Tianjin Tiancheng drug assessment Co., Ltd (Drug assessment center of Tianjin institute of pharmaceutical research) originates from the pharmacology and Toxicology Laboratory of the former three state research institutions: Beijing institute of pharmaceutical industry, Tianjin institute of traditional Chinese medicine and Tianjin institute of pharmaceutical industry. It integrates three national technology platforms of innovative drug pharmacokinetic, pharmacodynamics and toxicology, and provides druggability research, preclinical pharmacology research, non-clinical safety evaluation and clinical pharmacokinetics research.
The center undertakes the construction and operation tasks of State Key Laboratory of drug delivery technology and pharmacokinetics of Ministry of science and technology, Tianjin Key Laboratory of pharmacokinetics and pharmacodynamics, Tianjin new drug non-clinical evaluation technology engineering center, Tianjin biotechnology drug integrated service platform, Tianjin generic drug consistency evaluation comprehensive research center, etc., and participates in the national platform construction projects and new drug creation projects such as 1035 project, 863 plan, 973 Plan, and the national major special projects. We have served more than 300 enterprises, cooperated with nearly 50 research institutions, completed more than 1000 new drug R&D projects, and helped obtain more than 100 clinical trial approvals (including IND of FDA).
Laboratory animal license
The GLP certification of NMPA
International AAALAC certification
Radiation safety license
Verification of bioanalytical capability of NIFDC (Biomacromolecule and small molecule)
The qualification certificate of laboratory-to-laboratory comparison and examination for toxicity pathology detection
More than 50% of research team with master degree or above
The average working experience is 8.5 years
14 toxicologists certified by CST
Participates in the national platform construction projects and new drug creation projects such as 1035 project, 863 plan, 973 Plan, and the national major special projects.
Served more than 300 enterprises, cooperated with nearly 50 research institutions, completed more than 1000 new drug R&D projects, and helped obtain more than 100 clinical trial approvals (including IND of FDA).
In addition to drug evaluation, we also have the experience of the R&D services of products in various fields, such as medical devices, special medical food, health food, cosmetics and animal drugs.
High tech Enterprises
Excellent gazelle Enterprises
Top 20 Chinese pharmaceutical outsourcing companies
Chinese materia medica is the carrier of TCM theory, the main form of TCM clinical medication, and the important support for the development of TCM pharmaceutical industry. Systematic secondary development can excavate the core value of listed Chinese materia medica, focus on its clinical characteristics to increase curative effect, and improve the safety, effectiveness and quality controllability of preparation products, so as to promote the quality and efficiency of TCM industry.
Since 2006, under the leadership of academician Chang-xiao Liu and researcher Tie-jun Zhang, the TCM R&D center of TIPR has been committed to the secondary development of Chinese materia medica. Through systematic research, the TCM R&D center has established an innovative model and a series of key technologies for the secondary development of Chinese materia medica, and applied them to: (1) explanation of the treatment principles, compatibility theory and compatibility rules of Chinese materia medica for diseases, so as to develop and improve the TCM theory; (2) clarification of the material basis and pharmacodynamic mechanism of complex Chinese medicine system with modern scientific methods, objective indicators and experimental evidence; (3) discovery of the functional characteristics and comparative advantages of Chinese materia medica in order to excavate the clinical core value, guide clinical practice, and improve clinical efficacy; (4) establishment of scientific and effective quality control methods to ensure uniform, stable and controllable drug quality.
So far, research teams of TCM R&D center have completed the secondary development of 14 Chinese patent medicines, including Shufeng Jiedu Capsules, Qingyan Dripping Pills, Maren Soft Capsules, Niuhuang Jiangya Tablets, Bifeng Jiangya Tablets, Qianggan Capsules, Yuanhu Zhitong Dropping Pills, Liujing Toutong Tablets, Danhong Huayu Oral Liquid, Haima Bushen Pills”, Huoxue Zhitong Capsules, Fufang Yuxingcao Heji, Naoxinqing Tablets and Qingkailing Oral Liquid. They have also made the following remarkable research achievements: academic monographs of “TCM Quality control-technology, method and demonstration”, “Quality standard improvement of Chinese patent medicine”, “Theory and practice of TCM quality markers”, “Secondary development of Yuanhu Zhitong Dropping Pills” and “Secondary development of Liujing Toutong Tablets” in Science Press; approximately 100 research papers, including three special issues of Chinese Traditional and Herbal Drugs and more than 10 articles in SCI journals were published. At the same time, more than 40 invention patents were achieved.
Through secondary development, the clinical and market values of related Chinese patent medicines were improved significantly. Taking Shufeng Jiedu Capsule as an example. After systematic research, it was listed as the recommended medication for 12 major diseases by the national health commission and a category A species in the National Medical Insurance Catalogue (2017). Shufeng Jiedu Capsule was also selected into the “Report on the Scientific and Technological Competitiveness of TCM Large Varieties (2019 Edition)” with a science and technology impact factor of 73.20, which ranks first in the national respiratory system medicine and the first in all types of Chinese medicine in the past three years. In addition, two authorized invention patents were obtained, and the improved quality standard was included in the Chinese Pharmacopoeia (2020 edition). Through secondary development, the clinical application of Shufeng Jiedu Capsules has been fully expanded, benefiting more than 50 million patients. The products cover 29 provinces, cities, and autonomous regions, with annual sales increasing from 50 million to 600 million in 2019, which has achieved significant economic and social benefits. The achievement named “Research on secondary development of Shufeng Jiedu Capsule” won the first prize of Anhui Science and Technology Progress Award in 2017.
TCM R&D center of TIPR is committed to providing continuous technical support for the development of Chinese medicine industry. In the future, guided by clinical, corporate and market needs, we will continue to innovate research ideas and methods, and contribute to the value enhancement of more listed Chinese medicines and the sustainable development of Chinese medicine industry.
Tianjin Pharmaceutical Research Institute has a professional clinical project team and a perfect quality management system, which can provide phase I – IV clinical research and technical services for pharmaceutical enterprises, covering the solutions of the whole journey of drug R&D, such as project management, site management, audit, data management, biological sample detection, registration and medical support. We are customer-oriented to improve R&D quality, shorten R&D time Cycle and reduce R&D costs.
We have good cooperative relationship with dozens of top-three hospitals in China, and have completed 20 BE trials. At present, the clinical trials of three innovative drugs are progressing steadily.
Service Content
Clinical trial project management
On site management of clinical trial institutions
Training of clinical researchers
Subject recruitment
Third party audit
Data management and statistical analysis
Biological sample detection
Registration and medical support
Pharmacovigilance
