Modernizing Traditional Chinese Medicines

By November 23, 2015

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




in USA


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
Phase III Hutchison  Whampoa  Limited


(a) Data are available from
(b) Data are not available from


[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 MedicinesWorld Journal of Traditional Chinese Medicine


Categories: Pharmaceutical