华海药业(600521.SH)子公司瑞西奇拜单抗注射液上市许可申请获得受理
huahaipharmhuahaipharm(SH:600521) 智通财经网·2025-10-09 09:35

Core Viewpoint - Huahai Pharmaceutical (600521.SH) announced that its subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd. (referred to as "Huatai"), has received the acceptance notice for the domestic production drug registration application of HB0034 injection from the National Medical Products Administration. This drug is aimed at treating adult generalized pustular psoriasis (GPP) [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] - The drug has shown significant skin pustule clearance in GPP patients one week after a single intravenous administration compared to placebo, achieving the predefined primary research endpoint [1] - Safety results for HB0034 have been favorable, with no new safety signals identified [1]