Ascentage Pharma has obtained approval for its new BCR-ABL1 [a gene sequence found in certain forms of leukaemia] tyrosine kinase inhibitor (TKI), olverembatinib, from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region of the People’s Republic of China to treat haematological malignancy indications.
Indications for olverembatinib include use in adults with chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) resistant to TKIs and harbouring the T315I mutation.
It is also indicated for adults with CML-CP who are resistant to or intolerant of first and second-generation TKIs.
The development in Macau follows approvals on the Chinese mainland for the same indications.
Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved by China’s National Medical Products Administration.
It was developed by Ascentage Pharma with support from the National Major New Drug Development programme.
The asset targets BCR-ABL1 and a range of BCR-ABL1 mutants, including the T315I mutation.
Its clinical trial results have been incorporated into the National Comprehensive Cancer Network guidelines for CML management.
The commercialisation of olverembatinib in China is a joint effort between Ascentage Pharma and Innovent Biologics.
Ascentage Pharma chairman and CEO Dr Dajun Yang stated: “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.”
In June 2024, Ascentage Pharma and Takeda signed an option agreement to enter into an exclusive licence agreement for olverembatinib for CML and other haematological cancers.
