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14-Feb-2023

Clover Launches COVID-19 Booster Vaccine in the People’s Republic of China

--As part of China’s second booster campaign, Clover’s premium, broadly protective protein-based vaccine is now available in Zhejiang province with additional provinces and municipalities to follow in Q1 2023--

SHANGHAI, China, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced that the launch of its COVID-19 vaccine, a recombinant SARS-CoV-2 subunit vaccine, in the People’s Republic of China has begun with the first doses delivered and administered in Changxing, Zhejiang as part of China’s national second booster dose (fourth vaccination dose) campaign targeting older adults, immunocompromised individuals and individuals with comorbidities (LINK).

“We are very proud to be delivering on our commitment to help protect the elderly and other vulnerable populations with our premium COVID-19 booster vaccine, and commencing the launch in Zhejiang province where our vaccine is manufactured,” said Joshua Liang, Chief Executive Officer and Executive Director of Clover. “I would like to sincerely thank everyone who contributed to making today’s launch possible, including our employees, clinical trial investigators and participants, health authorities in China and around the world, and our CEPI partners who provided instrumental technical and funding support.”

Clover’s COVID-19 vaccine was authorized for emergency use in China in December 2022. Subsequently, the China National Health Commission formally announced its national immunization plan for a second booster dose campaign and recommended prioritizing specified vaccines that demonstrate broad neutralization against Omicron, including Clover's, for use.

“We are thrilled to see our partnership with Clover reach this important milestone and to witness the moment its COVID-19 vaccine has become available to at-risk populations,” said Dr. Richard Hatchett, Chief Executive Officer of CEPI. “With its attributes as a protein-based vaccine and compelling efficacy and safety data, Clover’s vaccine has the potential to provide immediate support to the COVID-19 response in China and to play a strategic role in the international community’s ongoing management of SARS-CoV-2.”

In a global Phase 2/3 clinical trial with over 30,000 participants across five countries, Clover’s COVID-19 vaccine achieved 100% efficacy against severe COVID-19 and hospitalization caused by all strains of SARS-CoV-2 circulating during the trial (LINK). In addition, a study embedded within this Phase 2/3 trial demonstrated that a household contact was 84% less likely to get a SARS-CoV-2 infection when the infected household member had received Clover’s vaccine, compared to households where the infected household member was not vaccinated (LINK). Finally, in a separate Phase 3 study, Clover’s COVID-19 vaccine demonstrated broad and robust cross-neutralization of multiple Omicron subvariants, including Omicron BA.1, BA.2, and BA.5, when it was administered as a third dose heterologous booster after two doses of inactivated vaccine—a response that was superior to a third dose of inactivated vaccine (LINK) (LINK). Analysis of the booster vaccine’s cross-neutralization of more recently circulating subvariants including Omicron BF.7, BQ.1.1 and BA.2.75 is consistent with prior data.

In addition to Zhejiang province, Clover has started launch preparation activities in multiple strategically prioritized provinces and municipalities where it expects additional launches in Q1 2023. Further expansion within China will continue through 2023 based on production capacity and market dynamics. Outside of China, Clover is also prioritizing additional regulatory submissions directly in select countries, primarily in Asia Pacific and Latin America, based on the potential to generate significant near-term revenue and impact via bilateral supply agreements.

About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable.

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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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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Last Updated: 14-Feb-2023