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CHENGDU, China, Sept. 9, 2021 /PRNewswire/ — Clover Biopharmaceuticals, Ltd. (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced that its wholly-owned subsidiary, Zhejiang Clover Biopharmaceutical, Inc., received a Pharmaceutical Manufacturing Permit from the Zhejiang Medical Products Administration for the production of Clover’s protein-based COVID-19 vaccine candidate at its facility in Changxing, Zhejiang province, China (Changxing facility).
Clover’s in-house, commercial-ready biologics manufacturing Changxing facility has a centrally-automated and flexible start-to-finish platform based on single-use technologies. The Changxing facility was designed to adhere to current Good Manufacturing Practices (cGMP) standards in accordance with NMPA, FDA, and EMA regulations. At peak capacity, the Changxing facility will have the potential to annually produce more than one billion doses of antigen for Clover’s COVID-19 vaccine candidate, SCB-2019.
Pending positive results from SPECTRA, Clover’s global pivotal Phase 2/3 clinical COVID-19 vaccine candidate trial, the Company plans to submit conditional regulatory approval applications for SCB-2019 (CpG 1018/Alum) to the NMPA, EMA, and WHO thereafter. Pending conditional approval, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) which may occur as early as year-end 2021.
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG 1018/Alum), Clover’s COVID-19 vaccine candidate, is anticipated to potentially be one of the first protein-based COVID-19 vaccines commercialized globally through the COVAX Facility. Employing the Trimer-Tag™ technology platform, Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (S-Trimer™) based on the original strain of the SARS-CoV-2 virus. Clover’s COVID-19 vaccine candidate is the combination of SCB-2019 and two adjuvants, Dynavax’s 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 therapeutic candidates. We have leveraged the Trimer-Tag™ technology platform to become a COVID-19 vaccine developer and potentially one of the first companies to commercialize a protein-based COVID-19 vaccine globally through the COVAX Facility. For more information, please visit our website: www.cloverbiopharma.com and follow the company on LinkedIn.
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 in this [document], 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.
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