诺诚健华-B(09969.HK):国家药品监督管理局批准奥布替尼在中国上市
格隆汇 12 月 28日丨诺诚健华-B(09969.HK)发布公告,由公司开发的一种新型、高度选择性且有效的小分子布鲁顿酪氨酸激酶(“BTK”)抑制剂奥布替尼已获国家药品监督管理局的上市批准,用于治疗中国的套膜细胞淋巴瘤(“MCL”)和慢性淋巴细胞白血病╱小细胞白血病(“CLL/SLL”)患者。自2015年公司注册成立以来,奥布替尼是公司第一个获得国家药监局批准的药物。
淋巴瘤是从淋巴细胞发展而来的血癌。淋巴瘤的两种主要类型是霍奇金淋巴瘤(“HL”)和非霍奇金淋巴瘤(“NHL”)。所有NHL中有85%是B细胞淋巴瘤,可通过BTK抑制剂治疗。NHL包括由淋巴样组织引起的一组异质性恶性肿瘤,在中国最常见的亚型包括MCL、CLL/SLL等。
BTK是治疗B细胞恶性肿瘤的循证靶点。BTK抑制剂具有治疗NHL的巨大市场潜力。根据弗若斯特沙利文的数据,2018年中国的NHL患病率达454,982人,从2014年至2018年的复合年增长率为5.9%,预计从2023年的复合年增长率为3.1%,到2030年将达到约73万人。
公告表示,公司正在对奥布替尼进行广泛的临床研究,包括在中国和美国针对B细胞恶性肿瘤和自身免疫性疾病的单一疗法和联合疗法。奥布替尼对BTK以外的激酶的活性极低。迄今为止可获得的临床和临床前数据表明,基于报导的数据,与已批准的BTK抑制剂相比,奥布替尼在保持良好疗效的同时,具有更高的靶点选择性、靶点占有率及安全性。
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