信達生物(01801.HK):抗IL-23單克隆抗體I期臨牀研究在中國完成首例受試者給藥
格隆匯 9 月 1日丨信達生物(01801.HK)發佈公告,公司自主開發的重組抗白介素(“IL”)23p19亞基抗體注射液(IBI-112)的I期臨牀研究完成中國首例健康受試者給藥。該研究是一項評價在中國健康受試者單劑皮下注射或靜脈給藥時IBI-112的安全性、耐受性(主要目標)、藥代動力學和藥效學的隨機、雙盲、安慰劑對照、劑量遞增的I期臨牀研究。
根據披露,目前全世界2-3%的人口患有銀屑病,中國銀屑病患者約為600萬名。炎症性腸病(“IBD”)近年來全球發病率也有明顯提高趨勢。然而,無論是銀屑病還是IBD的治療藥物均尚未滿足巨大的醫療需求。近年來,IL-23和其他生物藥物因其良好的療效和安全性引起越來越多的關注,但目前國內尚無自主研發的IL-23p19靶點藥物。IBI-112是公司自主研發的創新藥,通過特異性結合IL-23p19亞基,阻斷IL-23介導信號通路,發揮抗炎作用,具有治療銀屑病、IBD等自身免疫性疾病的潛力。公司看到IBI-112在臨牀前研究中良好的安全性和有效性數據,相信該臨牀進展具有重要意義。公司期待IBI-112的後續臨牀研究結果,希望能為更多有需要的患者提供新的治療選擇。
IBI-112是由公司自主研發的,有自主知識產權的一種重組抗IL23p19亞基單克隆抗體注射液。該產品特異性結合IL-23p19亞基,從而阻止IL-23與細胞表面受體結合,阻斷IL-23受體介導信號通路。臨牀前數據顯示IBI-112靶點明確,作用機制清楚,抗炎症作用顯着,有望為自身免疫性疾病患者提供更有效的治療方案。
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