Regulatory Approvals and Product Launches - Clover Biopharmaceuticals received regulatory approval for its COVID-19 vaccine in China in December 2022, marking its entry into the commercial market as the second booster dose[11]. - SCB-2019 was included in the emergency use authorization in China and recommended as a booster for specific populations, with commercial launch occurring in multiple provinces[26]. - SCB-2019 (CpG 1018/alum adjuvant) received emergency use authorization in China by the end of 2022, with plans for commercial launch in China and globally in 2023 through bilateral agreements[31]. - The company plans to commercialize AdimFlu-S (QIS) in the second half of 2023, contributing to revenue growth starting in 2023 and beyond[44]. Financial Performance - Total revenue decreased from RMB 382.62 million in 2021 to RMB 232.46 million in 2022, a decline of approximately 39.2%[50]. - Cash and bank balances decreased from RMB 2,835.3 million as of December 31, 2021, to RMB 1,856.5 million as of December 31, 2022, a reduction of RMB 978.8 million, primarily due to preparations for the commercialization of SCB-2019 and ongoing R&D activities[18]. - The company reported a pre-tax loss of RMB 2,451.90 million in 2022, down from a loss of RMB 6,016.30 million in 2021, representing a 59.3% improvement[61]. - The adjusted loss for the year ended December 31, 2022, was RMB 2,356.9 million, compared to RMB 2,083.5 million in 2021, indicating a year-over-year increase of approximately 13.1%[64]. Research and Development - The next-generation COVID-19 candidate vaccine and internally developed adjuvants are currently in preclinical and Phase I studies, showing potential for broad neutralization against Omicron variants[12]. - The company plans to introduce at least one mid-to-late stage vaccine project in 2023, focusing on respiratory virus vaccines and pediatric vaccines in China and the Asia-Pacific region[34]. - The company achieved significant milestones in R&D, manufacturing, and registration, with its Changxing production base in China and CDMO base in the EU passing GMP inspections, marking a key step towards commercialization[31]. - SCB-2019 demonstrated strong cross-neutralizing responses against the Omicron variant in clinical trials, with over 30,000 participants enrolled across multiple countries[39]. Strategic Partnerships and Collaborations - Clover aims to expand its mid-to-late stage pipeline by seeking new partnerships, focusing on leading respiratory vaccine products in China and the Asia-Pacific region[12]. - Clover's strategic collaborations include partnerships with organizations such as Dynavax and the Global Vaccine Alliance, enhancing its vaccine development capabilities[15]. - The company has established an exclusive distribution agreement for AdimFlu-S (QIS) in China, establishing its position as the only company with a commercialized quadrivalent seasonal flu vaccine and a recommended COVID-19 vaccine[25]. Leadership and Management - The company has expanded its leadership team with Dr. Ambrosino, who has over 35 years of experience in biopharmaceuticals and vaccine development, appointed as a non-executive director in June 2022[89]. - The company has a strong leadership team with extensive experience in the pharmaceutical and vaccine industries, including key appointments in recent years[113]. - The company has appointed a new Chief Financial Officer, Wang Yuqing, who has 25 years of experience in financial management in the US and Greater China[114]. - The company has established a scientific advisory committee to guide its research and development efforts, leveraging the expertise of its members[94]. Market Position and Growth Potential - The company is positioned as the only Chinese firm with both a commercial quadrivalent seasonal influenza vaccine and a recommended COVID-19 vaccine[11]. - The quadrivalent flu vaccine market in China is expected to continue growing, with a market share of 70% in 2022 and a projected annual growth rate of approximately 35% pre-pandemic[44]. - The company aims to establish a specialty in respiratory vaccines and create a business in the pediatric vaccine market[122]. - The company is positioned for future growth through strategic appointments and a focus on vaccine and biopharmaceutical innovation[81]. Operational Efficiency and Cost Management - The company is focused on enhancing its core strengths in vaccine development while prudently evaluating expenditures and streamlining operations to improve efficiency[47]. - Administrative expenses increased from RMB 345.71 million in 2021 to RMB 410.24 million in 2022, an increase of about 18.7%[51]. - R&D expenses decreased from RMB 1,826.30 million in 2021 to RMB 1,465.32 million in 2022, a reduction of approximately 19.7%[55]. - The company is actively managing its cash and financial policies to ensure sufficient liquidity for short-term funding needs[68].

