人福醫藥(600079.SH):鹽酸胍法辛緩釋片獲得美國FDA批准文號
格隆匯11月26日丨人福醫藥(600079.SH)宣佈,近日,公司控股子公司宜昌人福收到美國食品藥品監督管理局(FDA)關於鹽酸胍法辛緩釋片的批准文號。鹽酸胍法辛緩釋片用於注意力缺陷多動症(ADHD)治療,適用於兒童及對興奮劑不適合、不耐受或已顯示無效的6-17歲青少年。
宜昌人福於2019年提交鹽酸胍法辛緩釋片的ANDA申請,累計研發投入約為150萬美元。Takeda Pharmaceuticals U.S.A., Inc.持有鹽酸胍法辛緩釋片的兩項專利,到期日分別為2021年6月20日和2023年1月4日,截至目前無任何一方認為宜昌人福的鹽酸胍法辛緩釋片侵犯上述專利權。
根據IQVIA數據統計,2019年鹽酸胍法辛緩釋片在美國市場的總銷售額約為4500萬美元,主要生產廠商包括APOTEX、TEVA、TWI等。根據米內網數據統計,鹽酸胍法辛緩釋片暫未在國內獲批上市銷售,目前已有南京海納醫藥科技有限公司、鄭州大明藥物科技有限公司、河南中帥醫藥科技發展有限公司、濟南百諾醫藥科技開發有限公司等公司向國家藥監局申報。
公司表示,此次鹽酸胍法辛緩釋片獲得美國FDA批准文號標誌宜昌人福具備了在美國市場銷售該產品的資格,將對公司拓展美國仿製藥市場帶來積極的影響,公司後續將積極推進該產品在美國市場的上市準備工作。
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