Takeda Joins Forces with Ascentage Pharma to Target Drug-Resistant Leukemia

Introduction to the Agreement

Ascentage Pharma, a global biopharmaceutical company, has signed an option agreement with Takeda. This deal allows Takeda to enter into an exclusive global license for developing and commercializing olverembatinib outside mainland China, Hong Kong, Macau, and Taiwan. Olverembatinib is a promising third-generation tyrosine kinase inhibitor (TKI) aimed at treating chronic myeloid leukemia (CML) and other blood cancers.

Unmet Needs in CML Treatment

Although TKIs have greatly improved the treatment of CML, there are still significant challenges. Many patients develop resistance to these drugs or have mutations that are difficult to treat. Olverembatinib aims to address these issues, offering a new hope for patients who have limited options.

Financial Details and Investment

Under the terms of the agreement, Ascentage Pharma will receive 100 million USD from Takeda. If Takeda decides to exercise the option, Ascentage Pharma could receive up to an additional 1.2 billion USD in milestone payments. Additionally, Takeda will make a minority equity investment in Ascentage Pharma.

Responsibilities and Approvals

As part of the agreement, Ascentage Pharma will handle all clinical development of olverembatinib until Takeda decides to exercise its option. The drug is already approved in China for treating adult patients with TKI-resistant CML or those with the T315I mutation.

Statements from Leadership

Dr. Dajun Yang, Chairman, and CEO of Ascentage Pharma, expressed enthusiasm about the partnership. He highlighted the potential for expanding olverembatinib's impact globally. Teresa Bitetti, president of Takeda's Global Oncology Business Unit, also shared optimism regarding the drug's promising clinical results and the opportunity to benefit more patients globally.

About Olverembatinib

Olverembatinib has been granted multiple designations, emphasizing its potential. In China, it has received Priority Review and Breakthrough Therapy Designations. In the US, it has been granted Orphan Drug and Fast Track Designations by the FDA. The drug is also included in the China 2022 National Reimbursement Drug List.

Olverembatinib's Clinical Success

The drug has shown promising results in clinical trials, leading to its approval and usage in China. It is currently in Phase 3 studies globally, which could pave the way for broader approval and usage worldwide.

About Ascentage Pharma

Ascentage Pharma specializes in developing therapies for cancer, chronic hepatitis B, and age-related diseases. The company focuses on inhibiting protein-protein interactions to induce apoptosis, or programmed cell death. They have a pipeline of 9 clinical drug candidates targeting various pathways and are involved in over 40 clinical trials across the US, Australia, Europe, and China.

Global Reach and Recognition

Ascentage Pharma has received significant recognition and numerous designations for its innovative drug candidates. They are involved in multiple national R&D projects and have obtained numerous Orphan Drug Designations from the US FDA and the EMA of the EU.

Forward-Looking Statements

Ascentage Pharma noted that forward-looking statements are based on current expectations but are subject to change. The company does not update these statements unless required by law, acknowledging that future results may differ materially from current expectations.