诺诚健华(09969.HK)套细胞淋巴瘤创新药获美国FDA孤儿药资格
诺诚健华(09969.HK)公布,旗下的布鲁顿酪氨酸激(酉每)抑制剂「奥布替尼」,已获得美国食品药品监督管理局(FDA)授予孤儿药资格,用於治疗套细胞淋巴瘤(MCL),为公司首次获得FDA的孤儿药资格认定。
该产品为诺诚健华自主研发的1类创新药,用於治疗淋巴瘤及自身免疫性疾病,於去年12月25日获得中国国家药品监督管理局批准上市,用於治疗复发难治慢性淋巴细胞白血病、小淋巴细胞淋巴瘤患者,以及复发/难治性套细胞淋巴瘤患者的两项适应症。
诺诚健华董事长崔霁松透露,奥布替尼将在美国积极拓展其在肿瘤及自身免疫领域的其他适应症。
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