Ascentage Pharma, a global biopharmaceutical company engaged in developing therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, recently announced the signing of an option agreement with Takeda to enter into an exclusive licence agreement for olverembatinib, an oral, BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukaemia (CML) and other haematological cancers.
If exercised, the option would allow Takeda to licence exclusive global rights to develop and commercialise olverembatinib in all territories outside of among others, mainland China, Hong Kong, Macau, Taiwan, China.
Despite the impact TKIs have had in the treatment of patients with CML, there remains a significant unmet need for patients whose disease is resistant to these therapies or who develop hard-to-treat mutations following these treatments.
Under the terms of this option agreement, Ascentage Pharma is set to receive 100 million USD from Takeda to acquire the option to licence olverembatinib. Ascentage will also be eligible for an option exercise fee and additional potential milestones of up to approximately 1.2 billion USD.
Additionally, Ascentage Pharma is expected to receive a minority equity investment from Takeda.
As part of the agreement, Ascentage Pharma will continue to be solely responsible for all clinical development of olverembatinib before the potential exercise of the option to licence olverembatinib. Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) harbouring the T315I mutation, and in adult patients with CP-CML resistant to and/or intolerant of first-and second-generation TKIs.