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利好 | 信達生物升超9%,擴大與禮來創新生物藥授權許可
uSMART友信智投 08-19 15:15

uSMART友信智投8月19日消息,週三港股下午交易時段,信達生物高開高走,截至14:51分,信達生物升9.58%,報54.35港元,成交額為5.05億港元。

昨日港股市後,信達生物發佈公告稱,該公司與禮來製藥達成關於雙方共同在中國開發的抗PD-1單克隆抗體免疫腫瘤藥物達伯舒®(信迪利單抗注射液)的擴大授權授權合約。

根據該協定條款,禮來將獲得達伯舒®在中國以外區域的獨家許可,並計畫將達伯舒®推向美國和其他地區市場。本公司將收到2億美元首付款,並有資格獲得高達8.25億美元潛在開發和商業化里程碑付款,以及雙位數比例的淨銷售額提成。雙方也將保留開發達伯舒®聯合其他藥物作為其自有部分臨床專案的權利。

本公司認為,該協議標誌著公司在創新產品管線進入全球市場邁出了堅實的第一步。憑藉禮來的全球商業化專長和達伯舒®的臨床療效,公司將進一步加快使命落地,造福全球患者。

目前,公司有超過20項臨床研究(其中10多項是註冊臨床試驗)正在進行中,以評估達伯舒®在各類腫瘤上的有效性和安全性,包括達伯舒®聯合禮來的力比泰®(注射用培美曲塞二鈉)和鉑類化療作為一線治療非鱗狀非小細胞肺癌(NSCLC)的研究。本公司同時正在中國以外開展達伯舒®的臨床研究工作。

此外,2020年8月8日,雙方在IASLC WCLC世界肺癌大會2020年線上主題論壇公佈了ORIENT-11研究期中分析結果。ORIENT-11是一項隨機、雙盲、III期對照臨床研究,對比達伯舒®或安慰劑聯合力比泰®(注射用培美曲塞二鈉)和鉑類化療用於無EGFR敏感突變或ALK基因重排的晚期或復發性非鱗狀NSCLC一線治療。

基於獨立資料監察委員會進行的期中分析,達伯舒®聯合力比泰®(注射用培美曲塞二鈉)和鉑類化療對比安慰劑聯合力比泰®(注射用培美曲塞二鈉)和鉑類化療,顯著延長了無進展生存期,達到預設的優效性標準。中國國家藥品監督管理局(NMPA)已於2020年4月23日正式受理達伯舒®該新適應症上市申請。

據悉,公司和禮來期待未來在美國食品藥品監督管理局和其他國家遞交該適應症及其他適應症的申請。2020年8月,NMPA正式受理達伯舒®聯合健擇®(注射用吉西他濱)和鉑類化療一線治療鱗狀NSCLC的新增適應症申請。

 

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