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Henlius Strengthens Autoimmune-Inflammation Portfolio by In-Licensing a Novel, Best-in-Class Potential Anti-IL-1RAP mAb

2026-01-14

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.


References

[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.