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四環醫藥(00460.HK):渼顏空間自主研發的注射用聚己內酯微球面部填充劑獲得國家藥監局批准
格隆匯 04-02 19:00

格隆匯4月2日丨四環醫藥(00460.HK)公吿,集團旗下渼顏空間生物科技(吉林)有限公司自主研發的注射用聚己內酯微球面部填充劑("該產品")正式獲得中國國家藥品監督管理局批准第三類醫療器械註冊證。標誌着四環醫藥在醫美領域的重大突破,也為國內再生醫美材料市場注入了新的活力。

注射用聚己內酯微球面部填充劑,市場簡稱"少女針",是一種再生注射類材料,並以其獨特的作用機理使其在醫美市場中備受矚目。該產品注射到皮下組織後,其中的聚己內酯凝膠載體可起到即時填充的效果,能迅速改善面部凹陷問題。而在凝膠載體被降解吸收後,聚己內酯微球可持續刺激注射部位產生積極作用,以達到長期的填充效果。該產品單次治療療程僅需注射1次,效果持續時間通常為1年以上,其卓越的臨牀療效和安全性得到了充分驗證。

集團研發的這款"少女針"由預灌封注射器、一次性使用無菌注射針和封裝在注射器中的凝膠顆粒懸液組成,設計精巧,使用便捷。其適用於注射到鼻脣溝部位皮下層,以糾正中到重度鼻脣溝皺紋,能有效提升面部整體年輕感。從公司在售產品佈局來看,"少女針"的獲批填補了集團再生材料III類醫療器械的空白。從市場格局來看,集團的"少女針"成為國內上市的前三款產品之一,也是第二款自主研發的國產"少女針"。這一成果是四環醫藥"醫美+創新藥"戰略的又一重要里程碑。

根據權威機構摩熵諮詢發佈的《2024醫美注射材料市場發展分析報吿》,2023年中國注射用再生材料市場規模約達30億元人民幣(以出廠價計),在整個醫美注射材料市場中的份額佔比約11%。再生材料市場呈現出迅猛的增長態勢,報吿預計到2025年,其市場規模將躍升至約72億元人民幣,市場份額佔比也將提升至約16%。在再生材料板塊中,"少女針"憑藉效果自然、維持時間長等優勢,成為最新興、先進的醫美注射材料之一,深受消費者喜愛。以2023年為例,"少女針"系列產品在國內的銷售額同比增長超過50%,市場反響極其熱烈,未來發展前景十分樂觀。

除上述已獲批的注射用聚己內酯微球面部填充劑(少女針)外,渼顏空間在再生材料領域還有多款產品佈局,管線中還包括聚乳酸面部填充劑(童顏針)、新型再生材料注射用聚羥基脂肪酸酯微球(PHA)填充劑、注射用羥基磷酸鈣微球面部填充劑、絲素蛋白類填充劑、以及更具獨特工藝的液態再生材料等重磅產品。

隨着人們對美的追求不斷進階,醫美行業也迎來了蓬勃發展的黃金時期,再生材料市場的需求呈現出持續攀升的強勁態勢。四環醫藥憑藉其深厚的研發底藴與強大的市場運營能力,成功將"少女針"推向市場。這一成果不僅極大地豐富了自身醫美產品線,更讓四環醫藥具備了在快速增長的再生材料市場中領航的潛力,有望在未來成為該領域的龍頭企業,有力地推動本集團在醫美領域邁出更為堅實、穩健的步伐。

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