目前，H药已于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超5, 000人，其中2项国际多中心临床试验入组白人的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药的3项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）和British Journal of Cancer。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、《CSCO 非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO 结直肠癌诊疗指南》、《CSCO 免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并于2025年6月在日本启动了一项桥接研究，旨在评估该产品联合化疗一线治疗ES-SCLC在日本患者中的疗效及安全性。

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。

Henlius Completes Patient Enrolment in the U.S. Bridging Study of Serplulimab in Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Shanghai, China, October 22, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its independently developed innovative anti-PD-1 mAb serplulimab (trade name in Europe: Hetronifly®) has successfully completed enrolment of all 200 patients in the U.S. bridging clinical study (ASTRIDE) comparing serplulimab plus chemotherapy with atezolizumab plus chemotherapy in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC). This milestone paves the way for Henlius to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

The ASTRIDE study is a randomized, controlled, open-label clinical trial designed to evaluate the efficacy and safety of serplulimab plus chemotherapy versus atezolizumab plus chemotherapy in U.S. patients with ES-SCLC. The results will serve as key clinical evidence supporting the registration of serplulimab in the U.S. market. The study is fully managed and executed by Henlius’ U.S. clinical and regulatory affairs teams across more than 100 oncology centres, representing one of the largest ES-SCLC clinical trials ever conducted in the U.S. with locally enrolled patients. Serplulimab is the only anti-PD-1 mAb currently conducting a bridging trial in the U.S. Its steady progress underscores Henlius’s global leadership in clinical design, execution, and regulatory engagement.

David R. Gandara, M.D., the principal leading investigator of the ASTRIDE study, Professor Emeritus and Co-Director of the Experimental Therapeutics Program at UC Davis Comprehensive Cancer Centre (UCDCCC), said: “I’m so pleased to see this bridging study of serplulimab complete accrual. I anticipate that this trial will add a new therapeutic option for our patients with extensive stage small cell lung cancer.”

Jing Li, Vice President of Global Product Development at Henlius, said: ”The completion of patient recruitment in the ASTRIDE study not only marks a major milestone in the U.S. clinical operation of serplulimab, but also signifies the full establishment of Henlius’ local product development in the U.S., laying a solid foundation for future global multicentre studies of the company’s innovative pipeline.”

Dr. Ely Benaim, U.S. Chief Medical Officer at Henlius, said: ”Our U.S. team’s independent execution of the ASTRIDE study reflects our deep integration into the U.S. clinical ecosystem. We are committed to maintaining close collaboration with our investigator network to advance serplulimab’s registration process and bring this promising therapy to patients in need.”

Henlius previously conducted a randomized, double-blind, placebo-controlled, international Phase 3 study (ASTRUM-005) to evaluate serplulimab for first-line treatment of ES-SCLC. The results were first presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in The Journal of the American Medical Association (JAMA)—marking the first small-cell lung cancer immunotherapy study ever featured in JAMA’s main edition. At the 2025 ASCO Annual Meeting, the final analysis of ASTRUM-005 was released: as of December 31, 2024 (median follow-up 42.4 months), the four-year overall survival (OS) rate was 21.9% in the serplulimab group versus 7.2% in the control group, with a manageable safety profile—further validating its durable survival benefit for patients with ES-SCLC.

Building on these positive results, serplulimab has been granted Orphan Drug Designation (ODD) by both the U.S. FDA and the European Commission (EC) for the treatment of SCLC and has been approved for first-line treatment of ES-SCLC in nearly 40 countries and regions including China, the U.K., Germany, Singapore and India. Serplulimab’s clinical data in SCLC have been included in the ESMO Magnitude of Clinical Benefit Scale (MCBS), ranking higher than peer products, and have been featured in oral and panel sessions at leading international congresses such as ESMO and the World Conference on Lung Cancer (WCLC). Henlius continues to advance its global regulatory and clinical program for serplulimab. In addition to the ES-SCLC program, the company is conducting an international multicentre Phase 3 trial (ASTRUM-020) evaluating serplulimab with concurrent chemoradiotherapy (cCRT), in patients with limited-stage small cell lung cancer (LS-SCLC), which completed full patient enrolment in January 2025.

As one of the first Chinese biopharmaceutical companies to independently conduct innovative immuno-oncology studies in the U.S., Henlius remains committed to a science-driven approach, advancing precision treatment strategies through internationally compliant clinical practices and localized development to deliver affordable, accessible, and patient-centred therapeutic innovations to patients worldwide.

About Serplulimab

Serplulimab is a recombinant humanized anti-PD-1 mAb injection (trade name in Europe: Hetronifly®). It is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and has been approved for marketing in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India.

In March 2022, serplulimab was officially approved for marketing 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), and non-squamous non-small cell lung cancer (nsqNSCLC).

Focusing on lung and gastrointestinal cancers, Henlius has been actively advancing the synergistic development of serplulimab with other in-house products and its combination with novel therapies. The product has received clinical trial authorizations in multiple countries and regions including China, the U.S., and the EU, and is being evaluated in over ten global, multicentre clinical trials on immuno-oncology combination therapies. To date, more than 5,000 patients have been enrolled in clinical studies of serplulimab across China, the U.S., Turkey, Poland, Georgia, and other countries, 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. Three pivotal clinical studies of serplulimab have been published in leading journals including 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, Colorectal Cancer, 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 Designation (ODD) by both the U.S. FDA and the European Commission (EC). Furthermore, in June 2025, Henlius initiated a bridging study in Japan to evaluate the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for ES-SCLC in Japanese patients.

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.