ABVC ABVC BioPharma Inc

via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and oncology/hematology, today provided an update on its development of combination therapy for the treatment of cancer and immunity booster dietary supplements. The Company is currently marketing dietary supplements, as well as continuing to pursue clinical trials of pharmaceutical compounds; both of which are derived from the same source: Maitake Mushroom. The Company expects to initiate clinical trials at several prestigious medical institutes in the United States and Asia. Marketing and sales of dietary supplements in the US, Canada, and Asia have begun, and the Company expects revenue generation through its Fremont-based wholly-owned CDMO BioKey, Inc.

The United States Food & Drug Administration (US FDA) has approved four INDs: ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1519 for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 for Myelodysplastic Syndrome (MDS), and ABV-1703 for Pancreatic Cancer Therapy. The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient. The active ingredient of BLEX 404 is the β-glucan extracted from Grifola frondosa (maitake mushrooms), an edible fungus with high medical and commercial values in Asia; it contains various bioactive constituents such as polysaccharides, pyrrole alkaloids, ergosterol, etc., and has been widely served as functional foods for a long time in daily life.[1]

BioKey is a wholly-owned CDMO subsidiary of the Company based in Fremont, California, and has been working as the manufacturing unit for the Company’s projects. BLEX 404 is a combination therapy drug; the same combination of BLEX 404 has been formulated into dietary supplements in tablet and liquid forms by BioKey, Inc. Both the drug and dietary supplements are derived from the same source: Maitake Mushroom. The dietary supplements are already marketed in Asia through Define Biotech Co. Ltd. with a $3 million contract for three years. The Company and its subsidiary will work with Shogun for the US and Canadian markets. At the same time, the safety and efficacy of the Drug formulation will be studied in Phase II clinical trials as a combination therapy for oncology, which is being co-developed by BioKey, Inc. ("BioKey") and the Rgene Corporation.

Utilizing the safety results from the previous study conducted by the ABVC team, including certain affiliates, which indicated that certain dose levels (RDLs) of BLEX 404 Oral Liquid, when combined with current cancer treatment medicines, showed promising results for patients. ABVC is now set to begin the first series of Phase II studies to determine the efficacy and safety of these combined drugs and the most effective dose level. Standard cancer treatments, while effective, often come with debilitating side effects that diminish patients' quality of life. However, we believe our innovative immunotherapy product addresses this challenge by leveraging the body's immune system to target cancer cells more precisely, minimizing collateral damage to healthy tissues and organs. As a result, patients experience fewer adverse effects such as nausea, hair loss, and fatigue, allowing them to tolerate treatment more effectively.

Moreover, our immunotherapy product can potentially synergize with existing standard treatments, amplifying their therapeutic impact. By bolstering the body's natural defenses, it enables standard treatments like chemotherapy and radiation therapy to eradicate cancer cells more effectively, improving tumor regression rates and prolonged remission periods.

"We are extremely proud of our R&D team's hard work. The R&D team successfully endured FDA's rigorous process to achieve this goal," said Uttam Patil, Ph.D., Chief Executive Officer of ABVC. He added, "We are working on initiating RGC-1501, which will be the first of three co-development projects with Rgene. Our subsidiary, BioKey, Inc., serves as the CRDMO, assisting as regulatory and manufacturing partner for the drug product and will receive a payment of $600,000 from Rgene as a milestone payment for Taiwan FDA’s Approval of RGC-1501 IND and an additional payment of approximately $500,000 on the completion of the work order as the clinical development partner. BioKey, a wholly-owned subsidiary of the Company based in Fremont, California, produces dietary supplements derived from the maitake mushroom in tablet and liquid forms. BioKey is set to produce an additional $1 million worth of products for the global market and continue to work on distribution for the US and Canadian markets with Shogun Maitake."

Management believes the Company's pipeline of products has excellent market potential. The global cancer therapeutics market is expected to be worth around US$ 393.61 billion by 2032 from US$ 164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.[2] According to a report by Vantage Market Research, the global Dietary Supplements Market was valued at $152.3 billion in 2022 and is projected to reach $269.5 billion by 2030, with a compound annual growth rate (CAGR) of 8.5% over the forecast period.[3] The global pharmaceutical CDMO market was valued at $94.17 billion in 2022 and will expand to $172.0 billion by 2032, with a CAGR of 6.2% from 2023 to 2032.[4] Straits Research reports that the global botanical drug market size was valued at $163 million in 2021 and is expected to be valued at $3.2 billion. The market is expected to grow at a CAGR of 39% during the forecast period (2022–2030).[5]

About ABVC BioPharma & Its IndustryABVC 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 utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. 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 for PMA (pre-Market Approval).

Forward-Looking StatementsThis 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.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Contact:Leeds ChowEmail: leedschow@ambrivis.com

[1] https://www.sciencedirect.com/science/article/abs/pii/S0960852407001083?via%3Dihub[2] https://www.precedenceresearch.com/cancer-therapeutics-market[3]https://www.vantagemarketresearch.com/industry-report/dietary-supplements-market-2031[4] https://www.globenewswire.com/en/news-release/2023/06/07/2683991/0/en/Pharmaceutical-CDMO-Market-Size-Will-Expand-to-USD-172-02-BN-by-2032.html[5] https://straitsresearch.com/report/botanical-drugs-market