14 June 2012 | News | By BioSpectrum Bureau
Biostar, military varsity to tie up for drug trial
The letter of intent awaiting approval from China's military authorities
Singapore: Biostar Pharmaceuticals, a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, has signed a letter of intent with The Fourth Military Medical University (FMMU) to jointly conduct phases I to III clinical trials for Viacom Pine II Cream drug. The letter of intent has been submitted to China's military authorities for approval.
Viacom is a prescription drug developed by the First Affiliated Hospital of Dermatology of FMMU specifically for the needs of China's military and will be used to treat skin diseases such as bacterial and fungal infections, dermatitis and eczema. Viacom has passed all standard tests related to quality, stability, toxicology and efficiency. Phases I to III clinical trials must be conducted for a period of three years prior to receiving final approval from military authorities to start production.
FMMU is one of China's most prestigious military medical universities and research centers and its primary purpose is to advance China's military medicine. In January 2012, Biostar was one of nine PRC pharmaceutical companies selected to cooperate with FMMU in the fields of research and product development.
According to the terms agreed upon, FMMU will be responsible for submitting applications and receiving approvals to commence clinical trials; coordinating with China's military authorities during clinical trials and securing all needed approvals to continue phases I to III of these clinical trials for the next three years at FMMU's facilities; securing final production approvals by October 2015; and providing the technology to ensure the quality and effectiveness of the product.
Biostar will be responsible for coordinating with FMMU to complete the clinical trials before October 2015; bearing all costs of clinical trials and approvals; completing the construction of the production line and obtaining the GMP certification on time; and manufacturing the drug using the technology provided by FMMU.
Biostar's Chief Executive Officer and Chairman Ronghua Wang commented, "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 PRC armed forces. Additionally, these types of skin diseases affect a large portion of China's population and, if not treated properly, could result in severe health complications. Once Viacom receives approval from the military authorities to be sold in military hospitals, we will apply to receive SFDA's approval to sell it in health care centers and hospitals all over the country."