Sunway is a privately-held, Shanghai-based biotechnology company founded in 1995. It is one of only two companies in the world to have successfully developed and commercialized a gene therapy product. Sunway's H101 (Recombinant Human Adenovirus Type 5), an adenovirus agent for the treatment of head and neck cancer, was approved in China in 2005.

Ad2/HIF-1a is an engineered form of the HIF-1a gene designed to promote the growth of new blood vessels and improve circulation in the limbs of patients with peripheral arterial disease. Genzyme is currently conducting a Phase 2 clinical trial of Ad2/HIF-1a involving more than 300 patients at 40 U.S. and European medical centers. The trial is examining the safety and effectiveness of locally delivered Ad2/HIF-1a to benefit patients with intermittent claudication, a form of peripheral arterial disease that results in disabling pain or fatigue in the legs, brought on by exercise.

Under the collaboration with Sunway, Genzyme will transfer its process for manufacturing Ad2/HIF-1a to Sunway, who will produce the product at its Shanghai facility for clinical trials. Sunway will design, fund and conduct Phase 1 and Phase 2 studies in China, focusing on patients with critical limb ischemia, a more severe form of peripheral arterial disease that often leads to the need for limb amputation. Genzyme previously completed a Phase 1 study of Ad2/HIF-1a involving patients with critical limb ischemia.

A Phase 3 development program would be funded equally by Genzyme and Sunway, and the companies envision jointly commercializing a therapy in China if the development program is successful.