ABVC Announces the Approval of the Plan for GMP Production Facilities of Vitargus by Taiwan Science Park Administration
03 Agosto 2023 - 10:20AM
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 $4.3
billion by 2029, at a CAGR of 7.7%, driven, in part, by the rising
geriatric population
worldwide. [1][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 MastersonEmail:
tmasterson@allelecomms.com
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