復旦張江(688505.SH):JAK1選擇性抑制劑治療特應性皮炎的藥物臨牀試驗申請獲受理
格隆匯11月5日丨復旦張江(688505.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《受理通知書》, FZJ-003膠囊即口服JAK1選擇性抑制劑(規格:25mg、50mg)用於治療中度至重度特應性皮炎的臨牀II期試驗申請獲得受理。由於藥品的研發週期長、審批環節多,容易受到一些不確定性因素的影響,敬請廣大投資者謹慎決策,注意防範投資風險。
特應性皮炎(Atopic Dermatitis,AD)是一種慢性炎症性疾病,通常以皮疹的形式出現。根據WHO過往數據顯示,全球目前至少有2.5億人受到AD的困擾,中國AD患者發病率約為10%。目前,40%的患病人羣為中重度AD患者,皮疹可能會覆蓋身體的大部分部位,並伴有劇烈且持續的瘙癢及皮膚乾燥、開裂、發紅或變暗、結痂或滲出等症狀。瘙癢通常還會引起睡眠障礙,嚴重影響生活質量。目前,生物製劑在中重度AD治療領域中佔主導地位,但口服 JAK 製劑在臨牀研究中亦表現出了讓人驚豔的效果,同時在起效時間和使用方式上有天然的優勢。
公司此次向國家藥監局註冊申請事項為FZJ-003膠囊於治療類風濕關節炎 I期臨牀試驗期間,擬開展新適應症的藥物II期臨牀試驗申請。
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