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神州細胞(688520.SH):子公司新冠中和抗體藥物獲得藥物臨牀試驗批件
格隆匯 12-03 18:33

格隆匯12月3日丨神州細胞(688520.SH)公佈,近日,公司控股子公司神州細胞工程有限公司(“神州細胞工程”)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批件》,公司在研產品SCTA01C注射液以及SCTA01C注射液與SCTA01注射液聯合使用的臨牀試驗申請獲得批准(批件號:2021L90025、2021L90026、2021L90027)。

SCTA01C是神州細胞工程自主研發的新冠病毒單克隆中和抗體,臨牀前試驗表明,該抗體可高效中和包含Alpha,Beta,Gamma,Delta,Kappa,Lambda,Mu等十幾種世界衞生組織認定的主要變異株,與多個國外同類上市中和抗體比較具有更高的中和活性。

SCTA01C與SCTA01分別結合RBD的不同表位,可共同結合於同一RBD。兩種抗體組合比SCTA01單藥可更有效抵禦高頻突變的變異株。臨牀前試驗顯示,兩種抗體組合具有比單個抗體藥物更低的病毒耐藥突變逃逸的風險。因此,SCTA01與SCTA01C聯合用藥,將有望成為廣譜治療高頻突變病毒感染的COVID-19的抗體藥物療法。

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