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ABVC BioPharma Plans to Expand Investment in U.S. for Production Facilities and Products for Unmet Medical Needs

Over $100 Million Invested in the U.S. 

As part of the investments completed to date, ABVC has acquired a pharmaceutical manufacturing facility in California, originally established in 2000, with a transaction value of USD 60 million. It supports ABVC’s clinical-stage projects by producing small-scale GMP-certified drug products for clinical trials from Phase I to Phase III. The facility specializes in API processing, formulation development, encapsulation, and packaging, ensuring compliance with regulatory standards. The facility plays a crucial role in ABVC’s clinical-stage pipeline, which includes six drug candidates and one medical device, supporting clinical trials in oncology, CNS disorders, and ophthalmology. The facility currently supports small-scale GMP-certified manufacturing, with the potential for expanded production as ABVC scales its commercial operations.

ABVC plans to allocate significant resources toward constructing “gigafactories” in the U.S., for its products. The initial phase of such development represents an estimated investment of USD 120 million. The factories are expected to be built to enable the use of cutting-edge technologies- including vertical farming, hydroponic systems, and AI-driven environmental controls- to cultivate high-value medicinal plants under controlled, pesticide-free conditions. Initially, the goal is to achieve an annual output of over 1,000 metric tons of botanical raw materials, as we plan to design the facility to reduce raw material costs by 30%, enhance product quality, and provide a sustainable, traceable supply chain to support ABVC’s botanical-based pharmaceuticals. Together, these projects are expected to significantly expand ABVC’s drug manufacturing capacity, create more than 500 new jobs across research, manufacturing and quality control operations, and support projected product sales exceeding $100 million USD annually within five years.

“With more than USD 100 million already invested, ABVC is fully focused on building world-class pharmaceutical and botanical production infrastructure in the United States, which explains the anticipated additional investments,” said Uttam Patil, Ph.D., Chief Executive Officer of ABVC. “We aim to deliver high-quality, plant-based therapies to patients worldwide while creating a secure, sustainable, and efficient global supply chain.”

For more information, please visit www.abvcpharma.com 

For more information about ABVC and its subsidiaries, stay updated on the latest updates or visit https://abvcpharma.com. Visit https://biolite-japan.com for more information on BioLite Japan. ABVC urges its shareholders to sign up on the Company's website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

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

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