InnoCare Pharma has received approval from the Centre for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) to begin clinical trials of mesutoclax (ICP-248), a B-cell lymphoma-2 (BCL2) inhibitor, for the treatment of myeloid malignancies, including myelodysplastic syndromes (MDS)..

诺诚健华宣布，公司收到中国国家药品监督管理局（NMPA）药品审评中心（CDE）通知，批准其B细胞淋巴瘤-2（BCL2）抑制剂mesutoclax（ICP-248）针对包括骨髓增生异常综合征（MDS）在内的髓系恶性肿瘤开展临床试验。

Mesutoclax is an oral, selective BCL2 inhibitor. BCL2 is a key protein involved in regulating cell death (apoptosis), and its abnormal expression is linked to the development of various blood cancers. By targeting BCL2, mesutoclax aims to restore normal cell death processes in cancer cells, showing potential anti-tumour effects..

Mesutoclax是一种口服的选择性BCL2抑制剂。BCL2是一种参与调控细胞死亡（凋亡）的关键蛋白，其异常表达与多种血液癌症的发生有关。通过靶向BCL2，mesutoclax旨在恢复癌细胞中的正常细胞死亡过程，显示出潜在的抗肿瘤效果。

MDS is a group of complex blood disorders marked by abnormal growth of blood-forming stem cells, genetic changes, poor blood cell production, and a risk of developing into acute myeloid leukaemia (AML). It affects around 4 in 100,000 people each year, with higher rates in older adults, especially those over 70..

MDS是一组复杂的血液疾病，其特征是造血干细胞异常生长、基因改变、血细胞生成减少，并有发展为急性髓系白血病（AML）的风险。它每年影响约十万分之四的人，老年人发病率更高，特别是70岁以上的人群。

Mesutoclax has already received Breakthrough Therapy Designation in China for treating BTKi-treated relapsed or refractory mantle cell lymphoma, making it the first BCL2 inhibitor to achieve this recognition in the country. The drug is currently undergoing a Phase III trial in combination with orelabrutinib as a first-line therapy for chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

梅舒托克拉克斯已在中国获得治疗BTKi治疗后复发或难治性套细胞淋巴瘤的突破性疗法认定，成为该国首个获得此认可的BCL2抑制剂。该药物目前正在进行一项与奥拉布替尼联合用于慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）一线治疗的III期试验。

A separate trial is also underway for its use in treating AML..

一项针对其治疗急性髓系白血病（AML）的单独试验也在进行中。

This newly approved study represents the fourth clinical indication for mesutoclax, with the company continuing to advance its development across several blood cancers both in China and internationally.

这项新批准的研究代表了mesutoclax的第四项临床适应症，该公司继续在中国和国际上推进其在多种血液癌症中的开发。

Source: businesswire.com

来源：businesswire.com