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TCM Biotech International Corp.

(By David Silver)

16 April, 2007
Founded in 1998, TCM Biotech International Corp. (TCM) is focused on the research and development of Cordyceps cultures. TCM has mastered the fermentation technology for the only authentic Cordyceps sinensis, as recorded in the ancient Chinese text "Compendium of Materia Medica."

Cordyceps sinensis - Starting off as a caterpillar, ending as a fungus, and the basis of TCM's new drug candidate, TCM-700C.

Cordyceps sinensis is a species of parasitic fungus that grows on, and eventually takes over, the common caterpillar. As the fungus grows outward it leaves the body of the caterpillar intact, giving this traditional Chinese medicinal ingredient its unique and distinctive 'half animal, half plant' appearance. TCM uses only genuine Cordyceps sinensis identified by DNA sequence and registered in GenBank.

The company possesses exclusive gene patents and identification technology for various mycelium cultures (Hirsutella sinensis, Paecilomyces hepialid, etc.). Amongst such cultures, the cultivation of Hirsutella sinensis is considered the most difficult to process. TCM's key breakthroughs have shortened the fermentation process of the Hirsutella sinensis culture from 35-40 days to only 7 days; no competitor has been able to match this achievement.

TCM specializes in the use of new drug R&D protocols and methodologies in research on traditional Chinese herbal medicines. Besides pursuing better safety, efficacy and process quality control, the company's use of proprietary fermentation processes to cultivate selected mycelia enables it to maintain consistent raw materials.

Modern laboratory and fermentation facilities at Taiwan-based TCM Biotech International Corp.

Complementing conventional therapies

In terms of new drug R&D, TCM seeks to develop adjuvant therapy that can compensate for the shortcomings of conventional Western medicines. In this regard, the company seeks to complement--not compete--with Western pharmaceutical therapies. For example, one of TCM's recent projects has been to develop agents to remedy some of the problems encountered when chronic hepatitis C virus (HCV) infected patients are treated with Western antiviral drugs. With approximately 200 million HCV patients worldwide, it is estimated that the cost of treatment will exceed US$3.9 billion in 2007. Furthermore, since existing HCV drugs have a sub-optimal cure rate and induce severe side effects in some patients, few HCV patients actually receive adequate treatment.

To address this issue, the company has taken advantage of the ability of the cultured mycelia of Cordyceps sinensis to modulate the body's immune system to develop the new Chinese herbal medicine formulation for chronic HCV patients, TCM-700C, which contains as its main ingredient Paecilomyces hepiali mycelium (TCM-777). When used together with the existing combination drug treatment employing Interferon and Ribavirin, TCM-700C can increase the original response rate by approximately 10-20%, and shows similar efficacy against even low response rate genotype 1 HCV infection.

The action mechanism of TCM-700C is thought to be due to NK cell stimulation, allowing the human immune system to more effectively clear HCV when used in combination with the conventional HCV drugs, Interferon and Ribavirin.

HCV treatment adjuvant therapy TCM-700C was approved for Phase II clinical trials in Taiwan by both the US Food and Drug Administration (FDA) and Taiwan's Department of Health (DOH). TCM enrolled patients for this clinical trial beginning early 2007.

Looking forward

With promising prospects for additional discoveries and developments along similar lines, TCM is looking forward to developing other new drugs--such as drugs against lung cancer--on the basis of an abundant experience with mycelium cultures. The company is also seeking strategic partners who can collaborate on clinical trials of its new Chinese herbal medicine formulation TCM-700C while helping develop global markets. TCM is also offering mass production fermentation--for example, of Hirsutella sinensis culture--and welcomes any inquiry for its contract manufacturing services.

TCM Biotech International Corp.
7F., No. 11, Lane 35, Jihu Rd., Neihu District, Taipei 114
Taiwan, R.O.C
Contact: Stephanie Hsu / Project Manager
Tel: +886-2-2658-1677 ext. 703
Fax: +886-2-2658-1018
Email: info@tcmbio.com
Website: www.tcmbio.com

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