The Conversation (0)
ABVC BioPharma, Inc. ("ABVC" or the "Company") (NASDAQ: ABVC) today announced that its wholly owned subsidiary, BioKey (Cayman), Inc. ("BioKey"), has strengthened its operational platform and long-term development capacity at its 28,176-square-foot pharmaceutical development and manufacturing facility in Silicon Valley. The site continues to serve as a central component of ABVC's global chemistry, manufacturing, and controls ("CMC") and U.S.-Asia development strategy.
BioKey's Fremont, California facility currently incorporates formulation development laboratories, analytical laboratories, quality-aligned production areas, and warehousing, and is capable of being expanded to allow for multiple development programs to be executed in parallel within a single integrated, U.S.-based location.
Single-Site, Multi-Product U.S.-Based Development & Manufacturing
BioKey's facility is designed as a single-location, multi-product development center, supporting:
- Pharmaceutical formulations
- Botanical and plant-based products
- Controlled-release and specialized solid-oral dosage forms
- Functional food and nutraceutical products
All activities, from formulation through pilot-scale preparation, are performed entirely within the United States, providing a fully domestic development pathway that seeks to reduce cross-border complexities and enhance supply-chain resilience, both of which we believe are attractive to potential partners.
Comprehensive CMC, Analytical, and Development Capabilities
BioKey's operational capabilities include:
- Formulation development for pharmaceuticals and functional food products
- Process development and pilot-scale preparation
- Analytical testing, stability studies, and quality documentation
- Technical and regulatory support for U.S. and international submissions
- Cross-functional support for technology-transfer and long-term development programs
This integrated structure enables simultaneous support of multiple therapeutic and nutraceutical projects under coordinated oversight.
Expansion Outlook Through 2030: Supporting Up to [1,000] Jobs
ABVC and BioKey have outlined a medium-term development plan targeting expanded U.S.-Asia CMC execution and increased participation in global pharmaceutical and functional food innovation.
By 2030, ABVC anticipates that BioKey's expanded activities, operational growth, and partner-supported programs will enable and support up to [1,000] jobs across formulation, analytical development, quality operations, regulatory support, documentation, data management, and supply-chain coordination.
Facility Expansion Capacity
With over 12,054 sq. ft. of expansion-ready space, the Fremont, CA, site can accommodate:
- Additional analytical capacity
- Expanded development and production workflows
- Technology-transfer and documentation centers
- Functional food and clinical material preparation zones
Management Commentary
Dr. Uttam Patil, ABVC's Chief Executive Officer, stated "BioKey is an essential pillar of ABVC's global development strategy. Our 28,176-square-foot Silicon Valley facility provides a fully U.S.-based platform capable of supporting multiple pharmaceutical, botanical, and functional food programs from early formulation through pilot preparation."
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
View the original release on www.newmediawire.com
