舒泰神(300204.SZ):BDB-001注射液(ANCA相關性血管炎適應症)獲新藥臨牀試驗默示許可
格隆匯8月19日丨舒泰神(300204.SZ)公佈,2021年8月19日,公司及全資子公司北京德豐瑞生物技術有限公司(簡稱“德豐瑞”)從國家藥品監督管理局藥品審評中心網站獲悉,公司及子公司申報的BDB-001注射液用於治療ANCA相關性血管炎適應症已獲新藥臨牀試驗默示許可。
BDB-001注射液於2018年6月15日首次獲得國家藥品監督管理局藥物臨牀試驗批件,批件號為CXSL1800015,適應症為中重度化膿性汗腺炎,目前已進入II期臨牀試驗;於2020年2月7日獲得國家藥品監督管理局藥物臨牀試驗批件,為新增適應症臨牀試驗註冊申請,批件號為2020L00003,目前正在西班牙、印度、印度尼西亞、孟加拉國四個國家開展II/III期國際多中心臨牀試驗。
該次獲批的新增適應症為用於治療抗中性粒細胞胞質抗體(anti-neutrophil cytoplasmic antibody,ANCA) 相關性血管炎(ANCA-associated vasculitis,AAV)的患者。抗中性粒細胞胞質抗體相關性血管炎是由ANCA介導的以寡免疫複合物沉積的壞死性小血管炎為特徵的一組疾病。按照2012年CHCC會議的分類方法,AAV包括顯微鏡下型多血管炎、肉芽腫性多血管炎、嗜酸性肉芽腫性多血管炎。ANCA是系統性壞死性血管炎的血清學特徵性抗體之一,其主要靶抗原為蛋白酶-3和髓過氧化物酶。ANCA可刺激中性粒細胞釋放細胞因子,從而誘導中性粒細胞產生脱顆粒作用,促使氧自由基和裂解酶的釋放,進而導致血管內皮細胞的裂解和破壞。
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