和譽-B(02256.HK)自主研發創新FGFR2/3高選擇性抑制劑ABSK061臨牀申請獲國家藥監局批准
格隆匯3月3日丨和譽-B(02256.HK)發佈公吿,2022年3月3日,和譽醫藥宣佈其自主研發的口服FGFR2/3高選擇性抑制劑ABSK061獲得國家藥監局臨牀研究許可,即將開展針對晚期實體瘤的國內首次人體I期臨牀試驗。ABSK061也成為全球範圍內第一個獲得FDA以及國家藥監局許可,進入臨牀試驗的選擇性FGFR2/3小分子抑制劑。
根據披露,ABSK061是和譽醫藥獨立自主研發並擁有全球知識產權的一款新一代口服、高活性、高選擇性小分子FGFR2/3抑制劑。首代泛FGFR抑制劑已在針對多種攜帶 FGFR2/3變異的腫瘤中展現出臨牀療效並在全球範圍內逐步獲批上市,但安全窗及藥效均受限於FGFR1抑制相關副作用。通過降低對FGFR1的抑制以及保持對FGFR2/3的高活性,ABSK061作為第二代FGFR抑制劑有望在臨牀上取得更好的安全窗及療效,並逐步取代第一代泛FGFR抑制劑。除腫瘤以外,ABSK061還具備拓展用於治療包括軟骨發育不全在內的多種非腫瘤適應症的巨大潛力。
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