Aiping Tian, PhD; Xinrui Hu, Phd; Ning Du, Wei Jin, PhD; Lixing Liu, PhD; Jie Li, PhD; Jiayang Chen, PhD; Jinyuan Chang, PhD; Lianzhen Chen, PhD; Zhongge Wang, PhD; Bin Dong, PhD; Linlin Fan, PhD; Mingming Bo, PhD
Competition Sponsor: Chinese Academy of Medical Sciences
Skin toxicity is the most common side effect of anti-tumor targeted drugs, which affects the quality of life of patients and the implementation of the best dose of drugs. There is no specific drug for this kind of skin injury, and the conventional treatment based on hormone has little effect. TDX105, a traditional Chinese medicine developed by our team in the early stage, has obvious curative effect advantages and good development prospects compared with the current conventional treatment. The patent of the compound has been authorized and the technology transformation has been completed, and we plan to further research and develop new drugs. In this project, the ultimate goal is to develop new drugs. Based on the relevant laws and regulations of domestic and international new drug development and registration, combined with the actual industry, we carried out a comprehensive CMC (chemical manufacturing and control) research on TDX105, providing a modern preparation with controllable quality, stable uniformity and large-scale production for the evaluation of product effectiveness and safety. The research contents include: quality control research of medicinal materials/Chinese Herbal Slices; research and establishment of industrial feasible intermediate preparation technology; research and establishment of preparation technology suitable for large-scale production and clinical application; carry out quality control research and establish a complete quality control system; complete the pilot magnification of the production process to further determine the feasibility and stability of the process industry; carry out stability studies to determine the inner packaging materials, storage conditions and expiration date.