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舒泰神:BDB-001注射液用於冠狀病毒感染所致相關疾病的治療獲新藥臨牀試驗批件
格隆匯 02-09 16:53

格隆匯2月9日丨舒泰神(300204.SZ)公佈,公司及全資子公司北京德豐瑞生物技術有限公司(“德豐瑞”)於2020年2月7日收到了國家藥品監督管理局簽發的關於BDB-001注射液用於冠狀病毒感染所致相關疾病的治療的《藥物臨牀試驗批件》,批件號:2020L00003,適應症為用於新型冠狀病毒感染者降低重症肺炎的發生率、降低急性呼吸窘迫綜合徵的發生率。

30年的超過4000PubMed研究報告提示補體C5a分子是急性感染、組織損傷炎症早期出現的最強因子,被公認為是廣譜炎性放大器,是補體過度激活導致劇烈炎症反應的主要效應分子,是感染、損傷急救藥的理想靶點。

BDB-001注射液是我司全資子公司德豐瑞授權許可開發的德國Inflarx公司的針對人C5a分子的單克隆抗體藥物能特異性結合C5a,使C5a喪失結合受體的能力,從而阻斷其誘導的生物學功能,如中性粒細胞趨化、細胞內溶菌酶的釋放、炎性細胞因子水平上升和氧呼吸爆發等,抑制炎症級聯反應,從而控制炎症進一步發展,且不抑制免疫功能。同時不影響C5裂解及膜攻擊複合物(MAC)的形成,保留了補體介導的溶菌作用。

BDB-001注射液於20180207日獲得了國家食品藥品監督管理總局治療中重度化膿性汗腺炎的臨牀試驗申請受理;於201807月獲得批准,進行上述適應症的臨牀研究。目前BDB-001注射液正在開展I期臨牀研究,在入組健康受試者中均未見明顯的不良反應,安全性良好。

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