ABVC's New Horizon for Oncology and Hematology Aims at Cancer Market of Several Hundred Billion Dollars

Rhea-AI Summary

ABVC BioPharma, Inc. provides an update on the development of combination therapy for cancer and immunity booster dietary supplements derived from Maitake Mushroom. The company is marketing supplements and pursuing clinical trials of pharmaceutical compounds approved by the US FDA. BioKey, the company's subsidiary, is working on the manufacturing and distribution of these products, aiming to tap into the growing global markets for cancer therapeutics, dietary supplements, and pharmaceutical CDMO services.

Positive

• ABVC BioPharma, Inc. is developing combination therapy for cancer and immunity booster dietary supplements derived from Maitake Mushroom.
• The company is marketing dietary supplements and pursuing clinical trials of pharmaceutical compounds approved by the US FDA.
• BioKey, the company's subsidiary, is working on the manufacturing and distribution of these products.
• The global markets for cancer therapeutics, dietary supplements, and pharmaceutical CDMO services are projected to witness significant growth.
• The company's pipeline of products is believed to have excellent market potential in the evolving healthcare landscape.

Negative

• None.

Financial Analyst

The announcement from ABVC BioPharma concerning the progression of their cancer treatment and immunity booster dietary supplements derived from Maitake Mushroom could have a notable impact on their financial outlook. With the US FDA approval of four INDs for various cancers and the initiation of Phase II clinical trials, ABVC is advancing its position in the oncology sector. This progress is likely to be viewed positively by investors, as it signals potential future revenue streams and a stronger product pipeline.

The strategic positioning of their wholly-owned CDMO, BioKey, Inc., to manufacture and market these products could streamline operations and reduce time-to-market, which is crucial for capitalizing on the burgeoning cancer therapeutics market projected to reach $393.61 billion by 2032. Moreover, the existing $3 million contract with Define Biotech Co. Ltd. and the anticipated milestone payments from Rgene Corporation could provide immediate financial benefits and bolster investor confidence.

However, it is imperative to consider the inherent risks associated with clinical trials, as any setbacks could adversely affect the company's stock price. Additionally, the competitive landscape in both the cancer therapeutics and dietary supplements markets is intense and ABVC's success will largely depend on the efficacy and safety outcomes of their clinical trials.

Oncology Doctor

The therapeutic potential of ABVC BioPharma's BLEX 404, particularly in combination therapy for oncology, represents a significant advancement in cancer treatment. Combination therapies are increasingly becoming the standard of care in oncology due to their ability to target multiple pathways and reduce the likelihood of drug resistance. ABVC's focus on minimizing side effects aligns with current medical objectives to improve patients' quality of life during treatment.

By leveraging the immunomodulatory properties of β-glucan from Maitake Mushroom, ABVC's approach could enhance the efficacy of existing treatments and provide a more tolerable alternative to patients. This is particularly relevant for conditions like Triple Negative Breast Cancer and Non-Small Cell Lung Cancer, where treatment options are limited and often associated with severe side effects.

However, the transition from dietary supplements to pharmaceutical compounds will require rigorous clinical validation. The safety and efficacy data from Phase II trials will be critical in determining whether these treatments can be integrated into standard oncology protocols and if they can truly offer a therapeutic advantage over existing treatments.

Market Research Analyst

ABVC BioPharma's foray into the dietary supplements market with products derived from Maitake Mushroom taps into a growing consumer trend towards natural and functional foods. With a global dietary supplements market projected to reach $269.5 billion by 2030, ABVC's early entry and marketing initiatives in Asia, the US and Canada could position them favorably within this sector.

Furthermore, the company's diversification strategy, which includes both pharmaceuticals and dietary supplements, allows them to cater to different market segments and mitigate risks. The botanical drug market, which is anticipated to grow at a CAGR of 39% from 2022 to 2030, presents another lucrative opportunity for ABVC's Maitake Mushroom-derived products.

While the potential is significant, ABVC's success will depend on their ability to navigate regulatory hurdles, build brand recognition and establish effective distribution channels. The partnership with Shogun for North American markets could be pivotal in achieving these objectives. It is also worth noting that consumer preferences and regulatory environments can shift rapidly, which necessitates a flexible and responsive market strategy.

FREMONT, CA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- 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 Industry
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 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 Statements
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.

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 Chow
Email: 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

What is ABVC BioPharma, Inc. developing?

ABVC BioPharma, Inc. is developing combination therapy for cancer and immunity booster dietary supplements derived from Maitake Mushroom.

Which markets are ABVC BioPharma, Inc. targeting?

The company is targeting the global markets for cancer therapeutics, dietary supplements, and pharmaceutical CDMO services.

What has the US FDA approved for ABVC BioPharma, Inc.?

The US FDA has approved four INDs for ABVC BioPharma, Inc.: ABV-1501 for Triple Negative Breast Cancer, ABV-1519 for Non-Small Cell Lung Cancer, ABV-1702 for Myelodysplastic Syndrome, and ABV-1703 for Pancreatic Cancer Therapy.

Where is BioKey, the subsidiary of ABVC BioPharma, Inc., based?

BioKey, the subsidiary of ABVC BioPharma, Inc., is based in Fremont, California.

What is the expected growth rate for the global cancer therapeutics market by 2032?

The global cancer therapeutics market is expected to grow at a CAGR of 9.20% from 2023 to 2032.

What is the projected value of the global Dietary Supplements Market by 2030?

The global Dietary Supplements Market is projected to reach $269.5 billion by 2030.

What is the estimated CAGR for the global pharmaceutical CDMO market from 2023 to 2032?

The global pharmaceutical CDMO market is expected to grow at a CAGR of 6.2% from 2023 to 2032.

What is the expected CAGR for the global botanical drug market during the forecast period (2022–2030)?

The global botanical drug market is expected to grow at a CAGR of 39% during the forecast period (2022–2030).