Core Viewpoint - Huahai Pharmaceutical (600521.SH) announced that its subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd. (referred to as "Huatai"), has received a notice of acceptance from the National Medical Products Administration for the registration application of HB0034 injection, aimed at treating adult generalized pustular psoriasis (GPP) flare-ups [1] Group 1 - HB0034 is the first domestically developed innovative anti-IL-36R antibody in China, which can exert anti-inflammatory biological effects by inhibiting the IL-36 pathway [1] - Currently, there are no domestically developed targeted IL-36R antibodies approved for marketing globally [1] - Clinical research results indicate that compared to 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] Group 2 - The safety profile of HB0034 is favorable, with no new safety signals identified during the studies [1]

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]