上海醫藥(02607.HK):吲達帕胺片通過仿製藥一致性評價
格隆匯2月22日丨上海醫藥(02607.HK)公吿,近日,上海醫藥集團股份有限公司(以下簡稱“上海醫藥”或“公司”)控股子公司赤峯蒙欣藥業有限公司(以下簡稱“赤峯蒙欣”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)頒發的關於吲達帕胺片(以下簡稱“該藥品”)的《藥品補充申請批准通知書》(通知書編號:2023B00709),該藥品通過仿製藥質量和療效一致性評價。
吲達帕胺片主要用於原發性高血壓,由施維雅研發,最早於1977年在英國上市。2021年12月,赤峯蒙欣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。截至公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣523萬元。
截至公吿日,中國境內該藥品的主要生產廠家有山東方明藥業集團股份有限公司、遠大醫藥(中國)有限公司、天津太平洋製藥有限公司等。IQVIA數據庫顯示,2022年該產品口服固體制劑的醫院採購金額為人民幣5314萬元。2022年,赤峯蒙欣的該藥品銷售收入為人民幣331萬元。
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