長江健康(002435.SZ):海靈藥業成為注射用醋酸卡泊芬淨上市許可持有人
格隆匯3月18日丨長江健康(002435.SZ)宣佈,公司下屬全資子公司海靈藥業於近日收到國家藥品監督管理局《藥品補充申請批准通知書》,同意注射用醋酸卡泊芬淨(藥品批准文號:國藥準字H202003001、國藥準字H202003002,規格為50mg、70mg)藥品上市許可持有人由“博瑞製藥(蘇州)有限公司”變更為“海南海靈化學制藥有限公司”。
卡泊芬淨,一種棘白素族的半合成脂肽,是一種新的作用機制的抗真菌藥,能夠抑制許多絲狀真菌和酵母菌細胞壁的一種基本成分—β(1,3)-D-葡聚糖的合成來發揮殺菌作用,有良好的療效和耐受性,毒性作用小。體外藥理學研究顯示,卡泊芬淨對許多種致病性麴黴菌屬和念珠菌屬真菌具有抗菌活性。臨牀適用於成人患者和兒童患者(三個月及三個月以上)經驗性治療中性粒細胞減少、伴發熱病人的可疑真菌感染,以及治療對其它治療無效或不能耐受的侵襲性麴黴菌病。具有抗真菌普廣、療效優、安全性高等特點。
注射用醋酸卡泊芬淨為國家醫保乙類、國家基本藥物,據米內網數據顯示,2019年在中國城市公立醫院、縣級公立醫院、城市社區中心及鄉鎮衞生院的終端卡泊芬淨注射劑銷售額達22.3億元,同比增長18.49%,市場前景廣闊。
公司表示,該次海靈藥業成為注射用醋酸卡泊芬淨的上市許可持有人,對公司近期經營業績不會產生重大影響。公司以MAH制度為契機,積極儲備有發展潛力的藥品品種,豐富公司產品線,有利於公司可持續發展。
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