Clover Aims to Make 2023 a Breakthrough Year with COVID-19 Vaccine Commercial Launch and Strategic Priorities

  • Clover is looking forward to an exciting start in 2023, with the launch of its premium, broadly protective protein-based COVID-19 vaccines expected to kick off in the first quarter of the year across multiple provinces and municipalities in China. With this, Clover anticipates a sustained annual booster market for its vaccines, offering long-term protection against the virus.
  • SCB-2019 (CpG 1018/Alum) is anticipated to receive emergency use authorization (EUA) in multiple countries during the first half of 2023, and supply agreements for commercial use are expected to follow shortly after. This could be a major breakthrough for the medical community, offering a potential lifesaving solution in emergency situations.
  • Clover is looking forward to an exciting expansion of its mid- to late-stage pipeline starting in the first half of 2023, with the focus of developing a world-class respiratory vaccine portfolio as well as making a splash in the pediatric vaccine market in China and the Asia Pacific region. This is a major milestone for the company and promises to be an exciting journey for all involved.

Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197) has made a commitment to use innovative vaccines to save lives and improve public health across the world. Today, the company provided updates on its commercialization of SCB-2019 (CpG 1018/Alum) in China, as well as its goals for 2023. Clover is dedicated to unlocking the power of vaccines to continue its mission of saving lives and improving global health.

Clover has made a dramatic transformation from an R&D-focused biotech company to a commercial-stage vaccines leader in just two years! In 2021, we are focused on launching our vaccine in multiple countries and working with health authorities to increase booster coverage for vulnerable populations. We are also expanding our mid- to late-stage vaccine pipeline in order to create near-term value through our established vaccine development and cross-border collaboration capabilities.

Clover is poised to make an impact in the fight against COVID-19, both in China and around the world, with our premium and widely protective protein-based vaccine. We are proud to announce our plans to create a leading respiratory vaccine franchise and enter the pediatric vaccine market in China and the Asia Pacific, building on our competitive advantages and contributing to global health. Our vaccine is set to deliver protection in 2023 and beyond, providing a unique opportunity to make a real difference.

COVID-19 Vaccine Commercialization Updates

China is set to be one of the first countries to benefit from Clover’s premium and widely protective COVID-19 vaccine, SCB-2019. With the anticipated launch in the first quarter of 2023, the pandemic has resulted in an increased demand for the product, creating a long-term annual booster market opportunity across multiple provinces and municipalities.

  • In December 2022, SCB-2019 made history as the first vaccine to receive emergency use authorization (EUA) in China. The China National Health Commission followed this announcement by recommending SCB-2019 as a priority vaccine for their fourth dose booster campaign due to its broad neutralization against Omicron. To make the vaccine more accessible, the China National Healthcare Security Administration completed the price setting process for the commercialization of SCB-2019 via national procurement.
  • Clover is ready to launch its groundbreaking product, SCB-2019, in key provinces and municipalities in Q1 2023. With its high-end features, Clover has seen an abundance of interest and demand in the market, and is looking forward to further expansion in 2023 depending on production and market conditions. Get ready for the future of innovation – SCB-2019 is just around the corner!

Impact of Ongoing COVID-19 Outbreaks:

