This therapy is currently being developed to treat chronic myeloid leukemia (CML) as well as other hematological cancers.
If Takeda exercises this option, the company will have the global rights for the development and commercialisation of olverembatinib in all territories except for mainland China, Macau, Hong Kong, Taiwan and Russia.
As per the agreement, Ascentage Pharma will maintain sole responsibility for the clinical development of olverembatinib until Takeda potentially exercises its option to license.
Olverembatinib has already been approved and is available in China for treating adult patients with TKI-resistant chronic-phase CML or accelerated-phase CML that have the T315I mutation, as well as for those intolerant or resistant to first and second-generation TKIs.
Ascentage Pharma chairman and CEO Dr Dajun Yang said: “We are thrilled to enter into this agreement with Takeda, which would allow us to leverage the global commercial expertise of an organisation with a proven track record and global oncology footprint to potentially broaden the impact olverembatinib could have on patients in need around the world.
“We have seen the impact olverembatinib has had on patients with CML in China and look forward to progressing development of olverembatinib in POLARIS-2, the global registrational Phase III study in previously treated adult patients with CP-CML with or without the T315I mutation.”
Ascentage Pharma is eligible for an upfront payment of $100m upon the signing and could further receive an option exercise fee, along with additional milestones and royalty payments, should Takeda decide to license olverembatinib.
This decision is contingent upon customary regulatory approvals.
Moreover, Takeda will make a minority equity investment in Ascentage Pharma as part of this deal.