華東醫藥：含利多卡因Perfectha®產品獲歐盟CE認證 正積極籌備Glacial Spa™中國上市銷售工作
格隆匯5月17日丨華東醫藥(000963.SZ)公佈，近期，公司英國全資子公司Sinclair Pharma Limited (“Sinclair”)獲得了關於無菌、一次性使用、可吸收、含利多卡因的真皮填充劑(HA玻尿酸)(含利多卡因Perfectha®系列產品，以下簡稱“產品”、“本產品”)的歐盟CE認證證書。
Perfectha®系列產品是100%採用法國原產高品質原料製成的新一代雙相透明質酸填充劑，易於注射，具有持久的填充效果，能有效撫平面部皺紋並彌補體積損失，且幾乎無BDDE（1,4-丁二醇二縮水甘油醚，一種交聯劑）殘留，同時具有高彈性、極佳的流動特性和緩慢的酶降解能力。Perfectha®採用E-BIRD交聯技術，臨牀使用時限超過12年，全球累積銷售超350多萬支，不良事件發生率低，是安全可靠的產品。
此次獲得歐盟CE認證的含利多卡因Perfectha®系列型號包括PerfecthaFineLines Lidocaine，PerfecthaDerm Lidocaine，PerfecthaDeep Lidocaine，PerfecthaSubskin Lidocaine等，是在原Perfectha®系列產品基礎上添加了利多卡因成分，可以提高注射過程中的舒適度，求美者注射體驗感更佳。
含利多卡因Perfectha®產品獲得歐盟CE認證表明該產品符合歐盟相關要求，具備歐盟市場的准入條件，可以在歐盟和相關海外市場進行銷售，對於公司擴充海外銷售產品品類及國際業務拓展具有積極作用。公司將繼續秉承“以求美者為中心”的經營理念，積極加快核心醫美產品的研發和上市註冊進程。未來公司將一直致力於滿足求美者日益增長的多元化美學訴求，向全球求美者帶來更健康、更先進、更有科技內涵的美容產品和方案。
此外，公司引進美國R2公司的冷觸美容儀酷雪Glacial Spa™（F0）近日在上海2021屆CBE中國美容博覽會上重磅亮相，完成全球首秀。酷雪Glacial Spa™來自美國硅谷，由現代激光醫學之父，美國麻省總醫院（哈佛醫學院附屬教學醫院，位於波士頓）威爾曼光電醫學中心主任Rox Anderson, M.D.為核心的技術團隊研發，是美國R2公司的一項最新膚色管理方案，也是冷凍美膚領域當中的“新起之秀”。酷雪Glacial Spa™在全球範圍內創新地將冷凍技術應用到祛斑醫療美容領域，突破了傳統光電項目的技術瓶頸，從源頭低温精準定向抑制黑色素生成和傳遞，減少色素沉澱，零損傷不破皮，簡單卓效，將給予求美者安全舒適的膚色管理體驗，填補了目前市場上這一功效型膚色管理項目的空白，開啟了冷凍美學時代。目前公司正在積極籌備Glacial Spa™中國上市銷售工作，該產品在國內無需按照醫療器械進行註冊報批，將由R2公司負責完成設備生產並進口到中國，預計今年2季度交付後7月正式投入市場銷售。
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