和黄医药旗下索凡替尼获FDA授予孤儿药资格
和黄医药公布,索凡替尼获美国食品药品监督管理局(FDA)授予孤儿药资格,用於胰腺神经内分泌肿瘤的治疗。和黄医药首席执行官贺隽(Christian Hogg)表示,目前神经内分泌肿瘤的治疗中仍存在许多尚未满足的需求,治疗方法非常有限,是次资格认定对患者来说是积极的一步,进一步强调研发工作的重要性,以将索凡替尼带给更多有需要的患者。
若孤儿药资格经FDA获准上市,索凡替尼对此适应症将获得为期七年的市场独占权。孤儿药资格还可在美国带来一定的开发成本收益。
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