Abvc Biopharma Stock Price, News & Analysis
Company Description
ABVC BioPharma, Inc. (NASDAQ: ABVC) is a clinical-stage biopharmaceutical company in the pharmaceutical preparation manufacturing industry. The company focuses on developing therapeutic solutions in three main areas: oncology/hematology, central nervous system (CNS) disorders, and ophthalmology. According to company disclosures, ABVC has an active pipeline of six drug candidates and one medical device (ABV-1701/Vitargus®) under development.
For its drug products, ABVC states that it utilizes in-licensed technology from a network of research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company identifies its research partners as including Stanford University, the University of California at San Francisco, and Cedars-Sinai Medical Center. For its Vitargus® medical device, ABVC indicates that it intends to conduct global clinical trials through Phase III and has reported feasibility and regulatory progress in Australia.
Therapeutic focus areas and pipeline
ABVC describes itself as specializing in botanically based solutions that aim to deliver high efficacy with low toxicity to improve health outcomes. Within CNS, the company highlights programs targeting Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD), including ABV-1504 for MDD and ABV-1505 for ADHD. ABVC reports that Phase II trials for ABV-1504 in MDD were completed with good tolerance and no serious adverse effects, and that ADHD Phase IIb trials are being conducted at the University of California, San Francisco and multiple sites in Taiwan.
In oncology/hematology, ABVC reports that the U.S. Food & Drug Administration (US FDA) has approved four Investigational New Drug (IND) applications in its oncology pipeline: 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 company notes that ABV-1519 involves BLEX 404, a β‑glucan extract from maitake mushroom (Grifola frondosa), as a combination therapy agent with chemotherapy.
In ophthalmology, ABVC’s Vitargus® is described as a vitreous substitute for retinal detachment surgery. The company reports that Vitargus® has completed a feasibility study in Australia and received approval from the Australian Therapeutic Goods Administration to initiate the next trial phase at participating sites. ABVC also indicates that authorities in Taiwan approved its plan to set up a pilot Good Manufacturing Practice (GMP) facility, through its affiliate BioFirst Corporation, to produce Vitargus® and support process development work.
Business model and licensing strategy
ABVC’s disclosures emphasize a business model that combines internal R&D with licensing and collaboration agreements. The company has entered into multiple global licensing arrangements covering clinical trial, registration, manufacturing, supply, and distribution rights for selected pipeline assets.
- In CNS, ABVC and its subsidiary BioLite, Inc. entered multi-year global licensing agreements with AiBtl BioPharma Inc. (AIBL) for MDD and ADHD drug candidates. The company reports that these licensed products were valued by a third-party evaluation and that ABVC and BioLite each received AIBL shares, with potential milestone payments and royalties tied to future net sales.
- ABVC also reports a term sheet with Xinnovation Therapeutics Co., Ltd for exclusive licensing of ABV-1504 and ABV-1505 in mainland China, under which Xinnovation would bear clinical and registration costs in that territory if definitive agreements are completed.
- In ophthalmology, ABVC and its subsidiary BioFirst Corporation entered a global licensing agreement with ForSeeCon Eye Corporation for Vitargus® and related ophthalmology products. The company states that the agreement includes upfront payments, milestone payments, and royalties on net sales, and that ABVC will continue to act as an R&D partner for new ophthalmic pipelines.
- In oncology/hematology, ABVC and affiliates BioLite and Rgene Corporation entered a term sheet and subsequent licensing agreements with OncoX BioPharma Inc. for oncology products, including BLEX 404 for NSCLC. The company describes these agreements as including license fees that may be paid in cash or OncoX shares, as well as potential royalties on future net sales.
In its public communications, ABVC also notes that it engages in contract research, development, and manufacturing activities through its wholly owned subsidiary BioKey, Inc. BioKey is described as producing dietary supplements derived from maitake mushroom and providing regulatory and clinical development services, including Abbreviated New Drug Application (ANDA) regulatory work and a multi-year clinical development services contract with Rgene Corporation. ABVC characterizes BioKey’s evolution toward a contract research, development, and manufacturing organization (CRDMO) model.
Intellectual property and regulatory milestones
ABVC reports obtaining multiple patents related to its CNS and ophthalmology programs. These include patents in the United States, Taiwan, and Australia for Polygala extract in the treatment of major depressive disorder and ADHD, as well as a Taiwanese patent for storage media for the preservation of corneal tissue. The company states that these patents have terms extending into the 2040s and that it is seeking broader geographic coverage through additional applications.
