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863 Plan Brings Fruitful Results to Innovative Drugs in Biological Field
At present, a total of 13 drugs have obtained new drug certificates and 101 new drugs have entered the clinical trial phase. At the same time, there are hundreds of innovative and promising prospects in the preclinical experimental phase. The major varieties approved for listing in 2004 are as follows: “Taroâ€TM, an anti-diabetic new drug: The “Taroâ€TM, a new anti-diabetic drug with independent intellectual property developed in China through the combination of drug design and experimental research, was launched in November 2004. On the 7th, it was officially listed in Chongqing. The “Taroâ€TM was developed by the Academy of Military Medical Sciences, the Beijing Drug Molecular Design Center was incubated, and the Taiji Industrial Group was exclusively transformed. The drug has successively obtained national invention patent authorization, SFDA new drug certificate and production approval. Taiji Group strives to make it the top-ranking diabetes drug in China within five years. Recombinant human P53 adenovirus injection: "Recombinant human P53 adenovirus injection" is the world's first officially launched gene therapy drug. On October 16, 2003, he received the Class I New Drug Certificate issued by the State Food and Drug Administration. On January 20, 2004, he obtained the test production approval. The new drug marks China's first industrialization in gene therapy medicine, and once again proves that China has the ability to seize opportunities in the increasingly fierce international competition in the pharmaceutical industry. Since the products were put on the market, they have been in short supply and have produced good economic and social benefits. Tangcao tablet: After taking this medicine, it can obviously improve the clinical symptoms, improve immunity, and inhibit the replication of HIV. At the same time, it has no obvious toxic and side effects. In April 2004, the State Food and Drug Administration formally approved Tangcao tablets as the country's three new drugs and issued new drug certificates. Butylphthalide: The special topic “Ding Phenol Raw Materials and Series Preparations†is an effective ingredient extracted from celery and is an innovative drug for the treatment of acute ischemic stroke with China’s independent intellectual property rights. The drug was jointly developed by the Institute of Materia Medica, Chinese Academy of Medical Sciences and Shijiazhuang Pharmaceutical Group and has been officially approved for listing. This medicine has made China reach the international advanced level in the research field of therapeutic drugs for cerebrovascular diseases and has significant economic and social benefits. Recombinant staphylokinase for injection: the world's first "recombinant staphylokinase for injection" biological new drug, received the new type I drug certificate issued by SFDA on July 8, 2003, and has the construction of engineering bacteria, production methods and preparation and verification methods of antibodies And other 3 patents. As a novel recombinant protein thrombolytic agent, recombinant staphylokinase is superior to the currently clinically applied SK, UK, and t-PA in terms of efficacy, safety, specificity, and action time, and the production cost is low. The launch of "Injection Recombinant Staphylokinase" will provide a powerful tool for humans against the cardiovascular disease, the world's largest deadly disease. Qi Tai Ning: The micro-ecological agent "Kai Tai Ning" received a new drug certificate issued by the SFDA on December 12, 2003. Microecological drugs are a new generation of natural, mild, safe and non-toxic side effects drugs that can effectively reduce the abuse of antibiotics and have huge market potential. Through scientific and technological research, China has now overcome the major shortcomings of traditional microecological drugs requiring cryopreservation at 2-8°C and unstable quality, and has developed a highly stable microecological drug with internationally advanced quality that can be stored at room temperature for 2 years and has been constructed. The country's largest series of micro-ecological pharmaceutical industrialization bases, annual production of "series of micro-ecological biological new drugs," 900 million (bags, tablets). Recombinant Human New Type Tumor Necrosis Factor: New Antitumor Drug “Recombinant New Tumor Necrosis Factor†was awarded the National New Drug Certificate on March 17, 2004. The new drug has been transformed into a natural tumor necrosis factor molecule through protein engineering technology, and a highly selective and low-toxic selective receptor mutant with independent intellectual property rights has been obtained. The cooperative company is in the process of GMP demonstration of the production workshop and is expected to put into production at the end of the year. GM-CSF Oral Drugs: Bombyx mori is used as a bioreactor to efficiently express GM-CSF oral drugs. It was approved by the FDA on July 8, 2003 for clinical trials and was granted by the National Patent Office. Bombyx mori is the economic animal with the most traditional features of our country. The use of silkworm as a bioreactor to efficiently express biopharmaceuticals and develop oral dosage forms of protein drugs is the first of its kind for scientists in China and opens up new ideas for bioengineering pharmaceuticals.