华海药业:子公司瑞西奇拜单抗注射液上市许可申请获受理

Core Viewpoint - The company has received a notice of acceptance for the production registration application of HB0034, a targeted IL-36R antibody, which is the first domestically developed innovative drug for treating generalized pustular psoriasis (GPP) in adults [1] Group 1: Product Development - The drug HB0034 is designed to treat adult patients with GPP and is the first self-developed targeted IL-36R antibody approved for production in China [1] - The drug works by inhibiting the IL-36 pathway to exert anti-inflammatory biological effects [1] Group 2: Clinical Results - Research analysis indicates that compared to a placebo, a single intravenous administration of HB0034 leads to significant clearance of skin pustules in GPP patients within one week, achieving the predefined primary research endpoint [1] - The safety profile of HB0034 is reported to be good, with no new safety signals identified [1]