Ascentage Pharma Gets $100M Option Payment from Takeda

ROCKVILLE, Md. and SUZHOU, China, July 3, 2024 -- Ascentage Pharma (6855.HK), a global biopharmaceutical enterprise dedicated to pioneering and advancing cutting-edge therapies for blood cancers, announced that it has received a significant financial boost from its partnership with Takeda. On July 2, 2024, following the conditions of their Exclusive Option Agreement, Ascentage Pharma received a US$100 million option payment from Takeda for the third-generation BCR-ABL inhibitor, olverembatinib (HQP1351).

This collaboration between Ascentage Pharma and Takeda began on June 14, 2024, with an Exclusive Option Agreement. This agreement grants Takeda the exclusive right to negotiate an exclusive license for olverembatinib. The agreement stipulates an initial option payment of US$100 million. Furthermore, Ascentage Pharma stands to gain additional financial benefits, including an option exercise fee and potential milestone payments that could total approximately US$1.2 billion, alongside double-digit royalties from annual sales of the drug.

Ascentage Pharma is recognized for its comprehensive involvement in the global biopharmaceutical sector, with a mission to address unmet medical needs primarily in hematological cancers. The company went public on October 28, 2019, on the Main Board of the Hong Kong Stock Exchange under the stock code 6855.HK.

The company has developed a robust pipeline encompassing nine clinical-stage drug candidates. These include novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, candidates targeting IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is the only firm globally that is currently conducting clinical trials targeting all three known classes of key apoptosis regulators across more than 40 clinical studies. These trials include six global registrational Phase III studies taking place in the United States, Australia, Europe, and China.

Olverembatinib, Ascentage Pharma’s flagship product for treating drug-resistant chronic myeloid leukemia (CML), has gained significant regulatory recognition. It has been granted Priority Review and Breakthrough Therapy Designations by China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug has also been included in the China National Reimbursement Drug List (NRDL). In the international arena, olverembatinib has received Orphan Drug and Fast Track Designations from the US Food and Drug Administration (FDA) and an Orphan Designation from the European Medicines Agency (EMA).

In total, Ascentage Pharma has secured 16 Orphan Drug Designations from the US FDA and one Orphan Designation from the EMA for four of its investigational drugs. The company's strong research and development capabilities have enabled it to build a substantial portfolio of global intellectual property rights and establish partnerships with leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent. Additionally, Ascentage Pharma collaborates with prestigious research institutions including the Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute, and the University of Michigan.

As part of its strategic vision, Ascentage Pharma has assembled a team of experts with global experience in drug discovery and development. The company is also focused on building a world-class commercial manufacturing and Sales & Marketing team. One of its core objectives is to continually enhance its R&D capabilities and expedite clinical development programs to meet global unmet clinical needs, ultimately benefiting a broader patient population.