Sirona Biochem Announces CFDA Approval of SGLT2 Inhibitor for Phase I Clinical Trial

Sirona Biochem Corp. announced that partner, Jiangsu Wanbang Biopharmaceuticals, has confirmed the Investigational New Drug (IND) submission to China’s Food and Drug Administration (CFDA) for its SGLT2 inhibitor was approved for clinical trial. Wanbang will be entering a Phase I clinical trial for the treatment of Type 2 diabetes. The CFDA approval triggers a $500,000 USD milestone payment to Sirona Biochem.

Sirona Biochem’s SGLT2 inhibitor, TFC-039, was licensed to Wanbang’s parent company, Shanghai Fosun Pharmaceuticals in 2014 with rights for China. Since the initial licensing agreement, Fosun Pharma has invested more than RMB 29 million toward the development of the SGLT2 inhibitor.

According to the International Diabetes Federation and the World Health Organization, China now has some of the highest rates of diabetes cases, affecting 110 million people, or 11% of the population. Over 90% of the cases are Type 2 diabetes.

“Wanbang has been very dedicated to this project and we are pleased to be advancing to the clinic with the compound,” said Dr. Howard Verrico, CEO. “With the surging rates of diabetes in China, there remains a need for new therapies. TFC-039 will be able to enter this market as a once-daily drug or add-on therapy for the many people struggling with this disease.”