歌禮制藥-B(01672.HK):新增歐洲八國利托那韋上市許可申請
格隆匯3月1日丨歌禮制藥-B(01672.HK)發佈公吿,歌禮通過歐洲代理商向歐洲八國(西班牙、葡萄牙、意大利、比利時、波蘭、瑞典、荷蘭和丹麥)遞交了利托那韋(100毫克薄膜衣片)上市許可申請。除以上歐洲八國外,歌禮還完成了向德國、法國、愛爾蘭和英國的利托那韋上市許可申請遞交。其他包括歐亞地區、北美和南美地區、非洲地區和亞太地區的利托那韋上市許可申請計劃在近期遞交。
歌禮持續推進與國內公司和大型跨國製藥公司就利托那韋在中國和全球的商業化供應合作。口服利托那韋片是針對病毒蛋白酶的多種口服抗病毒藥物的藥代動力學增強劑及口服抗病毒藥物PAXLOVID(300毫克奈瑪特韋片+100毫克利托那韋片組合包裝)的組成之一。
根據披露,歌禮的目標是成為口服利托那韋片全球供應商之一。目前,歌禮擁有中國唯一通過生物等效性研究獲批上市的口服利托那韋片。歌禮口服利托那韋片於2021年9月獲中國國家藥品監督管理局批准上市(藥品批准文號:國藥準字H20213698)。歌禮使用高端製劑技術,大幅度提高難溶性利托那韋在人體內的生物利用度,從而達到與原研廠商艾伯維生產的艾治威?在人體中的生物等效。同時,歌禮於2022年1月3日宣佈,口服利托那韋片年產能已擴大至1億片,未來根據市場需求可以進一步快速擴大。
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