Shanghai (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
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