Suzhou-based Ascentage Pharma (HKG: 6855) has announced receiving a Drug Production License (A license) following the successful on-site inspection of its global industrial plant. This marks the first such license granted in Suzhou this year, highlighting the company’s significant progress in expanding its manufacturing capabilities.
Plant Profile and Capabilities
The GMP- and cGMP-compliant plant, located at the firm’s global headquarters, is capable of producing 250 million tablets or capsules annually. This capacity is sufficient to supply the entire global demand for Ascentage’s products. The plant is expected to play a crucial role in the company’s pipeline, particularly for APG-2575, a selective Bcl-2 inhibitor currently undergoing pivotal clinical trials.
Future Plans
Ascentage Pharma expects to utilize the new facility for clinical sample manufacturing, regulatory batch and process validation batch manufacturing, and commercial manufacturing. This comprehensive approach will support the development and commercialization of APG-2575, further solidifying Ascentage’s position in the global pharmaceutical market.-Fineline Info & Tech