On the regulatory side, ABVC highlights US FDA approvals of several INDs in oncology, including ABV-1501, ABV-1519, ABV-1702, and ABV-1703, and notes corresponding approval from Taiwan’s FDA for certain programs. For its CNS pipeline, the company indicates that ABV-1504 has completed Phase II trials and is being prepared for an End-of-Phase 2 meeting with the FDA to finalize a Phase III protocol, while ABV-1601 for MDD in cancer patients has completed Phase I study preparation.
Corporate structure and related ventures
ABVC BioPharma, Inc. is incorporated in Nevada and reports its principal operations address in Fremont, California in its SEC filings. The company’s structure includes subsidiaries and affiliates such as BioLite, Inc., Rgene Corporation, BioFirst Corporation, BioKey, Inc., and AiBtl BioPharma Inc. (AIBL). ABVC discloses that it holds a controlling interest in AIBL through share ownership obtained under licensing agreements.
In addition to its core biopharmaceutical activities, ABVC has described strategic investments in real estate and cooperation agreements intended to support its botanical drug supply chain and healthcare-related projects. These include acquiring partial ownership of property in China for development as a healthcare center, entering agreements to develop plant factories based on good agricultural practices (GAP) for botanical pipelines, and licensing healthcare-related know-how to partners that may operate on ABVC-associated land. The company presents these activities as potential alternative revenue sources and as support for its botanical-based drug development.
Stock listing and regulatory reporting
ABVC BioPharma’s common stock trades on NASDAQ under the ticker symbol ABVC. The company files periodic and current reports with the U.S. Securities and Exchange Commission (SEC), including Forms 10-K, 10-Q, and 8-K. In its filings, ABVC has disclosed matters such as licensing transactions, financing arrangements, changes in its independent registered public accounting firm, and compliance with Nasdaq listing requirements related to minimum bid price and stockholders’ equity.
FAQs about ABVC BioPharma, Inc.
- What does ABVC BioPharma, Inc. do?
ABVC BioPharma, Inc. is a clinical-stage biopharmaceutical company that develops drug candidates and a medical device in oncology/hematology, central nervous system disorders, and ophthalmology. It focuses on botanically based therapeutics and a vitreous substitute device called Vitargus®. - How many products are in ABVC’s pipeline?
According to company disclosures, ABVC has an active pipeline of six drug candidates and one medical device (ABV-1701/Vitargus®) under development. - What therapeutic areas does ABVC target?
ABVC’s programs target oncology/hematology indications such as triple negative breast cancer, non-small cell lung cancer, myelodysplastic syndrome, and pancreatic cancer, CNS indications including major depressive disorder and ADHD, and ophthalmology indications related to retinal detachment surgery and corneal tissue preservation. - How does ABVC work with research institutions?
The company states that it uses in-licensed technology from a network of research institutions, including Stanford University, the University of California at San Francisco, and Cedars-Sinai Medical Center, to conduct proof-of-concept clinical trials through Phase II. - What is Vitargus®?
Vitargus® (ABV-1701) is described by ABVC as a vitreous substitute and advanced-stage R&D product intended for use in retinal detachment surgery. The company reports that Vitargus® has completed a feasibility study in Australia and received regulatory approval there to initiate the next phase of clinical trials. - What role do licensing agreements play in ABVC’s business?
ABVC emphasizes global licensing agreements as a key part of its business model. It has entered agreements with AiBtl BioPharma Inc. for CNS drugs, ForSeeCon Eye Corporation for ophthalmology products including Vitargus®, and OncoX BioPharma Inc. for oncology products, with structures that include license fees, milestone payments, and potential royalties. - What is ABVC’s approach to botanically based drugs?
The company describes itself as specializing in botanically based solutions that aim for high efficacy and low toxicity. Examples include Polygala extract-based CNS therapies and BLEX 404, a β‑glucan extract from maitake mushroom used in its oncology pipeline. - Does ABVC have any contract development or manufacturing activities?
Yes. ABVC’s subsidiary BioKey, Inc. is described as producing dietary supplements derived from maitake mushroom and providing regulatory and clinical development services. ABVC states that it is developing BioKey as a contract research, development, and manufacturing organization (CRDMO). - Where is ABVC BioPharma based?
ABVC BioPharma, Inc. is incorporated in Nevada and reports its principal business location in Fremont, California in its SEC filings. - How can investors learn more about ABVC’s financial condition?
ABVC files annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K with the SEC. These filings include information on revenues, expenses, licensing arrangements, financing transactions, and other material events.