[2022 Full-Year Results Announcement](index=1&type=section&id=%E5%85%A8%E5%B9%B4%E6%A5%AD%E7%B8%BE%E5%85%AC%E5%91%8A) [Financial Highlights](index=1&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) In 2022, the company significantly narrowed its net loss to RMB 2.45 billion due to the elimination of fair value changes in convertible redeemable preferred shares, though adjusted net loss, reflecting core operations, expanded to RMB 2.36 billion, and cash and bank balances decreased to RMB 1.86 billion due to commercialization preparations 2022 vs 2021 Financial Indicators Comparison | Indicator | 2022 (RMB thousands) | 2021 (RMB thousands) | Change | | :--- | :--- | :--- | :--- | | Other income and gains | 23,246 | 38,262 | ↓40% | | Research and development expenses | (1,465,324) | (1,826,301) | ↓20% | | Administrative expenses | (410,237) | (345,710) | ↑19% | | Loss for the year | (2,451,903) | (6,016,303) | ↓59% | | Adjusted loss for the year* | (2,356,880) | (2,083,451) | ↑13% | | Cash and bank balances | 1,856,513 | 2,835,259 | ↓34% | - The reduction in loss for the year was primarily due to the fair value loss on convertible redeemable preferred shares decreasing from **RMB 3.81 billion** in 2021 to zero in 2022, as all preferred shares were converted to ordinary shares upon listing[31](index=31&type=chunk)[20](index=20&type=chunk) - Adjusted loss for the year is a non-IFRS measure that excludes the impact of non-cash and non-recurring items such as share-based payment expenses and fair value changes of convertible redeemable preferred shares[3](index=3&type=chunk)[99](index=99&type=chunk)[120](index=120&type=chunk) [Management Discussion and Analysis](index=5&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E8%88%87%E5%88%86%E6%9E%90) The company successfully transitioned into a commercial-stage biopharmaceutical company in 2022, with its core COVID-19 vaccine SCB-2019 approved for emergency use and commercialized in China, while also expanding its respiratory vaccine pipeline through an exclusive agreement for the quadrivalent influenza vaccine AdimFlu-S, and raising capital to support commercialization and production expansion [Business Review](index=6&type=section&id=%E6%A5%AD%E5%8B%99%E5%9B%9E%E9%A1%A7) The business review focuses on the progress and commercialization of the COVID-19 vaccine SCB-2019 (CpG 1018/Aluminum Hydroxide Adjuvant), which received Emergency Use Authorization (EUA) in China and is recommended as a booster, demonstrating broad and robust neutralizing responses against Omicron variants in clinical trials, and the company also expanded its commercial product portfolio by exclusively distributing the quadrivalent influenza vaccine AdimFlu-S in China - The COVID-19 vaccine SCB-2019 received Emergency Use Authorization (EUA) in China in December 2022 and was officially launched in Zhejiang Province in February 2023, subsequently expanding to 24 provinces and cities nationwide[7](index=7&type=chunk)[161](index=161&type=chunk)[166](index=166&type=chunk) - Phase III study data showed that SCB-2019 as a heterologous booster, against Omicron sub-variants (including BQ.1.1 and XBB.1.5), induced broad and good cross-neutralizing responses[9](index=9&type=chunk)[123](index=123&type=chunk) - An exclusive agreement was reached with Adimmune Corporation to distribute the quadrivalent seasonal influenza vaccine AdimFlu-S (QIS) in China, with revenue contributions expected from 2023 onwards[5](index=5&type=chunk)[12](index=12&type=chunk)[142](index=142&type=chunk) [Research and Development](index=8&type=section&id=%E7%A0%94%E7%99%BC) The company strategically refocused R&D resources on mid-to-late-stage and commercialization projects with long-term value, pausing certain early-stage programs like SCB-808, and plans to expand its respiratory and pediatric vaccine pipeline through business development opportunities in 2023, while also advancing multivalent COVID-19 vaccine candidates - The company reallocated resources to focus on late-stage/commercialization projects and paused several early-stage programs, including SCB-808[11](index=11&type=chunk) - Plans are in place to expand the mid-to-late-stage pipeline in 2023, with a focus on respiratory disease vaccines and pediatric vaccines, and at least one more vaccine in-licensing transaction is anticipated[42](index=42&type=chunk)[43](index=43&type=chunk) - A multivalent S-Trimer COVID-19 vaccine candidate is being advanced, with clinical development planned for 2023[41](index=41&type=chunk) Product