Olverembatinib by Ascentage Pharma Approved in Macau for Leukaemia

Ascentage Pharma has received approval for its new BCR-ABL1 tyrosine kinase inhibitor (TKI), olverembatinib, from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region of the People’s Republic of China. This approval is for the treatment of haematological malignancies.

Olverembatinib is specifically indicated for adults with chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) who are resistant to previous TKIs and have the T315I mutation. Additionally, it is indicated for adults with CML-CP who are resistant to or cannot tolerate first and second-generation TKIs.

This approval in Macau follows similar approvals on the Chinese mainland, where olverembatinib was previously sanctioned for the same indications. Notably, olverembatinib is the first third-generation BCR-ABL1 inhibitor to receive approval from China’s National Medical Products Administration.

Olverembatinib was developed by Ascentage Pharma with the support of the National Major New Drug Development program. The drug targets BCR-ABL1 and various BCR-ABL1 mutants, including the T315I mutation, which is particularly challenging to treat with earlier generation TKIs. Clinical trial outcomes for olverembatinib have been included in the National Comprehensive Cancer Network guidelines for managing CML.

The commercialisation of olverembatinib in China is a collaborative effort between Ascentage Pharma and Innovent Biologics. Highlighting the significance of this development, Ascentage Pharma’s chairman and CEO Dr. Dajun Yang remarked on the potential of olverembatinib to be a global best-in-class drug. He expressed pride in the fact that the drug will soon benefit patients with CML in Macau, marking a significant milestone in its clinical development.

Dr. Yang also emphasized Ascentage Pharma’s unwavering commitment to addressing unmet clinical needs in China and worldwide. He conveyed confidence that olverembatinib, along with the company’s other investigational drugs, would gradually bring more significant benefits to patients globally.

In June 2024, Ascentage Pharma and Takeda signed an option agreement to enter into an exclusive license agreement for olverembatinib for CML and other haematological cancers. This agreement underscores the growing recognition and potential of olverembatinib in treating various haematological malignancies.