Clover’s COVID-19 Vaccine Candidate Receives European Union GMP Certificate
SHANGHAI, China, Sept. 20, 2022 (GLOBE NEWSWIRE) -- 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 Biopharmaceuticals
Clover 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 Statements
This 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.
Executive Director, Corporate Communications
Director, Investor Relations