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

• Ascentage Pharma has executed an Exclusive Option to License Global Rights to Olverembatinib worldwide other than China and a few other areas.
• Ascentage Pharma to receive an option payment of 100 million USD upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately 1.2 billion USD, and double-digit royalties on annual sales
• Additionally, Takeda will purchase a minority interest in Ascentage Pharma

ROCKVILLE, Md. and SUZHOU, China, June 14, 2024 /PRNewswire/ -- Ascentage Pharma (6855 HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today the signing of 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 (TKI), which is currently in development for chronic myeloid leukemia (CML) 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.

Despite the impact TKIs have had in the treatment of patients with 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 this option agreement, Ascentage Pharma is set to receive 100 million USD 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 USD. Additionally, Ascentage Pharma is expected to receive a minority equity investment from Takeda.

As part of the agreement, Ascentage Pharma 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.

"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. "Olverembatinib has already had a significant impact for patients with CML in China. We are excited to further the development of olverembatinib in our ongoing global registrational Phase 3 studies."

"Throughout our history in oncology, Takeda has demonstrated a strong track record of working with companies that share our vision of bringing medicines to patients around the world with the highest unmet needs," said Teresa Bitetti, president of Takeda's Global Oncology Business Unit. "Through this agreement with Ascentage Pharma, we believe there is great potential to continue to advance this mission. We are highly encouraged by the promising results olverembatinib has shown in the clinic to date, and excited to have the opportunity to further develop and deliver it to patients with chronic myeloid leukemia and other hematological cancers."

About Olverembatinib

Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug has been included in the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates.

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