Press Release Details

-- Clover's seasonal influenza vaccine BLA submission has been completed in Brazil, boosting Clover's global presence -- 

 SHANGHAI, Nov. 7, 2023 /PRNewswire/ -- 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 the company completes the Biologic License Application (BLA) submission for its seasonal influenza vaccine (AdimFlu-S) to Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, or ANVISA). Upon approval, Clover will work with its local partner to commercialize the product in Brazil. 

"The BLA submission of AdimFlu-S in Brazil is another step towards our goal of becoming a global leader in the respiratory vaccine space and builds upon Clover's prior experience enrolling over 10,000 people in clinical trials across Brazil and South America," said Joshua Liang, Chief Executive Officer and Executive Director of Clover, "By leveraging our unique globalization capabilities, we will continue expanding to other countries and regions to diversify our sales and maximize our impact on public health." 

If approved in Brazil, Clover's seasonal influenza vaccine would have access to the Southern Hemisphere market, enabling annual sales in the first half of the year to supplement sales in the second half of the year in Northern Hemisphere markets such as China, while also better utilizing Adimmune's production capacity year-round. Brazil is an important vaccine market strategically, as the country has the world's second largest seasonal influenza vaccine market, with total local market size expected to surpass US$1 billion over the next 5 years, according to Globaldata.  

About Clover 

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.  

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.  

Clover Biopharmaceuticals:  

Corporate Communication: Lola Cao  

media@cloverbiopharma.com 

Investor Relations: Elaine Qiu  

investors@cloverbiopharma.com 

View original content:https://www.prnewswire.com/news-releases/clover-completes-bla-submission-for-seasonal-influenza-vaccine-in-brazil-301978684.html

SOURCE Clover Biopharma