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金城醫藥(300233.SZ)北京阿波羅土星生物醫藥科技有限公司收到臨牀試驗通知書
格隆匯 08-22 15:42

格隆匯8月22日丨金城醫藥(300233.SZ)公佈,2016年7月25日,公司召開第三屆董事會第二十九次會議,審議通過了《關於投資設立上海仟德股權投資合夥企業(有限合夥)的議案》,同意公司以自有資金出資5000萬元人民幣,與達孜東方高聖秋實資產管理有限公司等共同設立合夥企業。公司以自有資金出資5000萬元人民幣,佔合夥企業出資總額的40.32%。

2019年8月21日,公司收到上海仟德股權投資合夥企業(有限合夥)(“上海仟德”)通知,其下屬控股子公司北京東方略生物醫藥科技股份有限公司(“東方略”)全資子公司北京阿波羅土星生物醫藥科技有限公司與美國Inovio Pharmaceuticals Inc.聯合申報的1類治療性生物製品VGX-3100與CELLECTRATM器械聯合治療HPV-16/18相關宮頸高度鱗狀上皮內病變的成年女性的國際多中心三期臨牀試驗,獲得國家藥品監督管理局頒發的《臨牀試驗通知書》,主要內容如下:

根據《中華人民共和國藥品管理法》及有關規定,經審查,2019年05月31日受理的VGX-3100符合藥品註冊的有關要求,同意按照提交的方案開展本品與CELLECTRATM器械聯合治療HPV-16/18相關宮頸高度鱗狀上皮內病變的成年女性患者的Ⅲ期臨牀試驗。

VGX-3100是全球首款針對於HPV感染相關癌前病變的治療藥物。VGX-3100是東方略與美國癌症免疫治療公司Inovio Pharmaceuticals Inc.合作開發的一種DNA免疫治療產品,用於治療由人類乳頭狀瘤病毒(HPV)導致的癌前病變,東方略擁有其在大中華區(中國大陸、香港、澳門、台灣)開發和商業化的獨家權利。

公司於2018年6月14日與東方略簽署《戰略合作協議》,雙方約定:如果東方略在婦科、肝病及腫瘤領域獲得相關生物醫藥品種或技術,將與公司共同進行後續研發。同時,如果東方略對外轉讓該品種的專利技術或批文,在同等條件下,公司享有優先受讓權;如果東方略自行持有該產品批文,但將該產品委託第三方進行生產銷售,在同等條件下,公司享有優先受託權。公司將在東方略引進藥品的後續研發、落地方面對其進行大力支持,包括但不限於人才支持、技術諮詢、有償向其提供研發場所及設備等。

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