雙鷺藥業(002038.SZ)：3類新藥富馬酸替諾福韋二吡呋酯片(0.15g，0.2g)獲批
格隆匯9月4日丨雙鷺藥業(002038.SZ)宣佈，公司於近日收到國家藥監局核准簽發的3類新藥富馬酸替諾福韋二吡呋酯片(0.15g，0.2g)“藥品註冊證書”。
2020年8月21日公司曾披露獲得化藥四類富馬酸替諾福韋二吡呋酯片(0.3g)藥品註冊證書，主要用於治療成人和12歲及以上兒童慢性乙型肝炎感染以及人類免疫缺陷病毒1型(HIV-1)感染，系治療慢性乙型肝炎的一線用藥。該次獲得的3類新藥富馬酸替諾福韋二吡呋酯片(0.15g、0.2g)系國內獨家獲批，目前國內上市企業(包括原研)均為0.3g規格富馬酸替諾福韋二吡呋酯片。公司獲批的0.15g，0.2g規格主要用於2歲及2歲以上體重≥17kg成人和兒童患者的HIV-1感染以及慢性乙肝2歲及2歲以上且體重≥17kg成人和兒童患者，該產品系首次批准用於2歲以上兒童患者。該次獲批的0.15g和0.2g兩個規格產品按照現行藥品註冊法規視同通過一致性評價。
富馬酸替諾福韋二吡呋酯片是肝病治療領域最強有效的抗乙肝病毒藥物，幾乎沒有耐藥報道，可以強效逆轉肝臟纖維化甚至肝硬化，可以大幅度降低乙肝相關肝癌的發生率，但長期服用需隨時關注其對腎臟和骨骼的副作用。乙肝存量患者中中、老年患者居多，易發生骨質流失而致骨質疏鬆，公司的0.15g和0.2g小劑量規格可以在不降低療效的前提下有效降低其副作用，同時為2-12歲的兒童患者安全用藥提供最佳選擇。據醫藥魔方數據統計，2019年富馬酸替諾福韋二吡呋酯片國內市場，葛蘭素史克佔59.70%，成都倍特佔19.49%，其他企業佔20.81%。
公司表示，該次公司0.15g，0.2g富馬酸替諾福韋二吡呋酯片的獲批上市將增加公司的新藥儲備，也有利於增強公司抗感染用藥領域的產品儲備，增加公司兒童用藥產品種類。該產品上市後仍需公司加大產品宣傳和推廣性臨牀驗證。
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