Ascentage Pharma Enters into Exclusive Option Agreement with Takeda for Global Licensing of Olverembatinib, a Third-Generation BCR-ABL Inhibitor
Takeda
Biopharmaceutical Manufacturer
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Ascentage Pharma Signs Exclusive Option Agreement to License Global Rights of Olverembatinib Outside of China and Other Certain Regions
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Ascentage Pharma will receive a $100 million option payment upon the signing of the agreement and is eligible to receive up to approximately $1.2 billion in option exercise fees and additional potential milestone payments, as well as double-digit percentage royalties based on annual sales.
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Takeda Pharmaceutical Company Limited to Purchase Minority Stake in Jiangsu Ascentage Pharma Development Co., Ltd.
Ascentage Pharma (6855.HK) announced today that it has signed an exclusive option agreement with Takeda regarding the company's third-generation BCR-ABL tyrosine kinase inhibitor (TKI) Olverembatinib, which has best-in-class potential.®(Olverabatinib) Exclusive License Agreement Reached. Once the option is exercised, Takeda will obtain a global license for the development and commercialization of Olverabatinib, excluding regions such as mainland China, the Hong Kong Special Administrative Region, the Macao Special Administrative Region, and Taiwan.
Despite the advent of TKIs significantly improving the treatment of chronic myeloid leukemia (CML), there remains a substantial unmet need for patients who are resistant to existing therapies or develop difficult-to-treat mutations after treatment.
According to the terms of the option agreement, Ascentage Pharma will receive a $100 million option payment upon the signing of the agreement and is eligible to receive up to approximately $1.2 billion in option exercise fees as well as additional potential milestone payments. Additionally, Ascentage Pharma will receive a minority equity investment from Takeda.
According to the terms of the agreement, before the exercise of the option right, Jiangsu Ascentage Pharma Development Co., Ltd. will be solely responsible for all clinical development matters related to Olverembatinib. Olverembatinib is currently on the market in China and has received approval for two indications: treating adult patients with T315I mutation-positive chronic phase (–CP) and accelerated phase (–AP) CML resistant to any TKI; and treating adult patients with CML-CP who are resistant or intolerant to first- and second-generation TKIs.
Dr. Dajun Yang
Chairman and CEO of Ascentage Pharma
"We are very pleased to have reached this collaboration with Takeda. As a globally leading multinational pharmaceutical company, Takeda's outstanding influence and achievements in the field of oncology will help expand the impact of Olverembatinib on patients in need around the world. Olverembatinib has brought positive clinical benefits to CML patients in China, and we look forward to accelerating the advancement of its global Phase III clinical registration, thereby benefiting patients worldwide."
Teresa Bitetti
President of Takeda Global Oncology Business Unit
"Takeda has always maintained strong cooperation with companies that share our vision of addressing unmet clinical needs for patients worldwide in our dedication to the development of oncology treatments. Through our collaboration with Jiangsu Ascentage Pharma Development Co., Ltd., we will continue to fulfill this mission. The promising potential that Olverembatinib has demonstrated in clinical settings so far is highly encouraging. We are delighted to have the opportunity to further develop Olverembatinib for the benefit of more patients with CML and other hematological malignancies."
About Olverembatinib
Core product Orelabrutinib (trade name: Nulasta) for the treatment of chronic myeloid leukemia®) is the company's first marketed product, which has been approved in China and designated for priority review and breakthrough therapy by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. Currently, Orelabrutinib has been successfully included in the National Reimbursement Drug List, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022). The product has also received Fast Track designation, Orphan Drug designation from the U.S. FDA, as well as Orphan Drug designation from the European Union.
About Ascentage Pharma
Ascentage Pharma is a biopharmaceutical company based in China with a global outlook, dedicated to developing innovative drugs in the treatment areas of cancer, hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Hong Kong Stock Exchange, with the stock code: 6855.HK. The company has independently developed a protein-protein interaction targeted drug design platform and is at the global forefront of new drug research and development in the apoptosis pathway. Ascentage Pharma has established a pipeline of nine novel small molecule drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, or MDM2-p53; next-generation inhibitors targeting kinase mutants that emerge during cancer treatment, making it the only innovative company globally with clinical development programs for all key proteins in the apoptosis pathway. Currently, the company is conducting over 40 clinical trials in China, the United States, Australia, and Europe, six of which are global registrational Phase III clinical studies. To date, four of the company's investigational new drugs have received 16 FDA and one EU orphan drug designations, two FDA Fast Track designations, and two FDA Rare Pediatric Disease designations. The company has undertaken several national science and technology major projects, including five "Major New Drug Discovery" projects—one "Enterprise Innovative Drug Incubation Base" and four "Innovative Drug Development"—and one "Major Infectious Disease Prevention and Treatment" project.
Investor Relations Contact: IR@ascentage.com
Media Contact: PR@ ascentage.com
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