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CFDA approves Phase I clinical trial for Sirona's SGLT-2 inhibitor
August 29, 2018
By: Tim Wright
Editor-in-Chief, Contract Pharma
Sirona Biochem has received a $500,000 milestone payment from partner Wanbang Biopharmaceuticals for approval by the China Food and Drug Administration (CFDA) of the Phase I clinical trial for Sirona’s SGLT-2 inhibitor. Sirona’s SGLT-2 inhibitor, TFC-039, will continue to be developed for the treatment of Type 2 diabetes. Since the two companies signed a licensing agreement in 2014, Sirona Biochem has secured $1.5 million in development milestones from Wanbang. Shortly after the announcement of the approval, Sirona chief executive officer, Howard Verrico met with the Wanbang team at the Shanghai Fosun Pharmaceutical Industrial Development Company Limited headquarters in Shanghai. The meeting focused on next steps in the development of Wangeliejin, the name for TFC-039. Wanbang expressed their full dedication to the SGLT-2 inhibitor project. The team also shared that while Wanbang has primarily focused on developing generic drugs, developing TFC-039 shows a need for such a medication in China and their belief in Sirona’s compound. Clinical trials are currently being set up and anticipated to begin as early as October. “As we move into the second half of 2018, we are pleased with the dedication and progress Fosun has made in developing Sirona’s SGLT-2 inhibitor for the Chinese market. Following our most recent meeting in Shanghai, both teams remain enthused about the project and partnership,” said Dr. Verrico. “Wanbang’s powerful marketing, distribution and retail channels allows them to maintain a strong position in the diabetes treatment market. We look forward to the continued progress in working towards a treatment for Type-2 diabetes.”
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