Ascentage Pharma’s olverembatinib approved in Macau for leukaemia

Drug ApprovalLicense out/in
Ascentage Pharma’s olverembatinib is indicated for the treatment of haematological malignancy indications. Credit: Nemes Laszlo / Shutterstock.
Ascentage Pharma haolverembatinibroval for its new BCR-ABL1 [a gene haematological malignancy 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.
Ascentage Pharmaolverembatinib include use in adultBCR-ABL1BCR-ABL1hronic-phase chronic myeloid leukaemia (CML-leukaemiacelerated-phase CML (CML-AP) resistolverembatinibd harbouring the T315I mutation.haematological malignancy
The development in Macau follows apprCML-CPon the Chinese mainland for the same indications.
Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved by China’s National Medical Products Administration.
Olverembatinibtage Pharma’s olverembatinib apBCR-ABL1 inhibitorBCR-ABL1BCR-ABL1n Macau for leukaemia
NN-6561 bAscentage Pharmaor olverembatinibunction-Associated Stealeukaemiais (MASH): Likelihood of Approval
It was developed by Ascentage Pharma with support from the National Major New Drug Development programme.
Its clinical trial results have been incorporated into the National Comprehensive Cancer Network guidelines for CML management.
The commercialisatioAscentage Pharmanib in China is a joint effort between Ascentage Pharma and Innovent Biologics.
Ascentage Pharma cBCR-ABL1BCR-ABL1and CEO Dr DajunBCR-ABL1BCR-ABL1ated: “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 ofCancerssing unmet clinical neeCMLin 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 Polverembatinibda signed an option agreement to entAscentage Pharmasive Innovent Biologicsfor olverembatinib for CML and other haematological cancers.
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