In September 2007 Tianyuan's AC and ACYW135 Meningococcal Polysaccharide Vaccine got the new New Drug Certificate issued by Chinese State Food and Drug Administration (SFDA) and the approval number for manufacturing.
In previously executed clinical trials both high-quality vaccines showed excellent safety and efficacy.
Tianyuan is the first approved manufacturer in China, who introduced the quadrivalent Meningococcal Polysaccharide vaccine (ACYW135) on the Chinese market.
This is an important step, as Tianyuan is now in a good position to introduce an extended product portfolio, offering not only viral but also bacterial vaccines.
Group AC Meningococcal Polysaccharide Vaccine reaps the benefits of a two-year patent protection period in China while Group ACYW135 Meningococcal Polysaccharide Vaccine enjoys a three-year patent protection period.
Meningococcal Polysaccharide Vaccine
Meningococcal meningitis caused by the bacterium Neisseria meningitides, is a serious infection of the fluid in the spinal cord and the fluid that surrounds the brain and can result in brain damage and even death.
The bacteria are spread by direct close contact with the discharges from the nose or throat of an infected person.
Meningococcal meningitis is most common in infants and children. People who have had close or prolonged contact with a patient with meningococcal meningitis are at increased risk.
Bacterial meningitis can be treated with antibiotics, but an early diagnosis and treatment is crucial.
To prevent the disease, vaccines are the best choice.
Tianyuan's Meningococcal Polysaccharide Vaccine YUNAONING will become available as divalent (AC) or quadrivalent (ACYW135) formulation by the end of 2008. The vaccines consists of highly purified polysaccharides of the different meningococcal serogroups.
Although mostly serogroups A and C are prevalent in China, the quadrivalent vaccine provides additional protection. Both vaccines are high-quality vaccines. Tianyuan aspires to get the WHO-prequalification for its vaccines.