This month’s Innovation That Matters features an interview Dr. Li Chen, CEO of Hua Medicine. Chen and his colleagues at Hua had much to celebrate in November as their novel Type II diabetes treatment entered clinical trials in China. This milestone marks the first case in China for a “First-in-Man” study of a novel chemical entity with an entirely new mechanism of action for diabetes treatment.
Congratulations on entering Phase I. To start, could you provide some insights into the drug and the trial?
Sure. We licensed the drug, a fourth-generation glucokinase activator, from Roche in December 2011, and since then have worked with our partners to enter the clinic. Having succeeded in these tasks, we’ve now begun enrolling diabetes patients in a Phase I study. It is the first time a personalized medicine approach has been tested in Type II diabetes in China, so we’re very excited by our progress.
How has the novel nature of the drug affected the regulatory process?
It’s meant we’ve been breaking new ground. The Chinese FDA assessed our submission under its special review channel for innovative drugs, and the process was rigorous yet swift. We think it’s a significant step forward in regulatory oversight of drugs with novel mechanism of actions. Our use of a “Collaborative Innovation” operating model also helped us advance the drug quickly.
That sounds interesting. Could you explain the “Collaborative Innovation” approach?
“Collaborative Innovation” harnesses the growing drug discovery and development ecosystem in China to deliver products that improve patient outcomes. So, for example, we have partnered with WuXi for clinical drug supply and other services. We believe that tapping into our collective capabilities is central to the growth and internationalization of the Chinese pharmaceutical industry. Ultimately, it is the best way to improve the lives of patients.