Today, Takeda has announced a significant step forward in its oncology portfolio with the signing of an option agreement with Ascentage Pharma. This agreement paves the way for Takeda to potentially enter into an exclusive global license for olverembatinib, a promising third-generation BCR-ABL tyrosine kinase inhibitor (TKI) currently under development for chronic myeloid leukemia (CML) and other hematological cancers.
Olverembatinib, an oral therapy hailed as potentially best-in-class, addresses an unmet need for patients resistant or refractory to current TKIs or those who develop difficult-to-treat mutations. Under the terms, Takeda could gain global rights to develop and commercialize olverembatinib outside mainland China, Hong Kong, Macau, Taiwan, and Russia, pending exercise of the option.
Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, emphasized Takeda’s commitment to advancing treatment options for hematological cancers, citing the encouraging clinical results of olverembatinib. She expressed enthusiasm about potentially expanding its impact to a broader patient population.
As part of the agreement, Ascentage Pharma will retain responsibility for all clinical development activities until Takeda exercises its licensing option. Olverembatinib is currently approved in China for specific indications in CML and is undergoing further evaluation in global Phase 3 studies.
Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, highlighted the strategic alignment with Takeda to leverage its global commercial capabilities, aiming to maximize olverembatinib’s reach beyond its current market in China.
Financially, Ascentage Pharma stands to receive $100 million upon signing the option agreement, with additional payments contingent on Takeda’s decision to exercise the license option, subject to regulatory approvals. Furthermore, Ascentage Pharma will benefit from a minority equity investment by Takeda.
Olverembatinib has garnered orphan drug designation from the FDA and EMA, underscoring its potential therapeutic significance in treating a spectrum of cancers beyond CML.
This collaboration underscores Takeda’s strategic approach to complement internal innovation with external partnerships, aimed at delivering transformative therapies to patients globally.
