Melbourne-based BioDiem has announce that Changchun BCHT Biotechnology Company (BCHT) has received IND approval from the Chinese FDA (CFDA).
BioDiem is focused on developing and commercialising vaccines and infectious disease therapies. Its business model is to generate income from partnerships including with other vaccine and infectious disease treatment companies through existing and new licences to its LAIV vaccine and other technologies.
The company says the approval in China is an important milestone in the development of BCHT’s LAIV influenza vaccine manufactured under licence from BioDiem.
The IND approval will permit BCHT to commence clinical trials which are planned to start enrolment of patients in December 2015.
According to CFDA's requirement and BCHT's marketing strategy, a Phase I trial will be initially conducted in adults aged 18 to 49 and, thereafter, the trial will enrol younger people aged between 3 and 17 years. The trial protocol is being finalised together with CFDA experts.
“This is a significant milestone for BioDiem," said BioDiem CEO Julie Phillips. "In general, sales for flu vaccines in China are about 40 million to 50 million doses annually, which corresponds to 3- 4% of the population. The vaccination rate is very low compared with developed countries and, thus, the flu vaccine market has a great growth potential. A significant benefit of the LAIV ‘flu vaccine is that patients are vaccinated by a nasal spray instead of an injection.”