Takeda Signs Option Agreement with Ascentage Pharma to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

Takeda (TSE:4502/NYSE:TAK) today announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.

Despite the impact TKIs have had in the treatment of patients with CML, there remains significant unmet need for patients whose disease is resistant or refractory to these therapies or who develop hard-to-treat mutations following these treatments.

“Takeda has a long history of driving important treatment advances for patients, particularly those with hematological cancers facing treatment gaps,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “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 leukemia and other hematological cancers. This agreement aligns with our goal to support the advancement of both internal and external innovation to best serve patients.”

As part of the agreement, Ascentage Pharma will continue to be solely responsible for all clinical development of olverembatinib prior to potential exercise of the option to license. 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.

"We are thrilled to enter into this agreement with Takeda, which would allow us to leverage the global commercial expertise of an organization with a proven track record and global oncology footprint to potentially broaden the impact olverembatinib could have on patients in need around the world,” said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. “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 3 study in previously treated adult patients with CP-CML with or without the T315I mutation.”

Under the terms of this agreement, Ascentage Pharma will receive an option payment of $100 million upon signing of the exclusive option to license agreement and will be eligible for an option exercise fee and additional potential milestone and royalty payments if Takeda exercises the option to license olverembatinib, with the exercise of the option being subject to customary regulatory approvals. Additionally, Ascentage Pharma will receive a minority equity investment from Takeda.

About Olverembatinib

Olverembatinib is an oral, third-generation BCR-ABL tyrosine kinase inhibitor (TKI). Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (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. Ascentage Pharma is investigating olverembatinib in multiple clinical studies in several types of cancer. Olverembatinib has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) and orphan designation by the European Medicines Agency (EMA).

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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