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。

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 (NCT06812260) 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.

媒体：PR@Henlius.com

投资者：IR@Henlius.com