USFDA NDI notification of Antromax “Antrodia cinnamomea mycelia”
TAIPEI, May 20, 2021 – (ACN Newswire) – The history of Antrodia cinnamomea consumption by indigenous tribes in Taiwan dates back two hundred years ago, while people in the Western world know little about this ingredient. The USFDA NDI acknowledgement without objection to Greenyn’s Antromax was the 1st notification after numerous attempts in the past 14 years. We are honored to establish a stepping-stone for the A. cinnamomea to the US health markets estimated at 10 billion US dollars.
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USFDA acknowledged Antrodia cinnamomea as new dietary ingredients
On April 12th, Greenyn Biotechnology Corporation hosted a seminar – “The international development of Taiwan’s Antrodia cinnamomea and its clinical application,” and announced Antromax’s acknowledgement without objection by USFDA NDI. It was a great feat for Greenyn, and will certainly boost the morale of the Antrodia industry to devote more resources in the US market.
A. cinnamomea is an edible fungus grows on the endangered Cinnamomum kanehirae tree which is found only in Taiwan. This indigenous fungus is traditionally used to ameliorate liver disorders, hangovers, fatigue, and enhance immunity. “Ruby of Taiwan” was given to this miracle fungus.
“We are surprised that this time we have obtained the USFDA NDI No. 1170 notification without objection for Antromax for marketing in the United States,” pointed by Luo Hsuan, CEO of Greenyn. Over the past years, it was difficult to obtain such notification because A. cinnamomea is unknown to the western world; its’ safety data, eating and application history is very limited. “It is a significant milestone and a good timing for us to step into the global market. We do hope that Taiwan’s A. cinnamomea industry may take this opportunity to march into the global arena,” Luo Hsuan added.
According to Dr. Hsu Pang-kuei, the R&D director of Geeenyn, A. cinnamomea is rare and grows very slowly in the wild. For medicinal purposes, you need to wait three years until it is fully grown and it is impossible to increase production/cultivate indoor as the tree Cinnamomum kanehirae is protected under the plant conservation laws. Fortunately, with Greenyn’s solid-state fermentation technology, we are able to cultivate Antromax “A. cinnamomea mycelia” with active ingredients similar to the fully grown in just 3 months. This patented fermentation process will not only maintain the conservation of the tree, but will also lower the production cost, so the public may enjoy this natural healthy food at a reasonable price.
Clinical trials indicate Antrodia cinnamomea is effective as adjuvant treatment
During the seminar, Dr. Kao Shung-te, Attending Physician of China Medical University Hospital, shared the findings of Antromax in the clinical adjuvant treatment for hepatitis B. “Through medical trials, it is discovered that Antromax has an adjuvant treatment effect combined with the hepatitis B medicine. The liver function indexes are improved, and there are no adverse effect on the biochemical values in blood and urine.”
In addition, Dr. Houng Jer-yiing, Associate Dean of the I-Shou University Medical School, shared that the bioavailability of Antromax in different dosage forms have similar adjuvant effects – lowering liver function indexes, liver fat accumulation and alcohol-related liver injuries, as well as enhancing activities of antioxidant enzymes.
Greenyn’s facility is built to the international standards in the Central Taiwan Science Park with capacity of up-to 12 metric tons annually, which is sufficient for the global markets. Dr. Hsu says, “At present, we will focus on the US and Europe markets, and next we might start to promote in Asia such as Korea, Southeast Asian countries and Australia.” In view of the US herbal supplements market worth USD 9.6 billion, Greenyn is honored to lead Taiwan’s biotech industry to promote A. cinnamomea in the US markets. It is foreseeable that the health benefits of A. cinnamomea to the world during covid-19 will create another pride for Taiwan.
