昆藥集團(600422.SH):貝克諾頓成為普瑞巴林口服溶液上市許可持有人
格隆匯6月22日丨昆藥集團(600422.SH)公吿,此前,公司全資孫公司貝克諾頓(浙江)製藥有限公司(“貝克諾頓(浙江)”)與杭州和澤坤元藥業有限公司(“和澤坤元”)簽署了《普瑞巴林口服溶液技術與權益轉讓協議》(“轉讓協議”)。
據悉,和澤坤元作為轉讓協議項下之協議產品普瑞巴林口服溶液(規格:2%(473ml:9460mg)(“協議產品”)的知識產權所有人和上市許可持有人,將協議產品的相關知識產權及上市許可轉讓給貝克諾頓(浙江),協議轉讓費用為2000萬元人民幣,雙方將根據協議之約定辦理協議產品的上市許可持有人變更手續。
近日,貝克諾頓(浙江)收到國家藥品監督管理局核准簽發的普瑞巴林口服溶液《藥品補充申請批准通知書》,同意貝克諾頓(浙江)作為該藥品上市許可持有人(原上市許可持有人為和澤坤元)。
神經系統疾病是公司聚焦的核心治療領域之一,目前已有天麻素膠囊/注射液、氯硝西泮注射液等已上市產品。公司本次普瑞巴林口服溶液的引進及上市許可持有人變更獲批,將進一步豐富公司神經系統領域的產品管線,增強公司在神經系統疾病治療領域的競爭力。
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