國內第三家! 四環醫藥(00460.HK)加巴噴丁膠囊獲批生產
格隆匯10月21日丨四環醫藥(00460.HK)宣佈,集團開發的加巴噴丁膠囊已於2020年10月15日獲得國家藥監局頒佈的藥品生產批准。四環醫藥為中國第三家獲得生產該產品批准的企業。
產品屬於《國家基本醫療保險、工傷保險和生育保險藥品目錄》乙類範圍的品種,用於治療:(1)皰疹感染後神經痛:用於成人皰疹後神經痛的治療;及(2)癲癇:用於成人和12歲以上兒童伴或不伴繼發性全身發作的部分性發作的輔助治療,也可用於3至12歲兒童的部分性發作的輔助治療。
該產品口服吸收快、耐受性好、毒副作用小及治療效果好。在體內不代謝,不與血漿蛋白結合及不誘導肝酶。該產品能夠穿過人體大腦的血腦屏障,與其他抗癲癇病藥物相互作用的可能性很低,可單獨用於治療一般癲癇病外,也可作為難治性癲癇病的疊加用藥。該產品與目前使用的同類產品相比,作為難治性癲癇的疊加用藥作用尤為突出,且在神經病理性疼痛中具有獨特的優勢,成為治療神經病理性疼痛的一線用藥。
癲癇是僅次於腦卒中的常見慢性神經系統疾病。在任何年齡、地區和種族的人羣中都有發病,以兒童和老年人為兩個發病高峯。在中國,癲癇患病人數不少於900萬人。隨着患者羣體逐漸增多,抗癲癇藥物市場規模也在飛速攀升。於2018年,在中國公立醫療機構終端化學藥抗癲癇藥市場規模為人民幣49億元。於2019年,中國公立醫療機構終端化學藥抗癲癇藥通用名排行榜中該產品排名第七,銷售額為人民幣2.03億元,佔市場份額約4.14%。由於中國癲癇人羣就醫率普遍較低,未來抗癲癇用藥市場上升空間較大。
作為神經系統疾病領域用藥,該產品將和集團在相關治療領域的藥物發揮協同效應,包括已經上市的奧卡西平片,已獲得批准即將上市的咪達唑侖口腔黏膜溶液、重酒石酸卡巴拉汀膠囊、左乙拉西坦片,以及正在申報的艾司利卡西平片、拉考沙胺片。通過為患者提供更多更優質的治療選擇,進一步夯實四環醫藥在此領域的領先市場地位。
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