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SUZHOU, China and ROCKVILLE, Md., March 31, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today released its annual results for full year 2020, during which the company continued its rapid growth, despite the enormous challenges posed by the COVID-19 pandemic. During the reporting period, Ascentage Pharma achieved significant progress in clinical development, strategic partnerships, intellectual property rights, including the submission of its first ever New Drug Application (NDA) that was granted the Priority Review status by China's Center for Drug Evaluation (CDE). With all of these progress, Ascentage Pharma has reached the inflection point in its expansion from R&D to manufacturing and commercialization.
Staying committed to global innovations and achieving rapid advancement in clinical development
With increased investments in innovation, the company's research and development expenses for the year ended December 31, 2020, increased 21.7% from that of 2019, to RMB565 million. As of December 31, 2020, Ascentage Pharma has built a robust pipeline of eight clinical-stage and four preclinical-stage small-molecule drug candidates. This pipeline consists of inhibitors that target key proteins in the apoptotic pathways, including the Bcl-2, IAP, and MDM2-p53 pathways, to restore normal apoptotic functions; and next-generation tyrosine kinase inhibitors (TKIs) that target mutant kinases in cancers. In an effort to further enrich its pipeline, Ascentage Pharma has entered into an agreement during the reporting period to obtain the exclusive global rights to a MDM2 protein degrader developed using the Proteolysis-Targeting Chimeras (PROTACs) technology.
During the reporting period, Ascentage Pharma made significant progress with its drug candidates and continued to rapidly advance its clinical development programs. The company has over 40 Phase I or Phase II clinical trials ongoing in the United States, Australia, and China. APG-2575, the company's core apoptosis-targeting drug candidate, and the first China-developed selective Bcl-2 inhibitor entering clinical development in China, is currently being evaluated in 13 clinical studies in a range of hematologic malignancies globally. The clinical study that enrolled over 50 patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) has established clinical proof-of-concept (POC) in 2020, with preliminary results demonstrating an objective response rate (ORR) of more than 70% in the evaluable patients. Through its clinical development program, APG-2575 continues to show its excellent therapeutic potential.
Ascentage Pharma remains steadfastly committed to its global innovation strategy and its focus on the global market. As of March 31, 2021, four of Ascentage Pharma's investigational assets, including the Bcl-2 selective inhibitor APG-2575, the third-generation BCR-ABL inhibitor HQP1351, the novel dual-targeted Bcl-2/Bcl-xL inhibitor APG-1252, and the MDM2-p53 inhibitor APG-115, have been granted a total of 11 Orphan Drug Designations (ODDs) and a Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This is a record-setting achievement for any Chinese biopharmaceutical company, and a testament to the company's global innovation and R&D capabilities.
With its first NDA granted the Priority Review status, the company is gearing up for commercialization
Ascentage Pharma's core drug candidate, the third-generation BCR-ABL inhibitor HQP1351 reached numerous major milestones in the past year. In June 2020, an NDA for HQP1351 based on the results of two pivotal Phase II studies was submitted to the CDE of China's National Medical Product Administration (NMPA) for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia (CP CML) and accelerated phase CML (AP CML). This is Ascentage Pharma's first NDA submission since its inception. If approved, HQP1351 will become the first third-generation BCR-ABL inhibitor therapeutic in China.
Following the NDA submission, Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of the Ascentage Pharma, was granted a Marketing Authorization Holder (MAH) Pharmaceutical Manufacturing License (type B license) by the Medical Products Administration of Guangdong. This MAH Pharmaceutical Manufacturing License is the first ever awarded to a Class 1 novel chemical drug in Guangdong Province, and it helps laying a solid foundation for the future commercial manufacturing and launch of HQP1351. In October 2020, HQP1351 was granted the Priority Review status by the CDE, bringing the drug candidate one step closer to commercialization. In March 2021, HQP1351 was granted a Breakthrough Therapy Designation by the CDE, a designation that has once again validated the clinical utility of HQP1351.
