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康方生物-B(09926.HK):GUMOKIMAB治療強直性脊柱炎II期臨牀試驗完成受試者入組
格隆匯 12-28 08:08

格隆匯12月28日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的創新藥Gumokimab(IL-17A單克隆抗體,研發代號:AK111)治療活動性強直性脊柱炎Ⅱ期臨牀試驗完成受試者入組。該臨牀試驗旨在評估Gumokimab治療活動性強直性脊柱炎受試者的療效與安全性。

強直性脊柱炎是累及中軸關節的慢性炎症性疾病,可導致患者脊柱畸形、功能喪失。根據弗若斯特沙利文報吿,中國強直性脊柱炎患者約有400萬人。IL-17是強直性脊柱炎發病機制中關鍵的炎症細胞因子,具有獨特的療效和安全性優勢,也展現了很好的商業價值,並已成為新的治療靶點。與AK111同靶點藥物Secukinumab及Ixekizumab已被美國食品藥品監督管理局(FDA)批准用於治療強直性脊柱關節炎。於2020年,IL-17A單克隆抗體藥物的全球銷售額已達約57.83億美元。

目前,中國尚無自主研發的針對IL-17的單克隆抗體藥物上市,臨牀需求強烈。Gumokimab作為中國自主創新藥,未來有望為強直性脊柱炎患者帶來新希望。

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