Hua Medicine, the leading innovative drug development and commercialization company in China, and Roche announced today a licensing agreement for Roche's Glucokinase Activator (GKA) program. GKA is a novel, small molecule activator of the glucokinase enzyme which plays a key role in regulating carbohydrate metabolism. By increasing this enzyme's activity, GKA has the therapeutic potential to help lower elevated blood glucose levels seen in diabetes.
Diabetes affects over 92 million people in China, 25 million in the US, and over 230 million people world-wide according to the New England Journal of Medicine. It is a disease characterized by chronic high blood glucose levels that, if left untreated, can eventually lead to long-term complications including cardiovascular disease, chronic renal failure, blindness, and strokes.
Roche first demonstrated efficacy in lowering blood glucose levels of diabetic patients in clinical trials using a previous generation of its GKA compounds. The current and most advanced generation of the GKA drug candidate that is being licensed by Hua, has been further optimized for safety and efficacy and is now ready to begin clinical studies.
"Roche's GKA was designed to be a best-in-class drug candidate based on their extensive preclinical, clinical, and mechanistic experience with GK activation," said Li Chen, CEO of Hua Medicine. "We are very excited to extend the outstanding scientific efforts initiated by Roche, and to be granted the opportunity to carry forward the clinical development of GKA. Our ultimate goal is to materialize the potential of GKA to help millions of patients suffering from diabetes in China and world-wide."
Under the agreement, Hua Medicine will receive the full preclinical and clinical documentation for Roche's GKA program, drug product API for RO5305552, as well as rights to potential back-up compounds. In return, Roche will receive an upfront payment, milestones and royalty. Hua Medicine has been granted the exclusive development, manufacturing, and worldwide sales and marketing rights with the rights to sub-license.
About Hua Medicine
Hua is focused on becoming the leading, fully-integrated biotech company in China targeting world-wide markets. It has recently announced $50 million in a new financing on September 2011. With these proceeds, the company intends to leverage the lower-cost yet highest-quality drug discovery capabilities available in China, while partnering or licensing the most promising drug assets from Asia, the US and EU. Through these efforts, Hua intends to be the driving force behind China's evolution into a global innovation center for drug development. For more information, please visit www.huamedicine.com