昊海生科(688366.SH):獲第三代玻尿酸產品醫療器械註冊證
格隆匯4月10日丨昊海生科(688366.SH)公佈,是全資子公司上海其勝生物製劑有限公司(以下簡稱“其勝生物”)於近日收到國家藥品監督管理局頒發的注射用交聯透明質酸鈉凝膠產品(“第三代玻尿酸產品”)《醫療器械註冊證》。
截至本公告發布日,公司已擁有三代玻尿酸產品。公司第一代玻尿酸產品“海薇”(通用名:注射用交聯透明質酸鈉凝膠)獲批於2013年,是國內首個獲得國家藥監局批准的單相交聯注射用透明質酸鈉凝膠,主要定位於面部塑形功能。公司自主研發的第二代玻尿酸產品“姣蘭”(通用名:注射用修飾透明質酸鈉凝膠)獲批於2016年,主要定位於中高端,具有動態填充功能的特性。其勝生物本次獲得《醫療器械註冊證書》的第三代玻尿酸產品採用一種新型的交聯透明質酸鈉凝膠的製備方法,製備的交聯透明質酸鈉凝膠相較於前兩代玻尿酸產品,具有無顆粒化特性及高內聚性,因此具有良好的生物相容性。
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