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4008465777

Research and Development

R&D Team

Tonghua Dongbao values both in-house R&D and external cooperation. To facilitate the development of new products, we have set up R&D offices across in Beijing, Shanghai, Hangzhou, and Tonghua for new drug development, research results commercialization, domestic and international drug registration, overseas business management, and production industrialization. These offices serve as an arena for top talents to develop their innovative ideas and potential. R&D efficiency is the lifeblood of Tonghua Dongbao. We are beefing up investment in human, financial and material resources to build the company into a leading innovator in diabetes treatment and a world-class platform for biopharmaceutical development. At present, we have 387 R&D staff and researchers, accounting for 13% of our employees, and among them there're 45 persons or 12% hold a master's or higher degree.

387
R&D staff
13%
of total employees
45
master's degree or above

Dongbao Beijing
Drug safety evaluation, clinical research, and regulatory affairs
Located in the Beijing Economic-Technological Development Area, which boasts favorable policies and a vibrant academic atmosphere for biopharmaceutical development, Dongbao Beijing is able to collaborate with many top-notch research institutions in preclinical studies, clinical studies, and regulatory affairs of generic and new drugs.
Dongbao Shanghai
Business development and international cooperation
Situated in the business district of Zhongshan Park, Dongbao Shanghai was established to build partnerships with domestic and overseas research institutions and high-tech companies for the development of novel drugs and innovative technologies.
Dongbao Hangzhou
Dongbao Purple Star (Hangzhou) Biopharmaceutical Co., Ltd.
Located in Qiantang New District, Dongbao Hangzhou serves as the research center of novel drugs. It has built novel drug pipelines that integrate in-house and external research resources. The branch aims to build up R&D strength in novel drugs and/or new dosage forms for diabetes and other endocrine disorders.
Dongbao Overseas Affairs Division
Overseas business, international market development, and international registration
The division develops and manages the company's markets and agents outside China. It gathers global market information and has its finger on the pulse of cutting-edge technologies and international market trends. Keeping abreast of the latest ICH, FDA, EMA and other international regulatory guidelines on drug registration, the business unit, based on the company's international business strategies and regulations in target markets, also develops plans, prepares and submits documents for product registration in other countries, and works with overseas agents and drug regulatory authorities to facilitate registration and obtain registration approvals.
Pharmaceutical Research Institute
Pre-clinical studies and pilot production
The company’s Pharmaceutical Research Institute is located in the Tonghua National Pharmaceutical High-tech Zone. The 5-story research facility covers an area of 10,494 sq m, with a gross floor area of 44,770 sq m. F1 and F2 are designated as the quality testing center, F3 for the biopharmaceuticals research department, F4 for the chemical drug research department, and F5 for general administration and activity areas. With advanced instruments and equipment, the institute focuses on the development of new protein-based and chemical drugs.
Biopharmaceutical Industrial Park
Commercialization of research results
The Biopharmaceutical Industrial Park is located in the Tonghua National Pharmaceutical High-tech Zone, covering an area of 350,400 sq m with a planned gross floor area of 250,000 sq m. The industrial park is engaged in the R&D and production of protein-based biologics and traditional Chinese medicines. The research results for all products are commercialized from this facility.

Pharmaceutical Research Institute of Tonghua Dongbao

The research institute was established especially to develop new protein-based and chemical drugs.

Biopharma R&D Division

The division has upstream (fermentation and cell culture), downstream (purification), and formulation platforms for development of culture processes for bacteria, yeasts, and Chinese hamster ovary (CHO) cells, purification processes for polypeptides, recombinant proteins, and antibodies, and formulation processes for polypeptide and protein drugs. It also has a QbD-based pharmaceutical quality research platform for development of chemical manufacturing, and controls (CMC) and analysis techniques.

AKTA avant 150 Chromatography System
Cogent μScale TFF System
Cogent M1Ultrafiltration System
Waters e2695 HPLC
JASCO J005A Circular Dichroism (CD) Spectrometer
Differential Scanning Calorimeter

01/06

Chemical Drug R&D Division
The division undertakes the R&D of chemical drugs and intermediates, as well as the transfer of related technologies, to facilitate the availability of products. It has a complete set of equipment for lab-scale synthesis, drug substance (DS) production, analysis, and inspection to ensure smooth R&D operations.
TCM R&D Division
Thanks to abundant local herbal resources, the division is able to select quality ingredients and work on the secondary development of the time-tested legacy formulations and prescriptions.