恒瑞醫藥(600276.SH):獲得藥品註冊證書
格隆匯3月21日丨恒瑞醫藥(600276.SH)公佈,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》,批准公司自主研發的1類創新藥硫酸艾瑪昔替尼片(SHR0302片)上市,適應症為:用於對一種或多種TNF抑制劑療效不佳或不耐受的活動性強直性脊柱炎(AS)成人患者。這標誌着強直性脊柱炎口服靶向治療領域首次實現了中國原研。
強直性脊柱炎以慢性炎症和脊柱關節結構損傷為特徵,既往治療如非甾體抗炎藥(NSAID)雖可緩解患者的疼痛,但改善疾病活動性和延緩疾病進展的效果並不理想,常面臨起效慢、應答不足、無法阻止結構損傷等難題[1,2]。此外,傳統JAK抑制劑因靶點選擇性不足,可能增加感染和血液系統風險[3]。臨牀亟需一種快速強效、安全便捷且能延緩結構損傷的創新療法。硫酸艾瑪昔替尼片是一種高選擇性的JAK1抑制劑,可通過抑制JAK1信號傳導發揮抗炎和抑制免疫的生物學效應。
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