Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2021 Mar;81(4):503-507. doi: 10.1007/s40265-021-01482-5. Epub 2021 Mar 11.
Dysregulation of Bruton's tyrosine kinase (BTK) signalling has been linked to various B cell malignancies and autoimmune diseases. Orelabrutinib () is an orally administered, potent, irreversible and highly selective BTK-inhibitor being developed by InnoCare Pharma for the treatment of B cell malignancies and autoimmune diseases. In December 2020, orelabrutinib received its first approval in China for the treatment of patients with mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), who have received at least one treatment in the past. Clinical development of orelabrutinib for various indications is underway in the USA and China. This article summarizes the milestones in the development of orelabrutinib leading to this first approval.
布鲁顿酪氨酸激酶（BTK）信号的失调与各种 B 细胞恶性肿瘤和自身免疫性疾病有关。奥雷巴替尼（orelabrutinib）是由英派药业开发的一种口服、有效、不可逆和高度选择性的 BTK 抑制剂，用于治疗 B 细胞恶性肿瘤和自身免疫性疾病。2020 年 12 月，奥雷巴替尼在中国获得首个批准，用于治疗既往至少接受过一种治疗的套细胞淋巴瘤（MCL）或慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。奥雷巴替尼用于各种适应症的临床开发正在美国和中国进行。本文总结了奥雷巴替尼开发的重要里程碑，最终促成了这一首次批准。
