-- 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.
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.
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Corporate Communication: Lola Cao
Investor Relations: Elaine Qiu
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SOURCE Clover Biopharma