More than half of the special funds for the creation of major new drugs in China
2022-11-10 13:07:46
Zyzhan guide : "The first academic conference on drug clinical trials in 2014" was held in Zhongguancun, Beijing on February 21st. It was learned at the meeting that as of the end of 2013, China's "12th Five-Year Plan" period "major new drug creation" technology special expenses It costs about 6.5 billion yuan and still has a balance of more than 5 billion yuan.
Among the funds already spent, more than 70 new drugs have been produced; more than 150 large varieties have been transformed, with direct economic benefits of 80 billion yuan and indirect benefits of 300 billion yuan. Among the 17 major special projects approved by the State Council, the comprehensive index of major new drugs has jumped to second place.
36 new drugs <br> <br> As of September 2013, with the support of new drugs, "major projects" funds, a total of 52 varieties get 74 new drug certificate (including the "Eleventh Five-Year" achieved 33 varieties and 44 Certificate), 36 varieties have independent intellectual property rights, accounting for 69.23%.
52 varieties include: 9 chemicals, 9; 25 chemical products; 3 chemical products; 3; 1 biological product for treatment; 1 biological product for prevention; 1 biological product for treatment; 1; 1 Chinese medicine 5; Chinese medicine 6 9; and 1 pharmaceutical excipient.
Among them, the typical products of influenza prevention and control drugs developed in China are prolonged, such as oseltamivir phosphate capsules as preventive and therapeutic drugs, and peramivir trihydrate injection for first aid in critically ill patients. drug. Anti-diabetic nephropathy, a new Chinese medicine, Rhein, is about to enter Phase II clinical; Class I biotechnology new drug recombinant human urokinase has obtained a new drug certificate and production approval, and has built a production line with an annual output of 40,000 liters of fermentation broth.
China's targeted G-protein coupled receptor (GPCR) has been deployed in advance, and has been targeted at more than 20 GPCR-like targets such as C5aR, C3aR, and mGluR1, including immune system diseases, neurodegenerative diseases, asthma, and tumors. Twenty lead compounds with a completely new structure.
<br> <br> emphasis on medicine assessments on biological innovations, Hengrui Pharmaceuticals established ADC antibody conjugated to a small molecule platform, the first generation SHR-A1201 has been declared clinically document. The second generation of products is undergoing a comprehensive pre-clinical evaluation.
The vaccine supervision technology system passed the assessment of the World Health Organization, and the vaccine batching and laboratory comprehensive undertaking undertaken by the China Food and Drug Administration Institute were all passed. The self-developed Sabin strain polio inactivated vaccine has completed clinical trials and has applied for a new drug certificate.
From the analysis of the acceptance of the 1.1 categories of products in 2013, China is still in the stage of combining imitation and imitation with the first and second level of innovation. Many participants expect that the regulatory authorities will encourage high-level generic drugs to guide the development of generic drugs and production levels.
Some experts have also clearly stated that China is still in the initial stage of new drug research and development, and must learn from the experience of international new drug research and development to minimize the losses caused by the development of new drugs. It is recommended that clinical research institutions establish “biomarkers†as important observation endpoints. Because animal experiment results do not fully predict clinical outcomes, and patent acquisition or "newness" does not indicate safety and effectiveness.
Among the funds already spent, more than 70 new drugs have been produced; more than 150 large varieties have been transformed, with direct economic benefits of 80 billion yuan and indirect benefits of 300 billion yuan. Among the 17 major special projects approved by the State Council, the comprehensive index of major new drugs has jumped to second place.
36 new drugs <br> <br> As of September 2013, with the support of new drugs, "major projects" funds, a total of 52 varieties get 74 new drug certificate (including the "Eleventh Five-Year" achieved 33 varieties and 44 Certificate), 36 varieties have independent intellectual property rights, accounting for 69.23%.
52 varieties include: 9 chemicals, 9; 25 chemical products; 3 chemical products; 3; 1 biological product for treatment; 1 biological product for prevention; 1 biological product for treatment; 1; 1 Chinese medicine 5; Chinese medicine 6 9; and 1 pharmaceutical excipient.
Among them, the typical products of influenza prevention and control drugs developed in China are prolonged, such as oseltamivir phosphate capsules as preventive and therapeutic drugs, and peramivir trihydrate injection for first aid in critically ill patients. drug. Anti-diabetic nephropathy, a new Chinese medicine, Rhein, is about to enter Phase II clinical; Class I biotechnology new drug recombinant human urokinase has obtained a new drug certificate and production approval, and has built a production line with an annual output of 40,000 liters of fermentation broth.
China's targeted G-protein coupled receptor (GPCR) has been deployed in advance, and has been targeted at more than 20 GPCR-like targets such as C5aR, C3aR, and mGluR1, including immune system diseases, neurodegenerative diseases, asthma, and tumors. Twenty lead compounds with a completely new structure.
<br> <br> emphasis on medicine assessments on biological innovations, Hengrui Pharmaceuticals established ADC antibody conjugated to a small molecule platform, the first generation SHR-A1201 has been declared clinically document. The second generation of products is undergoing a comprehensive pre-clinical evaluation.
The vaccine supervision technology system passed the assessment of the World Health Organization, and the vaccine batching and laboratory comprehensive undertaking undertaken by the China Food and Drug Administration Institute were all passed. The self-developed Sabin strain polio inactivated vaccine has completed clinical trials and has applied for a new drug certificate.
From the analysis of the acceptance of the 1.1 categories of products in 2013, China is still in the stage of combining imitation and imitation with the first and second level of innovation. Many participants expect that the regulatory authorities will encourage high-level generic drugs to guide the development of generic drugs and production levels.
Some experts have also clearly stated that China is still in the initial stage of new drug research and development, and must learn from the experience of international new drug research and development to minimize the losses caused by the development of new drugs. It is recommended that clinical research institutions establish “biomarkers†as important observation endpoints. Because animal experiment results do not fully predict clinical outcomes, and patent acquisition or "newness" does not indicate safety and effectiveness.
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