Recently, AD Pharmaceuticals, a joint venture of Akeso (9926. HK) and Dawnrays Pharmaceutical (2348. HK), successfully put its world-class biopharmaceutical base at China-Singapore Guangzhou Knowledge City into operation. The commissioning of the base has prepared AD Pharmaceuticals for the upcoming product commercialization, indicating that AD Pharmaceuticals has entered a new level of development.

AD Pharmaceuticals is an important part of the Akeso China-Singapore Guangzhou Knowledge City Biopharmaceutical Base. The project is planned to become a world-class innovative biopharmaceutical industrialization production base that meets the GMP standards of the United States, European Union and China, with a total planned production capacity of 16,000 L, including an R&D building, quality inspection building, drug substance production workshop, preparation workshop, warehouse, power center, etc.

AD Pharmaceuticals has a production capacity of 8,000 L, including four 2,000 L bioreactors. Among them, the cell culture mainly use imported equipment from brands such as Roche, Siemens and Thermo Fisher, and the purification system includes a chromatography system, virus removal filtration system, automatic ultrafiltration system, etc. The control system of key equipment are based on Emerson's DeltaV open intelligent control platform, which can carry out centralized data management and step-by-step control, enable the automatic production of the batch process and maintain the batch-to-batch quality consistency of products.

AD Pharmaceuticals has built two preparation filling lines, namely a fully automatic pre-filled syringe filling line and a whole-line linked penicillin bottle preparation workshop line. The public system mainly adopts equipment from BWT, Ingersoll Rand, Winatech, Tica, Air Liquide, Schneider, Siemens and other brands.

Dr. Xia Yu, Founder, Chairman and CEO of Akeso, and General Manager of AD Pharmaceuticals, said, "Since its establishment, AD Pharmaceuticals has been adhering to the patient-centered and clinical value-oriented new drug development concept, and focusing on the development of innovative drugs and combined therapies for cardiovascular disease, tumors and other major diseases. Our innovative R&D has achieved initial results: Ebronucimab (R&D code: AK102), a new PCSK9 monoclonal antibody drug, has entered the Phase III clinical trial for the treatment of primary hypercholesterolemia and mixed hyperlipidemia, and the clinical trial on the treatment of many tumors with Pulocimab (R&D code: AK109), a new differentiated VEGFR-2 monoclonal antibody drug, has also entered the middle and late phases. AD Pharmaceuticals’ successful commissioning provides an important guarantee for the clinical development and future commercial sales of its two core products."

Mr. Xiong Rongli, Executive Director of Dawnrays Pharmaceutical and Founder and Chairman of AD Pharmaceuticals, said, "Thanks to the recognition and support of the government and financial institutions, and the hard work of the AD Pharmaceuticals team, since the establishment of the company, our two innovative products have made rapid progress and highlighted their potential. The commissioning of AD Pharmaceuticals will further release the company's innovation vitality and promote the clinical development of our innovative drugs more efficiently. Based on the strategic pattern of ‘overall planning, gradual implementation, clear macro and careful micro’, we hope to continue to build AD Pharmaceuticals into a high-tech biopharmaceutical company that contributes to human health."