SHANGHAI, April 29,
2024 /PRNewswire/ -- CARsgen Therapeutics Holdings
Limited (Stock Code: 2171.HK), a company focused on innovative CAR
T-cell therapies for the treatment of hematologic malignancies and
solid tumors, announces that responses regarding the status of the
Corrective and Preventive Actions (CAPAs) plan have been submitted
to the U.S. Food and Drug Administration (FDA). This submission is
related to the observations identified in the Form 483 issued after
the FDA inspection in December 2023
of our clinical manufacturing site in Durham, North Carolina. All relevant works are
progressing smoothly according to the previously committed
timetable.
The Company is committed to working closely with the FDA to
prioritize quality in production during clinical trials.
About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company with operations in
China and the U.S. and is focused
on innovative CAR T-cell therapies for the treatment of hematologic
malignancies and solid tumors. CARsgen has established a
comprehensive CAR T-cell research and development platform,
encompassing target discovery, innovative CAR T-cell development,
clinical trials, and commercial-scale production. CARsgen has
internally developed novel technologies and a product pipeline with
global rights to address major challenges of CAR T-cell therapies,
such as improving the safety profile, enhancing the efficacy in
treating solid tumors, and reducing treatment costs. CARsgen's
mission is to become a global biopharmaceutical leader that brings
innovative and differentiated cell therapies to cancer patients
worldwide and makes cancer curable.
Forward-looking Statements
All statements in this press release that are not historical
fact or that do not relate to present facts or current conditions
are forward-looking statements. Such forward-looking statements
express the Group's current views, projections, beliefs and
expectations with respect to future events as of the date of this
press release. Such forward-looking statements are based on a
number of assumptions and factors beyond the Group's control. As a
result, they are subject to significant risks and uncertainties,
and actual events or results may differ materially from these
forward-looking statements and the forward-looking events discussed
in this press release might not occur. Such risks and uncertainties
include, but are not limited to, those detailed under the heading
"Principal Risks and Uncertainties" in our most recent annual
report and interim report and other announcements and reports made
available on our corporate website, https://www.carsgen.com. No
representation or warranty is given as to the achievement or
reasonableness of, and no reliance should be placed on, any
projections, targets, estimates or forecasts contained in this
press release.
Contact CARsgen
For more information, please visit
https://www.carsgen.com/
Public Relations: PR@carsgen.com
Investor Relations: IR@carsgen.com
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SOURCE CARsgen Therapeutics