Shandong Xinbo helped Novo Shengtai to obtain clinical approval of Class 1 innovative drug STC008 injection
2024/08/13
The Drug Safety Evaluation Research Center of Shandong Xinbo Drug Research Co., Ltd. undertakes the comprehensive safety evaluation of the 1 -type innovative drug STC008 injection, showing that this product has good safety and helps it obtain clinical trial permits.
At present, there are no related products in China. The development of this product can meet the clinical needs of patients and bring greater market value. It is expected to become the treatment of tumor vicious liquid therapy of Best-in-Class. Essence
Part of the content is quoted from: https://mp.weixin.qq.com/s/t6g8hqjtluwexzh62cguoq
About Xinbo
Shandong Xinbo is a scientific research service-oriented enterprise that integrates pharmacodynamic research, toxicology research, drug analysis and testing services, animal pathology testing, and medical device evaluation services. It is a recognized high-tech enterprise and Shandong Province Enterprise Technology Center.
The company is located in Linyi Economic Development Zone, Dezhou City, Shandong Province, at the intersection of the Beijing Tianjin Hebei Shandong economy. The company has a pharmacology and toxicology research laboratory with a total area of over 16000 square meters, equipped with more than 800 sets of instruments and equipment. The toxicology research laboratory has been certified by the National Medical Products Administration (NMPA) for Good Laboratory Practice (GLP) in non clinical drug research. The certification scope covers 8 tests, including single dose toxicity test, repeated dose toxicity test, safety pharmacology test, reproductive toxicity test, genetic toxicity test, local toxicity test, immunogenicity test, toxicokinetics test, etc.
The company provides commissioned research services for non clinical safety evaluation of drugs to pharmaceutical companies, new drug research and development institutions, and research institutes. Since its establishment in 2010, the company has provided over 10000 services to more than 540 pharmaceutical companies, new drug research institutions, and research institutes both domestically and internationally. According to relevant regulations at home and abroad, nearly 400 innovative drug preclinical evaluation services have been completed, covering small molecule drugs, biomacromolecule drugs, new preventive and therapeutic vaccines, traditional Chinese medicine/natural medicines and other fields. We have also accumulated practical experience in the evaluation of emerging fields such as therapeutic vaccines, cell and gene therapy drugs. Completed the evaluation of nearly 4000 generic drugs.
The company has made methodological improvements and explorations in the areas of administration technology for young animals, continuous intravenous administration technology, and tracheal administration technology, and the relevant technologies have been applied in safety evaluation practice. The company focuses on the innovative development trends of the global pharmaceutical industry, focusing on the key links of innovative drug research and development, and relying on accumulated industry service experience to provide customers with preclinical drug research and development related services.