復星醫藥(02196.HK):獲MPP新冠口服藥生產許可 對收入等的影響尚無法預計
格隆匯1月21日丨復星醫藥(02196.HK)公佈,MPP(即"藥品專利池組織")授予公司控股子公司復星醫藥產業在區域內(即印度、巴基斯坦、科特迪瓦等105箇中低收入國家/地區)使用相關專利和專有技術對在研新冠治療口服藥物Molnupiravir (MK-4482和EIDD-2801)("合作藥物")開展生產、商業化及相關權利的非獨家許可。
媒體報道情況,近日,MPP發佈公吿及相關媒體報道稱,MPP向包括復星醫藥在內的27家藥企授權生產新冠治療口服藥物 Molnupiravir。
相關情況的核實:2022年1月7日,控股子公司復星醫藥產業與MPP就新冠口服藥物Molnupiravir授權生產等事宜簽訂《分許可協議》,主要內容如下:
1、許可內容
基於MSD-MPP協議,MPP授予復星醫藥產業在區域內(即印度、巴基斯坦、科特迪瓦等105箇中低收入國家/地區)使用相關專利和專有技術對在研新冠治療口服藥物Molnupiravir (MK-4482和EIDD-2801)開展生產、商業化(包括註冊、零售、分銷等)及相關權利的非獨家許可,上述生產包括Molnupiravir的原料(藥)及成品藥(製劑)。
合作藥物將在經SRA批准或通過WHOPQ認證的生產設施上進行生產。
2、產品價格
實際成本(可通過第三方審計核實)加上合理加價(經協商)。
3、專利許可使用費
根據購買方性質的不同,復星醫藥產業應按照年度淨銷售額(定義依據協議)的5%或10%向默沙東支付專利許可使用費。但基於MSD-MPP協議,前述專利許可使用費將自WHO宣佈COVID-19不再被列為"國際關注的突發公共衞生事件"的次月起開始收取。
4、其他
基於MSD-MPP協議,默沙東保留隨時撤銷或更改授予MPP合作藥物相關許可的權利。MPP有權依《分許可協議》終止本次分許可。
5、生效
《分許可協議》生效日期為2022年1月7日。
Molnupiravir (MK-4482、EIDD-2801)是一款由默沙東和Ridgeback聯合開發的口服核糖核苷類藥物,可抑制 SARS-CoV-2 (新冠病毒的致病因子)的複製,目前主要用於治療輕度到中度的新冠肺炎。
該藥物於2021年11月獲得英國藥品和健康產品管理局(MHRA)的附條件上市批准;於2021年12月先後獲得美國食品藥品監督管理局(FDA)的緊急使用授權(EUA)、日本厚生勞動省緊急特例批准。
根據MPP官網(https://medicinespatentpool.org/)公佈的信息,包括復星醫藥產業在內,MPP目前已向全球27家藥企授予非獨家的生產、商業化以及相關權利的許可,以向全球105箇中低收入國家/地區供應 Molnupiravir。
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