Ascentage Signs Option with Takeda for Exclusive Global License for Novel Blood Cancer Therapy

Rare Daily Staff

Chinese biotech Ascentage Pharma signed an option agreement with Takeda to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor, which is currently in development for chronic myeloid leukemia and other hematological cancers.

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

“Olverembatinib has already had a significant impact for patients with CML in China,” said Dajun Yang, chairman and CEO of Ascentage Pharma.

Despite the impact tyrosine kinase inhibitors (TKIs) have had in the treatment of patients with chronic myeloid leukemia (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 their option agreement, Takeda will pay Ascentage Pharma $100 million from Takeda to acquire the option to license olverembatinib. Ascentage will also be eligible for an option exercise fee and additional potential milestones of up to approximately $1.2 billion. Ascentage also expects to receive a minority equity investment from Takeda.

Ascentage will continue to be solely responsible for all clinical development of olverembatinib before the potential exercise of the option to license 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) harboring the T315I mutation, and in adult patients with CP-CML resistant to and/or intolerant of first-and second-generation TKIs.

Olverembatinib, developed for the treatment of drug-resistant CML and approved for use in China, has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration, and Orphan designation by the European Medicines Agency.