Amphotericin B liposome injection project

The total investment of the project is 75 million yuan. The project starts and ends from October 2020 to October 2024. The number of project teams is 15. The main business areas are high-end pharmaceutical preparations, core technology, liposome technology, intention country, intention unit of the United States, NanoTechPharmaInc (NACO Pharmaceuticals) Address: New Jersey, United States Collaborative Development Project Background: Injection amphotericin B is the gold standard for the treatment of invasive fungal infections, belonging to the polyene class of preparations. Its excellent antibacterial spectrum and bactericidal properties make it an essential class of drugs in clinical practice. However, due to its high toxicity and instability, injection amphotericin B is only considered for treatment when other antifungal drugs are not ideal, Its derivative formulation liposomes can significantly improve the safety and effectiveness of drugs, avoid adverse reactions during clinical use, and this type of formulation is definitely a future demand point for clinical use. North China Pharmaceutical has high-quality amphotericin B raw materials, which can fully meet the research and development and subsequent industrial production of this product. It also has years of experience in production and marketing of ordinary injections of this variety, providing support and guarantee for the production and market of this product after its launch. The expected goal is to conduct a dual report between China and the United States, to be listed domestically and in the United States, and to enhance the influence of Chinese medicine in the international market. The conditions (equipment/funds/personnel) are now met, and some equipment, funds, and technical difficulties/main difficulties are due to technical barriers for complex injections. The development difficulty is high, and the original research has been listed for more than 20 years. Currently, there are no generic drugs listed domestically or internationally, It can be seen that its replication is difficult, and its solutions and expected goals are to be achieved. The proposed partner, Nacor Corporation of the United States, is a research and development company dedicated to the development of 505 (b) (2) NDA new dosage forms and nanoinjection drugs. Its research and development team has years of experience in complex injection research and development, and has conducted exploratory research on the formulation process of amphotericin B liposomes. After preliminary process exploration, it has been able to achieve the level of 200 small trials, and cooperation with it can accelerate the research and development progress, And taking advantage of its company's familiarity with US registration and application, it will conduct dual reporting between China and the United States, list in both domestic and US markets, and enhance the influence of Chinese medicine in the international market. Other remarks (if there is a project proposal, please attach it)