During the reporting period, HQP1351 was also granted a series of ODDs and a FTD by the U.S. FDA, as the drug candidate was simultaneously advanced in its global clinical development. In the past year, the results from the pivotal Phase II studies of HQP1351 was presented through an oral presentation at the 62th American Society of Hematology (ASH) Annual Meeting, marking the third consecutive year in which clinical data of HQP1351 were selected for oral presentation at the ASH Annual Meeting.
As HQP1351 is on the brink of commercialization, efforts to build out the company's commercial infrastructures are well underway. In December 2020, the company appointed its Chief Commercial Officer to build a marketing and sales team possessing strong track record and deep experience in the field of hematologic oncology. Meanwhile, Ascentage Pharma has also made rapid progress with the building of its manufacturing capabilities. The company's Global Headquarters, R&D center, and manufacturing facility have already sealed their roof structures and will likely enter operations in 2021.
Capitalizing on external opportunities through multiple global collaborations
While capitalizing on its robust inhouse R&D capabilities, Ascentage Pharma leveraged its vast network of partners to access new drug candidates and additional resources to further advance its R&D programs. During the reporting period, the company entered into a strategic cooperation agreement with China's National Clinical Research Center for Hematological Diseases to promote the research and clinical development in the field. Ascentage Pharma also signed an agreement with the University of Michigan to gain access to the PROTACs technology, a technology platform that has attracted much attention lately, to further strengthen the company's preclinical pipeline.
Meanwhile, Ascentage Pharma has established global partnerships with multiple leading biotechnology and pharmaceutical companies. During the reporting period, the company entered into global clinical collaborations with MSD, and Acerta, the hematology research and development center of excellence of AstraZeneca, to jointly explore therapeutic potential of multiple combination therapies in a range of disease indications. In December 2020, the company's global strategic partner UNITY Biotechnology successfully advanced UBX1325 into clinical development for the treatment of age-related diseases, a development that led to a milestone payment to Ascentage Pharma.
Strengthening leadership position in the industry by building an intellectual property moat
Intellectual property rights are of vital importance to Ascentage Pharma, a China-based innovative biopharmaceutical company with a global footprint. As of December 31, 2020, the company has 110 issued patents and more than 450 patent applications globally, of which about 90 patents had been issued overseas.
"Leveraging our strategy of global innovation, Ascentage Pharma delivered multiple milestones in 2020, in defiance to the challenges posed by the COVID-19 pandemic," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "During the reporting period, we submitted our first NDA in China which was subsequently granted the Priority Review status by the CDE. This NDA submission bears tremendous significance for us as it marks a major step in our transition from clinical-stage biotech into a full-fledged global biopharmaceutical company with commercialized products. In the same period, the Bcl-2 inhibitor APG-2575, a core drug candidate in our apoptosis-targeting pipeline, achieved preliminary proof-of-concept clinical data that further demonstrated the drug candidate's therapeutic potential. In 2020, we initiated the company's first clinical study in Europe, and further expanded our global partnerships through the clinical collaboration agreements with MSD, and Acerta Pharma, the hematology research and development center of excellence of AstraZeneca. Furthermore, our inclusion into the Shenzhen-Hong Kong Stock Connect Program further expanded our investor base. Moving forward, as a biopharmaceutical company focused on developing and commercializing innovative therapies, we will press ahead with the implementation of our innovation strategies globally. To continue fulfilling our mission of 'addressing unmet clinical needs in China and around the world', we will further advance our clinical development to bring safe and effective therapies to patients as soon as possible and to create lasting value for our shareholders."
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, 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 eight 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, and China. HQP1351, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and a New Drug Application (NDA) for the drug candidate has been submitted and subsequently granted Priority Review by the Center for Drug Evaluation (CDE) in China. To date, Ascentage Pharma has obtained a total of 11 ODDs from the US FDA for four of the company's investigational drug candidates.
Forward-Looking Statements
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