Ascentage Pharma Achieves Global Recognition with Zero Deficiency in EU QP GMP Compliance Audit!

Ascentage Pharma (6855.HK) has achieved a major milestone in its global expansion journey – its Global Manufacturing Center has passed a Qualified Person (QP) audit from the European Union (EU), with no deficiencies found!

This successful audit demonstrates that the company’s quality management system is in line with the stringent EU GMP standards. This is great news for the biopharmaceutical company as they continue to develop novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases.

In March 2023, the EU conducted a rigorous four-day inspection of Ascentage Pharma’s Global Manufacturing Center, taking into account the EudraLex Volume 4 regulations. This audit covered all necessary aspects of quality assurance, from manufacturing processes and lab control to material management, facilities, equipment, data integrity, and IT systems. It was a comprehensive evaluation to ensure the highest standards of Good Manufacturing Practice for both human and veterinary medicinal products.

At the end of the audit, the auditor was full of praise for Ascentage Pharma’s Global Manufacturing Center, recognizing its superior quality management system, its up-to-date facilities and equipment, and the experienced staff that made it compliant with the EU GMP.

As a result of this zero-deficiency audit report from the EU QP, Ascentage Pharma is now well-positioned to manufacture and commercially distribute its innovative drugs around the world.

November 2022 marked a significant milestone in Ascentage Pharma’s global expansion with the Drug Manufacturing License (Certificate A) granted to its Global Manufacturing Center in China.

The successful inspection by the EU QP of its quality management system, compliant with GMP standards of China, the US, the EU, and guiding principles of the ICH, is a testament to the company’s commitment to delivering high-quality novel therapeutics to patients around the world.

Under the leadership of Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, the company will continue to strive for its mission of addressing unmet clinical needs in China and beyond.

About the EU QP system

Since its adoption by the EU GMP in 1975, the QP system has transformed the way pharmaceuticals are managed for quality. Over the past half century, it has proven itself to be a powerful tool and is now a fundamental part of the EU GMP.

Qualified Persons (QPs) are some of the most authoritative experts in pharmaceutical manufacturing, due to the strict requirements they must meet as set forth by the European Council Directive (2001/83/EC) and the EU GMP Annex 16 on the Certification by a Qualified Person and Batch Release. These requirements clearly define the legal status, required qualifications, and responsibilities of QPs, ensuring a high standard of quality in the industry.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a biopharmaceutical leader with a global footprint, dedicated to pioneering groundbreaking treatments for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma made its debut on the Main Board of the Stock Exchange of Hong Kong Limited, becoming the newest addition to the HKEX family with its stock code 6855.HK.

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´╝łNRDL). 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.

Ascentage Pharma is proud to announce that olverembatinib, its core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has achieved a number of notable milestones.

It 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), and has been included into the China 2022 National Reimbursement Drug List (NRDL).

Additionally, the US FDA and the EMA of the EU have granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) respectively to olverembatinib, bringing the total number of ODDs held by Ascentage Pharma to 16. This is a remarkable achievement that reflects the company’s commitment to developing innovative treatments for rare diseases.

At Ascentage Pharma, we are driven by the mission to address unmet clinical needs in China and beyond for the benefit of more patients. This mission is enabled by our robust R&D capabilities and global intellectual property rights, as well as our strategic partnerships with world-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.

In addition to building a talented team with global experience in the discovery and development of innovative drugs, we are also setting up world-class commercial manufacturing and Sales & Marketing teams to further strengthen our R&D and accelerate our clinical development programs.

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