2026年11月8日至11日，国际药物经济学与结果研究学会欧洲年会（ISPOR Europe 2026）在奥地利维也纳举行。作为全球卫生技术评估（Health Technology Assessment，HTA）与卫生经济学与结果研究（Health Economics and Outcomes Research，HEOR）领域的国际风向标，本届大会汇聚了全球卫生政策制定者、医保决策方与行业学术权威。在本次大会上，复宏汉霖多项研究成果以壁报形式公布，聚焦消化道肿瘤、乳腺癌领域核心管线及创新肿瘤药物全球上市与准入决策。
其中，公司自主研发的创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）用于PD-L1阳性可切除胃癌的长期健康结局模拟研究，通过量化其围术期治疗方案较化疗带来的潜在长期健康收益，为其药物经济学价值评价提供关键证据支持。同时，创新肿瘤药物全球上市优先级研究的多准则决策分析方法学研究，以及涵盖汉倍优®（帕妥珠单抗，美国及欧洲商品名：POHERDY®）在内的国产帕妥珠单抗生物类似药疗效与安全性比较研究也在此次大会上公布，全方位展示了公司以高质量证据持续深化药物价值评价与全球准入探索的扎实成果。
H药 汉斯状®：
量化长期健康收益，助力药物经济学价值评估
H药是全球首个且目前唯一*获批胃癌围手术期适应症的抗PD-1单抗，也是全球首个**一线治疗小细胞肺癌的抗PD-1单抗。截至目前，H药已在全球范围内***获批鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞癌（ESCC）和非鳞状非小细胞肺癌（nsqNSCLC）的一线治疗以及胃癌围术期治疗，并在局限期小细胞肺癌、结直肠癌等多个癌种中持续展现抗肿瘤潜力。
H药获批胃癌围手术期适应症主要基于一项III期临床研究（ASTRUM-006），该研究相关数据已在2026 年美国临床肿瘤学会（ASCO）年会以口头报告的形式首次正式发布，并同步在线发表于国际顶尖医学期刊《柳叶刀》（The Lancet，影响因子：88.5）。该研究共入组了588例PD-L1表达阳性（CPS≥5）且满足手术条件的局部进展期胃/胃食管结合部腺癌患者。研究数据显示，在PD-L1 CPS≥5人群中，与化疗对照组相比，斯鲁利单抗联合化疗新辅助治疗序贯斯鲁利单抗单药辅助治疗的方案显著延长无事件生存期（EFS），BICR评估的疾病进展、复发、新发其他恶性肿瘤或死亡风险大幅降低33%。
在已有临床获益证据的基础上，综合考量治疗成本与患者的长期健康收益，进一步评价治疗方案的药物经济学价值，是加速全球准入的关键。本次ISPOR大会公布的斯鲁利单抗胃癌围术期方案长期健康结局模拟研究（壁报编号：EE533），由天津大学贺小宁副教授领衔开展。该研究针对中国PD-L1阳性、局部晚期、可切除胃癌或胃食管结合部腺癌患者，基于ASTRUM-006研究的中国人群数据构建了10年半马尔可夫模型，模拟比较斯鲁利单抗围术期方案与SOX化疗围术期方案的长期生存及生活质量收益。模型将围术期治疗及复发/转移后续治疗纳入考量，结合生存时间与不同健康状态下的生活质量，预测斯鲁利单抗围术期方案与SOX化疗围术期方案在10年内可能带来的健康收益。
模型预测，在10年模拟期内，与SOX化疗围术期方案相比，斯鲁利单抗组患者处于无复发或转移状态的平均时间由4.61年增加至5.72年，增加1.11年。研究进一步综合生存时间与生活质量，以“完全健康地生活1年”为标准折算健康收益。两组折算结果分别为4.47年和3.83年，即斯鲁利单抗组平均每位患者增加的健康收益，相当于0.64年完全健康生存。 研究还模拟了两组患者首次复发或进展后接受相同治疗的情况。在这一设定下，两组折算后的健康收益分别为4.53年和3.83年，斯鲁利单抗组平均每位患者增加的健康收益，相当于0.70年完全健康生存。在两种后续治疗设定下，模型均预测斯鲁利单抗胃癌围术期方案可带来更多长期健康收益。
此次研究量化了斯鲁利单抗围术期方案相较SOX化疗围术期方案用于胃癌治疗的长期健康收益，为进一步结合全程治疗成本、评估其经济学价值提供数据基础。相关结果丰富了H药的长期价值证据，并为国家医保经济学论证提供支持。
聚焦全球准入，持续深化多元产品布局
肿瘤药物走向全球，需要综合不同国家和地区的患者需求、治疗价值及准入条件，在持续积累核心产品临床与卫生经济学价值证据的同时，复宏汉霖积极推进创新成果的全球落地。
在战略方法学引领方面，复宏汉霖全球价值、准入及卫生经济学负责人Kalman E. Wijaya博士开展了一项关于全球上市优先级评价的方法学研究（壁报编号：HTA101）。研究提出六维多准则决策分析（Multi-Criteria Decision Analysis, MCDA）框架，系统整合了疾病负担与未满足需求、临床价值、卫生经济学与HTA准备、定价与报销机会、医疗体系准入条件及上市实施可行性，为制定创新肿瘤药物各国上市优先级策略提供了一致性与可复制性的方法学参考。
