Xinhua News Agency, July 20th: Huahai Pharmaceutical announced that its subsidiaries, Huaota and Huabo Biopharm, received the "Drug Clinical Trial Approval Notice" for HB0034 Injection issued by the National Medical Products Administration, approving Huaota and Huabo to conduct Phase Ib clinical trials of HB0034 Injection in China.Indication: Generalized Pustular Psoriasis (GPP).To date, Huahai Pharmaceutical has invested approximately RMB 51.6 million in research and development expenses.
HB0034 is a humanized IgG1 (immunoglobulin G1) type monoclonal antibody targeting IL-36R (Interleukin-36 receptor). It can specifically bind to IL-36R and block the signaling of the IL-36 inflammatory pathway. HB0034 competitively blocks the binding of receptor agonists (IL36α, β, and γ) to IL-36R, downregulates downstream pro-inflammatory and pro-fibrotic signaling pathways, and inhibits epithelial cell/fibroblast/immune cell-mediated inflammatory responses. This reduces the release of cellular inflammatory factors that drive pathogenesis in inflammatory/skin diseases (including generalized pustular psoriasis, inflammatory bowel disease, systemic lupus erythematosus, and fibrotic diseases), thereby achieving disease control.
As of now, no anti-IL-36R drugs have been marketed. The more advanced research includes BI655130 (Spesolimab) from Boehringer Ingelheim and ANB019 (Imsidolimab) from AnaptysBio. Clinical trials are being conducted for diseases such as generalized pustular psoriasis (GPP), palmoplantar pustulosis (PPP), atopic dermatitis (AD), ulcerative colitis, Crohn's disease, and hidradenitis suppurativa. Early clinical studies have shown that these two IL-36R antibodies have good potential in treating generalized pustular psoriasis (GPP) with favorable safety and tolerability.
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