Pharma giant Takeda has signed an option agreement with Ascentage Pharma to enter into an exclusive licence agreement for olverembatinib for the treatment of chronic myeloid leukaemia (CML) and other haematological cancers.

If exercised, the option would allow Takeda to license global rights to develop and commercialise olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan, and Russia.

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In exchange, Ascentage will receive a $100m option payment upon signing the exclusive option agreement with Takeda, and a minority equity investment. Ascentage will also be eligible for an option exercise fee, and potential milestone and royalty payments pending regulatory approvals.

Olverembatinib, a tyrosine kinase inhibitor (TKI), is approved and marketed as Nelic in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) with the T315I mutation, and for those with CP-CML resistant disease or intolerant to first and second generation TKIs. According to GlobalData’s Pharma Intelligence Center, Nelic is forecast to generate $92m in 2030.

GlobalData is the parent company of Pharmaceutical Technology.

Under the terms of the agreement, Ascentage will continue to be solely responsible for all clinical development of olverembatinib prior to the potential exercise of the option to license. The asset is currently being investigated in a Phase III POLARIS-2 registrational study (NCT06423911) which plans to enrol 285 patients with CML.

Last month, Takeda announced a $900m restructuring plan after its annual profits for FY 2023 were hit by more than 50%. The company shared progress in an earnings call from six late-stage programmes that it says have the potential to generate significant value – one of which include therapies to treat rare blood disorders.

Takeda has had a long history with tackling TKIs. In October 2023, the Japanese pharma giant had to withdraw the TKI Exkivity (mobocertinib) after its Phase III trial failed to meet its primary endpoint. The TKI had received an accelerated approval by the US Food and Drug Administration (FDA) for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLCC).

Teresa Bitetti, president of the Global Oncology Business Unit at Takeda said: “We are highly encouraged by the promising results olverembatinib has shown in the clinic to date and excited to have the opportunity to potentially further develop and deliver it to patients with chronic myeloid leukaemia and other haematological cancers.”