Clover Biopharmaceuticals, Ltd. provided updates on the commercialization of SCB-2019 (CpG 1018/Alum) in China and strategic priorities in 2023. 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 First Quarter 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.

Recent Milestones: In early December 2022, SCB-2019 was included for emergency use authorization (EUA) in China. Subsequently, the China National Health Commission formally announced its national immunization plan for a fourth dose booster campaign and recommended prioritizing specified vaccines that demonstrate broad neutralization against Omicron, including SCB-2019, for use. Additionally, the price setting process for SCB-2019 commercialized via national procurement was completed with the China National Healthcare Security Administration.

Commercial Launch Expected to Begin in First Quarter 2023: Clover has started commercial launch preparation activities in multiple key provinces and municipalities, based on Clover's evaluation of market dynamics (including factors such as strategic fit, population size and competitive environment). To date, Clover has received robust interest and demand based on the premium product profile of SCB-2019 and expects the commercial launch in these strategically prioritized areas to begin in First Quarter 2023. Further expansion to additional provinces and municipalities is anticipated to occur throughout 2023, based on production capacity and market dynamics.

Impact of Ongoing COVID-19 Outbreaks: Near Term – Wider Window to Supply to Market: As COVID-19 continues to spread rapidly across China, the number of previously infected people is expected to increase significantly through the first half of 2023. Immunity induced by prior natural infection has been observed to wane rapidly, especially against Omicron, leading countries around the world to recommend booster vaccination at an interval range of one to six months after infection. While Clover's initial commercial launch in China starting in First Quarter 2023 will likely be primarily comprised of boosting infection-naïve individuals, Clover expects booster vaccination of previously infected individuals to begin in Second Quarter 2023 and to increase in proportion through the remainder of the year.

Thus, Clover anticipates a more sustained, rather than short-term, rollout of booster vaccinations throughout 2023, giving Clover a wider window of time to ramp up production and maximize the impact of its premium COVID-19 vaccine. Longer Term – Sustained & Robust Annual Booster Market: With the Chinese population's recent increasing awareness of the potential disease severity and impact of COVID-19, Clover believes that the level of certainty and the potential size of the future annual booster market for COVID-19 vaccines have increased significantly. Beyond the current National Procurement phase of COVID-19 vaccine rollout, Clover anticipates that a robust annual booster market for COVID-19 vaccines in a private market setting could emerge—similar to the growing seasonal influenza vaccination market—favoring premium products such as Clover's adjuvanted protein-based COVID-19 vaccines and introducing attractive product pricing dynamics.

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. Bilateral EUA Submissions and Procurement Deals: Clover is now prioritizing global (ex-China) 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. In addition to submitting multiple EUA applications and receiving at least one EUA for SCB-2019, Clover also expects to establish at least one bilateral supply agreement in H1 2023, which could begin to drive commercial value in 2023.

Other Regulatory Submissions: Although the near-term commercial opportunity derived from regulatory approvals of SCB-2019 with the European Medicines Agency (EMA) and the World Health Organization (WHO) is expected to be limited compared to bilateral deals, Clover plans to complete these regulatory submissions in 2023. EMA authorization and WHO Emergency Use Listing could continue to strengthen the value of SCB-2019 in the global market and validate Clover's global development capabilities. 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. Two GMP-Certified Commercial Facilities: Clover has the unique capability to commercially produce and supply SCB-2019 at two commercial manufacturing sites that have both passed inspections and achieved GMP-compliant status: Clover's in-house manufacturing facility in Changxing, Zhejiang Province (China GMP) and a contract development and manufacturing organization facility (European Union GMP). Capacity to Produce Hundreds of Millions of Doses: Across both manufacturing sites, Clover has the potential capacity to produce and supply hundreds of millions of doses annually.

In 2022, Clover successfully completed a strategic procurement and stockpiling campaign for key raw material inventory to support the potential production and release of over 100 million doses of SCB-2019 in 2023.