Clover’s COVID-19 Vaccine Candidate Receives European Union GMP Certificate
September 20 2022 - 4:43AM
Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global
clinical-stage biotechnology company developing novel vaccines and
biologic therapeutics, today announced that Clover’s contract
development and manufacturing organization (CDMO) has received a
European Union Good Manufacturing Practice (EU GMP) certificate for
the production of Clover’s lead COVID-19 vaccine candidate,
SCB-2019 (CpG 1018/Alum). The EU GMP certificate is in connection
with Clover’s regulatory submission to the European Medicines
Agency (EMA) and follows a successful inspection of the CDMO site
by the Ireland Health Products Regulatory Authority. It signifies
that the production of SCB-2019 meets the EU’s standards for
quality and safety.
“Obtaining the EU GMP certificate for SCB-2019
is a major milestone in our efforts to bring our premier COVID-19
vaccine candidate to global markets and a testament to the
significant progress our team has made towards commercial
readiness,” said Joshua Liang, Chief
Executive Officer and Executive Director of Clover. “We
would like to thank our CDMO partner for their ongoing
collaboration and look forward to getting SCB-2019 across the
regulatory finish line.”
Clover is working towards completing regulatory
submissions to the China National Medical Products Administration
(NMPA), the EMA, and the World Health Organization (WHO) for
SCB-2019 in the second half of 2022, while concurrently preparing
for its commercialization in China and globally upon receiving
regulatory approvals.
About SCB-2019 (CpG
1018/Alum)Employing the Trimer-Tag™ technology platform,
Clover developed the SCB-2019 antigen, a stabilized trimeric form
of the S-protein (referred to as S-Trimer™) based on the original
strain of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine
candidate by combining SCB-2019 with Dynavax’s (Nasdaq: DVAX) CpG
1018 advanced adjuvant and aluminum hydroxide (alum).
About Clover
BiopharmaceuticalsClover Biopharmaceuticals is a global
clinical-stage biotechnology company committed to developing novel
vaccines and biologic therapeutics. The Trimer-Tag™ technology
platform is a product development platform for the creation of
novel vaccines and biologic therapies. Clover leveraged the
Trimer-Tag™ technology platform to become a COVID-19 vaccine
developer and created SCB-2019 (CpG 1018/Alum) to address the
COVID-19 pandemic caused by SARS-CoV-2.For more information, please
visit Clover's website: www.cloverbiopharma.com and
follow the company on LinkedIn and Twitter.
Clover
Forward-looking StatementsThis press release contains
certain forward-looking statements and information relating to us
and our subsidiaries that are based on the beliefs of our
management as well as assumptions made by and information currently
available to our management. When used, the words "aim,"
"anticipate," "believe," "could," "estimate," "expect," "going
forward," "intend," "may," "might," "ought to," "plan,"
"potential," "predict," "project," "seek," "should," "will,"
"would" and the negative of these words and other similar
expressions, as they relate to us or our management, are intended
to identify forward-looking statements.
Forward-looking
statements are based on our current expectations and assumptions
regarding our business, the economy and other future conditions. We
give no assurance that these expectations and assumptions will
prove to have been correct. Because forward-looking statements
relate to the future, they are participant to inherent
uncertainties, risks and changes in circumstances that are
difficult to predict. Our results may differ materially from those
contemplated by the forward-looking statements. They are neither
statements of historical fact nor guarantees or assurances of
future performance. We caution you therefore against placing undue
reliance on any of these forward-looking statements. Any
forward-looking statement made by us in this document speaks only
as of the date on which it is made. Factors or events that could
cause our actual results to differ may emerge from time to time,
and it is not possible for us to predict all of them. Participant
to the requirements of applicable laws, rules and regulations, we
undertake no obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
All forward-looking statements contained in this document are
qualified by reference to this cautionary statement.
Clover
Biopharmaceuticals:Albert LiaoExecutive Director,
Corporate Communicationsmedia@cloverbiopharma.com
Elaine QiuDirector,
Investor Relationsinvestors@cloverbiopharma.com
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Dynavax Technologies (NASDAQ:DVAX)
Historical Stock Chart
From Sep 2023 to Sep 2024