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先健科技(01302.HK)2020年度純利升67.3%至2.16億元 研發領域取得多項重大進展
格隆匯 03-30 13:13

格隆匯 3 月 30日丨先健科技(01302.HK)公佈,截至2020年12月31日止年度,實現收益6.42億元(人民幣,下同);毛利5.13億元;公司擁有人應占純利2.16億元,同比增加67.3%;基本每股盈利5.0分。

純利增長主要歸因於(i)按公平值計入損益的金融資產公平值變動產生的收益導致其他收益增加;及(ii)按公平值計入損益的金融資產產生的投資收益導致其他收益增加。該兩項增加均與公司對ABG-Grail Limited及Ally Bridge Group Innovation Capital Partners III, L.P.的投資有關。

集團為醫治心血管及外周血管疾病與紊亂所用先進微創介入醫療器械的開發商、製造商及營銷商。現有三條主要產品線,包括結構性心臟病業務、外周血管病業務及起搏電生理業務。結構性心臟病業務主要包括先天性心臟病封堵器及左心耳封堵器。外周血管病業務主要包括腔靜脈濾器及覆膜支架。產品線起搏電生理主要與起搏器有關。該等產品線提供臨牀療效好及在商業上具吸引力的產品選擇。

現時,公司的分銷商遍佈亞洲、非洲、北美洲、南美洲及歐洲的多個國家,銷售網絡覆蓋全球各地。

自主研發的國產創新型醫療器械產品不僅可維持公司的競爭實力,亦可向全球患者提供效果更好的治療方案。2020年,公司持續加強創新能力及加速產品的研發進度,以維持其於業內的領先地位。

截至本年度業績公佈日期,公司在研發領域取得以下主要進展:

1、G-iliacTM髂動脈分叉支架系統(G-iliacTM)已獲中國國家藥品監督管理局正式註冊批准。G-iliacTM用與腹髂動脈瘤或髂總動脈瘤的治療,為我國自主研發並獲得註冊批准的首個腔內重建髂內動脈的器械;

2、LAmbreTM左心耳封堵器系統已獲美國食品藥品監督管理局批准,可於美國啟動研究者發起的臨牀試驗,且其手術器械均由集團以合理的價格有償提供。此試驗的獲批將提供額外有價值的臨牀數據,為該器械在美國的市場準入提供支持;

3、FustarTM mini可調彎導管、FiQureTM腔靜脈濾器回收系統及ZoeTrackTM導絲及若干其他產品獲國家藥品監督管理局註冊證書;

4、FuthroughTM主動脈覆膜支架破膜系統於歐洲獲CE認證;

5、FuthroughTM主動脈覆膜支架破膜系統、IBS AngelTM鐵基可吸收支架系統、IBS TitanTM鐵基可吸收藥物洗脱外周支架系統及主動脈覆膜支架系統已被認可為創新醫療器械。目前,公司已有十三項產品獲國家藥品監督管理局認可為創新醫療器械;及

6、IBSTM鐵基可吸收藥物洗脱冠脈支架(“IBS”)於2018年3月全球首次成功植入人體。六個月的隨訪結果顯示IBS開始降解且患者血管暢通。兩年的隨訪結果亦顯示患者血管暢通,且大部分支架已降解。隨訪結果初步證實了IBS的安全有效性,目前仍在收集更多有關IBS的安全性及有效性數據。同時,全球首例用於治療膝下動脈狹窄的IBS TitanTM鐵基可吸收藥物洗脱外周支架手術亦已成功實施。

知識產權為集團的重要無形資產,亦為集團提升於醫療器械市場核心競爭力的內在驅動力。截至2020年12月31日止年度內,集團已提交232項專利申請且152項專利獲批准。截至2020年12月31日,集團累計已提交1306項專利申請,其中434項獲批准。

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