Sirona Biochem announced its partner Wanbang Biopharmaceuticals has confirmed an investigational new drug (IND) submission to China's Food and Drug Administration (CFDA) for its SGLT2 inhibitor
The application will be reviewed by the CFDA for acceptance into clinical trials. Wanbang has confirmed it is processing a $500,000 payment to Sirona Biochem.
Sirona Biochem's SGLT2 inhibitor was licensed to Wanbang's subsidiary Shanghai Fosun Pharmaceuticals in 2014 with rights for China.
This compound, created for the treatment of Type 2 diabetes, will be only the second SGLT2 inhibitor listed in China following the listing of AstraZeneca's earlier this year.
Since the initial licensing agreement, Fosun Pharma has invested RMB 29 million for the research and development of the SGLT2 inhibitor. With acceptance of the IND application by the CFDA, Fosun Pharma will begin clinical trials, triggering another milestone payment to Sirona Biochem.
"We are very pleased with the progress that has been made by Wanbang thus far with the SGLT2 inhibitor and are eager to see the project through to clinical trials. With clinical trials also planned for our skin lightening agent TFC-1067 in 2018, this demonstrates the enormous potential of our proprietary platform technology," said Dr Howard Verrico, CEO of Sirona Biochem.