FREMONT, CA - (NewMediaWire) - May 04, 2023 - ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced it received a US patent certificate, US 11,554,154 B2, for PDC-1421, for the treatment of Major Depressive Disorder (MDD) on April 25, 2023.

The patent application was submitted to the US Patent and Trademark Office (USPTO) on July 22, 2020, under the title of “Polygala Extract for the Treatment of Major Depressive Disorder.” The invention relates to a method for treating Major Depressive Disorder by orally administering a composition containing a Radix Polygalae (Polygala tenuifolia Willd.) extract (PDC-1421). PDC-1421 is a drug product of ABV-1504 that can be prepared into a gelatin capsule for oral administration. The composition can be administered chronically over at least 25 days; the daily dose can be administered once per day, twice per day, or three times per day, wherein each dose is 380 - 760 mg of the botanical extraction.

ABV-1504 is a botanical-based Norepinephrine Transporter (NET) inhibitor that has completed Phase II clinical studies, with plans to initiate an End of Phase II (EOP II) meeting with the FDA shortly.

The patent was also submitted for Patent Cooperation Treaty (PCT) and subsequently filed in several countries, including the European Union, China, Japan in 2022.

“This patent grants the right to exclude others from using, offering, or selling Polygala tenuifolia Willd. extract (PDC-1421), the drug product of ABV-1504, throughout the United States until July 22, 2040,” said Dr. Howard Doong, ABVC Chief Executive Officer. “We believe the patent will be granted in the European Union, China, Japan, and other countries.”

Antidepressant Drugs Market is valued at ~$13.7 billion in 2018 and expected to reach ~$15.9 billion by 2025 with the CAGR of 2.15% over the forecast period. (https://brandessenceresearch.biz/Lifesciences-and-Healthcare/Antidepressant-Drugs-Market-Size-Share-and-Forecast-to-2025/Summary)

About ABVC BioPharma

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.

Contact:

Tom Masterson

Email: tmasterson@allelecomms.com

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