ABVC BioPharma Secures Japanese Patent for Its Natural MDD Treatment Candidate ABV-1504

SILICON VALLEY, CA - May 9, 2025 (NEWMEDIAWIRE) - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing botanical-based therapies for central nervous system (CNS), ophthalmology, and oncology/hematology indications, today announced that the Japan Patent Office has granted a new patent protection for its Major Depressive Disorder (MDD) candidate, ABV-1504. The patent, valid through 2040, strengthens ABVC’s global intellectual property portfolio for PDC-1421, the active botanical ingredient in ABV-1504. The compound is now protected in four major territories as shown below:

This comprehensive patent coverage reinforces ABVC’s international strategy to ultimately commercialize its botanical CNS pipeline in the most strategically important pharmaceutical markets.

Botanical Science Meets Global Market Demand

With MDD affecting over 280 million people worldwide and the global antidepressant market projected to reach $20 billion by 2030[1], ABV-1504 offers a differentiated, botanical-based alternative to traditional selective serotonin reuptake inhibitors (SSRIs). Derived from Polygala tenuifolia, the compound acts as a Norepinephrine Transporter (NET) inhibitor and has demonstrated favorable safety and efficacy in Phase II clinical studies[2]. ABV-1504 aims to provide a safer, non-addictive, and better-tolerated long-term treatment for individuals suffering from depression.

$667M Global Licensing Agreement with AiBtl BioPharma

In November 2023, ABVC and its subsidiary entered definitive global licensing agreement with AiBtl BioPharma Inc. for both ABV-1504 (MDD) and ABV-1505 (ADHD). Under the terms of the agreement: 

ABVC and its subsidiary received 46 million AiBtl shares as initial consideration and each are eligible for up to $7 million in milestone-based cash payments. Upon commercialization, ABVC and its subsidiary will each receive 5% royalties on net sales, up to $200 million. The transaction was independently valued at $667 million, of which approximately $475.6 million is attributed to ABV-1504, based on its clinical readiness, global IP strength, and commercial opportunity. We believe the transaction positions ABVC to unlock global value while advancing non-dilutive growth strategies for long-term shareholder return. The deal represents a core milestone in ABVC’s licensing and value realization strategy; it further reflects the commercial potential of ABVC’s botanical CNS pipeline. 

Additional IP Protection Strengthens Commercial Foundation

With the approval of the Japanese patent, ABVC now holds IP protection for ABV-1504 in four key territories: the U.S., Australia, Japan, and Taiwan - laying a strong foundation for worldwide licensing and commercialization efforts. 

Japan is one of the most mature and receptive pharmaceutical markets globally, with more than 5 million individuals affected by depression. The country’s antidepressant market is expected to reach $1.25 billion by 2025, representing approximately 5.7% of the global market.[3] Japan’s healthcare system has a long-standing history of integrating botanical-based medicines such as Kampo, which are widely prescribed by physicians and reimbursed under the national insurance system.[4] This cultural and regulatory framework creates a favorable environment for the introduction of scientifically validated, plant-derived therapies like ABV-1504.

Through the new patent and its strategic presence in Japan via BioLite Japan K.K., ABVC’s joint venture, which is run by a former Asian Pacific Executive of Pfizer, ABVC is now securing its intellectual property protection and actively engaging in local commercialization planning. BioLite Japan serves as the Company’s operational bridge for Japanese market expansion, fostering relationships with regulatory bodies, academic institutions, and industry partners. The team has previously participated in key biopharmaceutical events such as BioJapan, helping build brand awareness and initiate commercial dialogues within Japan’s robust healthcare ecosystem.

“Securing patent protection in Japan - one of the world’s most advanced pharmaceutical markets - further validates the innovation behind our botanical drug platform,” said Dr. Uttam Patil, ABVC Chief Executive Officer. “With strong IP protection in the U.S., Australia, Japan, and Taiwan, and a global licensing deal in place, we believe that ABV-1504 is well-positioned to compete internationally and deliver long-term value to our shareholders.”

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