Development of Beijing Lvzhu Biopharmaceutical Co., Ltd.

Our company took the lead in developing meningococcal polysaccharide conjugate vaccines of groups A and C, which was approved by the US Food and Drug Administration for clinical research in June 2003 +065438+ 10, and completed the first, second and third phase clinical research in March 2005 (funded by the Innovation Fund of the Ministry of Science and Technology in 2003), and declared the production number in April 2005; In May 2006, it obtained the certificate of new drug, and became the first manufacturer in the world to successfully develop meningococcal polysaccharide conjugate vaccine of group A and group C.

Group A, C, Y, W 135 meningococcal polysaccharide vaccines developed by our company were approved by the State Food and Drug Administration for clinical research in March 2005, and the third phase of clinical research was completed in June 5438+February of the same year, and the production approval was declared in April 2006. The product adopts our proprietary technology, the quality of meningococcal polysaccharide is obviously better than that stipulated by the World Health Organization, and the content of heat source material is only 60% stipulated by the World Health Organization. Solved the common problem of high fever rate of polysaccharide vaccine.

In June 2007, meningococcal polysaccharide conjugate vaccines of groups A and C passed GMP certification, and in June 2008, meningococcal polysaccharide vaccines of groups A, C, Y, W 135 passed GMP certification. At present, two new vaccines have been industrialized.