Recently, the EK1 nebulizer produced by Shanxi Jinbo Bio-Pharmaceutical Co., Ltd. was approved by the National Medical Products Administration to carry out clinical trials for the treatment of COVID-19, and the CIRP Pharmaceutical Safety Assessment Center undertook its preclinical safety assessment.
Since approval, the assessment work has been highly valued by the Ministry of Industry and Information Technology, the State Administration of Science, Technology and Industry for National Defence, and Shanxi Provincial Government. As the key laboratory of Shanxi Province and the industry, the CIRP Pharmaceutical Safety Assessment Center takes full advantage of its technical strengths, and collaborates with the drug development organizations to make breakthroughs in research, has submitted all the preclinical data to the Center for Pharmaceutical Assessment of National Medical Products Administration in June 2021 on top of substantial experimental researches and adequate data demonstration, providing strong technical support for the pharmaceutical to be approved for clinical trial as quickly as possible.
The Center is among the earliest organizations in China to conduct preclinical safety assessment on new pharmaceuticals, and has provided safety validation for the pharmaceutical application of dozens of pharmaceuticals up to now. In 2020, the Center obtained the only GLP qualification for radiopharmaceutical pre-clinical assessment granted in China. Since then, it has built a '4+1' new pharmaceutical R&D and transformation platform integrating national and provincial key laboratories & engineering research centers, specifically, the CAEA Center of Excellence on Nuclear Technology Applications for Nonclinical Assessment for Radiopharmaceutical, Shanxi Key Laboratory for Pharmaceutical Toxicology & Radiation Injury Pharmaceuticals, CNNC Key Laboratory for Radiotoxicology and Preclinical Assessment of Radiopharmaceuticals, and Shanxi Engineering Research Center for Preclinical Assessment and Transformation of Innovative Radiopharmaceuticals.