Overcome the bottleneck of the industrialization of the ‘’Thymalfasin‘’
On December 23, 2011, the “Innovative Putuo” column of the A4 edition of theShanghai Science and Technology News published the article “Focus on InnovationSubjects, Build a Development Platform”-The Putuo District TechnologyEnterprise Innovation Fund Project, which reported that our company hasovercome the “Thymalfasin”Industrialization bottleneck news, the following is the full text of the news：
Overcomethe bottleneck of the industrialization of the "Thymalfasin"
Biological medicine is one of the key development directions in the high-tech field in the 21st century. As an important branch of peptide medicine, the development of peptide medicine will have a profound impact on it. my country attaches great importance to the development of peptide pharmaceuticals and has included it in the "Outline of the National Mediumand Long-term Science and Technology Development Plan (2006-2020)".What are peptide drugs? Protein drugs and peptide drugs are composed of amino acids according to a specific sequence. According to the classification method commonly used in the international pharmaceuticals industry, all drugs with the number of amino acid molecules more than 50 belong to the protein category(including the well-known insulin, interference Supplements, etc.), and medicines with less than 50 amino acid molecules belong to the peptide category. The advantage of peptide drugs is that it belongs to protein drugs,comes from nature, has high biological activity and no side effects. However,it degrades quickly in the body, has low stability, limited using routes, and complex production technology.
Thymalfasin is a peptide drug composed of 28 amino acids in a specific sequence. Due to the arrangement of amino acids, this product has considerable technical difficulties in peptide synthesis, separation and purification. The 1990s was a downturn in the development of international peptide drugs. At that time, excessive production costs severely restricted the development of peptide drugs. Due to the complexity of synthesis technology,the cost of reagents used for peptide bulk drugs is very high. Under normal circumstances, its synthesis requires dozens of steps, or even hundreds of chemical reactions, and there are complex high-performance liquid phase purification processes, which are very difficult for the equipment. And thetechnical requirements of employees are also very demanding. In addition, the production scale of peptide drug bulk drugs has a great impact on the cost, and many factors cause the final product to be expensive, some even cost thousands of dollars per gram. At the same time, the research and development of peptide drugs is risky and requires high synthesis technology. The national review and production registration requirements for peptide drugs are now in line with international registration. Even if the product is approved for production registration, in the production process, due to various reasons such as process, technology and equipment, the various indicators of the product do not meet the requirements, and the product cannot be sold on the market.
The company has always been committed to developing low-toxicity and high-efficiency peptide drugs. After obtaining the innovation fund of the State, Shanghai and Putuo District Science and Technology Commission, Thymalfasin is a new product with independent intellectual property rights developed by Soho-Yiming for three years. The drug can be used as an immune enhancer drug with clear curative effect and small side effects. It has always been used as the first choice for the treatment of chronic hepatitis B. It has also been widely used as an aid for patients with cancer, AIDS, chronic hemodialysis patients and other patients with immune system function suppression or damage treatment.
With the support of leaders at all levels, especially the Science and Technology Commission of Putuo District, Soho-Yiming Company finally developed a new drug of Thymalfasin with the same quality as foreign products through independent research and development. It uses solid-phase peptide synthesis technology to connect amino acids one by one. The high-resolution preparative high-pressure liquid chromatograph has multiple purification and separation, freeze-drying and other process links, and the final product purity is above 98.5%, which has greatly improved compared with the national standard 96% purity, ensuring the product high quality. It conforms to the management approach that Soho-Yiming has always pursued: leading technology and winning by quality. Due to the long-term dependence on imports, the high price of the drug and the patient's own expense, Soho-Yiming has reduced the cost through process optimization and large-scale production. The drug has also been included in the scope of medical insurance, and more patients will benefit from it.