中國生物製藥(01177.HK):腫瘤治療輔助用藥“阿瑞匹坦膠囊”獲藥品註冊證書
格隆匯5月20日丨中國生物製藥(01177.HK)發佈公吿,集團開發的腫瘤治療輔助用藥“阿瑞匹坦膠囊”(商品名:善依)(獲批規格為:80mg、125mg)已獲中國國家藥品監督管理局頒發藥品註冊證書。該產品按照化藥新4類申報,視同通過仿製藥質量和療效一致性評價,是該品種第二家過評。該產品批准的適應症為:與其他止吐藥物聯合給藥,適用於預防高度致吐性抗腫瘤化療的初次和重複治療過程中出現的急性和遲發性噁心和嘔吐(CINV)。
該產品是繼鹽酸帕若諾司瓊注射液和注射用福沙匹坦雙葡甲胺後,集團又一個獲批的化療止吐用藥,腫瘤輔助產品線更加豐富。阿瑞匹坦臨牀定位明確、應用廣泛,作為新一代預防腫瘤化療引起噁心嘔吐的藥物將具有十分廣闊的應用前景。
根據披露,阿瑞匹坦是一種神經激肽-1(NK-1)受體阻滯劑,作用機制是通過與NK-1受體結合來阻滯P物質的作用。阿瑞匹坦可以通過血腦屏障,佔領大腦中的NK-1受體,對NK-1受體具有高選擇性和高親和性。同時,阿瑞匹坦對NK-2和NK-3受體,乃至其他用於治療化療誘發的噁心和嘔吐症狀的藥物的靶點(如多巴胺受體、5-HT受體)的親和性很低,因此其減少噁心和嘔吐的效果優於其他藥物。憑藉其安全性高、療效確切、給藥方便的特點,阿瑞匹坦已被《美國國家癌症綜合網路臨牀應用指南》等歐美權威指南一致推薦作為預防高致吐性抗腫瘤化療引起的噁心嘔吐的一線用藥和推薦用藥。
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