先聲藥業(02096.HK):先必新舌下片獲美國食品藥品監督管理局突破性療法認定
格隆匯9月2日丨先聲藥業(02096.HK)公吿,2024年8月29日,先必新舌下片(依達拉奉右莰醇舌下片)獲美國食品藥品監督管理局(FDA)突破性療法認定(BTD),用於治療急性缺血性腦卒中(AIS)。
先必新舌下片是一種腦細胞保護劑,由依達拉奉和右莰醇兩種活性成分組成,具有抗氧化、抗炎和協同增效作用,能夠顯著減少AIS導致的腦細胞損傷。該藥獨特的舌下片配方在舌下與唾液接觸後即可迅速崩解,通過舌下靜脈叢快速吸收進入血液發揮療效,有望增加卒中治療方式的靈活性。
先必新舌下片有望與公司已上市的先必新注射劑(依達拉奉右莰醇注射用濃溶液)組成序貫療法,利於患者在院內院外獲得完整療程。截至本公吿日期,先必新舌下片的中國新藥上市申請(NDA)正處於審評階段,並已在美國健康受試者中完成I期臨牀試驗。
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