欧洲药品管理局人用药品委员会（CHMP）发布积极意见，推荐批准H药 汉斯状 新增鳞状非小细胞肺癌（sqNSCLC）适应症
继ES-SCLC、nsqNSCLC及ESCC后，H药有望进一步完善其欧洲肺癌治疗版图，持续深化关键高发癌种布局
聚焦肺癌和消化道肿瘤，H药已在全球40多个国家和地区获批上市
2026年5月23日，上海——复宏汉霖（HK2696）（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药 汉斯状 （斯鲁利单抗，欧洲商品名：Hetronifly ）获得欧洲药品管理局（EMA）人用药品委员会（CHMP）积极意见，推荐批准其联合化疗用于不可手术切除的局部晚期或转移性鳞状非小细胞肺癌（sqNSCLC）的一线治疗。
此次积极意见发布，标志着H药在欧洲的适应症布局有望进一步扩容。此前，H药已在欧盟获批用于广泛期小细胞肺癌（ES-SCLC）、非鳞状非小细胞肺癌（nsqNSCLC）及食管鳞状细胞癌（ESCC）。根据欧盟法规，CHMP的积极意见将提交至欧盟委员会进行最终审议，若顺利获批，H药在欧盟成员国及欧洲经济区国家的适应症范围将得到进一步拓展，全面覆盖肺癌一线治疗，为更多患者提供新的治疗选择。
复宏汉霖（HK2696）执行董事、首席执行官朱俊博士表示：“CHMP就sqNSCLC适应症发布的积极意见是H药在欧洲注册进程中的又一重要里程碑，也标志着H药有望在欧盟实现肺癌一线治疗全覆盖。我们始终相信，创新药（886015）的价值不仅体现在科学突破本身，更在于持续拓展治疗覆盖、跨越不同医疗体系，真正触达患者。未来，我们将继续推进全球临床开发、注册与商业化进程，与合作伙伴携手提升创新治疗的可及性。”
关键III期研究ASTRUM-004奠定循证基础，支撑sqNSCLC全球注册推进
此次CHMP积极意见主要基于一项随机、双盲、国际多中心Ⅲ期临床研究ASTRUM-004。ASTRUM-004由同济大学附属东方医院（884301）周彩存教授担任牵头主要研究者，旨在研究斯鲁利单抗对比安慰剂分别联合化疗在既往未接受治疗的晚期sqNSCLC患者中的疗效和安全性。研究结果显示，与标准治疗方案相比，在未经治疗的局部晚期或转移性sqNSCLC患者中，斯鲁利单抗联合化疗显著改善了生存期，并在总生存期（OS）、无进展生存期（PFS）等关键指标上展现出积极结果，且安全性可控。
ASTRUM-004研究总人群最终分析结果于2023年世界肺癌大会（World Conference on Lung Cancer, WCLC）以口头报告形式首次亮相。2024年1月5日，ASTRUM-004研究在线发表于肿瘤学国际顶级期刊Cancer Cell并获封面推荐，凸显了该研究在国际临床领域的重要地位和其对sqNSCLC治疗领域的深远影响。基于ASTRUM-004研究结果，H药已于2022年正式获得中国国家药品监督管理局（NMPA）批准用于联合化疗一线治疗sqNSCLC。
从ES-SCLC到NSCLC广覆盖，H药欧洲肺癌一线治疗版图有望再扩容
肺癌始终是全球疾病负担最重的恶性肿瘤之一，非小细胞肺癌（NSCLC）约占全部肺癌病例的85%，其中sqNSCLC是重要亚型之一，患者仍存在显著未满足临床需求。随着此次sqNSCLC适应症获得CHMP积极意见，H药在欧洲市场有望进一步覆盖从小细胞肺癌到非小细胞肺癌多个关键亚型，持续完善其在肺癌领域的系统布局。
自2025年2月H药首次获得欧盟批准以来，复宏汉霖（HK2696）携手欧洲区域合作伙伴Accord持续推进其市场准入与商业化落地。截至目前，H药已在16个欧盟国家实现上市销售，并在奥地利、丹麦、德国、爱尔兰、意大利、西班牙和瑞典等10个国家纳入医保或公共支付体系，进入当地主流医疗保障体系。依托持续扩展的适应症布局，H药在欧洲市场的临床价值、商业潜力及长期可及性正不断提升。
从差异化适应症布局到百亿潜力释放，H药全球价值空间持续打开
作为复宏汉霖（HK2696）全球化战略的重要核心产品，H药目前已在全球40多个国家和地区获批上市，覆盖全球近半数人口，并围绕肺癌与消化道肿瘤等高发癌种持续推进多项国际临床研究及注册申请。从全球首个获批用于广泛期小细胞肺癌一线治疗的抗PD-1单抗，到持续拓展非小细胞肺癌及消化道肿瘤适应症，H药正逐步构建覆盖更广泛瘤种的全球临床价值体系。与此同时，公司正在美国、日本及更多国际市场同步推进桥接研究与注册计划，持续强化其全球商业化基础。
未来，复宏汉霖（HK2696）将继续聚焦全球重大未满足临床需求，依托一体化全球研发、注册、生产与商业化能力，持续推动更多创新成果在国际成熟市场实现突破，加速高质量创新生物药惠及全球更多患者。
Henlius’ Serplulimab Receives Positive CHMP Opinion for the Treatment of sqNSCLC
· The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a new indication for serplulimab (trade name: Hetronifly in Europe) for squamous non-small cell lung cancer (sqNSCLC)
· Following approvals in ES-SCLC, nsqNSCLC, and ESCC, serplulimab is expected to further expand its lung cancer treatment portfolio in Europe, deepening its presence in major high-incidence tumour types
· Focused on lung cancer and gastrointestinal cancers, serplulimab has been approved in more than 40 countries and regions worldwide
May 23, 2026, Shanghai — Henlius Biotech, Inc. (2696.HK) announced that serplulimab (trade name: Hetronifly in Europe), the company’s self-developed anti-PD-1 mAb, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending its approval in combination with chemotherapy for the First（FFBC）-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).
