欧盟获批一周年：复星医药子公司复宏汉霖H药汉斯状落地12国并纳入7国医保_星动态_新闻中心

2026-03-02

欧盟获批一周年：复星医药子公司复宏汉霖H药汉斯状落地12国并纳入7国医保

H药已在欧盟12个国家上市，并进入德国、意大利、西班牙等7国医保目录
H药已在全球超40个国家和地区获批上市，覆盖全球近半数人口
复宏汉霖携手合作伙伴，持续推进创新免疫治疗在全球的体系化落地

2026年2月，复星医药子公司复宏汉霖（2696.HK）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^{^®}）迎来在欧盟获批上市一周年里程碑。自2025年2月正式获得欧盟委员会（European Commission, EC）批准H药联合卡铂和依托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗以来，复宏汉霖携手欧盟区域合作伙伴Intas子公司Accord，持续推进斯鲁利单抗在欧洲的准入与落地进程。作为全球首个获批用于一线治疗ES-SCLC的抗PD-1单抗，截至目前，H药已于12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、瑞典等7个欧盟成员国完成医保或公共支付体系准入，进入当地主流医疗保障体系，进一步提升符合适应症的肿瘤患者的治疗获益。

欧盟医保准入通常需要经过严格的卫生技术评估（HTA），综合考量临床疗效、安全性、患者获益及成本效益等多重因素。根据2025年4月IQVIA发布的欧洲创新药可及性研究报告（数据周期2020-2023），创新药在欧洲纳入医保平均周期为578天。作为中国自主研发并实现国际化发展的创新免疫治疗药物，H药在欧盟获批一周年内即在多国实现医保覆盖，标志着该产品在临床价值、经济性及真实世界可及性方面进一步获得欧洲医疗体系的认可，也意味着其在欧洲市场完成了从“监管认可”向“体系化可及”的重要跨越。

以临床价值为核心

持续获得国际权威体系认可

H药在欧盟的成功破局，得益于其坚实的循证医学基础，其获EC批准主要基于ASTRUM-005研究。ASTRUM-005研究是一项随机、双盲、安慰剂对照的国际多中心III期研究，全面评估了斯鲁利单抗联合化疗对比安慰剂联合化疗用于ES-SCLC一线治疗的疗效和安全性。该试验在中国、欧盟波兰、土耳其、格鲁吉亚等多个国家共开设128个试验中心，入组585例受试者，其中约31.5%为白人。

基于ASTRUM-005研究提示的临床疗效，斯鲁利单抗先后获得美国、欧盟、瑞士、韩国、墨西哥等孤儿药资格认定，有助于H药用于治疗小细胞肺癌在当地研发、注册及商业化等方面享受一定的政策支持。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（Magnitude of Clinical Benefit Scale，MCBS），评分结果领先同类治疗方案，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。

全球研发与注册并行推进

持续拓展治疗边界

凭借其差异化的机制，H药在多种实体瘤的治疗中展现出独特优势，该药物不仅具备更强的PD-1内吞作用，可减少T细胞表面PD-1受体¹，实现快速、强效的免疫激活；还能减少PD-1对共刺激分子CD28的募集，从而更大程度保留CD28信号传导^2-4，增强下游AKT蛋白活性⁵，促进T细胞持续活化。聚焦肺癌与消化道肿瘤，H药已获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、ESCC和非鳞状非小细胞肺癌（nsNSCLC) 适应症，在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等40多个国家或地区获批上市，覆盖全球近半数人口。目前，复宏汉霖正持续在全球范围内积极推进H药的获批上市进程，并有望在2026年底前完成多项新适应症在欧盟的获批上市。

H药在欧盟市场的积极表现，为公司后续创新管线在欧盟及其他成熟市场的商业化奠定了积极基础，也为中国创新免疫治疗药物在国际成熟市场的价值实现路径提供了实践经验。复宏汉霖始终坚持“以患者为中心”的研发与全球化战略，持续推进创新药在不同医疗体系下的可负担性探索。未来，复宏汉霖将继续与全球合作伙伴及当地医疗机构紧密协作，加速推进H药在更多国家和地区的准入进程，推动高质量创新生物药惠及更广泛的患者群体。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EMA上市授权，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。