  • Clover’s premium COVID-19 vaccine is set to launch in China in the first quarter of 2023, providing an opportunity for boosting infection-naïve individuals. But the impact of this vaccine is expected to be much greater, with booster vaccinations for previously infected individuals beginning in the second quarter of 2023. As immunity wanes rapidly against Omicron, this will open up a much wider window for Clover to ramp up production and maximize the impact of its vaccine, with booster vaccinations becoming more frequent throughout the rest of the year.
  • Clover believes that the potential size of the future annual booster market for COVID-19 vaccines has grown significantly due to an increased awareness of the disease severity and impact among the Chinese population. We anticipate that a strong and sustained annual booster market for COVID-19 vaccines could emerge in the private market – much like the growing seasonal influenza vaccination market. This market could favor premium products such as Clover’s adjuvanted protein-based COVID-19 vaccines, creating attractive pricing dynamics.
  • Clover is aiming for SCB-2019 to receive an EUA in multiple countries by the end of 2023, paving the way for bilateral deals that could bring in revenue starting that same year. With the aim of expanding their global reach, Clover is determined to make SCB-2019 a success.
  • Clover is currently prioritizing global (ex-China) regulatory submissions in select countries throughout Asia Pacific and Latin America, with the anticipation of generating significant near-term revenue and impact through the establishment of bilateral supply agreements. In addition to submitting multiple EUA applications and successfully receiving at least one EUA for SCB-2019, Clover is aiming to secure at least one bilateral supply agreement by the first half of 2023, with the potential to begin driving commercial value in the same year.
  • Clover’s SCB-2019 has the potential to become a global success, and in 2023, the company plans to take the next step by submitting the drug for approval from the European Medicines Agency (EMA) and the World Health Organization (WHO). This will not only validate Clover’s development capabilities on an international scale, but also open up opportunities for SCB-2019 to be included on the WHO’s Emergency Use Listing and further strengthen its market value.

Clover is well-prepared to meet the global demand for SCB-2019 with its stock of key raw materials and its GMP-certified manufacturing facilities. In 2023, Clover has the potential to produce and release an impressive 100 million doses of SCB-2019 – a remarkable feat!

  • Clover is proud to provide SCB-2019 on a commercial scale at two GMP-certified facilities: our own in-house manufacturing plant in Changxing, Zhejiang Province (China GMP), and a contract development and manufacturing organization facility (European Union GMP). Both sites have been rigorously inspected and approved, ensuring the highest quality standards with every product.
  • Clover has the potential to produce and supply hundreds of millions of doses of its vaccine, SCB-2019, annually. This remarkable feat was made possible through a strategic procurement and stockpiling campaign in 2022, enabling the company to have the capacity to produce over 100 million doses of the vaccine in 2023.

R&D Pipeline Updates & Plans

Clover is set to expand its mid- to late-stage pipeline in the first half of 2023, with a focus on developing a leading respiratory vaccine franchise and establishing a presence in the pediatric vaccine market in the China and Asia Pacific region. To achieve this, Clover is actively pursuing a range of business development opportunities and is confident that these steps will open up a world of possibilities for the future.

  • In H1 2023, Clover plans to announce at least one mid- to late-stage vaccine in-licensing deal that can deliver near-term catalysts and value creation. With its proven R&D capabilities, Clover is seeking out differentiated (first/best-in-class) assets that can generate excitement and bring long-term rewards. Following the execution of the deal, Clover is ready to utilize its expertise to unlock powerful catalysts and continue driving value.
  • Clover is aiming to become a leader in the respiratory vaccine space by leveraging its cutting-edge R&D, manufacturing and commercialization capabilities. To gain an edge, Clover is focusing on developing co-formulated products for respiratory syncytial virus (RSV) and seasonal influenza to create lifecycle management opportunities and capitalize on the seasonal nature of viral outbreaks. With these strategic initiatives, Clover is poised to become a top player in the respiratory vaccine market, providing people with the protection they need from multiple seasonal diseases.
  • Clover is making its mark in the pediatric vaccine market in China, confident that its presence will not only benefit the pediatric population, but also open up a cross-selling opportunity for respiratory virus vaccines amongst older adults. EV71 and DTaP (diphtheria, tetanus, and pertussis) are the two areas of focus, with the former being the biggest culprit behind the occurrence of Hand, Foot and Mouth disease in children, and the latter helping to protect against the same. Clover is optimistic that this venture will be commercially successful and beneficial to all.

