来源：市场资讯
（来源：正心谷资本）
2026年3月30日，复宏汉霖（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）两项积极意见，推荐批准其联合化疗用于一线治疗局部晚期或转移性非鳞状非小细胞肺癌（nsqNSCLC）和用于PD-L1阳性的不可切除的局部晚期、复发或转移性食管鳞状细胞癌（ESCC）。此前，H药已在欧盟获批一线治疗广泛期小细胞肺癌（ES-SCLC）。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。
复宏汉霖执行董事、首席执行官
朱俊博士表示
CHMP发布的积极意见，是对H药卓越临床价值和坚实科学证据的有力印证，也标志着我们在拓展全球抗肿瘤版图上的又一重要里程碑。肺癌和消化道肿瘤是严重威胁人类健康的重大疾病，在欧洲乃至全球仍存在巨大且迫切的未满足临床需求。这两项新适应症若能顺利获批，将为当地患者带来新的治疗选择和生存获益。未来，我们将持续推进创新疗法的全球开发与注册进程，携手合作伙伴加速推动创新成果惠及更多患者。
坚实临床数据支撑，疗效与安全性获权威认可
此次CHMP积极意见主要基于ASTRUM-002和ASTRUM-007两项研究结果。相关研究均为随机、双盲、多中心III期临床试验，旨在评估斯鲁利单抗在相应适应症患者中的疗效和安全性。相关研究结果已在国际学术会议及学术期刊上公布。这两项临床证据此前已分别支持H药用于一线治疗nsqNSCLC和ESCC的适应症在中国获批上市。
ASTRUM-002由国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院石远凯教授担任牵头主要研究者，旨在研究斯鲁利单抗联合化疗（卡铂-培美曲塞）对比化疗（卡铂-培美曲塞）一线治疗晚期nsqNSCLC的疗效与安全性。研究结果表明，斯鲁利单抗组的无进展生存期（PFS）显著延长，达到预设的优效标准，且具有良好的安全性。ASTRUM-002研究的最终分析结果入选ESMO大会的LBA（Late-breaking Abstract），以口头汇报形式首次正式公布总生存期（OS）数据。最终分析结果显示，斯鲁利单抗联合化疗组的中位总生存期（mOS）达到26.8个月，成功突破两年的长期生存获益。
ASTRUM-007由国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院黄镜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联合化疗（顺铂+5-FU）在既往未接受治疗、PD-L1阳性的晚期ESCC患者中的疗效和安全性。研究结果显示，斯鲁利单抗联合化疗带来了总生存期（OS）和无进展生存期（PFS）的全面生存获益，并具备良好的安全性。ASTRUM-007研究此前刊登于国际权威期刊Nature Medicine。
欧洲商业化稳步推进，可及性持续提升
作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，H药自2025年2月获得欧盟委员会批准上市以来，复宏汉霖携手欧盟区域合作伙伴Intas子公司Accord，持续推进其在欧洲的准入与落地进程。截至目前，H药已在12个欧盟国家实现上市销售，并已在奥地利、丹麦、德国、爱尔兰、意大利、西班牙和瑞典等7个欧盟成员国纳入医保或公共支付体系，进入当地主流医疗保障体系，进一步提升符合适应症患者的治疗可及性。
在欧盟市场，创新药物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方面因素。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1。H药则在欧盟获批一年内即实现多国医保覆盖，体现了其临床价值及在成熟医疗体系中的可及性潜力。
机制优势赋能，全球研发与注册持续推进
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2，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3-5，增强下游AKT蛋白活性6，促进T细胞持续活化。聚焦肺癌与消化道肿瘤，H药已在中国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）、食管鳞癌（ESCC）及非鳞状非小细胞肺癌（nsqNSCLC）等多个适应症，并已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等40多个国家和地区获批上市，覆盖全球近半数人口。
与此同时，复宏汉霖正全面推进H药的全球临床开发计划，目前已在全球开展超过10项肿瘤免疫联合治疗研究，累计入组患者超过5,100例，并在美国和日本同步开展ES-SCLC的桥接试验。在消化道肿瘤领域，III期临床研究（ASTRUM-006）评估了H药联合化疗作为新辅助治疗，以及H药单药作为辅助治疗用于胃癌围手术期的治疗方案。该研究是全球首个以术后免疫单药替代术后辅助化疗的胃癌围手术期治疗方案，是该领域的重要临床突破7。作为全球首个胃癌围手术期以免疫单药取代术后辅助化疗的治疗方案，该适应症上市许可申请已获CDE受理并被纳入优先审评，有望于2026年于中国获批。在结直肠癌领域，III期国际多中心临床研究（ASTRUM-015）已完成患者入组。该研究评估了H药联合贝伐珠单抗及化疗用于转移性结直肠癌（mCRC）一线治疗的疗效与安全性。同时，其II期临床的最新数据进一步凸显了H药在带来高疾病负担的恶性消化道肿瘤领域持续拓展临床价值的潜力8。
未来，复宏汉霖将持续推进H药在全球范围内的注册和临床开发，进一步拓展其在不同肿瘤类型中的治疗潜力。
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EC批准，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。
Henlius Receives Two Positive CHMP Opinions for Serplulimab, Advancing Global Regulatory Progress
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued two positive opinions recommending new indications for serplulimab in 30 EEA countries
As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), serplulimab has been launched in 12 EU countries and included in reimbursement schemes in 7
Serplulimab has been approved in over 40 countries and regions worldwide, covering nearly half of the global population
Shanghai, China – March 30, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly®), has received two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP recommends approval of serplulimab in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma (nsqNSCLC) and with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (whose tumours express PD-L1 with a CPS ≥ 5.).
