复星医药子公司复宏汉霖携手卫材就抗PD-1单抗汉斯状®达成日本市场合作
2026年2月5日，上海&东京——卫材株式会社（总部：日本东京，首席执行官：内藤晴夫，以下简称“卫材”）与复宏汉霖（总部：中国上海，首席执行官：朱俊博士）今日共同宣布，双方已就抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）在日本达成一项独家商业化及共同独家开发与生产许可协议。
目前，复宏汉霖正在日本开展一项针对ES-SCLC的II期桥接临床试验，并计划基于该试验的结果，以及支持该适应症在中国和欧洲获批的III期临床试验数据，于卫材2026财年期间递交上市申请。此外，复宏汉霖也正在推进针对非微卫星高度不稳定型转移性结直肠癌的国际多中心III期临床试验，其它新适应症的开发也在规划之中。
根据协议，卫材将获得斯鲁利单抗在日本的独家商业化权益。除用于广泛期小细胞肺癌和非微卫星高度不稳定型转移性结直肠癌的治疗外，复宏汉霖还计划在日本开展斯鲁利单抗用于胃癌围手术期治疗的临床研究，并将承担该产品在日本的上市许可持有人（MAH）责任。
卫材将向复宏汉霖支付7,500万美元的首付款（约合116亿日元*），并在此基础上，支付最高不超过8,001万美元的监管里程碑付款（约合124亿日元），以及最高不超过2.333亿美元的销售里程碑付款（约合362亿日元）。此外，复宏汉霖还将基于产品销售额获得双位数比例的销售提成。卫材预计，该交易不会对其截至 2026年3月31日的合并财务业绩预测产生影响。
复宏汉霖执行董事、首席执行官
朱俊博士表示
我们非常高兴能与卫材在日本市场达成合作，共同推进斯鲁利单抗在这一重要市场的开发进程 。通过全球临床开发和监管审批，斯鲁利单抗已在多种肿瘤类型中展现出良好的潜力。日本是其国际化进程中的关键一步。我们期待结合复宏汉霖的创新研发能力与卫材深厚的本土经验，加速斯鲁利单抗的开发进程，早日满足日本患者未被满足的治疗需求。
卫材执行官、日本业务负责人由佐俊彦表示
斯鲁利单抗是一款率先布局广泛期小细胞肺癌等重大未满足医疗需求领域的抗PD-1单抗，已在中国和欧盟获得多项适应症批准。我们期待该药物未来能为日本的广泛期小细胞肺癌、非微卫星高度不稳定型转移性结直肠癌及其他难治型肿瘤患者提供新的治疗选择。卫材将与复宏汉霖通力协作，全力加速该产品在日本的可及，尽早惠及患者。
* 按1美元 = 155日元的汇率换算
【参考文献】
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National Cancer Center Japan, Cancer Information Service, Cancer Statistics (Japanese only)
https://ganjoho.jp/reg_stat/statistics/stat/cancer/ Last accessed: January 2026. -
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Cancer Statistics in Japan-2025
https://www.fpcr.or.jp/pdf/pamphlet/cancer_statistics_2025.pdf (P30) Last accessed: January 2026.
关于斯鲁利单抗
斯鲁利单抗是一款由上海复宏汉霖生物技术股份有限公司（以下简称“复宏汉霖”）自主研发的抗PD-1单克隆抗体，于2022年在中国获批上市。该产品已获得中国国家药品监督管理局批准，用于治疗鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌以及非鳞状非小细胞肺癌等多项适应症，并成为全球首个获批用于广泛期小细胞肺癌（ES-SCLC）一线治疗的抗PD-1单抗。目前，斯鲁利单抗已在包括欧盟、东南亚（印度尼西亚、柬埔寨、泰国、新加坡、马来西亚）以及南美洲（秘鲁）在内的40多个国家和地区获批用于ES-SCLC的治疗。
复宏汉霖正积极推进斯鲁利单抗在全球范围内的进一步应用，既包括单药治疗，也包括与公司自主研发或外部合作的多种创新疗法的联合治疗。此外，公司正在全球范围内开展多项临床研究，重点聚焦肺癌和消化道肿瘤等高发肿瘤领域，探索斯鲁利单抗在既往尚未应用抗PD-1单抗治疗的疾病领域中的潜力。
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。
关于卫材株式会社（Eisai Co., Ltd.）
卫材的企业理念是“以患者及日常生活中的人们为中心，提升医疗健康所带来的价值”。基于这一理念（亦称为“关心人类健康（human health care，hhc）”），卫材致力于通过缓解公众对健康的焦虑、减少健康不平等，切实创造社会价值。依托覆盖全球的研发机构、生产基地及营销子公司网络，卫材持续开发并提供创新药物，重点聚焦具有高度未满足医疗需求的疾病领域，尤其是在神经科学和肿瘤学等战略重点领域。
此外，卫材积极践行对消除被忽视热带病（NTDs）的承诺。消除被忽视热带病是联合国可持续发展目标（SDGs）中目标3.3的重要组成部分，卫材正与全球合作伙伴携手推进相关工作。
如需了解更多有关卫材的信息，请访问公司官网 www.eisai.com（全球总部：卫材株式会社），并通过 X、LinkedIn 和 Facebook 与我们取得联系。上述网站及社交媒体平台内容主要面向英国和欧洲以外的受众。
About Serplulimab
Serplulimab is an anti-PD-1 monoclonal antibody first developed by Shanghai Henlius Biotech, Inc. (“Henlius”), and launched in China in 2022. It has been approved by the National Medical Products Administration of China for indications including squamous non-small cell lung cancer, extensive-stage small cell lung cancer, esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer, and is the world's first anti-PD-1 antibody to be used as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It has been approved for the treatment of ES-SCLC in over 40 markets, including the EU, Southeast Asia (Indonesia, Cambodia, Thailand, Singapore, Malaysia), and South America (Peru).
Henlius is actively promoting the broader use of serplulimab both as a standalone product and in combination with other innovative therapies, including those developed in-house and externally. Furthermore, the company is conducting numerous clinical trials worldwide on therapies for conditions where existing anti-PD-1 antibodies have not yet been used, focusing on indications such as lung cancer and gastrointestinal tumors.
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/.
About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe.
