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康方生物(09926.HK):國家藥監局受理依若奇單抗的新藥上市申請
格隆匯 08-24 08:34

格隆匯8月24日丨康方生物(09926.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已經正式受理由公司自主研發的靶向IL-12/IL-23的全人源IgG1單克隆抗體依若奇單抗注射液(研發代號:AK101)的新藥上市許可申請(“NDA”)。本次申報的適應症為中度至重度斑塊型銀屑病。

依若奇單抗是公司成功獲批上市或NDA的第六款自主研發的創新藥物。依若奇單抗針對斑塊狀銀屑病患者共開展了5項臨牀研究,其中2項關鍵III期臨牀研究提供了依若奇單抗在中重度斑塊狀銀屑病患者中的16周和52周長期關鍵有效性數據。

中國銀屑病患病人數超過600萬,並呈逐年增加趨勢。銀屑病是一種慢性疾病,嚴重影響患者生活質量,且疾病負擔重。2022年中國銀屑病治療藥物市場規模約11億美元,預計將於2030年增長至95億美元。首個國產新藥IL-12/IL-23單抗依若奇具有突出的臨牀療效和安全性,將有望為我國患者提供更為高效、安全、便捷及經濟的治療選擇。

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