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愛朋醫療(300753.SZ):全資子公司獲得醫療器械註冊證
格隆匯 03-18 17:27

格隆匯3月18日丨愛朋醫療(300753.SZ)公佈,公司的全資子公司愛普科學儀器(江蘇)有限公司(“愛普科學”)近日取得國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》,產品名稱為化療注藥泵。

愛普科學原有“微電腦化療注藥泵”為第二類醫療器械產品,公司研發人員對其進行功能升級及軟件、硬件改進,於2019年根據《醫療器械分類目錄》的要求,申請註冊第三類醫療器械“化療注藥泵”。“化療注藥泵”是一種微電腦控制下的偏心轉子蠕動泵,含微電腦控制、自主參數、精密驅動、全程監控等功能,具有多重安全保護、中文顯示及低功耗等特點,給藥途徑為靜脈給藥。該產品專為癌症化療臨牀使用設計,具有持續給藥、時辰給藥兩種給藥模式,配用液袋規格豐富,可滿足不同品種、不同容量的化療藥品輸注需求,便於癌症患者化療使用。

國家癌症中心於2019年1月發佈的全國癌症統計數據報告顯示,2015年我國新發惡性腫瘤病例數約為392.9萬例,近10多年來惡性腫瘤發病率每年保持約3.9%的增幅,我國每年惡性腫瘤所致的醫療花費超過2200億。同時報告顯示近10餘年來惡性腫瘤生存率呈現逐漸上升趨勢,2015年我國惡性腫瘤的5年相對生存率約為40.5%,與2005年相比,我國惡性腫瘤生存率總體提高約10個百分點,但與發達國家相比仍有很大差距。

目前化療是治療癌症的重要手段之一,基於上述國內惡性腫瘤新發病例數據及相對生存率數據可以分析得出,配合化療使用的注藥泵類產品具有良好的市場前景。

上述醫療器械註冊證的取得,豐富了公司疼痛管理領域用第三類醫療器械的產品種類,更好地滿足了市場多樣化的需求,有利於進一步提高公司的市場拓展能力,對公司未來的經營將產生積極影響。

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