The first locally-developed traditional Chinese medicine for constipation authorized to initiate clinical trials in the U.S.

26 July 2023

Professor Bian Zhaoxiang, Associate Vice-President (Chinese Medicine Development), Director of the Clinical Division of the School of Chinese Medicine, and Director of The Centre for Chinese Herbal Medicine Drug Development (CDD), along with his team at CDD, have developed an innovative traditional Chinese medicine for treating chronic constipation. The medicine has been approved by the U.S. Food and Drug Administration to commence phase one of clinical trials. This is the first locally-developed new medicine based on traditional Chinese herbs in Hong Kong that is approved for clinical trials in the U.S.

Currently, about 14% of the global population suffer from chronic constipation. With the aim of providing a better treatment for patients, CDD has collaborated with the University of Chicago and the University of Macau to develop the new drug CDD-2101, based on previous pilot clinical research and fundamental research on the traditional Chinese herbal formula "Mazi Ren Wan". The main ingredients of CDD-2101 include six Chinese herbal medicines: including hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root.

Professor Bian Zhaoxiang said: "CDD-2101 is an innovative drug developed by combining traditional Chinese herbal formulas with advanced technology and is manufactured in accordance with international standards. The approval to conduct clinical trials by the U.S. Food and Drug Administration is an important milestone in the development of Chinese medicine in Hong Kong."

CDD-2101 will undertake its first phase of clinical trials in the U.S. within this year. The ultimate goal of the drug development plan is to collect enough safety and effectiveness data to gain approval from the U.S. Food and Drug Administration for CDD-2101 to become a marketable new drug.

Funded by the Innovation and Technology Commission's InnoHK research platform, CDD is the first comprehensive Chinese medicine research center of local universities. The School is encouraged by this landmark progress in their research.

For more information about this research, please click here to read the press release.

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Professor Bian Zhaoxiang (middle), Associate Vice-President (Chinese Medicine Development) and Director of the CDD; Ms Emily Au (left), Assistant Director (Research and Development) of the CDD; and Dr Lam Yan-yan (right), Assistant Professor of the CDD at HKBU