This is the first time that a new botanical drug developed in Hong Kong was authorised to conduct a clinical trial in the US
The Centre for Chinese Herbal Medicine Drug Development (CDD) of Hong Kong Baptist University (HKBU) has made significant progress in developing novel Chinese medicine for treating chronic constipation. With its success in the Investigational New Drug Application to the U.S. Food and Drug Administration (FDA), CDD has been authorised to conduct a phase I clinical trial of the new drug. This is the first time that a new botanical drug developed in Hong Kong was authorised to conduct a clinical trial in the US.
The clinical trial will be launched later this year to evaluate the safety, tolerability, and pharmacokinetics profile of the new drug on healthy individuals.
The main ingredients of CDD-2101 include hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root. The HKBU research team collaborated with partners including the University of Chicago and the University of Macau to submit an Investigational New Drug Application for CDD-2101 according to the requirements for botanical drug development of the U.S. FDA and was authorised to conduct a phase I clinical trial.
Professor Alexander Wai, President and Vice-Chancellor of HKBU, said, “HKBU is committed to promoting the development of Chinese medicine and conducting cutting-edge scientific and translational research in this area. The University received funding from the Innovation and Technology Commission’s InnoHK initiative to establish the CDD in 2020, which significantly boosted our comprehensive capabilities in the research and development of Chinese medicine. The clinical trial in the US will provide us with invaluable experience in conducting clinical trials at Hong Kong’s first Chinese Medicine Hospital in future.”
Professor Bian Zhaoxiang, Associate Vice-President (Chinese Medicine Development), Director of the Clinical Division of the School of Chinese Medicine, and Director of the CDD at HKBU, said, “CDD-2101 is a novel drug developed by combining a traditional Chinese herbal formulation and advanced technologies, with research and manufacturing conducted in compliance with international standards. Obtaining U.S. FDA’s authorisation to conduct a clinical trial for this new drug is an important milestone in the development of Chinese medicine in Hong Kong, and it reflects HKBU’s capabilities in and dedication to promoting the standardisation and internationalisation of Chinese medicine.”