作为公司多元产品布局的重要组成部分，汉倍优®（帕妥珠单抗，美国及欧洲商品名：POHERDY®）是复宏汉霖自主开发的帕妥珠单抗生物类似药，已在美国、欧盟、中国三大主流市场全部获批，是首个且唯一****海外获批上市的“中国籍”帕妥珠单抗，也是美国首款可与原研产品PERJETA（pertuzumab）互换使用的帕妥珠单抗生物类似药。其与公司自主研发的汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）联合，组成首个****中美欧获批的国产曲帕双靶组合，进一步夯实公司在HER2阳性乳腺癌领域的治疗布局。
为患者提供更多疗效可靠、安全性可比、且兼具经济性优势的治疗选择，是生物类似药临床应用的重要价值。本次ISPOR大会上，一项由对外经济贸易大学医疗保险与医疗服务研究中心王春露博士、复宏汉霖李世琪博士等研究者共同开展的比较研究（壁报编号：CO20）正式公布。该研究纳入包括汉倍优®在内的三款国产帕妥珠单抗生物类似药的Ⅲ期注册性临床试验，合并分析其与原研药的疗效及安全性，并以原研帕妥珠单抗为共同参照，对三款生物类似药开展间接比较。结果显示，三项试验均达到预设的等效性标准，合并分析进一步支持三款生物类似药与原研药疗效相当、安全性相似。在生物类似药的间接比较中，汉倍优®部分安全性指标上呈现有利数值趋势。此次研究为三款国产帕妥珠单抗生物类似药在HER2双靶治疗中作为原研药的替代选择补充了临床证据。
此次发布的研究从创新肿瘤药物的长期健康获益评估、延伸至全球上市决策与准入，并为生物类似药的临床应用补充比较证据，展现了复宏汉霖以循证研究深化创新药价值转化与全球落地、拓展高品质生物药治疗选择的持续探索。未来，复宏汉霖将继续以患者需求为导向，深化药物价值研究，推动研发创新、临床应用与全球准入协同发展，让高品质生物药惠及全球更多患者。
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，拥有全球员工超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。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8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、5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50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和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球超50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（通用名：dulpatatug）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。
*2026年6月，斯鲁利单抗获得NMPA批准成为全球首个获批胃癌围术期治疗的抗PD-1单抗，截至2026年11月是唯一。
**2023年1月，斯鲁利单抗获得NMPA批准成为全球首个获批一线治疗ES-SCLC的抗PD-1单抗。
***不同国家或地区的获批适应症请以当地药品监管部门发布的公告为准。
****截至2026年11月，在NMPA，FDA及EMA最新查询结果。
PERJETA是由F. Hoffmann-La Roche AG在欧盟注册、由Genentech, Inc.在美国注册的商标；复宏汉霖与上述两家商标所有者没有任何关联。
Henlius Presents New Studies at ISPOR Europe 2026 to Advance Treatment Value Assessment and Global Access
ISPOR Europe 2026 was held in Vienna, Austria, from November 8 to 11, 2026. As a leading international forum for health technology assessment (HTA) and health economics and outcomes research (HEOR), the conference brought together health policymakers, payer representatives, and leading experts from industry and academia worldwide. Henlius presented three studies as posters, focusing on key products in gastrointestinal and breast cancers, as well as global launch decision-making for innovative oncology medicines.
