Ascentage’s olverembatinib approved in Macau China

8 July 2024

Clinical-stage Chinese biotech Ascentage Pharma (6855: HK) yesterday announced that olverembatinib has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of China.

The drug is cleared for the treatment of adult patients with tyrosine kinase inhibitors (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs.

The company said that this approval marks another major milestone for olverembatinib following initial approvals granted to the drug in the Chinese mainland for the above indications. Olverembatinib is being jointly commercialized in China by Ascentage and Innovent Biologics. All lead drug candidates are being studied as they are an investigational drug and not approved in the USA.

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