Pipeline Overview | Category | Candidate Product | Status | | :--- | :--- | :--- | | Vaccine | SCB-2019 (CpG 1018/Aluminum Hydroxide Adjuvant) | Emergency Use Authorization granted in China | | Vaccine | Quadrivalent Influenza Vaccine AdimFlu-S | Approved in China, preparing for commercialization | | Vaccine | In-license at least one mid-to-late-stage vaccine project | Planned (Phase II/III/Approved) | | Vaccine | Multivalent COVID-19 Vaccine | Clinical development planned for 2023 | | Other | SCB-313 (TRAIL-Trimer) | Development paused | [Manufacturing](index=9&type=section&id=%E7%94%9F%E7%94%A2) The company successfully established a supply chain to support SCB-2019 commercial manufacturing, with its own facility in Changxing, Zhejiang, and CDMO partner facilities both passing GMP inspections (China GMP and EU GMP, respectively), and strategic procurement and stockpiling of key raw materials sufficient to support potential production of over 100 million vaccine doses - The company's own Changxing manufacturing facility (China GMP) and CDMO facility (EU GMP) have both passed inspections, demonstrating commercial manufacturing capability for SCB-2019[14](index=14&type=chunk)[35](index=35&type=chunk)[170](index=170&type=chunk) - Strategic procurement and stockpiling of key raw materials have been completed, supporting potential production of over **100 million doses** of SCB-2019[145](index=145&type=chunk) [Other Key Corporate Developments](index=9&type=section&id=%E5%85%B6%E4%BB%96%E4%B8%BB%E8%A6%81%E5%85%AC%E5%8F%B8%E7%99%BC%E5%B1%95) To address macroeconomic challenges and support company growth, the company completed a placement of 128 million new shares in December 2022, raising net proceeds of approximately HKD 500.5 million, which will be used to expand commercialization and production capacity and meet working capital needs, thereby improving the company's financial position - A placement of **128 million new shares** was completed in December 2022, raising net proceeds of **HKD 500.5 million** for expanding commercialization, production capacity, and working capital[162](index=162&type=chunk)[171](index=171&type=chunk) - To enhance efficiency, the company streamlined its organizational structure, reduced non-core positions (primarily in general administration and non-core R&D departments), and paused non-core activities such as monoclonal antibody platform development[108](index=108&type=chunk) [Outlook](index=9&type=section&id=%E6%9C%AA%E4%BE%86%E5%B1%95%E6%9C%9B) Looking ahead to 2023, the company will focus on executing its commercialization strategy, including expanding SCB-2019 sales in China and other countries, and commercializing the influenza vaccine AdimFlu-S in the second half of the year, while continuing to leverage its R&D and collaboration capabilities to introduce more mid-to-late-stage vaccine projects for near-term value creation and long-term sustainable growth - In 2023, the focus will be on expanding the commercialization of SCB-2019 in China and launching it in other countries[45](index=45&type=chunk) - Plans are in place to commercialize the influenza vaccine AdimFlu-S (QIS) in the second half of 2023, leveraging existing commercial infrastructure[45](index=45&type=chunk) - The company plans to further expand its mid-to-late-stage vaccine pipeline to create near-term value, with expectations for continued expansion and long-term sustainable growth in 2023[45](index=45&type=chunk)[146](index=146&type=chunk) [Financial Review](index=10&type=section&id=%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) For fiscal year 2022, the company's net loss significantly narrowed from RMB 6.02 billion to RMB 2.45 billion, primarily due to the absence of the large fair value loss on convertible preferred shares from the prior year, though the core operating metric "adjusted net loss" expanded from RMB 2.08 billion to RMB 2.36 billion, with R&D expenses decreasing due to clinical trial completion but administrative expenses rising due to increased personnel, and other expenses surging due to inventory write-downs and project termination fees, while cash reserves declined but liquidity was secured through equity financing and bank credit [Income Statement Analysis](index=10&type=section&id=%E6%90%8D%E7%9B%8A%E8%A1%A8%E5%88%86%E6%9E%90) In 2022, other income and gains decreased due to exchange losses, administrative expenses rose due to increased staff costs and consulting fees, and R&D expenses significantly reduced as late-stage clinical trials were largely completed in 2021, while other expenses surged primarily due to inventory write-downs, costs associated with exiting the Shanghai R&D center project, and exchange