石藥集團(01093.HK)與康諾亞生物訂立產品授權及商業化協議
格隆匯 3 月 10日丨石藥集團(01093.HK)公吿,公司全資附屬公司上海津曼特生物科技有限公司已與康諾亞生物醫藥科技(成都)有限公司訂立協議,內容有關產品CM310(一種抗IL-4Rα的重組人源化單抗)在中重度哮喘和慢性阻塞性肺病(COPD)等呼吸系統疾病獨家授權開發及商業化。
根據該協議,津曼特生物將獲得康諾亞生物授出該產品獨家權利,以於中華人民共和國(不包括香港特別行政區、澳門特別行政區及台灣地區)進行該產品該於等適應症開發與商業化,併成為上市許可持有人(MAH)。
作為獨家授權代價,津曼特生物同意向康諾亞生物支付人民幣7000萬元首付款及根據該產品於該地區的開發進度支付人民幣1億元開發里程碑付款。津曼特生物亦同意根據該產品於該地區達成銷售額向康諾亞生物支付銷售里程碑付款和銷售提成。
CM310是康諾亞生物研發的具有自主知識產權的靶向人白細胞介素4受體α亞基(IL-4Rα)的重組人源化單克隆抗體注射液。該產品通過與其特異性結合,從而抑制炎症反應,擬用於治療中重度哮喘,COPD和特應性皮炎等適應症。該產品在中國按治療用生物製品1類新藥申報,中重度哮喘的適應症於2019年7月獲臨牀試驗默示許可。CM310目前已經開展臨牀II期研究工作。
康諾亞生物成立於2016年,是一家專注於創新抗體藥物和其它治療性蛋白藥物的創新生物藥公司,由具有豐富科技成果轉化及國內外產業化經驗的專家創辦。現有員工200餘人。公司已獲得包括聯想星、高瓴資、漢康資、禮來亞洲基金、三正健康、博裕資等在內的多家國際知名機構投資,在成都、上海及北京設有研究開發和臨牀藥物生產基地。
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