ABVC Announces the Approval of the Plan for GMP Production Facilities of Vitargus by Taiwan Science Park Administration
- ABVC BioPharma plans to set up a pilot GMP facility in Taiwan to optimize manufacturing processes for Vitargus®, which could increase profitability for the company and its investors. The global market for retinal surgery devices is expected to reach $4.3 billion by 2029.
- None.
FREMONT, CA, Aug. 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company specializing in therapeutic solutions in oncology/hematology, neurology, and ophthalmology, announced that the Science Park Administration in Taiwan approved the plan for setting up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus®, a groundbreaking product in retinal detachment surgery, and to pursue the process development work for manufacturing optimization. The plan, proposed by ABVC's Taiwan affiliate and co-development partner, BioFirst Corporation, is to upgrade Vitargus’® manufacturing processes so that ultimately, it can handle the global market supply of Vitargus®. The factory is located in Hsinchu Biomedical Science Park, Taiwan and BioFirst Corporation is targeting to complete the construction in 2024.
BioFirst Corporation is dedicated to researching, developing, manufacturing, marketing, and securing exclusive global rights for innovative patented medical products. BioFirst Corporation has secured exclusive global rights for three Ophthalmology products from the National Health Research Institutes (NHRI). Among them, we believe that Vitargus®, a Vitreous Substitute, is the most advanced R&D product and is the first biodegradable hydrogel product used in retinal detachment surgery.
"Vitargus® has successfully completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods Administration (TGA) to initiate the next phase of trials, which is vital to obtaining approval of Vitargus® in Australia," said the CEO of ABVC, Dr. Uttam Patil. "By developing our facility’s infrastructure, we expect to significantly reduce expenses associated with the ongoing trial and ensure streamlined production processes, minimize costs associated with contracting external CROs, ensure enhanced efficiency, all of which we believe will increase profitability for ABVC BioPharma and its investors. Obtaining necessary Medical Devices GMP and International Organization for Standardization (ISO) certifications is ABVC’s priority, reinforcing our commitment to quality and compliance."
According to iHealthcare Analyst, Inc., the global market for retinal surgery devices is expected to reach
[1] https://www.ihealthcareanalyst.com/technological-advancement-ophthalmic-surgery-retinal-surgery-devices-market/
About ABVC BioPharma
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 is focused on utilizing in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of the clinical development process. 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.
Contact:
Tom Masterson
Email: tmasterson@allelecomms.com
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