losses, with the substantial narrowing of the loss for the year mainly attributable to the large, non-cash "fair value loss on convertible redeemable preferred shares" in 2021 being zero in 2022 Income Statement Item Changes (RMB thousands) | Item | 2022 | 2021 | Primary Reason for Change | | :--- | :--- | :--- | :--- | | Other income and gains | 23,246 | 38,262 | Exchange gains in 2021, exchange losses in 2022 | | Administrative expenses | (410,237) | (345,710) | Increase in staff costs and consulting fees | | Research and development expenses | (1,465,324) | (1,826,301) | Significant reduction in late-stage clinical trial expenses | | Other expenses | (593,658) | (66,700) | Increase in inventory write-downs and costs for exiting Shanghai R&D center project | | Fair value change of convertible redeemable preferred shares | 0 | (3,807,638) | Preferred shares converted to ordinary shares | | Loss for the year | (2,451,903) | (6,016,303) | Primarily due to the disappearance of fair value change of preferred shares | - The decrease in R&D expenses was primarily due to the substantial completion of late-stage clinical development for SCB-2019 in 2021, leading to a significant reduction in clinical trial costs[19](index=19&type=chunk)[133](index=133&type=chunk) - The increase in other expenses was mainly due to inventory write-downs, costs incurred from exiting the Shanghai R&D center project (termination fees, asset disposal losses, etc.), and severance payments from company restructuring[114](index=114&type=chunk)[199](index=199&type=chunk) [Statement of Financial Position Analysis](index=14&type=section&id=%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E8%A1%A8%E5%88%86%E6%9E%90) As of the end of 2022, the company's cash and bank balances decreased to RMB 1.86 billion, primarily due to strategic inventory procurement for SCB-2019 commercialization, leading to a significant increase in inventory to RMB 2.38 billion, and the company recorded a net liability of RMB 668 million as total liabilities exceeded total assets, mainly driven by RMB 2.50 billion in deferred revenue (a non-cash outflow liability), while new bank borrowings of RMB 294 million were added in the second half of 2022, and a total of USD 350 million in bank credit facilities were secured to support operations Statement of Financial Position Summary (As of December 31, RMB thousands) | Item | 2022 | 2021 | | :--- | :--- | :--- | | Current assets | 4,389,929 | 5,076,495 | | Non-current assets | 304,777 | 269,165 | | **Total assets** | **4,694,706** | **5,345,660** | | Current liabilities | 2,829,205 | 2,148,109 | | Non-current liabilities | 2,533,638 | 1,978,403 | | **Total liabilities** | **5,362,843** | **4,126,512** | | **(Net liabilities) / Total equity** | **(668,137)** | **1,219,148** | - Cash and bank balances decreased from **RMB 2.84 billion** to **RMB 1.86 billion**, primarily due to strategic procurement and stockpiling of key raw materials for SCB-2019 commercialization[77](index=77&type=chunk)[132](index=132&type=chunk) - The recorded net liability was mainly due to significant deferred revenue of **RMB 2.50 billion**, which does not require cash outflow within the next twelve months[72](index=72&type=chunk)[89](index=89&type=chunk) - To enhance capital efficiency, new short-term bank loans of **RMB 294 million** were added in the second half of 2022, and credit agreements totaling **USD 350 million** were entered into with China Merchants Bank and HSBC[115](index=115&type=chunk) [Non-IFRS Measures](index=14&type=section&id=%E9%9D%9E%E5%9C%8B%E9%9A%9B%E8%B2%A1%E5%8B%99%E5%A0%B1%E5%91%8A%E6%BA%96%E5%89%87%E8%A8%88%E9%87%8F) To better reflect core operating performance, the company disclosed adjusted loss for the year, which was RMB 2.36 billion in 2022, an increase from RMB 2.08 billion in 2021, and this metric excludes the impact of non-cash and non-recurring items such as share-based payment expenses and fair value changes of convertible redeemable preferred shares Reconciliation of Loss for the Year to Adjusted Loss for the Year (RMB thousands) | Item | 2022 | 2021 | | :--- | :--- | :--- | | Loss for the year | (2,451,903) | (6,016,303) | | Add: Fair value change of convertible redeemable preferred shares | – | 3,807,638 | | Add: Share-based payment expenses | 95,023 | 125,214 | | **Adjusted loss for the year** | **(2,356,880)** | **(2,083,451)** | - The company believes that adjusted loss for the year, a non-IFRS measure, better reflects the Group's normal operating performance and provides a stronger basis for comparing operating performance across different periods[23](index=23&type=chunk)[110](index=110&type=chunk) [Consolidated Financial