One study modeled the long-term health outcomes of serplulimab (HANSIZHUANG in China, Hetronifly® in Europe), Henlius’ independently developed innovative anti-PD-1 monoclonal antibody, in patients with PD-L1-positive resectable gastric cancer. By quantifying the potential long-term health gains of its perioperative regimen compared with chemotherapy, the study provided health outcomes evidence to support pharmacoeconomic evaluation. Also presented were a methodological study proposing a multi-criteria decision analysis (MCDA) framework for global launch prioritization of innovative oncology medicines, and a study comparing the efficacy and safety of three China-developed pertuzumab biosimilars, including HLX11 (HANBEIYOU in China, POHERDY® in the US and Europe), with reference pertuzumab. Together, these studies demonstrate Henlius’ continued efforts to advance medicine value assessment and global access through high-quality evidence.
Serplulimab: Quantifying Long-Term Health Benefits to Support Pharmacoeconomic Evaluation
Serplulimab is the world’s first and only* anti-PD-1 mAb globally approved for perioperative gastric cancer treatment. It was also the first** anti-PD-1 mAb approved as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Currently, serplulimab has been approved globally*** for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC), and gastric cancer (GC) indications. It has also shown anti-tumor potential in studies of limited-stage SCLC, colorectal cancer and other tumor types.
The approval of serplulimab for perioperative gastric cancer was primarily based on ASTRUM-006. The study results were first presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published online in The Lancet (IF: 88.5). ASTRUM-006 is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study enrolling 588 patients with PD-L1-positive (CPS ≥5), resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma. In the PD-L1 CPS ≥5 population, the regimen of neoadjuvant serplulimab plus chemotherapy followed by adjuvant serplulimab monotherapy significantly prolonged event-free survival (EFS) versus the chemotherapy control group, reducing the risk of disease progression, recurrence, other new malignancies, or death by 33%, as assessed by blinded independent central review (BICR).
Building on evidence of clinical benefit, evaluating a treatment’s pharmacoeconomic value by considering both treatment costs and patients’ long-term health gains is key to advancing global access. The long-term health outcomes simulation study of perioperative serplulimab for gastric cancer, presented at ISPOR Europe 2026 (poster number: EE533) was led by Dr. Xiaoning He of Tianjin University. Using data from the Chinese population in ASTRUM-006, the researchers developed a semi-Markov model with a 10-year time horizon to compare the survival and quality-of-life benefits of perioperative serplulimab versus SOX chemotherapy in Chinese patients with PD-L1-positive, locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma. The model incorporated perioperative and subsequent treatments, combining survival time with quality of life across different health states to project the long-term health gains associated with each regimen.
Over the 10-year simulation period, the model projected that patients receiving perioperative serplulimab would spend an average of 5.72 years alive without recurrence or metastasis, compared with 4.61 years with perioperative SOX chemotherapy, a gain of 1.11 years. The study further combined survival and quality of life to assess health benefits, using one year of life in full health as the standard. The projected outcomes were 4.47 and 3.83 quality-adjusted life years (QALYs) per patient in the serplulimab and SOX groups, respectively. This represents an additional health benefit equivalent to 0.64 years of life in full health per patient with serplulimab.
The study also modeled a scenario in which both groups received the same treatment after their first recurrence or progression. Under this assumption, the projected outcomes were 4.53 and 3.83 QALYs per patient, respectively, representing an additional health benefit equivalent to 0.70 years of life in full health per patient with serplulimab. Under both assumptions for subsequent treatment, the model projected greater long-term health benefits with the perioperative serplulimab regimen.
