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康哲藥業(00867.HK):磷酸蘆可替尼乳膏(白癜風適應症)新藥上市許可申請獲國家藥監局受理
格隆匯 09-24 19:56

格隆匯9月23日丨康哲藥業(00867.HK)公吿,磷酸蘆可替尼乳膏(白癜風適應症)新藥上市許可申請(NDA)已於2024年9月24日獲得中國國家藥品監督管理局(NMPA)受理。

蘆可替尼乳膏在中國真實世界研究中取得了積極結果。治療組主要療效指標第24周達到F-VASI75的患者比例為49.5%,顯著高於目標值14.1%(P<0.0001),研究達到了主要終點,證明蘆可替尼乳膏能夠有效治療非節段型白癜風患者,縮小皮損面積,恢復膚色。所有的次要療效指標均顯示出與主要療效指標一致的獲益趨勢,且治療時間越長,患者的白癜風治療效果持續改善。不良反應的嚴重程度均為1級或2級,未發生導致停藥或退出的不良事件(AE),未發生研究藥物相關的嚴重不良事件(SAE)。

白癜風是一種慢性自身免疫性疾病,其特徵是皮膚色素脱失,其發病原因為產生色素的細胞即黑素細胞的缺失。據估算,中國白癜風患者約1,400萬,東南亞十一國白癜風患者約650萬。白癜風患者中約85%為非節段型白癜風。外用皮質類固醇(TCS)及鈣調神經磷酸酶抑制劑(CI)均為非節段型白癜風的標籤外用藥,然而這些療法存在臨牀缺陷,長期用藥有不良反應或療效有限。

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