復旦張江(01349.HK):注射用海姆泊芬治療鮮紅斑痣的新藥臨試申請獲美國FDA受理
格隆匯12月22日丨復旦張江(01349.HK)公佈,公司於2021年12月21日收到美國食品藥品監督管理局("FDA")書面回覆,公司用於治療鮮紅斑痣之海姆泊芬美國註冊項目II期臨牀試驗申請獲得受理。
據悉,鮮紅斑痣(PWS)是一種常見的先天性真皮淺層毛細血管網擴張畸形,其表現為無數擴張的毛細血管所組成的較扁平而很少隆起的斑塊,病灶面積隨身體生長而相應增大,終生不消退,可發生於任何部位,但以面頸部多見,在新生兒中發病率高達千分之三至四。如不及時治療,65%以上的患者病灶會逐漸擴張,在40歲以前出現增厚或發生結節,嚴重影響容貌和心理。海姆泊芬進入人體後會迅速向組織擴散並特異性分佈於血管內皮細胞,在特定波長的鐳射或LED光照射下,會選擇性破壞富含光敏劑的血管內皮組織,病灶部位擴張畸形的毛細血管網將在光動力作用和後續的體內凝血系統作用下被清除,從而達到治療的目的。
海姆泊芬為集團首創藥物,也是全球首個針對鮮紅斑痣的光動力藥物,是集新藥靶、新化合物和新適應症於一體的新藥。作為第二代光敏劑,海姆泊芬光動力療法治療鮮紅斑痣具有療效確切、病灶消退均勻、代謝迅速、避光期短、瘢痕發生率低、治癒後極少復發等顯著優勢。同時,海姆泊芬用於鮮紅斑痣治療亦被收錄於第九版《皮膚性病學》教科書中。作為國家1.1類新藥,注射用海姆泊芬(商品名:復美達®)已於2017年正式於中國大陸地區上市銷售。
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