Botanical Drug Candidate: Fermented Fungus Mycelia (Antrodia camphorata) Antrodia camphorate has been sold as a dietary supplement for a decade in Taiwan and is now being marketing all over the world.

Antrodia camphorata, known as Antrodia cinnamomea or Ruby Mushroom®, is famous as a Taiwanese folk medicine. It is exclusively grown and available in Taiwan. The fruiting body of Antrodia camphorata requires cultivation and the raw material is protected by law.

Due to the increasing demands for folk medicines with anti-cancer & hepato-protecting properties and due to the limited supply of the rare mushrooms, the market price for the fruiting body of Antrodia camphorata now exceeds $55,000US per kg dry weight. It is probably the most expensive mushroom in the world. To fulfill the demand, Simpson Biotech has developed a process to ferment the mycelia.

Simpson Biotech consistently achieves very high yields with about 12% active compound content. Simpson Biotech is the world’s leader in process development for Hepasim and is the sole owner of intellectual property over all its active compounds.

Toxicity & Safety Studies for Fermented Fungus Mycelia (Antrodia camphorata)

Two double-blind, placebo-controlled clinical trials have been conducted in Taiwan, with 42 and 150 patients respectively, using the fermented Antrodia camphorata mycelia as a dietary supplement for inflammation-related diseases. The clinical trials showed conclusively in initial studies both the safety and efficacy of Antrodia camphorata. The studies demonstrated efficacy for anti-inflammation.

The fermented  Antrodia camphorata mycelia, which has been sold in Taiwan as a dietary supplement for over a decade, contains a high percentage (minimum 12 %) of Hepasim as the active ingredient. Validation assays were conducted using this concentrated form of the fermented Antrodia camphorata mycelia including Chromosomal Aberration Assay and Micronucleus Assay. Acute Oral, Sub-acute 28 day Oral, and Ames Test were conducted. The studies showed that fermented Antrodia camphorata mycelia possesses substantial therapeutic properties and has no mitigating safety issues.

Anti-Fibrosis & Anti-Inflammatory Compounds from Medicinal Fungus – A Risk Reduction Approach – Proof of concept of a new compound without an IND (Antrodia camphorata)

Antrodia camphorata (AC) is legendary as a medicinal fungus for liver diseases. Antrodia camphorata is found in the inner cavity of a legally protected species of Taiwanese evergreen, Cinnamomum kanehirai Hay. AC is in increasing demand to protect the liver, especially from chemical and drug detoxification, and alleviation of alcohol-related hangover symptoms.

Sub-merged fermentation is the only way to mass produce quality AC mycelia (ACM). Anti-fibrosis and anti-inflammatory active compounds are isolated from the mycelia of AC. Hepasim® represents five major compounds isolated from the fermented Antrodia camphorata Mycelia (ACM). These compounds are maleic and succinic acid derivatives with a cyclic imide backbone (J. Natural. Products. 2004, 67, 46-48). Simpson Biotech manufacturing methods reduce batch to batch variation, achieving an amazingly high concentration of these active compounds from the fermented mycelia (12-15% US Patent 7109232).