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和譽-B(02256.HK)實體瘤藥物臨牀申請獲美國批準
阿思達克 11-01 09:27
和譽-B(02256.HK)公佈,其附屬和譽醫藥自主研發的新一代抗FGFR耐藥突變抑制劑ABSK121臨牀試驗獲得美國食品藥監局(FDA)臨牀試驗許可,即將開展針對晚期實體瘤的國際首次人體I期臨牀試驗。 ABSK121爲一款口服的、高活性、高選擇性並克服耐藥突變的第二代小分子FGFR抑制劑,在多個臨牀前模型中展現出與已獲批FGFR抑制劑相當的強大抗腫瘤功效,並在FGFR耐藥突變腫瘤模型中也展示出優異藥效。
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