Serplulimab has previously been approved in the European Union (EU) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Under EU regulatory procedures, the CHMP’s positive opinion will be submitted to the European Commission (EC) for final decision. If approved by the EC, the indications of serplulimab in the EU Member States and the European Economic Area (EEA) will be further expanded.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinions strongly validate the clinical value and robust scientific evidence of serplulimab, marking another significant milestone in expanding our global oncology footprint. Lung cancer and gastrointestinal tumours pose severe threats to human health, representing substantial and urgent unmet medical needs in Europe and globally. If approved, these two new indications will provide local patients with new treatment options and survival benefits. Moving forward, we will continuously advance the global development and regulatory submissions of our innovative therapies, working alongside our partners to accelerate the delivery of clinical benefits to more patients.”
Robust Clinical Evidence with Recognized Efficacy and Safety
The CHMP opinions are primarily based on results from the ASTRUM-002 and ASTRUM-007 studies. These two Phase 3 clinical trials previously supported the approval of serplulimab in China for first-line treatment of nsqNSCLC and ESCC, respectively.
Both studies are randomized, double-blind, multicentre Phase 3 trials designed to evaluate the efficacy and safety of serplulimab in the respective patient populations. Results have been presented at international academic conferences and published in peer-reviewed journals.
ASTRUM-002, led by Professor Yuankai Shi from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, evaluated serplulimab in combination with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone in patients with advanced nsqNSCLC. The study demonstrated a statistically significant improvement in progression-free survival (PFS), meeting its primary endpoint with a favourable safety profile. Final results of ASTRUM-002 were presented as a late-breaking abstract at the European Society for Medical Oncology Annual Meeting (ESMO), showing a median overall survival (mOS) for the serplulimab plus chemotherapy group reached 26.8 months, successfully surpassing the two-year mark.
ASTRUM-007, led by Professor Jing Huang from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, evaluated serplulimab in combination with chemotherapy (cisplatin and 5-FU) versus placebo plus chemotherapy in previously untreated patients with PD-L1-positive advanced ESCC. The study demonstrated significant improvements in both overall survival (OS) and progression-free survival (PFS), with a favourable safety profile. The results were published in Nature Medicine.
Steady Commercialization and Enhanced Accessibility in Europe
As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC, serplulimab has made steady progress in the European market since receiving EC approval in February 2025.
Henlius, together with its EU regional partner Accord Healthcare Ltd (“Accord”), a subsidiary of Intas, has continued to drive market access and commercialization efforts in Europe. To date, Hetronifly® has been launched in 12 EU countries and has been reimbursed in Austria, Denmark, Germany, Ireland, Italy, Spain and Sweden so far, 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.
Differentiated Mechanism and Global R&D Advancement
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.
Serplulimab has been approved in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, ESCC, and nsqNSCLC. Up to date, it has been approved in over 40 countries and regions including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the global population.
Henlius continues to advance an extensive global clinical programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,100 patients enrolled. Bridging studies for ES-SCLC are being conducted in the United States and Japan.
In gastrointestinal cancers, ASTRUM-006, the phase 3 study is evaluating serplulimab in perioperative gastric cancer, including neoadjuvant combination therapy and adjuvant monotherapy, representing a novel treatment approach. 7 As the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy, its New Drug Application (NDA) has been accepted by the National Medical Products Administration (NMPA) and granted Priority Review. The indication is expected to be approved in China in 2026. In colorectal cancer, ASTRUM-015, the global phase 3 study evaluating serplulimab in combination with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.8
Looking ahead, Henlius will continue to advance global registration and clinical development of serplulimab, further expanding its potential across tumour types and bringing innovative treatment options to patients worldwide.
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 approved by the European Commission (EC), 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/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.
References
1.EFPIA Patients W.A.I.T. Indicator 2024 Survey, IQVIA, published in Apr.2025
2.Issafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972.
3.Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.
4.Patsoukis N, et al. Interaction of SHP-2 SH2 domains with PD-1 ITSM induces PD-1 dimerization and SHP-2 activation. Commun Biol. 2020;3(1):128.
5.Fenwick C, et al. Tumor suppression of novel anti-PD-1 antibodies mediated through CD28 costimulatory pathway. J Exp Med. 2019;216(7):1525-1541.
6.Primavera E, et al. Computer-Aided Identification of Kinase-Targeted Small Molecules for Cancer: A Review on AKT Protein. Pharmaceuticals (Basel). 2023;16(7):993.
7.China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer. Henlius. December 12, 2025. Accessed December,232025. https://www.henlius.com/en/NewsDetails-5670-26.html
8.Wang ZX, Peng J, Liang X, et al. First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. Med. 2024;5(9):1150-1163.e3. doi:10.1016/j.medj.2024.05.009
联系方式
媒体：PR@Henlius.com
投资者：IR@Henlius.com
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