Modernizing Traditional Chinese Medicines
Traditional Chinese or herbal medicines (TCM) have been used by patients and doctors for thousands of years. According to a 2006 overview in Toxicologic Pathology, the “documentation of Chinese materia medica (CMM) dates back to around 1,100 BC when only dozens of drugs were first described. By the end of the 16th century, the number of drugs documented had reached close to 1,900. And by the end of the last century, published records of CMM have reached 12,800 drugs.”[1]
Even with its historic longevity and therapeutic breadth, to date not a single TCM product has been marketed as a prescription drug in mainstream medical markets [2] — yet!
Thanks to Professor De-An Gou, his colleagues at Shanghai Institute of Materia Medica, and the Chinese government, analytical scientists are strengthening TCM through evidence-based characterization techniques. The U.S. Pharmacopeia and European Pharmacopoeia have adopted TCM quality monographs and several TCM products are in stage II and phase III clinical trials (see table below).
What scientists are witnessing are integrated research efforts that serve as a scientific bridge between long-held experiential and observational techniques of TCM practices with a system biology approach to understanding chemical compositions, active ingredient principles, etc.
As the first Waters Centers of Innovation Program partner solely focused on globalizing TCM, Prof. Guo and his colleagues capture the status of this scientific bridge in a recent publication in the World Journal of Traditional Chinese Medicine entitled: Current Status and Future Perspective in the Globalization of Traditional Chinese Medicines. This article outlines the key progress and issues related to TCM globalization efforts serving as a roadmap for the TCM industry and patients who are and can benefit from TCM products.
Summary of the Nine TCM products Filed for Application in FDA from China
|
Name |
Indication |
Clinical Trials.gov |
Clinical |
Manufacturer |
| Dantonic | Angina pectoris | NCT01659580 | Phase III | Tasly Pharmaceuticals, Inc |
| Ginkgonin | Coronary heart disease; Angina pectoris | (a) | Phase III | Shanghai Xingling Sci & TechPharmaceutical Co., Ltd |
| KYG0395 | Primary Dysmenorrhea | NCT01588236 | Phase II | Jiangsu Kanion Pharmaceutical Co.,Ltd |
| Fuzheng Huayu Tablet | Chronic Hepatitis Infection | NCT00854087 | Phase II | Shanghai University of TCM & Shanghai Sundise Traditional Chinese Medicine Co., Ltd. |
| XueZhiKang Capsule | Hyperlipidemia | NCT01327014 | Phase II | Beijing Peking University WBL Biotech Co., Ltd |
| WeiMaiNing | Lung cancer | (b) | Phase II | Huayi Pharmaceutical Co., Ltd |
| Kanglaite Injection | Stage IV NSCLC | NCT01640730 | Phase II | Kang Lai Te USA |
| Kanglaite Gelcap | Prostate Cancer | NCT01483586 | Phase II | KangLai Te USA |
| HMPL-004 | Ulcerative Colitis | NCT01882764 NCT01805791 |
Phase III | Hutchison Whampoa Limited |
(a) Data are available from https://clinicaltrials.gov/.
(b) Data are not available from https://clinicaltrials.gov/.
[1] Leung, A. (2006). “Traditional Toxicity Documentation of Chinese Materia Medica—An Overview“. Toxicologic Pathology.
[2] Wu, W (2015) “Current Status and Future Perspective in the Globalization of Traditional Chinese Medicines” World Journal of Traditional Chinese Medicine
