全球研发   从全球首个到本土可及，H药 汉斯状日本小细胞肺癌桥接试验完成首例患...

2025年6月25日，复宏汉霖（2696.HK）宣布，公司自主研发的H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）在日本开展的桥接临床试验（NCT）完成首例患者入组。

H药 汉斯状是全球首个获批用于一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，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，惠及逾11万患者。NCT06812260研究由关西医科大学附属医院Takayasu Kurata教授担任牵头主要研究者，此次桥接试验旨在评估该产品联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）在日本患者中的疗效及安全性，为后续H药在日本市场的注册申报奠定基础。

肺癌是全球发病率和死亡率最高的癌症，据GLOBOCAN最新数据显示，肺癌是日本发病率第二大高发癌种，2022年日本肺癌新发病例13.6万余例，肺癌死亡病例逾8.3万例，位居该国癌症死亡人数第一[1]。SCLC占肺癌总数的15%-20%，具有恶性程度高、转移早、疾病进展迅速等特点，预后极差。SCLC分为局限期和广泛期，在被确诊为SCLC的日本患者中，约40-50%为ES-SCLC，而其中在确诊后存活5年的患者不足4%[2,3]。

此前，复宏汉霖已针对H药汉斯状用于一线治疗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药用于治疗ES-SCLC陆续在中国、东南亚多国、欧洲、英国和印度获批用于一线治疗ES-SCLC。复宏汉霖在全球范围内积极推进H药在获批上市进程，目前，公司正在美国开展一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验，以进一步支持H药在美国的上市申报。

复宏汉霖将持续以科学证据为核心，通过本土化开发，推动精准治疗策略的落地，为日本乃至全球患者提供更贴合临床需求的治疗选择。

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;74(3):229-263. doi:10.3322/caac.21834

[2] Sawabata N, Asamura H, Goya T, et al; Japanese Joint Committee for Lung Cancer Registry. Japanese Lung Cancer Registry Study: first prospective enrollment of a large number of surgical and nonsurgical cases in 2002. J Thorac Oncol. 2010 Sep;5(9):1369-75.

[3] Oze I, Ito H, Nishino Y, et al. Trends in Small-Cell Lung Cancer Survival in 1993-2006 Based on Population-Based Cancer Registry Data in Japan. J Epidemiol. 2019 Sep 5;29(9):347-353.

关于日本桥接研究（NCT）

本研究为一项在日本初治广泛期小细胞肺癌（ES-SCLC）患者中进行的单臂、开放、II期的桥接研究。合格的患者将每三周接受一次HLX10（重组人源化抗PD-1单克隆抗体注射液）联合化疗（卡铂-依托泊苷）治疗。主要研究目的为评价HLX10联合化疗在日本初治ES-SCLC患者中的疗效，次要目的为评估HLX10联合化疗的安全性、药代动力学（PK）和免疫原性。主要研究终点为第24周缓解（完全缓解[CR]或部分缓解[PR]）率。次要研究终点包括总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、缓解持续时间（DOR）、生活质量、安全性、PK和免疫原性指标。

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，已有6款产品在中国获批上市，4款产品在国际获批上市，5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国内首个生物类似药汉利康（利妥昔单抗）、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）、汉达远（阿达木单抗）、汉贝泰（贝伐珠单抗）、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）以及汉奈佳（奈拉替尼）。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 Doses First Patient in Japanese Bridging Study of Serplulimab for Extensive-Stage Small Cell Lung Cancer

Shanghai, China, June 25, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in its Japanese bridging study (NCT) of its self-developed innovative anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly).

Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, benefiting over 110,000 patients to date. The Japanese bridging studyis, led by Professor Takayasu Kurata of Kansai Medical University Hospital, aims to evaluate the efficacy and safety of serplulimab in combination with chemotherapy for the first-line treatment of extensive-stage SCLC (ES-SCLC) in Japanese patients. This milestone lays a foundation for future regulatory submissions in Japan.

Lung cancer is the leading cause of cancer-related deaths worldwide. According to the latest GLOBOCAN data, it is the second most commonly diagnosed cancer in Japan, with over 136,000 new cases and more than 83,000 deaths reported in 2022, making it the country’s top cause of cancer-related mortality[1]. SCLC accounts for 15%–20% of all lung cancers and is characterized by high malignancy, early metastasis, and rapid disease progression, with a dismal prognosis. ES-SCLC accounts for 40%–50% of SCLC cases in Japan, and fewer than 4% of these patients survive five years post-diagnosis[2,3].

Henlius previously conducted ASTRUM-005, a randomized, double-blind, placebo-controlled, global phase 3 study evaluating serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC. The results were first presented as an oral presentation at the 2022 ASCO Annual Meeting and subsequently published in JAMA, one of the world's top four medical journals—marking the first SCLC immunotherapy study to be published in the journal's main issue. At the 2025 ASCO Annual Meeting, final analysis results of the study were presented: as of December 31, 2024 (median follow-up: 42.4 months), the 4-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 underscoring the long-term survival benefit of serplulimab for ES-SCLC patients.

Driven by the strong clinical data from ASTRUM-005, serplulimab has been approved for first-line treatment of ES-SCLC in China, Europe, UK, India and multiple Southeast Asian countries. In parallel, Henlius is conducting a head-to-head bridging study in the U.S. comparing serplulimab to the current standard-of-care, atezolizumab, to support its potential U.S. regulatory submission.

Henlius remains committed to science-based development and will continue advancing localized strategies to enable precision treatment, aiming to deliver clinically relevant therapeutic options for patients in Japan and around the world.

About NCT

This is a single-arm, open-label, phase 2 bridging trial conducted in Japanese patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). Eligible patients will be administrated once every three weeks with HANSIZHUANG in combination with chemotherapy (carboplatin-etoposide). The primary objective of the study is to evaluate the efficacy of HANSIZHUANG in combination with chemotherapy in Japanese patients with previously untreated ES-SCLC. The secondary objectives are to evaluate the safety, pharmacokinetics, and immunogenicity of HANSIZHUANG in combination with chemotherapy. The primary endpoint is the response (complete response (CR) or partial response (PR)) rate at week 24. Secondary endpoints include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity parameters.

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. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 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 HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

(复星医药)