Taiwanese supplement firm Greenyn Biotechnology to promote Antrodia cinnamomea as an effective ingredient for curing hangover and treating liver diseases in Asia.
The US Food and Drug Administration (FDA) has issued a Letter of No Objection to the firm’s application, which requested for its mushroom extract to be recognised as a New Dietary Ingredient (NDI).
“Not only will this allow us to distribute Antrodia cinnamomea to all states in the US, it will help us in marketing Antrodia cinnamomea to other countries, as it is proof of our product’s safety. For example, we included the US FDA’s Letter in our application to the Thai FDA, and we’ve just received the Novel Food approval from them,” said Chen-Meng Kuan, R&D Manager at Greenyn Biotechnology.
Kuan noted that there are many manufacturers who produce Antrodia cinnamomea but none of them received the Letter of No Objection. He attributes this to the firm’s findings in a final report and a pre-print paper that were submitted to the FDA, which detailed human clinical trials that proved the safety and efficacy of Antrodia cinnamomea mycelium, the proprietary ingredient of Greenyn Biotechnology.
“We tried it on patients with chronic hepatitis infection for a year. Each dose was quite high at 1,500 mg and there were no side effects observed. This gave us an advantage,” said Kuan of the final report by China Medical University, which has not been published yet.
The efficacy of Antrodia cinnamomea
Antrodia cinnamomea is generally classified into two types: the fruiting body, and the mycelium – like Greenyn’s proprietary extract.
Fruiting bodies contain the most polysaccharides, which are active ingredients for immune modulation, not liver care. The mycelium variety contains the active ingredient triterpenoid, which is known as a powerful anti-inflammatory agent that improves liver function.
“There are different production technologies for mycelium. Greenyn uses solid-state fermentation so that we can get more of the active compound triterpenoids. Most other manufacturers use liquid state fermentation, which can shorten the fermentation time, but cannot produce high amounts of triterpenoids. That’s what differentiates our extract from the others in the market,” said Kuan.
Antrodia cinnamomea is an indigenous Taiwanese mushroom with several medicinal benefits that are attributed to the abundance of bioactive constituents, including polysaccharides and triterpenes. However, its efficacy in treating chronic hepatitis B has not been extensively proven, which prompted Greenyn Biotechnology to conduct clinical trials for this purpose.
In one of its clinical trials, 44 Japanese adults between 20 to 64 years old participated in a randomised, double-blind, placebo-controlled clinical study. Each participant took one Antrodia cinnamomea mycelia extract (ACME) capsule (250 mg of ACME powder) or a placebo capsule daily for 12 weeks. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were analysed at four different points of the trial.
ALT and AST are enzymes found in the liver. When the liver is damaged or stressed, these enzymes leak into the bloodstream, so higher levels can indicate liver issues.
In comparison with the placebo group, the mean ALT level of regular drinkers in the ACME group was significantly reduced after the study. The results suggests that ACME may relieve the liver injury caused by chronic alcohol use and showed an improvement in liver health overall. No treatment-related adverse effects were observed throughout this study.
Target Markets
Greenyn has been distributing Antrodia cinnamomea in Japan for the past five years, but sales have been slow due to the lack of clinical trials required for a functional food claim. Recently, the firm submitted the necessary papers and hopes to boost sales once it receives approval from the Japanese authorities.
It is also working on getting regulatory approval in South Korea. In both Japan and South Korea, most clients are interested in using the ingredient for hangover remedies due to the widespread drinking culture.
Last year, the firm entered the Vietnamese market, focusing on liver care and hangover remedies, as many consumers drink, and hepatitis B infection rates are high.
In Indonesia, where drinking is less common, the market for hangover cures is limited. However, liver care products focusing on detoxification are expected to be popular due to concerns about pesticide residues in vegetables, which can damage the liver.
The firm is also marketing its product as remedies for liver care and hangover in Malaysia. As for Singapore, the focus is on liver care due to stricter government regulations on drinking, which limits the market for hangover remedies.
Most of the Antrodia cinnamomea formats are in capsule form to mask the extract's smell, which might not be acceptable to some people. It is also available as tablets, and the firm is looking at producing liquid sachets for hangover solutions, or for consumers who have difficulty swallowing pills or prefer liquid formulations.
“Another interesting application of our extract is its ability to reduce fatigue. Once liver function is improved, fatigue levels decrease, helping to improve vitality,” said Kuan.
The firm’s future plans include developing ingredients that improve sleep and exploring applications in skincare and sports nutrition.
Greenyn Group was established around 30 years ago. Initially, it distributed well-known ingredients from other countries to brand owners in Taiwan. As many brands lacked the capability to manufacture or develop their own products, the firm began providing formulation and education services to their clients. To increase profit margins, it decided to build its own R&D team to develop proprietary ingredients for the global market, which includes Antrodia cinnamomea mycelia.
Source: Journal of Dietary Supplements
DOI: https://doi.org/10.1080/19390211.2022.2152147
“Hepatoprotective effect of Antrodia Cinnamomea mycelia extract in subhealth Japanese adults: a randomized, double-blind, placebo-controlled clinical study”
Authors: Chun-Yi Ho, Chen-Meng Kuan et al.