Statements](index=18&type=section&id=%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) This section provides the company's detailed audited consolidated financial statements for the year ended December 31, 2022, including the consolidated statement of profit or loss and other comprehensive income and the consolidated statement of financial position, showing a loss for the year of RMB 2.45 billion and basic and diluted loss per share of RMB 2.22, with the company in a net liability position of RMB 668 million at year-end [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=18&type=section&id=%E7%B6%9C%E5%90%88%E6%90%8D%E7%9B%8A%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%A8%E9%9D%A2%E6%94%B6%E7%9B%8A%E8%A1%A8) For the year ended December 31, 2022, the company recorded a loss for the year of RMB 2.452 billion, a significant reduction from RMB 6.016 billion in 2021, with total comprehensive loss for the year amounting to RMB 2.431 billion, and basic and diluted loss per share of RMB 2.22 Consolidated Income Statement Key Data (RMB thousands) | Item | 2022 | 2021 | | :--- | :--- | :--- | | Loss before tax | (2,451,903) | (6,016,303) | | Loss for the year | (2,451,903) | (6,016,303) | | Other comprehensive income for the year, net of tax | 20,455 | 109,491 | | **Total comprehensive loss for the year** | **(2,431,448)** | **(5,906,812)** | - Basic and diluted loss per share attributable to ordinary equity holders of the parent was **RMB 2.22**, compared to **RMB 13.02** in 2021[160](index=160&type=chunk) [Consolidated Statement of Financial Position](index=20&type=section&id=%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E8%A1%A8) As of December 31, 2022, the company's total assets were RMB 4.695 billion and total liabilities were RMB 5.363 billion, resulting in a total equity of negative RMB 668 million (i.e., net liabilities), with net current assets of RMB 1.561 billion, and significant items on the asset side include inventory of RMB 2.384 billion, while significant items on the liability side include contract liabilities and deferred revenue totaling approximately RMB 4.052 billion Consolidated Statement of Financial Position Key Data (As of December 31, RMB thousands) | Item | 2022 | 2021 | | :--- | :--- | :--- | | **Non-current assets** | 304,777 | 269,165 | | **Current assets** | 4,389,929 | 5,076,495 | | Of which: Inventories | 2,384,340 | 768,691 | | Of which: Cash and cash equivalents | 1,607,409 | 2,767,371 | | **Current liabilities** | 2,829,205 | 2,148,109 | | Of which: Contract liabilities | 1,555,297 | 1,423,546 | | **Non-current liabilities** | 2,533,638 | 1,978,403 | | Of which: Deferred revenue | 2,496,900 | 1,931,963 | | **(Net liabilities) / Net assets** | (668,137) | 1,219,148 | [Notes to the Consolidated Financial Statements](index=22&type=section&id=%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8%E9%99%84%E8%A8%BB) The notes explain the basis of financial statement preparation, emphasizing that despite the net liability position at year-end, the directors believe the company can continue as a going concern based on future cash flow forecasts, and the notes detail changes in accounting policies, segment information, composition of income and expenses, tax situation, and loss per share calculation methods, with inventory write-down being the largest item in other expenses, and no income tax paid due to losses, with a significant amount of unrecognized deferred tax assets - The financial statements are prepared on a going concern basis; despite net liabilities, the directors believe the Group has sufficient liquidity to meet operational needs for the next 12 months, considering cash and net current assets, and that deferred revenue will not result in cash outflow[92](index=92&type=chunk)[72](index=72&type=chunk) - Total other expenses amounted to **RMB 594 million**, with the largest item being "write-down of inventories to net realizable value" at **RMB 476 million**, and an additional loss of **RMB 55.3 million** incurred from exiting the Shanghai R&D center project[187](index=187&type=chunk)[199](index=199&type=chunk) - As of the end of 2022, the Group had accumulated tax losses of **RMB 1.933 billion**, for which no deferred tax assets were recognized due to uncertainty regarding future taxable profits[207](index=207&type=chunk)[233](index=233&type=chunk) - The Board of Directors does not recommend the payment of a final dividend for the year ended December 31, 2022[243](index=243&type=chunk)[208](index=208&type=chunk) [Corporate Governance and Other Information](index=30&type=section&id=%E4%BC%81%E6%A5%AD%E7%AE%A1%E6%B2%BB%E5%8F%8A%E5%85%B6%E4%BB%96%E8%B3%87%E6%96%99) The company emphasizes its adherence to high corporate governance standards, having