Policy & Regulation
Ascentage Pharma's olverembatinib receives Chinese regulatory approval
8 July 2024 -

Ascentage Pharma (6855.HK), a China-based global biopharmaceutical company, announced on Sunday that it has received approval from the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of the People's Republic of China to market its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI) intended for the treatment of adult patients with tyrosine kinase inhibitors (TKI)-resistant chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) harbouring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs.

The company says that this move represents another major milestone for olverembatinib following the initial approvals offered to the product in the Chinese mainland for the above indications.

Olverembatinib has been developed by Ascentage Pharma with support from the National Major New Drug Development program. It is the first third-generation BCR-ABL1 inhibitor approved by China's National Medical Products Administration (NMPA). It is being jointly commercialised in China by Ascentage Pharma and Innovent Biologics.

Dr Dajun Yang, Ascentage Pharma chairman and CEO, said, 'Olverembatinib has the potential to be a global best-in-class drug. We are glad that the drug is set to benefit patients with CML in Macau, China, with the approval marking another major milestone in the clinical development of olverembatinib. Since its inception, Ascentage Pharma has steadfastly committed to its mission of addressing unmet clinical needs in China and around the world. We are confident that over time, olverembatinib and our other investigational drugs will bring greater benefits to more patients globally.'