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昆藥集團(600422.SH):磷酸萘酚喹原料藥通過CDE技術審評
格隆匯 11-23 15:35

格隆匯 11 月 23日丨昆藥集團(600422.SH)公佈,近日,公司磷酸萘酚喹原料藥通過國家藥品監督管理局藥品審評中心(“CDE”)技術審評,在CDE原料藥、藥用輔料和藥包材登記信息公示平台上顯示登記號轉為“A”狀態。

次通過審批的磷酸萘酚喹原料藥是一種新型4-氨基喹啉類藥物,主要與青蒿素聯用製成口服劑治療瘧疾。2018年,全世界估計發生2.28億例瘧疾病例,死亡人數為40.5萬人。全球近85%的瘧疾在撒哈拉以南非洲十九個國家和印度發生。據國外研究機構Coherent Market Insights統計,2019年全球抗瘧藥(針劑及口服劑)的市場總額超過8億美元,而以青蒿素為基礎的聯合療法(artemisinin combination therapyACT)的全球市場規模,Grand View Research發表市場研究,預計到2025年,有望達到近7億美元(約合人民幣46億元)

目前除原研企業上海新華聯製藥有限公司以外僅有昆藥集團通過CDE術審評。

公司磷酸萘酚喹原料藥通過CDE技術審評,表明該原料藥已符合國家相關藥品審評技術標準,可國內市場進行銷售製劑方面,公司擁有唯一的磷酸萘酚喹與青蒿素聯用的複方磷酸萘酚喹片,該製劑是全球唯一的一次性服用即能治療瘧疾的藥物該原料獲准生產後,公司具備全產業鏈生產獨家品種複方磷酸萘酚喹片能力持續為海外市場提供優質安全的一次性治療瘧疾的解決方案

鑑於公司此前生產銷售的複方磷酸萘酚喹片銷售收入佔公司以往營業總收入比例較低,此次磷酸萘酚喹原料藥通過CDE技術審評對公司經營業績不構成重大影響。

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