ABSTRACT
In June 2004,the US Food and Drug Administration (FDA) issued Guidance for Industry:Botanical Drug Development,which opened a new path for the internationalization of traditional Chinese medicine (TCM).In October 2006,the first botanical drug product Veregen TM was approved by the FDA.The regulatory policy for botanical and herbal medicine coincides with the internationalization strategy of Hutchison MediPharma Ltd.(hereinafter referred to as Hutchison).In 2006,Hutchison's first herbal mixture medicine andrographis paniculata HMPL-004 successfully obtained Investigational New Drug (IND) from the US.From 2006 to 2014,there are eight clinical studies of HMPL-004 being conducted in Europe and the US,from Phase 1 safety study to proof-of-concept trials in ulcerative colitis (UC) and Crohn's disease.To strengthen HMPL-004 development on a global scale,Hutchison made business alliance with Nestle Health Science in clinical development as well as basic research.Due to futile outcome of an interim analysis,the Phase Ⅲ registration study in UC was terminated.However,valuable lessons were learned with the birth of the generation botanical drug product HMPL004-6599.