HENLIUS (02696): Phase 1 clinical trial of HLX109 injection (an anti-IL1RAP monoclonal antibody) for the treatment of generalized pustular psoriasis approved to commence in Australia

HENLIUS (02696) announced that recently, the Phase 1 clinical trial of its independently developed HLX109 injection (an anti-IL1RAP monoclonal antibody) (HLX109) for the treatment of generalized pustular psoriasis has been approved by the relevant Human Research Ethics Committee and has completed clinical trial filing with the Australian Therapeutic Goods Administration. HLX109 is an independently developed monoclonal antibody targeting IL1RAP, intended for the treatment of generalized pustular psoriasis. IL1RAP (interleukin-1 receptor accessory protein) is a key co-receptor in the receptor signaling complexes of inflammation-related cytokines such as IL-1, IL-33, and IL-36. HLX109 can specifically bind to IL1RAP, blocking the recruitment of IL1RAP to the ligand-receptor complexes formed by IL-1, IL-33, and IL-36 with their corresponding receptors, thereby inhibiting the formation of the complete signaling complex and the activation of downstream inflammatory signaling pathways. Preclinical studies have shown that HLX109 has an inhibitory effect on inflammatory responses and demonstrates a favorable safety profile. As of the date of this announcement, no monoclonal antibody targeting IL1RAP has been approved for marketing globally.