Huaota Biopharm has filed a new drug application (NDA) for interleukin-36 receptor antibody HB0034 in generalised pustular psoriasis (GPP) following successful Phase II trial showing rapid pustule clearance within one week of intravenous administration versus placebo. The candidate demonstrated favourable safety profile with no new signals reported in acute flare management of the rare neutrophilic dermatology condition characterised by systemic inflammation and life-threatening complications, including sepsis. HB0034 becomes China's first domestic IL-36R antibody submission, competing with Boehringer Ingelheim's spesolimab approved in 2022.

GPP affects approximately 10,000 patients in China, acute flares requiring immediate intervention to prevent multiorgan failure. The condition was added to China's Second Rare Disease Catalogue in 2023, facilitating accelerated review pathways. Huaota subsidiary Huabo Biopharm has invested RMB 210.38 million in development, with potential to address significant unmet needs in the orphan dermatology market through a novel mechanism inhibiting IL-36 pathway-mediated inflammation.

According to PharmCube's NextBiopharm® database, the milestone put HB0034 above other IL-36R-targeting mAbs in clinical stage. Click here to request a free trial for NextBiopharm®.