昆藥集團(600422.SH):與安成藥業就碳酸司維拉姆片開展合作
格隆匯2月20日丨昆藥集團(600422.SH)公佈,公司九屆二十二次董事會議召開,審議通過關於與台灣安成國際藥業股份有限公司就碳酸司維拉姆片開展合作的議案。
同意公司與安成國際藥業股份有限公司(“安成藥業”)簽訂《技術資料轉讓合同》、《碳酸司維拉姆片委託技術開發合同》,通過技術資料轉讓、委託技術開發等合作方式獲取碳酸司維拉姆片800mg的完整註冊文件及相關生產技術,以使公司能夠向中華人民共和國國家藥品監督管理局(NMPA)進行該產品的仿製藥註冊申請並獲得生產批件,並獲得碳酸司維拉姆片劑在中國大陸地區上市和銷售的全部權利。為此目的,公司將向安成藥業支付總計120萬美元的合作款項,並承擔因項目合作在中國產生的税費約9750美元。
碳酸司維拉姆片為健贊公司(Genzym,現賽諾菲)於2007年在美國首上市的新型磷結合劑,適應症為用於控制正在接受透析治療的慢性腎臟病(CKD)成人患者的高磷血癥。此次合作符合公司進入代謝性慢性疾病治療領域的發展戰略,如目標產品最終順利獲註冊並上市,有利於補充豐富公司化藥板塊產品線,增強公司市場競爭力和持續發展能力。但是,鑑於此次合作系採用技術資料轉讓及委託技術開發等方式,申請註冊的過程存在技術受讓方對生產技術吸收接受程度、BE實驗進度、原輔料可及性等方面制約,註冊可能存在不能完成或完成晚於預期的風險。
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