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康哲藥業(00867.HK):替拉珠單抗中國Ⅲ期臨牀研究取得積極結果
格隆匯 07-21 21:34

格隆匯7月21日丨康哲藥業(00867.HK)宣佈,集團創新產品替拉珠單抗注射液("產品")中國Ⅲ期臨牀研究("試驗")取得積極結果。

試驗為一項隨機、雙盲、安慰劑對照、多中心的臨牀研究,共入組220例患者,旨在中國人羣中評價產品治療中度至重度斑塊型銀屑病患者的安全性及有效性。

初步試驗結果顯示,與安慰劑相比,產品治療12周時可顯著提高達到銀屑病面積和嚴重程度指數較基線至少改善75%(PASI75)的患者的比例,顯著優於安慰劑。

集團將積極推進產品在中國的新藥上市申請(NDA)工作。

有關替拉珠單抗注射液

產品是一種人源化的lgG1/k單克隆抗體,旨在選擇性地與白介素細胞-23(IL-23)的p19亞基結合,並抑制其與IL-23受體相互作用,從而抑制促炎症細胞因子和趨化因子的釋放。產品已在美國、歐洲、澳大利亞和日本獲批上市,用於治療符合系統治療或光療指徵的中度至重度斑塊狀銀屑病的成年患者。銀屑病是一種自身免疫性疾病,病因複雜,而IL-23被認為是銀屑病發病機制的重要驅動因子之一。在我國,銀屑病的發病率約為0.47%,患者人數超過650萬,其中約30%的患者病情已發展為中重度,且近62%的中重度患者對現有治療方案不滿。替拉珠單抗注射液有望成為安全、有效以及最具效益比的IL-23新型單抗,惠及更多中國銀屑病患者及家庭

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