— China commercial launch in multiple provinces and municipalities expected to begin in Q1 2023, and Clover anticipates a significant and sustained long-term annual booster market for its premium, broadly protective protein-based COVID-19 vaccines in China —
— SCB-2019 (CpG 1018/Alum) anticipated to receive emergency use authorization (EUA) in at least one additional country and to complete multiple EUA submissions during H1 2023, with commercial value driven via bilateral supply agreements expected beginning in 2023 —
— Expansion of Clover’s mid- to late-stage pipeline expected starting in H1 2023, with a focus on (1) building a leading respiratory vaccine franchise and (2) establishing a presence in the pediatric vaccine market in China and the Asia Pacific —
SHANGHAI, China, Jan. 15, 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 provided updates on the commercialization of SCB-2019 (CpG 1018/Alum) in China and strategic priorities in 2023.
“Clover transformed into a commercial-stage, vaccines-focused biotech company with proven R&D capabilities in 2022. In 2023, we are focused on launching our vaccine in multiple countries and working with health authorities in China and globally to increase booster coverage for vulnerable populations,” said Joshua Liang, Chief Executive Officer and Executive Director of Clover. “We are also planning to expand our mid- to late-stage vaccine pipeline for near-term value creation by leveraging our established vaccine development and proven cross-border collaboration capabilities.”
“Clover is well positioned to make a significant impact on the COVID-19 response with our premium and broadly protective protein-based vaccine, both in China and globally, where the need to boost protection will likely provide attractive and unique opportunities for us in 2023 and beyond,” said Dr. Nicholas Jackson, President of Global Research and Development of Clover. “In addition, we are excited to share our development plans to build a leading respiratory vaccine franchise and establish a presence in the pediatric vaccine market in China and the Asia Pacific, which will further strengthen Clover’s competitive advantages and contribution to global health.”
COVID-19 Vaccine Commercialization Updates
China Commercialization: The commercial launch for SCB-2019 in China in multiple provinces and municipalities is expected to begin in Q1 2023. Given the scale and impact of the ongoing COVID-19 outbreaks across China, Clover now anticipates a significant and sustained long-term annual booster market opportunity in China for Clover’s premium and broadly protective COVID-19 vaccine.
Global (Ex-China) Commercialization: Clover expects SCB-2019 to receive an EUA in at least one additional country and to complete multiple EUA submissions during H1 2023, potentially driving revenue via bilateral deals starting in 2023.
Commercial Manufacturing Plan: Clover’s good manufacturing practice (GMP)-certified manufacturing facilities have the potential capacity to meet demand for SCB-2019 across multiple markets. Stockpiled inventory of key raw materials to-date enables Clover to potentially produce and release over 100 million doses of SCB-2019 in 2023.
R&D Pipeline Updates & Plans
Mid- to Late-Stage Pipeline Expansion: Clover plans to expand its mid- to late-stage pipeline (Phase 2, Phase 3, Commercial) beginning in H1 2023, with a focus on (1) building a leading respiratory vaccine franchise and (2) establishing a presence in the pediatric vaccine market in the China and Asia Pacific region. Clover is currently pursuing multiple business development opportunities in these areas.
COVID-19 R&D Pipeline:
Corporate & Financial Updates
About SCB-2019 (CpG 1018/Alum)
Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein based on the original strain of the SARS-CoV-2 virus, and combined it with Dynavax’s (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum). Phase 2/3 data from 30,000+ participants across five countries showed that SCB-2019 (CpG 1018/Alum) achieved 100% efficacy against severe COVID-19 and hospitalization caused by all strains of SARS-CoV-2 circulating during the trial, and a potentially best-in-field safety profile. Clover is developing SCB-2019 (CpG 1018/Alum) as a universal booster candidate for potential use regardless of previous vaccination technology or infection history. To date, these trials have shown that SCB-2019 (CpG 1018/Alum) elicited a robust neutralization of variants including Omicron. In December 2022, SCB-2019 (CpG 1018/Alum) was included for emergency use authorization in the People’s Republic of China and included in the National Health Commission’s fourth dose booster implementation plan.
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
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:
Albert Liao
Executive Director, Corporate Communications
media@cloverbiopharma.com
Elaine Qiu
Director, Investor Relations
investors@cloverbiopharma.com
________________________________________
1 Milne G, Hames T, Scotton C et al. (2021). Does infection with or vaccination against SARS-CoV-2 lead to lasting immunity? Lancet Respir Med. Dec9(12):1450-1466.
2 Nguyen, D., Lamothe, P., Woodruff, M. et al. (2022). COVID-19 and plasma cells: Is there long-lived protection? Immunological Reviews.Jul8(309)1:40-63.
3 US: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#infection, Canada: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html#a6.2, UK: https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a, Australia: https://www.health.gov.au/our-work/covid-19-vaccines/advice-for-providers/clinical-guidance/clinical-recommendations, Israel: https://corona.health.gov.il/en/vaccine-for-covid/over-12/, South Africa: https://globalenvironmentandtechnology.app.box.com/s/nn930h2cpff35uooq7sdd12mhxepssn2/file/1063790237613, WHO: https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-(covid-19)-vaccines
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