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康哲藥業(00867.HK)創新藥替拉珠單抗注射液的中國註冊性試驗完成首例受試者給藥
格隆匯 12-28 11:38

格隆匯APP獲悉,12月28日,康哲藥業(00867.HK)重磅創新藥替拉珠單抗注射液(Tildrakizumab)在中國的註冊性橋接試驗於西京醫院順利完成首例受試者給藥,這是繼該產品今年八月獲得中國IND批件後的又一重大進展。

該研究為一項隨機、雙盲、安慰劑對照、多中心的III期臨牀研究,主要目的為在中度至重度慢性斑塊狀銀屑病患者中,評估與安慰劑相比,Tildrakizumab治療12周的有效性。該項研究擬入組220位受試者,由西京醫院(中國人民解放軍空軍軍醫大學第一附屬醫院)牽頭,將在全國約21家中心進行。其主要研究者包括中國醫師協會皮膚科醫師分會會長、中華醫學會皮膚性病學分會副主委、亞洲銀屑病學會副理事長王剛博士,中華醫學會皮膚性病學分會候任主委、中國醫師協會皮膚科醫師分會候任會長高興華博士,中華醫學會皮膚性病學分會副主委、衞生部臨牀重點專科建設項目負責人徐金華博士等全國知名皮膚和銀屑病領域專家。

替拉珠單抗注射液

特異性靶向IL-23的單克隆抗體

替拉珠單抗注射液是一種人源化的lgG1/k單抗,旨在選擇性地與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。目前,該產品已在美國以商品名ILUMYATM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,同時也已在歐洲、澳大利亞、日本被批准商業化。

銀屑病在我國的發病率約為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。斑塊狀銀屑病為最常見的形式,約佔銀屑病患者的90%。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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