SUZHOU, China and ROCKVILLE, Md., April 25, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it recently received a zero-deficiency report from the GMP compliance audit of Ascentage Pharma's Global Manufacturing Center by a Qualified Person (QP) of the European Union (EU). This successful audit indicates that the company's Global Manufacturing Center and quality management system implemented at the site are now compliant with the standards of the EU GMP, marking the achievement of a major milestone that will pave the way for the company's continued global expansion.

In March 2023, a QP of the EU carried out an inspection at Ascentage Pharma's Global Manufacturing Center over a four-day period. Under guidance by the EudraLex Volume 4 regulations (Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Volume 4), the audit covered quality assurance, manufacturing processes, lab control, material management, facilities and equipment, data integrity, and IT systems of the manufacturing site.

The auditor spoke highly of Ascentage Pharma's Global Manufacturing Center at the end of the audit, and confirmed that the site possesses a high-standard quality management system, facilities, equipment, as well as experienced staff that make the site completely compliant with the requirements of the EU GMP. As a result, Ascentage Pharma received a zero-deficiency audit report from the EU QP that will pave the way for the manufacturing and global commercialization of the company's innovative drugs.

"Ascentage Pharma's Global Manufacturing Center, which was granted a Drug Manufacturing License (Certificate A) in China in November 2022, has built a quality management system that is compliant with GMP standards of China, the US, the EU, and guiding principles of the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "The clearance from this inspection by the EU QP indicates approval by a major international certification body for the quality management system implemented at our Global Manufacturing Center. It is a significant milestone in our global expansion and it will accelerate our transition into a fully vertically-integrated biopharma. Remaining steadfastly committed to the mission of addressing unmet clinical needs in China and around the world, we will forge ahead with the development of innovative drugs and observe the most stringent quality management to bring more high-quality novel therapeutics to patients around the world."

About the EU QP system

The EU GMP first adopted the QP system in 1975. In the near 50 years that followed, it was proven to be an advanced system for pharmaceutical quality management and has thus become a core element of the EU GMP.

The EU has strict requirements for QPs and has clearly defined the legal status, required qualifications and responsibilities of QPs in the European Council Directive (2001/83/EC) and the EU GMP Annex 16 on the Certification by a Qualified Person and Batch Release. These high requirements make QPs some of the most authoritative experts in pharmaceutical manufacturing.

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.

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 a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into 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. 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.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements

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