ABVC’s 28,000 sq ft Silicon Valley Manufacturing Facility Stands Ready as Global Supply Chains Realign and Trust-based Localization Becomes Key

SILICON VALLEY, CA - August 8, 2025 (NEWMEDIAWIRE) - ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and oncology/hematology, today reaffirmed the strategic positioning of its fully owned subsidiary, BioKey, Inc., as a U.S.-based pharmaceutical platform designed to meet the urgent global demand for resilient, transparent, and compliant drug development and production.

BioKey operates a 28,000-square-foot FDA-compliant pharmaceutical facility in Fremont, California, at the heart of Silicon Valley’s life sciences hub, which is home to more than 3,000 biotech companies.[1] While many are virtual or focused solely on early-stage R&D, BioKey is among the few with physical manufacturing capacity and regulatory execution under one roof.

“While many are virtual, BioKey is physical. While others are adjusting, we are already aligned,” said Dr. Uttam Patil, ABVC's Chief Executive Officer.

The BioKey site supports over 50 clinical trial batches annually, with infrastructure in place for both clinical supply and early commercial production. Its regulatory team specializes in FDA IND filings, including 505(b)(2) and botanical-based drug applications, offering rare expertise in both U.S. compliance and cross-border translation. BioKey’s current lease is a 5-year term set to expire in the winter of 2026, with the option to extend. While terms of a new lease are yet to be finalized, BioKey intends to continue operations at the current manufacturing facility for the foreseeable future.

In 2025, the United States enacted tariffs of up to 40% on select pharmaceutical and medical imports from Asia. Meanwhile, the global pharmaceutical contract development and manufacturing (CDMO) market, valued at $140 billion in 2024, is projected to grow at a CAGR of 10.2%, reaching $262 billion by 2030.[2] Companies with established U.S. infrastructure - especially those with proven compliance records - are now at a strategic advantage.

“BioKey wasn’t built in response to this policy shift - we built it ahead of it,” said Dr. Patil. “We believe that foresight is now becoming a distinct competitive advantage.”

With strong roots in both U.S. regulatory practice and cross-border development, BioKey offers a rare operational bridge for Asia-originated drug programs - particularly those from Taiwan, Japan, South Korea, and Southeast Asia - seeking to enter the U.S. market without the risk of building infrastructure from scratch.

For Asian biotech companies, the advantages of collaborating with BioKey include:

• FDA regulatory alignment for IND, 505(b)(2), and botanical drug submissions
• Support in formulation transfer and CMC documentation - potentially reducing preparation time by 12 to 18 months
• Access to a fully operational 28,000 sq ft cGMP facility, avoiding significant upfront CapEx
• Culturally fluent project management for bilingual technical communication and FDA meetings

“We understand the challenges Asian developers face when entering the U.S. - from formulation to filings to language. We built BioKey to solve them,” Dr. Patil added.

According to IQVIA, 72% of Asia-based pharmaceutical companies cited increased difficulty accessing the U.S. market post-2024, with lack of local facilities and regulatory barriers being top concerns.[3]

“BioKey reflects our belief that localization is not optional - it’s inevitable. In this new global landscape, trust will not be assumed. It must be demonstrated. And BioKey is ready,” Dr. Patil concluded.

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 pivotal clinical trials (Phase III) through global partnerships.

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:
Uttam Patil
Email: uttam@ambrivis.com

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