创新加速度 | 复宏汉霖创新型抗IL1RAP单抗HLX109获澳大利亚临床试验批准，加速推进炎症疾病领域创新布局

复宏汉霖

2026/11/04

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2026年11月4日，上海——复宏汉霖（2696.HK）宣布，公司创新型抗IL1RAP 单抗HLX109已获得澳大利亚人类研究伦理委员会批准，并完成澳大利亚药品管理局（Therapeutic Goods Administration，TGA）的临床试验备案（CTN），拟开展针对泛发性脓疱型银屑病（GPP）的临床研究。此次HLX109在澳大利亚获批临床，进一步丰富了复宏汉霖在非肿瘤领域的早期创新管线储备，拓展了公司在慢性炎症疾病领域的研发探索。

以白介素1（IL-1）家族细胞因子为核心的信号传导通路，是驱动多种炎症性疾病的关键机制¹。上述细胞因子之间往往存在协同放大效应，当多种细胞因子同时失调，可显著加重疾病的严重程度²。泛发性脓疱型银屑病（GPP）是一种罕见、严重且具有潜在生命威胁的系统性炎症性皮肤病，具有显著异质性，并面临复发、长期控制不佳等未满足的临床需求^3-4。近年来，IL-36受体抑制剂（如Spesolimab）以及针对TNF-α、IL-17或IL-23等通路的生物制剂已成为成为GPP治疗的常见治疗方案，但作为靶向IL-1信号通路下游单一细胞因子的治疗策略，仍存在疗效局限，难以实现全面、持久的疾病缓解⁵。白介素 1 受体辅助蛋白（interleukin 1 receptor accessory protein, IL1RAP / IL-1RAP）是IL-1超家族的共受体，靶向IL-1RAP能够同时阻断IL-1、IL-33、IL-36等多条炎症通路的信号传导，有望为多通路驱动的炎症性疾病带来更为理想的治疗获益^6-8。

HLX109是一款潜在同类最优（best-in-class，BIC）的IL1RAP靶向单克隆抗体，通过特异性结合IL-1家族关键共受体IL1RAP，从而阻断IL-1、IL-33 及IL-36不同亚型细胞因子与其受体复合物的相互作用，进而抑制下游信号通路的活化。与仅靶向IL-36受体的药物相比，HLX109能够同时干预上述三条核心炎症信号通路，有望从源头上更广泛、高效地缓解炎症反应。此外，HLX109经长效化工程改造，引入特定突变以延长抗体半衰期，从而优化药代动力学特征并降低给药频率。此外，HLX109具有独特的分子设计，并采用复宏汉霖自主研发的重组人透明质酸酶作为辅料，采取皮下注射方式给药，非临床试验提示其优异的药代动力学、药效学特征和良好的安全性特征。

未来，复宏汉霖将继续坚持“以患者为中心”的研发理念，加速推进具有全球竞争力的差异化创新管线布局，为全球患者提供更可及、更有效的创新治疗选择。

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。

参考文献

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3. Issa NT, et al. Generalized Pustular Psoriasis: A Contemporary Review[J]. J Drugs Dermatol. 2026; 25(8): 63121.

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Henlius’ IL1RAP-Targeted Antibody HLX109 Approved for Clinical Trial in Australia

November 4, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its innovative anti-IL1RAP monoclonal antibody, HLX109, has received approval from the Human Research Ethics Committee (HREC) in Australia and completed the Clinical Trial Notification (CTN) with the Therapeutic Goods Administration (TGA). A clinical trial of HLX109 is planned for patients with generalized pustular psoriasis (GPP). The clinical approval of HLX109 in Australia further strengthens Henlius’ early-stage innovative pipeline in non-oncology areas and expands its R&D efforts in chronic inflammatory diseases.

The interleukin-1 (IL-1) family cytokine signaling network plays a critical role in driving inflammation across a broad range of inflammatory diseases.¹ Dysregulation of these cytokine pathways, which often interact synergistically, may contribute to disease progression and severity.² Generalized pustular psoriasis (GPP) is a rare, severe, and potentially life-threatening systemic inflammatory skin disease characterized by significant clinical heterogeneity, recurrent flares, and substantial unmet needs for sustained disease control.³⁻⁴ In recent years, IL-36 receptor inhibitors (e.g., spesolimab), as well as biologics targeting TNF-α, IL-17, or IL-23 pathways, have emerged as important treatment options for GPP. However, approaches targeting individual inflammatory cytokine pathways may have limitations in achieving broad and durable disease control.⁵ Interleukin-1 receptor accessory protein (IL1RAP/IL-1RAP) is a shared co-receptor of the IL-1 superfamily. Targeting IL-1RAP may enable modulation of multiple inflammatory signaling pathways, including IL-1, IL-33, and IL-36, offering a potential therapeutic approach for inflammatory diseases driven by complex and interconnected immune mechanisms.⁶⁻⁸

HLX109 is a potential best-in-class (BIC) IL1RAP-targeting monoclonal antibody candidate. By specifically binding to IL1RAP, a key co-receptor of the IL-1 family, HLX109 is designed to block the interaction of IL-1, IL-33, and IL-36 cytokines with their receptor complexes, thereby inhibiting downstream inflammatory signaling activation. Unlike approaches targeting the IL-36 receptor alone, HLX109 has the potential to simultaneously modulate multiple key inflammatory pathways mediated by the IL-1 family, offering a broader approach to regulating inflammatory responses. Additionally, HLX109 features a unique molecular design and incorporates a recombinant human hyaluronidase independently developed by Henlius as an excipient. Formulated for subcutaneous administration, non-clinical studies indicate superior pharmacokinetic (PK) and pharmacodynamic (PD) profiles as well as a favorable safety profile.

Looking ahead, Henlius will continue to advance its patient-centric R&D strategy, accelerate the development of a differentiated and globally competitive innovative pipeline, and 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.

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