華海藥業(600521.SH):製劑產品芬戈莫德膠囊獲得美國FDA批准文號
格隆匯9月13日丨華海藥業(600521.SH)公佈,近日,公司收到美國食品藥品監督管理局(“美國FDA”)的通知,公司向美國FDA申報的芬戈莫德膠囊的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
芬戈莫德膠囊主要用於治療多發性硬化症。芬戈莫德膠囊由Novartis研發,於2010年在美國上市。當前,美國境內,芬戈莫德膠囊仍受專利保護僅有原研產品上市銷售。2021年該藥品美國市場銷售額約1,931,105,438美元(數據來源於IMS數據庫)。
截至目前,公司在芬戈莫德膠囊項目上已投入研發費用約1210萬元人民幣。
此次芬戈莫德膠囊獲得正式批准標誌着公司具備了在美國市場銷售上述產品的資格,公司會根據與原研公司達成的協議進行商業化。該產品ANDA文號的獲批有利於公司不斷擴大美國市場銷售和強化產品供應鏈,豐富產品梯隊,提升公司產品的市場競爭力,對公司的經營業績產生積極的影響。
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