COVID-19 R&D Pipeline:

  • Clover is launching commercially in China and concurrently conducting real-world effectiveness studies, which could offer valuable insight into the prevention of severe illness and death due to COVID-19 caused by newly circulating Omicron variants in at-risk populations. With data potentially available in H2 2023, the studies have the potential to bolster SCB-2019’s commercial value and competitive positioning.
  • Clover is hard at work developing a pioneering multivalent SARS-CoV-2 vaccine, which uses the revolutionary Trimer-TagTM technology platform to provide broad protection against existing and future strains of the virus. Aiming to begin clinical trials in 2023, Clover plans on utilizing immunological bridging to SCB-2019 to support potential regulatory approvals. Be sure to stay tuned as this groundbreaking vaccine has the potential to revolutionize the fight against SARS-CoV-2.
    • SCB-2020S COVID-19 Vaccine Candidate (chimeric beta and original strain): SCB-2020S is a second generation and potentially broadly protective COVID-19 vaccine candidate that is being evaluated with CAS-1, Clover’s in-house adjuvant system. In an ongoing Phase 1 study in South Africa, initial immunogenicity results indicated a robust immune response and broad neutralization against multiple Omicron strains elicited by SCB-2020S (CAS-1) that were in line with data for SCB-2019. A favorable safety and tolerability profile for SCB-2020S and CAS-1 was also observed. The results demonstrated clinical proof-of-concept for (1) antigen strain-change utilizing the Trimer-TagTM technology platform and (2) the immunogenicity and safety of Clover’s in-house CAS-1 adjuvant. Clover expects the study data to support the further development of Clover’s planned multivalent SARS-CoV-2 vaccine candidate, as well as the planned use of CAS-1 adjuvant in other new vaccines internally and via partnerships.

Corporate & Financial Updates

  • Clover is proud to introduce SCB-2020S, its second-generation, potentially broadly protective COVID-19 vaccine candidate that is being evaluated with its own proprietary adjuvant system, CAS-1. In a Phase 1 study in South Africa, the results indicated a robust immune response against multiple Omicron strains, as well as a favorable safety and tolerability profile. These promising results demonstrate the potential of Clover’s Trimer-TagTM technology platform and CAS-1 adjuvant for developing a multivalent SARS-CoV-2 vaccine and for use in other new vaccines, both internally and via partnerships.
  • Clover is expecting a significant decrease in R&D and G&A expenditures for 2023 in comparison to the previous two years. This is due to the completion of the major late-stage clinical development for SCB-2019, which included multiple global Phase 2/3 clinical trials, as well as the company’s ongoing efforts to streamline corporate operations.

About SCB-2019 (CpG 1018/Alum)

Clover’s SCB-2019 antigen, a stabilized trimeric form of the S-protein based on the original strain of the SARS-CoV-2 virus, has achieved remarkable results in Phase 2/3 trials. Combining SCB-2019 with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide (alum), the vaccine has demonstrated an extraordinary 100% efficacy against severe COVID-19 and hospitalization caused by all strains of SARS-CoV-2 circulating during the trial. Furthermore, its safety profile appears to be one of the best-in-field. As a universal booster candidate, SCB-2019 (CpG 1018/Alum) has also shown to elicit a robust neutralization of variants, including Omicron. In December 2022, the vaccine was granted emergency use authorization in the People’s Republic of China and incorporated into the National Health Commission’s fourth dose booster implementation plan.

About Clover Biopharmaceuticals

At Clover Biopharmaceuticals, we believe in harnessing the power of cutting-edge vaccines to create a healthier, safer world. Our integrated research, development, and manufacturing capabilities, combined with our extensive global partnerships, enable us to develop a diverse pipeline of vaccine candidates that have the potential to significantly reduce the spread of preventable diseases—and even to make more diseases preventable. We strive to make a positive impact on the world and to save lives through our innovative vaccines.

Clover Forward-looking Statements

At Nurture Tech, we have faith in our management’s beliefs and the data currently at our disposal. We are always striving to anticipate the future, so we make use of words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” and “would” to express our forward-looking statements and information.

Forward-looking statements provide us with a glimpse into the future of our business, economy and other conditions. However, we can’t guarantee that our expectations and assumptions will be accurate. These statements are subject to change due to inherent risks, uncertainties and evolving circumstances. Our results may differ from the expectations outlined in the forward-looking statements, making it difficult to predict the outcome. We advise readers to not rely heavily on these statements and to be aware of the fact that they are subject to change. We will update any forward-looking statements as necessary to comply with applicable laws, rules and regulations. For more information, please refer to the cautionary statement.

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