By quantifying the projected long-term health gains of perioperative serplulimab compared with chemotherapy, the study provides a foundation for further pharmacoeconomic evaluation incorporating costs across the full course of treatment. The findings strengthen the evidence base for serplulimab’s long-term value and can support pharmacoeconomic assessments for national reimbursement in China.
Advancing Global Access and Strengthening a Diversified Product Portfolio
Bringing innovative medicines to patients worldwide requires consideration of patient needs, therapeutic value, and access conditions across countries and regions. As Henlius continues to build clinical and health economic evidence for its core products, the company is also advancing the global reach of its innovations.
To inform global launch strategy, Dr. Kalman E. Wijaya, Henlius’ Global Head of Value Access and Health Economics, conducted a methodological study on global launch prioritization (poster number: HTA101). The study proposed a preliminary multi-criteria decision analysis (MCDA) framework encompassing six domains: disease burden and unmet medical need; clinical differentiation and therapeutic value; health economic evidence and HTA readiness; pricing and reimbursement opportunity; healthcare-system access environment; and operational launch feasibility. The framework aims to support consistent and reproducible country launch prioritization for innovative oncology medicines.
A key component of Henlius’ diversified portfolio, HLX11 (HANBEIYOU in China, POHERDY® in the U.S. and Europe) is an independently developed pertuzumab biosimilar approved in China, the U.S., and the EU. It is the first and only**** China-developed pertuzumab biosimilar approved outside China. Together with Henlius’ independently developed HANQUYOU (trastuzumab, HERCESSI™ in the U.S. and Zercepac® in Europe), it forms the first**** China-developed trastuzumab–pertuzumab combination with approvals across all three markets, further strengthening the company’s portfolio for HER2-positive breast cancer.
Providing patients with more treatment options offering reliable efficacy and comparable safety is an important contribution of biosimilars. A comparative study presented at ISPOR Europe 2026 (poster number: CO20) was conducted by researchers including Dr.Chunlu Wang of the Center for Health Insurance and Health Services Research at the University of International Business and Economics, and Dr. Shiqi Li of Henlius. The study included Phase 3 registrational trials of three China-developed pertuzumab biosimilars, including HLX11. Researchers pooled efficacy and safety data comparing the biosimilars with reference pertuzumab and used reference pertuzumab as a common comparator for indirect comparisons among the biosimilars.
All three trials met their prespecified equivalence margins. The pooled analysis further supported comparable efficacy and similar safety between the biosimilars and reference pertuzumab. In indirect comparisons among the biosimilars, HLX11 showed favorable numerical trends on selected safety measures, although the differences were not statistically significant. These findings add clinical evidence supporting the three biosimilars as alternatives to reference pertuzumab in pertuzumab-containing dual HER2 blockade regimens.
Together, these studies extend from assessing the long-term health benefits of innovative oncology medicines to informing global launch and access decisions, while adding comparative evidence to support treatment choices. They reflect Henlius’ continued efforts to advance the value and global reach of innovative medicines through evidence-based research and expand treatment options with high-quality biologics. Guided by patient needs, Henlius will continue to deepen medicine value research and advance R&D innovation, clinical application, and global access to deliver more accessible and effective 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 over 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. To date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight 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 five 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 50 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 for perioperative gastric cancer. To date, it has been approved in over 50 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 dulpatatug (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 the company's website and follow the company on LinkedIn.
* In June 2026, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for perioperative gastric cancer treatment. As of November 2026, it remains the only one.
** In January 2023, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for the first line treatment of ES-SCLC.
*** Approved indications may vary by country or region. Please refer to announcements issued by local regulatory authorities for approved indications in each market.
****As of November 2026, based on the latest search results from the NMPA, FDA, and EMA.
PERJETA is a trademark registered in the European Union by F. Hoffmann-La Roche AG and in the United States by Genentech, Inc.; Henlius is not associated with either trademark owner.
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