EQS-News: ABVC BioPharma s ADHD and MDD Drug Polygala Tenuifolia a Natural Wonder With Potential of Transforming Mental Health Treatment of More Than 30 Billion Market

FREMONT, CA - January 15, 2025 (NEWMEDIAWIRE) - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company focused on innovative treatments in ophthalmology, CNS (central nervous system), and oncology/hematology, is proud to announce the advancements in its innovative treatments for Major Depressive Disorder (MDD) and Attention-Deficit/Hyperactivity Disorder (ADHD), highlighting the promising results achieved through rigorous clinical research and development.

Polygala tenuifolia, a revered botanical remedy in traditional medicine, appears to be emerging as a modern marvel in mental health treatment. Known for its adaptogenic properties, this remarkable plant has been shown to offer immense potential in addressing mental health challenges such as Attention-Deficit/Hyperactivity Disorder (ADHD) and Major Depressive Disorder (MDD). Backed by cutting-edge research and clinical trials, we believe that Polygala tenuifolia has the ability to redefine the boundaries of natural medicine.[1]

Literature Highlights on Polygala tenuifolia

Polygala tenuifolia, or Yuan Zhi, has long been utilized in traditional Chinese medicine to improve cognitive function and mental clarity. Its root contains bioactive compounds like polygala saponins and xanthones, which exhibit neuroprotective and anxiolytic properties. Studies reveal that these compounds modulate the dopaminergic and serotonergic pathways, offering therapeutic potential for mood disorders and ADHD.[2] Additionally, its antioxidant properties enhance neuroplasticity, making it a promising candidate for holistic mental health care.[3]

ABVC BioPharma’s Pioneering Research

ABVC BioPharma has harnessed the therapeutic potential of Polygala tenuifolia in its proprietary PDC-1421 formulation. Recent internal clinical trials underscore the efficacy and safety of PDC-1421 in treating ADHD and MDD, addressing our perceived growing demand for natural, plant-based alternatives to synthetic drugs.

• ADHD Treatment (ABV-1505):
  Phase II Part I clinical studies demonstrated that PDC-1421 capsules are both safe and effective. The ADHD-RS-IV score improvements from baseline through eight weeks of treatment were remarkable: 83.3% in the Intention-To-Treat (ITT) population and 80.0% in the Per-Protocol (PP) population. Both high and low doses surpassed the 40% improvement benchmark, showcasing the capsule’s consistent efficacy. (In-house study results)
• MDD Treatment (ABV-1504):
  PDC-1421 achieved a Montgomery–Asberg Depression Rating Scale (MADRS) score reduction of -13.21 from baseline over six weeks, with a placebo-subtracted difference of -4.1. Compared to traditional antidepressants like Prozac, PDC-1421 exhibited superior outcomes with a more favorable safety profile. (In-house study results)

Why Natural Solutions Matter

The rise in mental health disorders necessitates safe, effective, and accessible treatments[4]. Synthetic drugs often come with significant side effects and dependency risks, deterring patients from seeking help. We believe Polygala tenuifolia offers a sustainable and holistic alternative that aligns with the growing global preference for natural remedies.

"The need for plant-based therapies has never been greater," said Uttam Patil, Ph.D., Chief Executive Officer of ABVC. "Our innovative research on PDC-1421 exemplifies how nature-inspired solutions can meet the challenges of modern mental health care."

Shaping a Healthier Future

As Prozac production faces safety concerns, and public interest in plant-derived medications rises, PDC-1421 stands as a beacon of hope. Polygala tenuifolia is not just a natural remedy; it is a testament to the synergy between traditional wisdom and modern science.

Driving Growth in Expanding Markets

ABVC BioPharma is strategically positioned in growing markets. The global MDD market is projected to grow from $11.51 billion in 2022 to $14.96 billion by 2032, with a steady CAGR of 2.8%.[5] The global ADHD treatment market is also growing, expected to increase from $15.23 billion in 2022 at a CAGR of 7.3% through 2032.[6] Additionally, the global botanical drug market, valued at $163 million in 2021, is forecasted to experience an impressive CAGR of 39% through 2030, reaching $3.2 billion.[7]

For more information about ABVC and its subsidiaries, stay updated on the latest updates or visit https://abvcpharma.com. ABVC urges its shareholders to sign up on the Company's website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

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 through Phase III.

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:
Dr. Uttam Patil
Email: uttam@ambrivis.com

[1] https://www.sciencedirect.com/science/article/abs/pii/S0944711322005724

[2] https://www.mdpi.com/2304-8158/13/21/3358

[3] https://bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-021-03437-5

[4] https://www.who.int/teams/mental-health-and-substance-use

[5] https://www.futuremarketinsights.com/reports/major-depressive-disorder-treatment-market#:~:text=The%20major%20depressive%20disorder%20(MDD,US%24%2011.51%20billion%20in%202022

[6]  https://www.polarismarketresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-market

[7] https://straitsresearch.com/report/botanical-drugs-market

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