China Biopharma, Inc., has reached a tentative agreement with Delmont Laboratory to introduce its immunotherapeutic vaccine Staphage Lysate that treats diseases of staphylococcal infection. According to this initial agreement, Delmont Laboratory will supply bulk materials and China Biopharma will contract local manufactures for the final packaging in China.
CBPC will also conduct a study before a definitive agreement is to be signed. This product requires a clinical study and an approval from the Chinese SFDA before it is sold in China, though the product already has the FDA approval.
As many as 1.2 million U.S. hospital patients may be infected each year with a Staph infection which is resistant to antibiotics, according to a research conducted by Association for Professional in Infection Control and Epidemiology.
Each year up to 119,000 of these patients may die from the tough-to-treat strain of bacterium, called methicillin-resistant Staphylococcus aureus (MRSA). No effective drugs are currently available in China to treat this infection and this vaccine is greatly needed.
The approval process may take about two years and once approved it would bring up to $20-30 million sales revenue every year.
Source: PR Newswire