complied with the Corporate Governance Code and the Model Code for Securities Transactions by Directors during the reporting period, with the Audit Committee reviewing annual results, and the report details the use of net proceeds from the 2021 Global Offering (IPO) and 2022 placement, with most funds utilized as planned for core product R&D, manufacturing, and commercialization - The company has adopted and complied with the Listing Rules' Corporate Governance Code and the Model Code for Securities Transactions by Directors during the reporting period[244](index=244&type=chunk)[221](index=221&type=chunk) - The Audit Committee, comprising three independent non-executive directors, reviewed the annual results and discussed accounting policies and internal controls with management[278](index=278&type=chunk)[249](index=249&type=chunk) Global Offering (IPO) Net Proceeds Utilization (As of 2022/12/31) | Use | Planned Use (RMB millions) | Accumulated Used (RMB millions) | Unutilized (RMB millions) | | :--- | :--- | :--- | :--- | | R&D, manufacturing, and commercialization of core products | 1,006.9 | 701.6 | 305.3 | | R&D, manufacturing, and commercialization of other products | 348.5 | 225.8 | 122.7 | | Working capital and others | 193.6 | 193.6 | 0 | | **Total** | **1,549.0** | **1,121.0** | **428.0** | 2022 Placement Net Proceeds Utilization (As of 2022/12/31) | Use | Planned Use (RMB millions) | Actual Used (RMB millions) | Unutilized (RMB millions) | | :--- | :--- | :--- | :--- | | Expand commercialization and production capacity | 404.1 | 41.5 | 362.6 | | Expanded working capital needs | 44.9 | 5.8 | 39.1 | | **Total** | **449.0** | **47.3** | **401.7** |

Financial Performance - As of June 30, 2022, cash and cash equivalents decreased to RMB 2,255.6 million from RMB 2,767.4 million as of December 31, 2021, a reduction of RMB 511.8 million due to ongoing investments in R&D and preparations for the commercialization of SCB-2019[11]. - The loss for the six months ended June 30, 2022, was RMB 1,136.1 million, a decrease of RMB 178.7 million from a loss of RMB 1,314.8 million for the same period in 2021[14]. - Adjusted loss for the six months ended June 30, 2022, was RMB 1,072.2 million, compared to RMB 724.6 million for the same period in 2021, reflecting the impact of share-based payment expenses and certain non-cash items[15]. - The total comprehensive loss for the period was RMB 1,103.1 million, compared to RMB 1,289.1 million in the previous year, reflecting a decrease of 14.5%[85]. - The company reported a pre-tax loss of RMB 1,136.1 million for the six months ended June 30, 2022, compared to a loss of RMB 1,314.8 million for the same period in 2021[171]. - The basic and diluted loss per share for the six months ended June 30, 2022, was RMB 1.05, an improvement from RMB 3.76 in the same period of 2021[171]. Research and Development - R&D expenses increased to RMB 855.3 million for the six months ended June 30, 2022, up from RMB 633.8 million for the same period in 2021, primarily due to preparations for commercial launch and increased service fees from CDMO[12]. - The company announced significant progress in its pipeline, particularly with the SCB-2019 COVID-19 vaccine project, achieving key data milestones for efficacy, safety, and tolerability[18]. - The clinical pipeline has diversified with the advancement of SCB-2020S and SCB-219M into Phase I clinical trials, with multiple milestones expected in the second half of 2022[18]. - The company initiated a Phase III clinical trial in June 2022 to evaluate the safety and immunogenicity of SCB-2019 as a booster in individuals previously vaccinated with other vaccines[23]. - The company initiated a Phase I clinical trial for SCB-2020S, a second-generation broad-spectrum COVID-19 candidate vaccine, in May 2022[24]. - The company has established a comprehensive R&D platform supported by 291 employees across China, the US, and Europe as of June 30, 2022[70]. Clinical Trials and Vaccine Development - In April 2022, the company reported 100% efficacy in preventing severe COVID-19 in elderly individuals (60 years and older) five months post-primary immunization with SCB-2019[23]. - The company reported that the SCB-2019 vaccine showed a strong booster response against the Omicron variant in early studies[52]. - The SCB-2019 (CpG 1018/alum) booster induced a 19-fold increase in neutralizing antibodies against the Omicron variant BA.2 and a 12-fold increase against BA.1 in individuals previously vaccinated with two doses[53]. - The cumulative protective efficacy of SCB-2019 (CpG 1018/alum) was 89.7% for one dose and 93.8% for two doses in individuals previously infected with COVID-19, significantly reducing