悦康藥業(688658.SH):阿莫西林膠囊通過仿製藥一致性評價
格隆匯 2 月 7日丨悦康藥業(688658.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的關於阿莫西林膠囊(按C16H19N3O5S計0.25g)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。
阿莫西林屬於青黴素類廣譜β-內酰胺類抗生素,對大多數致病的革蘭氏陽性菌及革蘭氏陰性菌均有強大的抑菌和殺菌作用,臨牀廣泛用於治療敏感菌所致上呼吸道感染、泌尿生殖道感染、皮膚軟組織感染、下呼吸道感染以及與其他藥物聯用根除幽門螺桿菌,且輕中度腎病患者無需調整劑量。目前阿莫西林國內已有膠囊、片劑、顆粒劑、分散片等劑型。阿莫西林膠囊已進入甲類醫保和2018年國家基藥目錄。
經米內網查詢,2019年中國(城市公立)樣本醫院年度銷售趨勢顯示阿莫西林膠囊劑銷售額為24116萬元。該藥品在中國境內的主要生產廠家包括:聯邦製藥、華北製藥、石藥中諾藥業(石家莊)、奧美製藥等。截至本公吿日,公司針對阿莫西林膠囊(按C16H19N3O5S計0.25g)的一致性評價已投入研發費用約人民幣1176.85萬元。2020年公司的阿莫西林膠囊(按C16H19N3O5S計0.25g)銷售收入為1749.63萬元(未經審計)。
阿莫西林膠囊(按C16H19N3O5S計0.25g)通過仿製藥一致性評價,有利於擴大產品的市場份額,提升市場競爭力,併為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。該產品通過仿製藥一致性評價對公司業務不構成重大影響。
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