Greenyn Biotechnology received USFDA NDI acknowledgement without objection for Antrodia cinnamomea mycelia “Antromax”.
Taipei - 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.
Dr. Kao Shung-te (middle) of China Medical University Hospital and Dr. Houng Jer-yiing (left) of I-Shou University Medical School presented the study results of the randomized double-blind clinical trial and the bioavailability of Antromax in different dosages forms, respectivley.
Antromax®– dripping pills, mycelia powder, emulsion powder (left to right).
Taiwan’s Antrodia industry sets to enter the international markets
“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 “mycelia of A. cinnamomea” 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.
Manufacturing site of Greenyn Biotechnology in Taichung
Health food of Antromax® in livercare in Taiwan (left) and Antromax® complex beverage (right).
Health benefits of Antromax
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 have 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 of the 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 benefit of A. cinnamomea to the world during covid-19 will create another pride for Taiwan.
https://www.youtube.com/watch?app=desktop&v=T1f84y2vzeY&feature=youtu.be