先声药业(02096.HK):先必新舌下片获美国食品药品监督管理局突破性疗法认定
格隆汇9月2日丨先声药业(02096.HK)公吿,2024年8月29日,先必新舌下片(依达拉奉右莰醇舌下片)获美国食品药品监督管理局(FDA)突破性疗法认定(BTD),用于治疗急性缺血性脑卒中(AIS)。
先必新舌下片是一种脑细胞保护剂,由依达拉奉和右莰醇两种活性成分组成,具有抗氧化、抗炎和协同增效作用,能够显著减少AIS导致的脑细胞损伤。该药独特的舌下片配方在舌下与唾液接触后即可迅速崩解,通过舌下静脉丛快速吸收进入血液发挥疗效,有望增加卒中治疗方式的灵活性。
先必新舌下片有望与公司已上市的先必新注射剂(依达拉奉右莰醇注射用浓溶液)组成序贯疗法,利于患者在院内院外获得完整疗程。截至本公吿日期,先必新舌下片的中国新药上市申请(NDA)正处于审评阶段,并已在美国健康受试者中完成I期临床试验。
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