ABVC BioPharma announced today that the Japan Patent Office has granted patent protection for ABV-1504, the company's botanical-based treatment candidate for Major Depressive Disorder (MDD). The patent, valid through 2040, strengthens ABVC's global intellectual property portfolio for PDC-1421, the active botanical ingredient in ABV-1504.
The newly secured Japanese patent joins existing protections in the United States, Australia, and Taiwan, providing comprehensive coverage in key pharmaceutical markets. This strategic patent portfolio reinforces ABVC's international commercialization strategy for its botanical central nervous system (CNS) therapies.
Botanical Alternative in a Growing Market
With depression affecting over 280 million people worldwide and the global antidepressant market projected to reach $20 billion by 2030, ABV-1504 offers a differentiated approach to treatment. The compound's active ingredient, PDC-1421, is derived from Polygala tenuifolia and functions as a Norepinephrine Transporter (NET) inhibitor.
Phase II clinical studies have demonstrated favorable safety and efficacy profiles for ABV-1504. The botanical-based treatment aims to provide a safer, non-addictive alternative to traditional selective serotonin reuptake inhibitors (SSRIs), potentially offering better-tolerated long-term management for individuals suffering from depression.
Dr. Uttam Patil, ABVC Chief Executive Officer, emphasized the significance of the patent approval: "Securing patent protection in Japan - one of the world's most advanced pharmaceutical markets - further validates the innovation behind our botanical drug platform. 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."
Strategic Importance of the Japanese Market
Japan represents a particularly promising market for ABV-1504, with more than 5 million individuals affected by depression. The country's antidepressant market is expected to reach $1.25 billion by 2025, accounting for approximately 5.7% of the global market.
The Japanese healthcare system has a long-standing tradition of integrating botanical-based medicines such as Kampo, which are widely prescribed by physicians and reimbursed under the national insurance system. This cultural and regulatory framework creates a favorable environment for scientifically validated plant-derived therapies like ABV-1504.
Through its joint venture BioLite Japan K.K., led by a former Asian Pacific Executive of Pfizer, ABVC is actively engaging with local regulatory bodies, academic institutions, and industry partners. The team has participated in key biopharmaceutical events such as BioJapan to build brand awareness and initiate commercial dialogues within Japan's healthcare ecosystem.
$667 Million Global Licensing Agreement
In November 2023, ABVC entered a definitive global licensing agreement with AiBtl BioPharma Inc. for both ABV-1504 (MDD) and ABV-1505 (ADHD). The transaction was independently valued at $667 million, with approximately $475.6 million attributed to ABV-1504 based on its clinical readiness, global IP strength, and commercial opportunity.
Under the terms of the agreement, ABVC and its subsidiary received 46 million AiBtl shares as initial consideration. Each is eligible for up to $7 million in milestone-based cash payments and, upon commercialization, will receive 5% royalties on net sales, up to $200 million.
This licensing agreement represents a core milestone in ABVC's strategy to unlock global value while advancing non-dilutive growth strategies for long-term shareholder return.
Comprehensive Patent Protection
The approval of the Japanese patent completes ABVC's intellectual property protection for ABV-1504 across four key territories:
| Country | Patent Number / Application No. | Status | Valid Through |
|---------|----------------------------------|--------|--------------|
| United States | US 11,554,154 B2 | Granted | 2041 |
| Australia | 2021314052 | Granted | 2041 |
| Taiwan | 109130285 | Granted | 2040 |
| Japan | 2023-502736 | Granted | 2041 |
This comprehensive patent coverage lays a strong foundation for worldwide licensing and commercialization efforts, positioning ABVC BioPharma to potentially deliver a novel botanical-based solution for the millions suffering from depression globally.
About ABVC BioPharma
ABVC BioPharma is a NASDAQ-listed (ABVC) clinical-stage biopharmaceutical company developing botanical-based therapies for central nervous system, ophthalmology, and oncology/hematology indications. The company maintains an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development.
For its drug products, ABVC utilizes in-licensed technology from its network of world-renowned research institutions, including Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center, to conduct proof-of-concept trials through Phase II of clinical development.
