China’s Biostar Pharmaceuticals is teaming up with the country’s Fourth Military Medical University (FMMU) to jointly conduct Phase I–III clinical trials with the latter’s Viacom Pine II Cream, which is in development initially for use by the military to treat skin diseases including bacterial and fungal infections, dermatitis, and eczema.
Under terms of the Letter of Intent signed between the organizations, Biostar will coordinate with FMMU to complete clinical trials before October 2015, and will fund and carry out trials and approvals, as well as complete the construction of a production line, obtain GMP certification, and manufacture the drug using FMMU technology. FMMU will submit applications relating to the start of trials, coordinate with China’s military authorities, and secure final product approvals.
The LOI follows a cooperation agreement signed in January 2012 under which Biostar was sleected to share resources and ideas with FMMU, and to collaborate on the clinical trials of products in development for China’s military, and hospitals managed by FMMU. “Following the initial clinical research, Viacom has demonstrated encouraging results for the treatment of several skin diseases such as bacterial and fungal infections, dermatitis, and eczema, which are common among members of the People’s Republic of China armed forces,” explains Ronghua Want, Biostar chairman and CEO. “Once Viacom receives approval from the military authorities to be sold in military hospitals, we will apply to receive the State Food & Drug Administration’s approval to sell it in healthcare centers and hospitals all over the country.”