基石藥業-B(02616.HK)首次披露兩款自身免疫/炎症性疾病全新雙抗分子靶點
格隆匯7月3日丨基石藥業-B(02616.HK)發佈公告,公司首次披露兩款自主研發、針對自身免疫/炎症性疾病的雙特異性抗體藥物靶點:CS2013(B細胞激活因子[BAFF]/ 增殖誘導配體[APRIL]);和CS2015(OX40配體[OX40L]/ 胸腺基質淋巴細胞生成素[TSLP])。這兩款藥物具備同類最佳/同類首創潛力,目前均處於臨牀前候選化合物(PCC)確認階段,臨牀前研究數據將在相關國際學術會議上公佈。此外,基石藥業計劃於2025年下半年啓動新藥臨牀試驗申請(IND)準備工作。
根據披露,CS2013通過差異化分子設計同步阻斷B細胞和漿細胞發育及存活所需的兩個關鍵配體-BAFF與APRIL,臨牀前研究顯示其可觸發高效協同效應;同時較融合蛋白類藥物具備更優的藥代動力學特性,例如較長的半衰期,潛在更長的給藥間隔,支持皮下給藥等。擬開發適應症包括系統性紅斑狼瘡(SLE)、類風溼性關節炎(RA)、IgA腎病(IgAN)等多種B細胞相關自身免疫性疾病。
CS2015作爲一款潛在同類首創、同時靶向OX40L(免疫應答細胞上的關鍵配體)和TSLP(上皮細胞分泌的重要預警分子)的雙抗,通過雙重抑制Th2介導炎症反應的關鍵調控因子,爲特應性皮炎(AD)、哮喘等2型炎症性疾病提供新的治療策略;臨牀前數據同樣顯示其具備長半衰期與皮下給藥潛力。
基石藥業首席執行官、研發總裁、執行董事楊建新博士表示:“自身免疫/炎症性疾病領域在全球範圍內存在顯着未滿足需求-疾病種類繁多、患者基數龐大、且多數需要終身用藥,使其逐漸成爲僅次於腫瘤的第二大疾病市場。與現有單抗藥物相比,基石藥業的CS2013有望通過對成熟靶點的協同阻斷實現治療升級, CS2015則有望開創全新作用機制,兩款藥物共同體現了我們拓展非腫瘤管綫的戰略佈局,也是基石藥業踐行‘創新爲驅動,成爲改善全球患者健康的引領着’願景的重要實踐。”
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