Clover’s COVID-19 Vaccine Candidate Receives European Union

SHANGHAI, China, Sept. 20, 2022 (GLOBE NEWSWIRE) — Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a worldwide clinical-stage biotechnology firm creating novel vaccines and biologic therapeutics, right this moment introduced that Clover’s contract improvement and manufacturing group (CDMO) has acquired a European Union Good Manufacturing Practice (EU GMP) certificates for the manufacturing of Clover’s lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The EU GMP certificates is in reference to Clover’s regulatory submission to the European Medicines Agency (EMA) and follows a profitable inspection of the CDMO web site by the Ireland Health Products Regulatory Authority. It signifies that the manufacturing of SCB-2019 meets the EU’s requirements for high quality and security.

“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,” stated 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 in the direction of finishing regulatory submissions to the China National Medical Products Administration (NMPA), the EMA, and the World Health Organization (WHO) for SCB-2019 within the second half of 2022, whereas concurrently making ready for its commercialization in China and globally upon receiving regulatory approvals.

About SCB-2019 (CpG 1018/Alum)
Employing the Trimer-Tag™ know-how platform, Clover developed the SCB-2019 antigen, a stabilized trimeric type of the S-protein (known as S-Trimer™) primarily based on the unique pressure of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavax’s (Nasdaq: DVAX) CpG 1018 superior adjuvant and aluminum hydroxide (alum).

About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a worldwide clinical-stage biotechnology firm dedicated to creating novel vaccines and biologic therapeutics. The Trimer-Tag™ know-how platform is a product improvement platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag™ know-how platform to change into a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to deal with the COVID-19 pandemic brought on by SARS-CoV-2.
For extra data, please go to Clover’s web site: www.cloverbiopharma.com and comply with the corporate on LinkedIn and Twitter.

Clover Forward-looking Statements
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Clover Biopharmaceuticals:
Albert Liao
Executive Director, Corporate Communications
[email protected]

Elaine Qiu
Director, Investor Relations
[email protected]