2026年1月14日，在2026年摩根大通医疗健康大会上，复星医药子公司复宏汉霖（2696.HK）宣布与专注肿瘤及炎症疾病创新疗法开发的优迈生物科技（连云港）有限公司（以下简称"优迈生物"）签署全球独占许可协议。根据协议，复宏汉霖获得一款具有"同类最优"（best-in-class，BIC）潜力的靶向白介素-1受体辅助蛋白（IL-1RAP）的单克隆抗体的全球独占授权。此次合作标志着复宏汉霖在深耕肿瘤免疫治疗的同时，积极拓展免疫炎症疾病领域的靶点布局。
以IL-1家族细胞因子为核心的信路传导通路，是驱动多种自身免疫及炎症性疾病的关键机制[1]。然而，现有疗法多靶向IL-1信号通路下游单一细胞因子，存在疗效局限。IL-1RAP是该家族中关键的共受体，通过靶向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，有望从源头上更广泛、精准地调控炎症信号[2-3]，为炎症和自免等存在巨大未满足临床需求的疾病领域，提供了突破性的治疗策略[4]。目前，全球范围内尚无同靶点类药物获批上市。
本次引进的抗IL-1RAP单抗由优迈生物依托其高效的专有抗体发现平台研发，是一款具有完全自主知识产权的多通路抑制长效抗体分子。前期成药性评价数据表明，该分子在多种动物模型中均表现出优异疗效，在自然发病动物病例中亦展现出显著治疗效果；动物药代动力学（PK）数据显示其半衰期较长，可支持患者长周期给药，有望满足自免患者对更高疗效与更优依从性的临床需求。
复宏汉霖持续构建以肿瘤为基石，以自身免疫与炎症疾病等为战略协同的多领域、多层次的创新管线生态。此前，公司已通过利妥昔单抗汉利康?、阿达木单抗汉达远?等产品，快速切入类风湿关节炎、银屑病等自免市场，并凭借创新型GARP/TGF-β1单抗HLX6018、人唾液酸酶融合蛋白HLX79及更多早期创新分子，不断拓展该赛道的前瞻布局。
未来，复宏汉霖将继续秉持自主创新与战略合作双轮驱动，不断夯实差异化创新优势，加速推动更多创新疗法早日惠及全球患者。
【参考文献】
[1] Dinarello CA. Interleukin-1 in the pathogenesis and treatment of inflammatory diseases. Blood. 2011 Apr 7;117(14):3720-32.
[2] Lang D, Knop J, et al. The type II IL-1 receptor interacts with the IL-1 receptor accessory protein: a novel mechanism of regulation of IL-1 responsiveness. J Immunol. 1998 Dec 15;161(12):6871-7.
[3] Ali S, Huber M, et al. IL-1 receptor accessory protein is essential for IL-33-induced activation of T lymphocytes and mast cells. Proc Natl Acad Sci U S A. 2007 Nov 20;104(47):18660-5.
[4] Lopez-Castejon G, Brough D. Understanding the mechanism of IL-1β secretion. Cytokine Growth Factor Rev. 2011 Aug;22(4):189-95.
关于优迈生物
优迈生物成立于2017年7月，聚焦肿瘤及炎症疾病领域，专注于新机制大分子first-in-class（FIC）与best-in-class（BIC）创新药管线研发，于2021年获得天汇资本战略投资。公司搭建了完整的早期抗体发现技术平台，可高效完成候选抗体的发现与优化。在坚持自主创新研发的核心战略下，优迈生物积极拓展多元化对外合作，已与多家行业知名企业达成项目合作。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，5个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状?的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状?（斯鲁利单抗，欧洲商品名：Hetronifly?）、自主研发的中美欧三地获批单抗生物类似药汉曲优?（曲妥珠单抗，美国商品名：HERCESSI?，欧洲商品名：Zercepac?）、国内首个生物类似药汉利康?（利妥昔单抗）、地舒单抗生物类似药Bildyos?和Bilprevda?，以及帕妥珠单抗POHERDY?。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
Henlius Strengthens Autoimmune-Inflammation Portfolio by In-Licensing a Novel, Best-in-Class Potential Anti-IL-1RAP mAb
January 14, 2026 – At the 2026 J.P. Morgan Healthcare Conference, Shanghai Henlius Biotech, Inc.(2696.HK) announced that it has entered into an exclusive global license agreement with U-mab Biopharma (Lianyungang) Co.,Ltd.("U-mab"), a company focused on developing innovative therapies for oncology and inflammatory diseases. Under the agreement, Henlius has secured rights to a monoclonal antibody (mAb) targeting Interleukin-1 Receptor Accessory Protein (IL-1RAP) with best-in-class(BIC) potential. Building upon its core expertise in tumor immunotherapy, this partnership marks an expansion of Henlius’ efforts into immune-inflammatory diseases.
The IL-1 cytokine family and its signaling pathways are a principal mediator in the pathogenesis of various autoimmune and inflammatory diseases[1]. Current therapeutic approaches predominantly target individual downstream cytokines within this pathway, resulting in limited clinical efficacy. IL-1RAP, a key shared co-receptor in the IL-1 receptor family, represents a novel upstream target. By inhibiting IL-1RAP, it can simultaneously block signaling from multiple inflammatory pathways, including IL-1, IL-33, and IL-36, thereby enabling more comprehensive regulation of the inflammatory cascade at its source [2-3]. This mechanism offers a promising therapeutic strategy for inflammatory and autoimmune diseases with significant unmet medical needs [4]. To date, no IL-1RAP-targeting therapies have received regulatory approvals worldwide.
The anti-IL-1RAP monoclonal antibody is a long-acting, multi-pathway inhibitory agent developed by U-mab using its high-efficiency antibody discovery platform and possesses full intellectual property rights. Preliminary druggability evaluation data indicate that the product exhibits excellent efficacy across several animal models, including in spontaneous disease models. Pharmacokinetic studies in animals demonstrate an extended half-life, supporting a less frequent dosing regimen in the clinic, potentially meeting the umet needs of autoimmune patients for higher efficacy and better compliance.
Henlius is building a diverse and integrated product pipeline, strategically centered on oncology with expansion into autoimmune and inflammatory diseases. It has already commercialized products such as rituximab (HANLIKANG) and adalimumab (HANDAYUAN), enabling a swift entry into autoimmune markets including rheumatoid arthritis and psoriasis. To build on this foundation, Henlius is advancing a series of innovative candidates. These include the novel GARP/TGF?β1 mAb HLX6018 and the human sialidase fusion protein HLX79, alongside other early-stage molecules. Together, these efforts are expanding a pipeline that combines broad therapeutic reach with focused modality expertise.
Going forward, Henlius will advance its innovation strategy through a combination of internal R&D and strategic collaboration, strengthening its differentiated pipeline and accelerating the global delivery of novel therapies.
About U-mab
U-mab Biopharma, founded in July 2017, is a biotechnology company focused on discovering and developing novel first-in-class (FIC) and best-in-class (BIC) biologic therapeutics for oncology and inflammatory diseases. The company received a strategic investment from Tianhui Capital in 2021 and has established a fully integrated, proprietary platform for early-stage antibody discovery and engineering—enabling the rapid identification and optimization of high-quality therapeutic candidates. Guided by a core strategy of innovation-driven internal R&D, U-mab actively pursues strategic collaborations with industry leaders to advance its pipeline toward clinical development.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 10 products have been approved for marketing across multiple countries and regions, and 5 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company''s launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly? in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI? in the U.S., Zercepac? in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos? and Bilprevda?, and pertuzumab Poherdy?. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.