微泰醫療-B(02235.HK)2021年收入升101.1%至1.51億元 研發管線取得重大進展
格隆匯3月26日丨微泰醫療-B(02235.HK)公佈2021年度業績,期內集團實現收入1.51億元人民幣(單位下同),同比增長101.1%;毛利7088.3萬元,同比增長94.0%;母公司擁有人應占虧損4815.3萬元,同比收窄60.2%;每股基本虧損0.13元,不派息。
公吿稱,收入增加主要由於公司已有產品市場份額不斷擴大,銷售規模增長,以及持續葡萄糖監測系統開始商業化所致。
截至2021年12月31日,集團有4大類產品和在研管線。集團的產品獲得14張中國醫療器械註冊證。此外,6款產品獲得歐盟CE標誌,並有1款產品獲得美國FDA510(k)批准。集團有8款處於不同開發階段的在研產品。
於2021年,集團在研發管線方面取得了重大進展,包括(1)按計劃於2021年11月獲得國家藥監局AiDEX G7持續葡萄糖監測系統產品的上市許可;(2)開展貼敷式胰島素泵和持續葡萄糖監測系統的兒童及青少年適應症拓展臨牀研究;(3)第二代貼敷式胰島素泵、AiDEX X持續葡萄糖監測系統、閉環人工胰腺系統遞交型式檢驗;(4)Equil貼敷式胰島素泵提交FDA註冊申請,以及(5)基於集團的重要技術優勢,推進糖尿病數字化管理產品的研發及應用。
商業化方面,集團的核心產品Equil貼敷式胰島素泵銷售收入在2021年度較2020年度大幅增長111%,銷售網絡已覆蓋超過800家醫院。2021年,Equil貼敷式胰島素泵被納入”中國胰島素泵治療指南“,也是目前首個且唯一在中國獲批的貼敷式胰島素泵產品。中國第一款獲批的免校準、實時持續葡萄糖監測系統AiDEX G7已於2021年12月份開始生產並商業化,為來自醫院、零售藥店用户、零售終端和電子商務平台的醫患用户提供實時、精準的血糖監測方案。
集團在海外市場的業務也取得了顯著進展,主要產品在2021年獲得多個歐洲國家的醫保準入。2021年度的海外產品收入較2020年度大幅增長191%,主要因為Equil貼敷式胰島素泵和AiDEX G7持續葡萄糖監測系統進入更多的歐洲市場銷售,以及血糖監測系統在歐洲和拉美市場的增長。
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