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恩華藥業(002262.SZ):Protollin獲得FDA藥品臨牀試驗批准
格隆匯 07-22 15:47

格隆匯7月22日丨恩華藥業(002262.SZ)公佈,公司於2020年12月份與I-MabBiopharma US Limited(簡稱“I-Mab US”)共同作為被許可方,與許可方The Brigham andWomen’s Hospital, Inc.(簡稱“BWH”)及Biodextris Inc.(簡稱“BDX”)就合作開發Protollin(一種用於神經系統疾病的新型免疫刺激療法的藥品)簽署了《許可協議》。

近日,協議許可方BWH收到美國食品藥品監督管理局(FDA)獲准開展臨牀試驗的通知(IND編號:IND 27042)。根據該IND批准函,FDA於2021年7月21日已完成對Protollin臨牀試驗申請(IND 027042)的審核,並批准BWH在美國開展臨牀試驗。

Protollin是一種由特殊細菌的外膜蛋白和脂多糖(LPS)組成的對機體先天免疫系統有刺激作用的的新型免疫療法。臨牀前數據表明,Protollin具有通過調控免疫細胞治療疾病的潛力。初步數據支持其在阿爾茨海默症等疾病中的潛在應用。

公司表示,對於上述藥物,公司將根據協議約定向許可方提供資金,用於在美國開展Protollin臨牀試驗。上述藥品的研發成功並上市,將進一步豐富公司的中樞神經領域產品線,有利於進一步提升恩華業績。

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