上海醫藥(601607.SH):鹽酸氟桂利嗪膠囊通過仿製藥一致性評價
格隆匯1月11日丨上海醫藥(601607.SH)公佈,近日,公司控股子公司正大青春寶藥業有限公司(以下簡稱“正大青春寶”)收到國家藥監局頒發的關於鹽酸氟桂利嗪膠囊的《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價。
鹽酸氟桂利嗪膠囊主要用於典型(有先兆)或非典型(無先兆)偏頭痛的預防性治療,以及由前庭功能紊亂引起的眩暈的對症治療。該藥品由比利時楊森公司研發,最早於1982年上市。2020年9月,正大青春寶就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至本公吿日,正大青春寶針對該藥品的一致性評價已投入研發費用約人民幣945萬元。
截至本公吿日,中國境內該藥品的主要生產廠家為山東方明藥業集團股份有限公司、江蘇平光製藥(焦作)有限公司、石家莊市華新藥業有限責任公司。
IQVIA數據庫顯示,2021年1月-11月,該藥品醫院採購金額為人民幣1.64億元。2021年,正大青春寶的該藥品銷售收入為人民幣379.26萬元。
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