Chongqing Zhifei Biological Product Co., Ltd. got the approval documents for clinical test of its Mycobacterium Vaccae for Injection (Vaccae) from the SFDA (State Food and Drug Administration).
According to the approval documents, the product could be used as a biological product in Phase III clinical test for the prevention of tuberculosis.
As a product independently-developed and sold by Zhifei Biological, Vaccae could be used as adjuvant drug for the chemotherapy of tuberculosis. The product generated income of CNY 36.64 million, CNY 46.01 million and CNY 41.36 million in 2010, 2011 and the first three quarters of 2012, respectively, with an average gross profit margin of about 89.24%.
According to the 2012 global tuberculosis report issued by the WHO (World Health Organization), a total of 13 vaccines for the prevention of tuberculosis in the world have entered clinical research stage and only India’s M.indicus pranii (MIP),which is still being developed, has entered Phase III clinical test stage. According to Zhifei Biological, the approval of the Vaccae to be used in Phase III clinical test means China has caught up with other countries in the study in this field.
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