ABVC BioPharma Receives Registration Approval for Maitake Mushroom Dietary Supplement by the Taiwan Ministry of Health and Welfare
FREMONT, Calif., March 14, 2023 /PRNewswire/ -- ABVC Biopharma, Inc. ("ABVC" or the "Company") (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that BioKey, a wholly-owned subsidiary of the Company based in Fremont, California, received an approval of Maitake Mushroom Dietary Supplement Tablet from Taiwan Ministry of Health and Welfare (MHW) on February 6, 2023. This approval served as an Import License (IL) for the shipment of Maitake Mushroom Tablets which have been developed and manufactured by BioKey for commercial sales in Taiwan under the brand name "DFN." BioKey is currently producing dietary supplements derived from the Maitake Mushroom in tablet and liquid forms.
The Company has entered into a three-year distribution agreement with Define Biotech Co. Ltd., whereas Define Biotech is granted exclusive rights to distribute DFN in China and Taiwan in exchange for $3.0 million worth of new product orders over the three-year period. Shipment of the first bulk lot of Maitake Mushroom Tablets to Define Biotech is in progress for the commercial launch in Taiwan. Define Biotech is a Taiwan-based pharmaceutical marketing company that focuses on sales of drugs, dietary supplements, and medical products in the Asia-Pacific region.
BioKey will manufacture the supplements in a humid, temperature-controlled environment free of pesticides and chemicals at its cGMP Manufacturing facility in Fremont, California. Although many mushroom-based supplements are currently available, BioKey believes its manufacturing process provides a significant competitive advantage based on quality, consistency, and its formulation process.
"We are pleased to receive the registrational approval of our Maitake Mushroom Tablets "DFN" from Taiwan MHW," said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. "Based on the distribution agreement with Define Biotech for the commitment to purchase $3.0 million worth of the new product over the three-year period, we expect our subsidiary in California to achieve financial profitability in 2023."
The global dietary supplements market size was valued at $140.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.6% from 2021 to 2028 (Grand View Research, February 2021). Botanicals held the second largest share within the dietary supplement category in 2020 and are expected to witness significant growth over the forecast period (Vision Research Reports). Immunity- boosting herbs saw a surge in demand in 2020 and a steady growth trend is expected to continue for the foreseeable future.
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the company is focused on utilizing in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of the clinical development process. The company's network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III.
The Maitake Mushroom is rich in bioactive polysaccharides, especially beta-glucans. Beta-glucans in Maitake Mushrooms have often been found to improve the immune system and reduce cholesterol, resulting in improved artery functionality and overall better cardiovascular health. In a clinical trial on postmenopausal breast cancer patients reported in 2009 (J Cancer Res Clin Oncology (2009) 135:1215), oral administration of Maitake extract demonstrated immunomodulatory effects. In addition, a separate clinical trial found Maitake extracts to enhance neutrophil and monocyte function in patients with myelodysplastic syndrome, boosting production of lymphokines (protein mediators) and interleukins (secreted proteins), demonstrating an improved immune response. Further, clinical trials have shown beta- glucans to lower blood glucose levels, thereby helping to activate insulin receptors, while reducing insulin resistance in diabetes management.
This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential," or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward- looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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