景峯醫藥(000908.SZ)利多卡因軟膏新藥獲得美國ANDA批准文號
格隆匯10月20日丨景峯醫藥(000908.SZ)公佈，近日，公司控股子公司Sungen Pharma,LLC(以下簡稱“尚進”)收到美國食品藥品監督管理局(即美國FDA)的通知，尚進向美國FDA申報的利多卡因軟膏新藥簡略申請(ANDA，即美國仿製藥申請，申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
審批主要結論：已經確定利多卡因軟膏5%是生物等效的，因此治療也等效於阿斯利康(Astra Zeneca)公司已上市的原研(RLD)苦息樂卡因軟膏(Xylocaine Ointment，5%)。
據悉，利多卡因(Lidocaine)又稱為苦息樂卡因(Xylocaine)，為一種局部麻醉藥，它是可卡因的一種衍生物，但沒有可卡因產生幻覺和上癮的成分。利多卡因在最基本的健康照護系統中最必要的藥物清單——世界衞生組織基本藥物標準清單登錄有案。利多卡因可被用於神經傳導阻滯，也可以直接用於皮膚來麻醉，一般施用一到三分鐘後即生效，效果維持一到三小時。
該藥物用於皮膚，可以防止某些皮膚狀況(如擦傷，輕微燒傷，濕疹，昆蟲叮咬)引起的瘙癢和疼痛，並治療由痔瘡和生殖器/肛門區域的某些其他問題引起的輕微不適和瘙癢(例如，肛裂，陰道/直腸周圍瘙癢)。利多卡因對妊娠婦女通常較安全，對丁卡因(Tetracaine)或苯佐卡因過敏的人而言，利多卡因也相對安全；同時也是抗心律失常藥的1b等級用藥。目前美國市場的主要生產商有Sandoz,Amneal,Taro,Akorn,andTeligent等。根據IMS數據顯示，利多卡因軟膏2018年在美國市場的銷售額約6千多萬美元。目前國內尚未見這個產品的進口上市。
公司稱，本次利多卡因軟膏獲得美國FDA批准文號標誌着公司具備了在美國市場銷售該產品的資格，為尚進在國際商開拓半固體制劑和藥政路線建立了相關平台和機制，這將對公司拓展美國市場、提升公司業績帶來積極的影響。
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