Peg-interferon and other new genetic drugs
The main business performance of Ternary gene comes from interferon α 1B, which has a unique molecular structure and function. In order to maintain the continuous growth of the company's performance, the company is fully promoting the development of the existing interferon related products into the clinical trial stage.
The main business performance of Ternary gene comes from interferon α 1B, which has a unique molecular structure and function. In order to maintain the continuous growth of the company's performance, the company is fully promoting the development of the existing interferon related products into the clinical trial stage. Sanyuan gene was listed on the North Stock Exchange to raise funds, mainly used for the company's four key R&D and innovation projects: the phase iii clinical trial of recombinant human interferon α 1B aerosol inhalation in the treatment of pediatric RSV pneumonia; Phase iii clinical trial of recombinant human interferon α1b for prevention and treatment of COVID-19; Phase ii clinical trial of a novel PEGylated interferon mutant injection with accompanying gene Detection in the treatment of hepatitis B; Phase ⅰ / ⅱ clinical study of tumor immunotherapy with γδT cells.
The development of clinical trials of interferon α1b aerosol inhalation for RSV pneumonia and interferon α1b prevention and treatment of COVID-19 will greatly expand the clinical application of interferon in pediatric and adult respiratory fields. The development of the above two projects will become the world's first interferon product delivered by atomized inhalation, as a major innovative drug approach for major new indications, which is in line with the development trend of clinical application in pediatric respiratory and adult respiratory clinical fields. The company has kept abreast of the latest developments in novel Coronavirus worldwide, conducted clinical research cooperation with a number of designated COVID-19 treatment centers, and adjusted the clinical trial plan in a timely manner according to the changes in the epidemic characteristics of the virus and the development of new drugs. In terms of population selection, the new omicron variant is susceptible to infecting children, and there is a global lack of innovative drug development targeting younger children. The company intends to conduct a clinical study on COVID-19 in children based on the favorable safety results of the completed aerosol inhalation of human interferon α 1B for the treatment of viral disease in children. There are no approved drugs for treating children worldwide.
The new PEGylated interferon mutant injection is molecularly designed to combine high efficiency, long-term efficacy and safety, and is administered weekly for clinical use, which will improve patient compliance. The safety of the drug has been preliminarily demonstrated in phase I clinical trials, and the innovative use of site-specific PEG modification improves product quality and reduces manufacturing costs. This innovative technology has been granted 17 patents in China, the United States, Japan, South Korea and Egypt, and is a new generation of comprehensive high-performance interferon with long acting, high efficiency and low toxicity. Based on the core technology of this project, the platform construction has been completed, which has been identified as the long-acting interferon Engineering Research Center by Beijing Science and Technology Commission. Interferon sensitive gene detection technology is expected to replace the current treatment means of guiding drug use according to experience and serological indicators, and can more accurately test the patients who are suitable for the use of interferon treatment, thus improving the accuracy of interferon treatment of chronic hepatitis B. This combination program is aimed at hepatitis, a major infectious disease, and its unique advantages are in line with the guidance of global and Chinese hepatitis treatment guidelines in recent years, that is, precise diagnosis and treatment with clinical cure as the main treatment goal. The successful development of the project will also create huge economic and social benefits.
γδT cells have a direct killing effect on tumor cells and are non-MHC limiting. Therefore, γδT cells have a broader tumor recognition spectrum than other lymphocytes, and are more prone to rapid activation and effect, especially with the good synergistic effect of recombinant human interferon α 1B. In addition, γδT is unique in that it combines adaptive (γδ TCr-mediated) and innate (NK cell-like) immunity to specifically recognize and eliminate tumor cells without affecting normal healthy cells. Moreover, γδT cells perform their tumor-killing function in an MHC-independent manner, and thus can be used in allotherapy without the risk of GVHD. Basic and clinical research on γδT cell immunotherapy will further expand the company's oncology application field, further enrich the product mix, add luster to the road of human cancer fighting, and create huge economic and social benefits.