the risk of severe COVID-19[56]. - The company is developing a universal COVID-19 booster vaccine, expected to be completed in 2022, which can be used regardless of prior vaccination history[51]. - The company has achieved positive preliminary data in its Phase II/III studies for the SCB-2019 vaccine, with ongoing trials for various booster scenarios[52]. Financial Position and Assets - Total current assets as of June 30, 2022, amounted to RMB 4,894.6 million, including cash and cash equivalents of RMB 2,282.7 million[102]. - Total liabilities as of June 30, 2022, were RMB 5,036.4 million, resulting in a debt-to-asset ratio of 96.6%[107]. - The company's net assets decreased to RMB 176,586,000 from RMB 1,219,148,000, a significant drop of 85.5%[177]. - Cash and cash equivalents decreased to RMB 2,255,642,000 from RMB 2,767,371,000, a reduction of 18.5%[175]. - The company reported a total comprehensive loss of RMB 1,103,133,000 for the period, compared to a loss of RMB 1,136,085,000 in the previous period[180]. Corporate Governance and Management - The company appointed new executives, including a CFO and a Chief Talent Officer, in June 2022 to strengthen its management team[28]. - The audit committee consists of two independent non-executive directors and one non-executive director, ensuring compliance with listing rules[141]. - The company has adopted corporate governance standards and has complied with the relevant codes during the reporting period[134]. - The board does not recommend the payment of an interim dividend for the reporting period[142]. - The company has established policies regarding insider information to comply with securities regulations[137]. Strategic Partnerships and Market Position - The company aims to explore strategic partnerships with global biopharmaceutical companies and academic institutions to maximize the commercial potential of its pipeline products[34]. - The company has established a long-term agreement with PAHO to supply SCB-2019 (CpG 1018/alum) to the COVAX mechanism, ensuring equitable access to the vaccine[60]. - The company plans to expand global partnerships to ensure fair distribution of SCB-2019 (CpG 1018/alum) to populations in need, particularly in low- and middle-income countries[60]. - The company’s stock was included in the Hang Seng Composite Index starting March 2022, allowing it to be traded through the Hong Kong Stock Connect[29]. Operational Updates - The company is preparing for GMP inspections at its Changxing facility in Q3 2022 and is collaborating with leading CDMO production bases to submit rolling registration applications to regulatory authorities[18]. - The company has made significant progress in improving its GMP facility in Changxing, with further inspections planned for Q3 2022[48]. - The Changxing facility has been certified to operate under EU GMP standards and is expected to produce up to hundreds of millions of SCB-2019 annually at peak capacity[71]. - The company plans to submit registration applications for its COVID-19 vaccine SCB-2019 (CpG 1018/alum adjuvant) to three regulatory agencies in the second half of 2022[48].

Clinical Trials and Vaccine Development - Clover Biopharmaceuticals initiated global Phase 2/3 clinical trial SPECTRA, enrolling over 30,000 participants, demonstrating strong final protective efficacy results for its COVID-19 vaccine candidate[9] - Preliminary data from SCB-2019 indicated strong immune responses against all variants of concern, including Omicron, reinforcing its potential as both a primary immunization and booster vaccine[10] - Clover's COVID-19 vaccine candidate is designed to have high protective efficacy against variants and requires standard cold storage and transportation conditions, enhancing its logistical feasibility[9] - The company is focused on developing variant-specific COVID-19 vaccines, such as the second-generation candidate SCB-2020S (CAS-1), to ensure safety and broad protective efficacy against current and future variants[11] - SPECTRA trial data showed SCB-2019 demonstrated 100% efficacy in preventing severe COVID-19 and 84% efficacy in preventing moderate to severe cases[27] - The SCB-2019 candidate vaccine demonstrated a rapid and strong boosting response in neutralizing antibody titers for previously infected individuals[48] - A Phase II study was initiated in Brazil to evaluate SCB-2019 as a heterologous booster for individuals previously vaccinated with AstraZeneca or CoronaVac[49] - SCB-2020S, a next-generation COVID-19 vaccine, is in early development stages[48] - The company is actively communicating with regulatory authorities to support conditional approval for SCB-2019 (CpG 1018/alum) and plans to include booster clinical