智通财经APP获悉，诺诚健华-B(09969)宣布，公司旗下布鲁顿酪氨酸激酶(BTK)抑制剂奥布替尼用于治疗多发性硬化(MS)已经通过中国国家药品监督管理局(NMPA)的临床研究用新药(IND)审评，获批在中国开展临床II期研究。截至发稿，诺诚健华涨7.03%，报20.55港元，成交额1.99亿港元。
据悉，这是一项评估奥布替尼用于多发性硬化患者的国际多中心临床II期研究，将评估其有效性、安全性、耐受性、药代动力学和生物活性。2020年11月，奥布替尼获美国FDA批准开展治疗多发性硬化临床II期研究。奥布替尼是诺诚健华自主研发的具高度靶标选择性的新型BTK抑制剂，可用于治疗自身免疫性疾病，目前正在中国及美国进行多中心、多适应症的临床试验，显示了良好的靶点占有率和安全性。除了多发性硬化，奥布替尼已在中国就系统性红斑狼疮(SLE)开始IIa期临床试验。
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