Academic Report | Dean Liu Zhaoping of Shandong Xinbo was invited to attend a seminar on regulations and secondary development technology related to the re evaluation of traditional Chinese medicine i
2024/11/05
Dean Liu Zhaoping of Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "Shandong Xinbo") was invited to attend the conference and give an academic report on the topic of "Strategies and Pathways for Safety Re evaluation of Traditional Chinese Medicine Injections".
Dean Liu Zhaoping
Shandong Xinbo Pharmaceutical Research Co., Ltd
Review of Academic Reports
Dean Liu pointed out in the report that with the increasing attention of the country to the adverse reactions of traditional Chinese medicine injections and the deepening of research by Chinese experts and scholars, their safety has been qualitatively changed, and the national medical insurance list has also lifted the restrictions on the clinical use of some varieties to a certain extent. However, the increase in clinical dosage of traditional Chinese medicine injections after the lifting of restrictions will inevitably lead to an increase in the number of adverse reaction reports, and their safety risks will once again become a focus of public attention. Therefore, safety will inevitably become the key to the re evaluation of traditional Chinese medicine injections.
Based on the research foundation of Shandong Xinbo on drug sensitization and the international research results on drug hypersensitivity reactions, Dean Liu proposed that non immune-mediated drug hypersensitivity reactions (such as allergic reactions) are the most common adverse reactions of traditional Chinese medicine injections in clinical practice. Establishing industry and regulatory recognized methods for detecting allergic reactions is the key to the safety evaluation strategy of traditional Chinese medicine injections.
Shandong Xinbo will explore mechanisms, establish positive drugs, screen models, and separate allergens from multiple perspectives to achieve the goal of establishing standardized detection methods for allergies. It will closely integrate with pharmaceutical research to form a scientific, comprehensive, and standardized safety evaluation research system, promote the introduction of relevant guiding principles and applications by the country, and ultimately achieve the goal of re evaluating the safety of traditional Chinese medicine injections. This will promote the development of traditional Chinese medicine in China and benefit human health.
Shandong Xinbo Pharmaceutical Research Co., Ltd. is a scientific research service-oriented enterprise that integrates pharmacological research, toxicology research, drug analysis and testing services, animal pathology testing, and medical device evaluation services. It is a high-tech enterprise, Shandong Province Enterprise Technology Center, and Shandong Province Gazelle Enterprise.
About Xinbo
The company is located in the Beijing Tianjin Hebei Shandong economic zone, and has established a pilot base in the Linyi Economic Development Zone of Dezhou City, known as the "Nine Dash Tianqu" and "Gateway to Shenjing". At present, more than 16000 square meters of pharmacology and toxicology research laboratories that meet international standards have been built, equipped with more than 800 advanced instruments and equipment at home and abroad. Among them, the toxicology research laboratory can conduct 9 studies including single dose toxicity tests, repeated dose toxicity tests, safety pharmacology tests, reproductive toxicity tests, genetic toxicity tests, local toxicity tests, immunogenicity tests, toxicokinetics tests, and carcinogenicity tests in accordance with the GLP standards of NMPA and FDA.
The company is committed to providing high-quality commissioned research services for new drug and medical research and development institutions. Since its establishment in 2010, it has provided over 10000 services to more than 540 pharmaceutical companies, new drug research institutions, and research institutes both domestically and internationally. According to domestic and foreign regulatory requirements, Shandong Xinbo has completed preclinical evaluation services for nearly 400 innovative drugs, including small molecule drugs, biomacromolecule drugs, new preventive and therapeutic vaccines, and traditional Chinese medicine/natural medicine evaluation work. Shandong Xinbo has assisted research and development units in obtaining more than 50 clinical approvals for new drugs, especially in the evaluation of rapidly developing therapeutic vaccines, cell and gene therapy drugs in recent years, and has accumulated rich experience.
In addition, the company continuously innovates its practices and breaks through barriers, improving and tackling technologies such as difficult administration to young animals, continuous intravenous administration, and tracheal administration, establishing mature technologies, and applying them to safety evaluations. The company also pays attention to the demand for innovative development in the global pharmaceutical industry, focusing on the key link of innovative drug research and development. With the accumulated experience in serving the domestic and international pharmaceutical industry, it provides comprehensive preclinical research and development services for new drugs in the global pharmaceutical industry.