data in registration applications[57] Financial Performance and Funding - Cash and cash equivalents increased from RMB 516.2 million as of December 31, 2020, to RMB 2,767.4 million as of December 31, 2021, primarily due to C-round financing in March 2021 and IPO proceeds in November 2021[17] - Other income and gains rose from RMB 24.3 million in 2020 to RMB 38.3 million in 2021, mainly due to foreign exchange gains and increased interest income from higher average cash balances[17] - R&D expenses surged from RMB 228.2 million in 2020 to RMB 1,826.3 million in 2021, driven by increased clinical trial costs for SPECTRA and preparations for commercial launch[18] - Administrative expenses increased from RMB 76.4 million in 2020 to RMB 345.7 million in 2021, attributed to hiring for rapid expansion and IPO-related costs[18] - Net loss for the year escalated from RMB 912.9 million in 2020 to RMB 6,016.3 million in 2021, primarily due to rising R&D and administrative expenses[20] - The company received a milestone payment of USD 64 million from GAVI in December 2021, bringing total funds received from GAVI to USD 224 million[30] - CEPI committed to provide up to USD 397.4 million in additional funding in November 2021[31] - The total comprehensive loss for the year ended December 31, 2021, was RMB 5,906.81 million, compared to RMB 914.92 million in 2020[87] - The fair value loss of convertible redeemable preferred shares amounted to RMB 3,807.6 million for the year ended December 31, 2021, an increase of RMB 3,209.9 million compared to RMB 597.7 million for the year ended December 31, 2020[96] Research and Development Initiatives - The company achieved significant progress in 2021, leveraging the Trimer-Tag™ technology platform to develop innovative protein vaccines and tumor immunotherapies, with a focus on SCB-2019 (CpG 1018/alum adjuvant) as a universal booster candidate[10] - The company plans to expand and strengthen its R&D infrastructure, manufacturing capabilities, and commercialization resources to create long-term value and growth opportunities[13] - New R&D center established in Shanghai, China, announced in January 2022 to enhance preclinical development and production capabilities[35] - The company is exploring additional indications and combination therapies for SCB-313, which is in five Phase I clinical trials in China and Australia[48] - The company has established an Antibody Innovation Center in the UK in February 2022 to develop novel monoclonal antibody platform technologies for treating tumors and infectious diseases[84] Strategic Partnerships and Collaborations - The company maintains strategic partnerships with CEPI, Dynavax, GAVI, UNICEF, and PAHO to support its commitments to the COVAX mechanism and meet demand in China[13] - Strategic partnerships established with global health organizations like CEPI and GAVI to provide COVID-19 vaccines to affected regions[40] - The company has established a partnership with Ascentage Pharma to jointly conduct studies on SCB-313 and APG-1387 for treating malignant ascites and peritoneal cancer[48] Management and Leadership - Clover's workforce is considered a valuable asset, with a world-class management team and support from leading vaccine science advisory committees guiding the development strategy[13] - Nicholas Jackson, Ph.D., appointed as Global R&D President in February 2022, brings over 22 years of experience in vaccine and immunotherapy research and development[84] - The management team includes professionals with significant experience in the pharmaceutical and biotech industries, enhancing the company's strategic capabilities[140] - The company appointed Dr. Phillip Eric Lee as Chief Financial Officer and Chief Operating Officer in January 2021 and February 2022 respectively[151] Market Presence and Future Outlook - The company aims to commercialize SCB-2019 and is preparing for conditional registration applications with regulatory bodies including the NMPA, EMA, and WHO[38] - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2025[119] - The company provided guidance for the next fiscal year, projecting revenue growth of 30% to $195 million[119] - The company is exploring potential acquisitions to enhance its product portfolio, with a budget of $50 million allocated for this purpose[119] Sustainability and Corporate Governance - The management team emphasized a focus on sustainability initiatives, aiming to reduce operational carbon footprint by 30% by 2025[119] - The company is committed to sustainable development and adheres to environmental protection laws and regulations in China[173] - The company has purchased liability insurance to provide appropriate protection for its directors[199]