Ascentage Pharma and Takeda Sign $1.3 Billion Global Licensing Agreement for Cancer Drug

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Ascentage Pharma, a leading global biopharmaceutical company, has entered into an option agreement with Takeda, a prominent global biopharmaceutical firm. This agreement grants Takeda the exclusive option to license olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), for global development and commercialization, excluding certain territories such as mainland China, Hong Kong, Macau, and Taiwan. Ascentage Pharma will receive an upfront option payment of $100 million from Takeda. Upon exercising the option, Ascentage could receive additional fees and milestones totaling approximately $1.2 billion, along with double-digit royalties on annual sales. Moreover, Takeda will acquire a minority equity stake in Ascentage Pharma. Ascentage Pharma retains responsibility for all clinical development of olverembatinib until the option is exercised.

The drug is already approved and marketed in China for adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation, and for CP-CML patients resistant to or intolerant of first- and second-generation TKIs. Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, expressed enthusiasm about the partnership, emphasizing the potential to leverage Takeda’s global expertise to expand the impact of olverembatinib on a worldwide scale. Teresa Bitetti, President of Takeda’s Global Oncology Business Unit, highlighted the promising clinical results of olverembatinib and Takeda’s commitment to addressing high unmet medical needs in oncology. Olverembatinib is Ascentage Pharma’s flagship product for treating drug-resistant CML. It has received numerous designations, including Priority Review and Breakthrough Therapy Designations by China’s CDE, Orphan Drug Designation and Fast Track Designation by the US FDA, and Orphan Designation by the EMA of the EU.

The drug is also listed in China’s 2022 National Reimbursement Drug List (NRDL). Ascentage Pharma (6855.HK) is a globally-focused biopharmaceutical company specializing in novel therapies for cancer, chronic hepatitis B, and age-related diseases. The company, listed on the Hong Kong Stock Exchange, is pioneering therapeutics that restore apoptosis by inhibiting protein-protein interactions. Ascentage Pharma has a diverse pipeline of 9 clinical drug candidates targeting key apoptosis regulators and is conducting over 40 Phase I/II clinical trials worldwide. For further inquiries, please contact: Investors Contacts: IR@ascentage.com, Media Contacts: PR@ascentage.com. This press release contains forward-looking statements as of the date of publication. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, except as required by law. Actual future results may differ materially from current expectations due to various factors.