在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药汉斯状^{^®}（斯鲁利单抗，欧洲商品名：Hetronifly^{^®}）作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。

One-Year Anniversary of EU Approval: Hetronifly^{^®} Now Launched in 12 EU Countries and Reimbursed in 7

Serplulimab has been launched in 12 EU countries and included in reimbursement schemes in Germany, Italy, Spain and other Member States
Approved in over 40 countries and regions worldwide, covering nearly half of the global population
Henlius continues to advance the systematic global rollout of innovative immunotherapies with partners

This February, Henlius (2696.HK) marks the one-year anniversary of the European Union approval of its self-developed anti-PD-1 monoclonal antibody serplulimab (trade name in Europe: Hetronifly^{^®}).

In February 2025, the European Commission (EC) granted marketing authorization for serplulimab in combination with carboplatin and etoposide as a first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). As the first anti-PD-1 monoclonal antibody approved globally for first-line treatment of ES-SCLC, serplulimab has since advanced steadily across the European market.

Over the past year, Henlius, together with its EU regional partner Accord Healthcare Ltd (“Accord”), a subsidiary of Intas, has continued to drive market access and commercialization efforts. To date, Hetronifly^{^®} has been launched in 12 EU countries and has been reimbursed in Austria, Denmark, Germany, Ireland, Italy, Spain, Sweden, entering mainstream healthcare systems and supporting improved outcomes for eligible patients.

Reimbursement decisions in the EU are typically subject to stringent health technology assessment (HTA) processes, evaluating clinical efficacy, safety, patient benefit and cost-effectiveness. According to IQVIA, the average reimbursement approval lead time cross EU Member States is 578 days ¹.

Achieving reimbursement coverage across multiple Member States within one year of EU approval reflects recognition of the clinical value and real-world applicability of serplulimab within mature European healthcare systems. It also marks a key step in transitioning from regulatory approval to broader patient accessibility across the region.

Strong Clinical Foundation and International Recognition

The approval of serplulimab by the EC is primarily based on data from the ASTRUM-005 study, a randomized, double-blind, placebo-controlled international multi-centre phase 3 study evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. The study has set up a total of 128 sites across countries including China, Poland, Türkiye, and Georgia, enrolling 585 subjects, of whom around 31.5% were Caucasians.

Based on the clinical outcomes demonstrated in ASTRUM-005, serplulimab has received Orphan Drug Designations (ODDs) by the US FDA, the European Commission, Swissmedic, Korea MFDS and Mexico COFEPRIS, supporting regulatory and development pathways in small cell lung cancer.

In addition, clinical data of serplulimab in ES-SCLC were incorporated into the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS), where it achieved the highest score among evaluated therapies for this indication. The data have also been presented through oral presentations and dedicated sessions at international academic conferences including ESMO and the World Conference on Lung Cancer (WCLC).

Parallel Global Development and Expanding Indication Footprint

Serplulimab demonstrates unique advantages in treating various solid tumours via its differentiated mechanism of action. The drug not only induces stronger PD-1 internalization, reducing PD-1 receptor presence on T cells for rapid and potent immune activation ²—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signalling ^3-5, enhancing downstream AKT activity ⁶, and promoting sustained T-cell activation. Focused on lung cancers and gastrointestinal cancers, serplulimab has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), ESCC, and non-squamous non-small cell lung cancer (nsNSCLC).

Up to date, it has been approved in over 40 countries and regions including China, the U.K., the EU, Singapore, India, Switzerland and Peru, covering nearly half of the global population. Henlius continues to advance regulatory submissions globally, and additional EU approvals for new indications are anticipated before the end of 2026.

The progress achieved in the EU market over the past year lays a solid foundation for the commercialisation of Henlius’ broader innovative pipeline in Europe and other mature markets. It also provides practical experience for the value realization pathway of innovative immunotherapies developed in China within global healthcare systems.

Henlius remains committed to its patient-centred R&D and globalization strategy. The company will continue working closely with global partners and local healthcare stakeholders to expand access to innovative biologics across more countries and regions, bringing high-quality therapies to a broader patient population.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products authorized by the European Medicines Agency (EMA), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly^{^®} in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/ and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

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EFPIA Patients W.A.I.T. Indicator 2024 Survey, IQVIA, published in Apr.2025

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