ABVC BioPharma, Inc. has strategically concluded licensing agreements for all its pipelines, a significant achievement that underscores its commitment to sustainable business solutions. This proactive approach to regulatory compliance and responsible resource management has positioned the Company for future growth.
By meticulously planning and maintaining transparent communication with regulatory bodies and stakeholders, the Company has successfully navigated the complex regulatory landscape, ensuring the integrity and safety of its pipeline network. With licensing agreements now in place for all pipelines, the Company is well-positioned to continue its mission of delivering high-efficiency solutions to enhance the quality of life for patients with psychiatric, oncolytic, and ophthalmic disorders.
In November 2023, the Company and one of its subsidiaries, BioLite, Inc. (“BioLite”), each entered into a multi-year, global licensing agreement with AiBtl BioPharma Inc. (“AIBL”) for the Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder). The license covers the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights. The parties are determined to collaborate on the global development of the Licensed Products and work to strengthen new drug development and business collaboration, including technology, interoperability, and standards development. As per each of the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock at $10 per share.
Impact of the Deal:
A third-party valuer valued the indications of MDD and ADHD at $667 million, and the Company and its subsidiary would each receive $3,500,000 cash on fundraising as a licensing fees milestone payment and royalties equaling 5% of net sales, up to $100 million, upon the product’s launch in the market. Upon the issuance of the shares, AIBL became a subsidiary of ABVC.
In April 2024, the Company and one of its affiliates, Rgene Corporation (“Rgene”), each entered into a multi-year, global licensing agreement with OncoX, which specializes in dietary supplements for Oncology for the Company and Rgene’s Oncology drugs with the indications of NSCLC, TNBC, MDS, and Pancreatic Cancer.
As per the respective agreements, each of ABVC and Rgene is set to receive milestone payments in either cash or shares worth $50M for all four indications.
Impact of the Deal:
A third-party valuer valued all the oncology indications at $105 million, and the Company and its affiliates would each receive $5,000,000 cash on fundraising as a licensing fees milestone payment and royalties equaling 5% of net sales, up to $50 million, upon the product’s launch in the market.
In late March 2024, biopharmaceutical company ABVC BioPharma announced it had made a global licensing agreement with ForSeeCon Eye Corporation, along with its subsidiary BioFirst Corporation. The license will enable it to move forward with its Vitargus® device, which helps patients during vitrectomy (a surgery that treats problems with the retina and vitreous.)
This product is part of ABVC’s Ophthalmology efforts. It demonstrates its continual commitment to innovation in the healthcare industry and improving patients’ lives. Thanks to the deal, the company will be able to move forward with its clinical trial, registration, manufacturing, supply, and distribution rights, making Vitargus® available to a wider pool of patients. It’s one of multiple recent successes that have seen ABVC forge ahead in the biopharma industry and innovate.
Impact of the Agreement:
The Vitargus® device, valued at $187 million by third parties, is poised to tap into a rapidly growing market. The global market for retinal surgery devices is projected to reach $5.1 billion by 2031, with a compound annual growth rate (CAGR) of 7.7%. This growth is driven by a combination of factors, including the aging global population and technological advancements in the market, such as those introduced by ABVC Pharma. This market potential underscores the licensing deal’s significant opportunity for the company’s future growth and innovation. ABVC received its first licensing payment of $30,000 following the deal and another $3.5 million after the first successful fundraiser. Additionally, it will receive royalties for net sales, which will be worth 5% up to a maximum of $60 million. Subsidiary BioFirst will receive the same royalties and licensing fees.
Through the deal, ABVC also received distribution rights for other eye products from ForSeeCon. This will allow ABVC to win customers and take advantage of additional revenue streams. ABVC will also be a research and development partner for ForSeeCon, boosting their potential to uncover more ophthalmic products in the future, such as vitreous substitutes. These developments have attracted investor attention to ABVC BioPharma. Following the news of the licensing agreement, ABVC Pharma’s shares — which are listed on NASDAQ — jumped from 1.05 to 1.28, representing an increase of 21.9%
One month later, the share price rose again to 1.59. While the price has since stabilized at a lower value, this follows the overall pattern of a series of peaks and troughs.
Background to ABVC:
ABVC Pharma is a clinical-stage biopharmaceutical company focused on identifying and in-licensing compounds from research institutions. It delivers solutions for ophthalmology, central nervous systems, oncology, and hematology. It emphasizes substances that tackle major diseases and illnesses, especially those that haven’t yet been addressed elsewhere. Most of the company’s drugs are derived from plant substances and have already successfully completed pre- clinical, animal model studies, or Phase 1 safety studies (if not all three). In addition to developing its Vitargus® device, the company has an active pipeline of six drugs. It also carries out research with acclaimed partners like Stanford University.
Other Recent Developments:
In addition to its achievements in Ophthalmology, ABC BioPharma has enjoyed recent success in neurodevelopmental research. In December 2023, it announced an update on its ADHD clinical study, a collaboration with partner University of California San Francisco Medical Center (and multiple Taiwanese medical centers).
The Study is called “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II”. The previous phase was carried out successfully years prior and accepted by the FDA in October 2020. ABVC looks forward to completing the next part of the study and showing the potential of plant medicine for conditions like ADHD.
The company is also completing studies for solutions related to Major Depressive Disorder (MDD) and depression in cancer patients.