The positive CHMP opinion marks a potential further expansion of serplulimab’s indication portfolio in Europe. Previously, serplulimab had already been approved in the European Union for extensive-stage small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer (nsqNSCLC), and esophageal squamous cell carcinoma (ESCC). Under the EU regulatory framework, the CHMP positive opinion will be submitted to the European Commission (EC) for final review. If approved, serplulimab’s indications across EU Member States and European Economic Area (EEA) countries will be further expanded, enabling broader coverage of First（FFBC）-line lung cancer treatment and providing new treatment options for more patients.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important Milestone（MIST） in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of First（FFBC）-line lung cancer treatment indications in the EU. We firmly believe that the value of Innovative（IIPR） medicines lies not only in scientific breakthroughs themselves, but also in continuously expanding treatment coverage across different healthcare systems to ultimately reach more patients in need. Moving forward, we will continue to advance our global clinical development, regulatory, and commercialisation efforts, while working closely with our partners to improve access to Innovative（IIPR） therapies worldwide.”
Pivotal Phase 3 Trial ASTRUM-004 Establishes Evidence Base Supporting Global Regulatory Advancement in sqNSCLC The positive CHMP opinion was primarily based on ASTRUM-004, a randomised, double-blind, International（IGIC） multicentre phase 3 clinical trial. LED（884095） by Dr. Caicun Zhou of Shanghai East Hospital, Tongji University School of Medicine, the study was designed to evaluate the efficacy and safety of serplulimab versus placebo, each in combination with chemotherapy, in patients with previously untreated advanced sqNSCLC. Study results demonstrated that, compared with the standard-of-care regimen, serplulimab plus chemotherapy significantly improved survival outcomes in patients with previously untreated locally advanced or metastatic sqNSCLC, showing positive results across key endpoints including overall survival (OS) and progression-free survival (PFS), with a manageable safety profile.
The final analysis results of the overall population from the ASTRUM-004 trial were First（FFBC） shared in an oral presentation at the 2023 World Conference on Lung Cancer (WCLC). On January 5, 2024, the study was published online in Cancer Cell, a leading International（IGIC） oncology journal, and was featured on the journal cover, highlighting the study’s significance within the global clinical oncology community and its potential impact on the treatment landscape of sqNSCLC. Based on the results of ASTRUM-004, serplulimab received approval from China’s National Medical Products Administration (NMPA) in 2022 in combination with chemotherapy for the First（FFBC）-line treatment of sqNSCLC.
Expanding from ES-SCLC to Primary Coverage of NSCLC: Serplulimab Poised to Further Strengthen Its First（FFBC）-Line Lung Cancer Portfolio in Europe Lung cancer remains one of the most significant contributors to the global cancer burden. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, among which squamous non-small cell lung cancer (sqNSCLC) represents a major subtype with substantial unmet clinical needs. With the positive CHMP opinion for the sqNSCLC indication, serplulimab is expected to further expand its coverage across multiple key lung cancer subtypes in the European market, ranging from SCLC to NSCLC, further strengthening its integrated lung cancer portfolio.
Since receiving its First（FFBC） approval in the European Union in February 2025, Henlius, together with its regional partner Accord, has continued to advance market access and commercialisation efforts for serplulimab across Europe. To date, serplulimab has been commercially launched in 16 European countries and has been included in reimbursement or public healthcare coverage systems in 10 countries, including Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, thereby gaining access to mainstream healthcare systems in these markets. Supported by its continuously expanding indication portfolio, serplulimab is steadily enhancing its clinical value, commercial potential, and long-term accessibility in the European market.
From Differentiated Indication Expansion to Unlocking Blockbuster Potential, Serplulimab Continues to Expand Its Global Value Proposition As a core product underpinning Henlius’ globalisation Strategy（MSTR）, serplulimab has been approved in more than 40 countries and regions worldwide, covering nearly half of the global population. The product continues to advance multiple International（IGIC） clinical trials and regulatory filings across major high-incidence cancers, including lung cancer and gastrointestinal cancers. From becoming the world’s First（FFBC） anti-PD-1 mAb approved for the First（FFBC）-line treatment of ES-SCLC, to continuously expanding into NSCLC and gastrointestinal cancer indications, serplulimab is progressively building a broader global clinical value portfolio across multiple tumour types. Meanwhile, the company is simultaneously advancing bridging studies and regulatory plans in the United States, Japan, and additional International（IGIC） markets, further strengthening the foundation for its global commercialisation Strategy（MSTR）.
Looking ahead, Henlius will continue to focus on major unmet clinical needs worldwide and leverage its integrated global capabilities spanning R&D, regulatory affairs, manufacturing, and commercialisation to accelerate breakthroughs in International（IGIC） mature markets and expand access to high-quality Innovative（IIPR） biologics for patients worldwide.