舒泰神(300204.SZ):BDB-001注射液提交用於冠狀病毒感染所致相關疾病的治療的臨牀試驗申請
格隆匯2月2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”)向國家藥品監督管理局提交了關於BDB-001注射液用於治療冠狀病毒感染所致相關疾病的治療的臨牀試驗的申請。
藥品名稱:BDB-001注射液;擬定適應症:冠狀病毒可特異性地過度激活補體系統;本品可抑制病毒等因素造成的補體系統激活所致的炎性反應;用於冠狀病毒等感染者的治療:預防肺炎的發生、防止肺炎重症化、降低急性呼吸窘迫綜合徵的發生率。
在 H1N1感染小鼠、H5N1感染小鼠、H7N9感染非洲綠猴等研究中,發現補體系統過度激活,具體表現為C3、C5a、C5b-9、MBL-c等補體系統相關分子在肺部沉積以及MASP2、C3aR、C5aR的上調等,大量產生的C5a,使得以中性粒細胞為代表的多形核白細胞大量趨化至肺部,進而導致C5a濃度在肺部快速上升並形成一個正向循環式級聯反應,誘發細胞因子風暴,最終發展為重症肺炎和急性呼吸窘迫綜合徵,危及患者生命。使用抗C5a抗體抑制補體系統的激活可有效降低H5N1和H7N9導致的急性肺損傷,提示抑制C5a活性是治療補體過度激活導致的肺損傷的可行方案。
綜合上述研究,抑制補體過度激活可能是治療冠狀病毒感染造成的肺部病理變化的良好手段,而充分抑制肺部C5a活性是達到這一目標的有效選擇。
近30年的超過4000篇PubMed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。能夠在冠狀病毒感染中預防肺炎重症化,降低重症肺炎、急性呼吸窘迫綜合徵等的發病率。
BDB-001注射液於2018年02月07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2018年07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,在已入組的健康受試者中均未見明顯的不良反應,安全性良好。
此次新藥臨牀試驗申請以支持有效疫情防控,保障公眾生命安全與身體健康為初心,後續能否獲得國家藥品監督管理局的批准臨牀試驗、上市尚存在諸多不確定。公司將持續春節假期無休的奮鬥精神,克服疫情當前的多重困難,再接再勵推進上述項目的下一步工作,並按有關規定及時對該項目後續進展情況及時履行信息披露義務。
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