華海藥業(600521.SH)獲授予生產新冠口服藥物奈瑪特韋的仿製藥和許可產品的非獨家許可
格隆匯3月18日丨華海藥業(600521.SH)公佈，近日，MPP發佈公吿及相關媒體報吿稱，MPP向包括華海藥業在內的35家藥企授權生產新冠病毒治療藥物奈瑪特韋/利托那韋的仿製藥。
公司與MPP簽訂的《分許可協議》的主要內容如下：
基於Pfizer-MPP協議，MPP授予華海藥業在區域內(即印度尼西亞、越南、埃塞俄比亞等95箇中低收入國家)使用相關專利和專有技術，對“奈瑪特韋(Nirmatrelvir)”的仿製藥和許可產品(“奈瑪特韋/利托那韋組合”)開展生產，並對許可產品進行商業化(包括註冊、零售、分銷等)的非獨家許可。
許可產品是一個組合包裝的口服小分子新冠治療藥物，其包括兩個抗病毒藥物，即奈瑪特韋(Nirmatrelvir)和利托那韋(Ritonavir)。
上述生產包括對(1)奈瑪特韋原料(藥)及成品藥(製劑)的生產，以及(2)奈瑪特韋/利托那韋組合的生產。
此次許可下相關產品的生產將在經SRA批准或通過WHO PQ認證的生產設施上進行生產。
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)。
專利許可使用費：根據購買方性質的不同，華海藥業應按照年度淨銷售額(定義依據協議)的5%或10%）向輝瑞支付專利許可使用費。但基於Pfizer-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。但在低收入國家的銷售，將豁免向輝瑞支付專利許可使用費。
公吿顯示，許可產品是口服小分子新冠治療藥物“奈瑪特韋/利托那韋組合”，用於治療成人伴有進展為重症高風險因素的輕至中度新型冠狀病毒肺炎(COVID-19)患者。
根據公開信息，輝瑞的奈瑪特韋/利托納韋組合包裝藥物已獲得(其中主要包括)美國食品藥品監督管理局(美國FDA)的緊急使用授權(EUA)、歐洲藥品管理局(EMA)的有條件批准、日本厚生勞動省的緊急特例批准以及中國國家藥品監督管理局的應急附條件批准。
根據MPP官網(https://medicinespatentpoolorg/)公佈的信息，包括華海藥業在內，MPP目前已向全球35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95箇中低收入國家供應許可產品。
MPP，是一家由聯合國支持的非營利性公共衞生組織，其主要辦公地位於瑞士日內瓦。MPP通過自願許可和專利池的創新方法，致力於增加中低收入國家/ 地區獲得藥品的機會。
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