Ascentage Pharma, Takeda forge $1.3bn deal to advance leukemia treatment

Ascentage Pharma (6855 HK), a leading biopharmaceutical company, has announced a significant development in its partnership strategy by signing an option agreement with Takeda Pharmaceutical Company Limited. This agreement grants Takeda the option to acquire exclusive global rights to develop and commercialize olverembatinib, a promising third-generation BCR-ABL tyrosine kinase inhibitor (TKI), outside of China and a few other regions. This oral medication is currently in development for chronic myeloid leukemia (CML) and other hematological cancers.

Financial Terms and Strategic Impact

Under the terms of the agreement, Ascentage Pharma will receive an upfront option payment of $100 million from Takeda. If Takeda exercises this option, Ascentage is eligible for an option exercise fee along with potential additional milestones that could total up to approximately $1.2 billion. Moreover, Takeda will make a minority equity investment in Ascentage Pharma, further solidifying the partnership.

Development and Commercial Prospects

Olverembatinib is designed to address the significant unmet need in the treatment of patients with CML, particularly those whose disease is resistant to current TKIs or who develop difficult-to-treat mutations. The drug is already approved and marketed in China for patients with resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation, as well as for patients with CP-CML resistant to first- and second-generation TKIs.

Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, expressed enthusiasm about the collaboration: “This agreement with Takeda will leverage their global commercial expertise to potentially broaden the impact olverembatinib could have on patients worldwide. We are excited to advance the development of olverembatinib in our ongoing global registrational Phase 3 studies.”

Takeda’s Commitment to Oncology

Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, highlighted Takeda’s history of successful partnerships aimed at addressing high unmet medical needs. “Through this agreement with Ascentage Pharma, we see great potential to continue advancing our mission in oncology,” said Bitetti. “Olverembatinib has shown promising results in the clinic, and we are eager to further develop and deliver it to patients globally.”

Regulatory Achievements and Future Plans

Olverembatinib has received several important designations that underscore its therapeutic potential, including Priority Review and Breakthrough Therapy Designations from China’s National Medical Products Administration (NMPA), as well as Orphan Drug and Fast Track Designations from the US FDA and an Orphan Designation from the EU’s EMA.

The strategic partnership between Ascentage Pharma and Takeda represents a significant step forward in bringing advanced treatments to patients with chronic myeloid leukemia and other hematological disorders globally. With both companies committed to innovative solutions in healthcare, this collaboration is poised to make a substantial impact on the treatment landscape for these challenging conditions.