諾誠健華(09969.HK)套細胞淋巴瘤創新藥獲美國FDA孤兒藥資格
諾誠健華(09969.HK)公布,旗下的布魯頓酪氨酸激(酉每)抑制劑「奧布替尼」,已獲得美國食品藥品監督管理局(FDA)授予孤兒藥資格,用於治療套細胞淋巴瘤(MCL),為公司首次獲得FDA的孤兒藥資格認定。
該產品為諾誠健華自主研發的1類創新藥,用於治療淋巴瘤及自身免疫性疾病,於去年12月25日獲得中國國家藥品監督管理局批准上市,用於治療復發難治慢性淋巴細胞白血病、小淋巴細胞淋巴瘤患者,以及復發/難治性套細胞淋巴瘤患者的兩項適應症。
諾誠健華董事長崔霽松透露,奧布替尼將在美國積極拓展其在腫瘤及自身免疫領域的其他適應症。
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