RegeneRx and Lee's Pharm accelerate RGN-259 development in China

US biotech RegeneRx Biopharmaceuticals (OTC Bulletin Board: RGRX) and Hong Kong-based Lee’s Pharmaceutical (HKEx: 0950) have announced acceleration of development of RGN-259 in China.

According to Lee's Pharm, the company's licensee and partner in China, in April the Chinese Food and Drug Administration (CFDA) modified its regulations for conducting clinical trials in China with "locally" developed drug candidates that have been partially developed outside of the country, as is the case with RGN-259.

Previously, the CFDA required Phase I and Phase II clinical trials to be conducted with a drug candidate entirely made in China (including both the active pharmaceutical ingredient and the finished product). In April, the CFDA changed its regulations to allow Phase I and II clinical trials with drug candidates manufactured abroad. This rule change is intended to speed up drug development in China since "local" drug development in China may now rely on drugs sourced outside of the country in early clinical trials. Phase III and all registration studies must still be conducted with the drug candidate fully manufactured in China.