[Company and Financial Overview](index=2&type=section&id=%E5%85%AC%E5%8F%B8%E8%B3%87%E6%96%99) [Corporate Information](index=2&type=section&id=%E5%85%AC%E5%8F%B8%E8%B3%87%E6%96%99) Provides basic corporate information, including board composition, registered offices, auditors, and listing details - The company is incorporated in the Cayman Islands, headquartered in Shanghai, with its principal place of business in Hong Kong[2](index=2&type=chunk) - The company's stock code is 2197, listed on the Hong Kong Stock Exchange on November 5, 2021, with Ernst & Young as the auditor[3](index=3&type=chunk) [Financial Highlights](index=4&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) The company shifted from a profit to a loss, primarily due to the absence of significant one-off income and reduced expenses across all categories Key Financial Data for H1 2024 (vs. H1 2023) | Metric | Six Months Ended June 30, 2024 (RMB'000) | Six Months Ended June 30, 2023 (RMB'000) | Change | | :--- | :--- | :--- | :--- | | Revenue | (10,100) | 257 | Turned to negative revenue | | Other Income and Gains | 67,148 | 2,510,809 | -97.3% | | R&D Expenses | (98,297) | (385,603) | -74.5% | | Administrative Expenses | (42,075) | (109,468) | -61.6% | | Period (Loss)/Profit | (95,123) | 650,624 | Shifted from profit to loss | | Adjusted Period (Loss)/Profit | (87,259) | 674,468 | Shifted from profit to loss | - Cash and bank balances **decreased from RMB 1.096 billion** at the end of 2023 to **RMB 830 million** at the end of the reporting period, mainly due to daily operations and repayment of bank loans[4](index=4&type=chunk)[5](index=5&type=chunk) - R&D expenses **decreased significantly by 75%** (approximately RMB 287 million) year-over-year, as R&D activities for the COVID-19 vaccine SCB-2019 were completed and operations were streamlined[6](index=6&type=chunk) - Other expenses **decreased by 99.8%** year-over-year, primarily because a **RMB 1.237 billion** inventory provision for the COVID-19 vaccine was recorded in the prior-year period, with no such expense this period[6](index=6&type=chunk)[29](index=29&type=chunk) [Management Discussion and Analysis](index=6&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) [Business Summary and Outlook](index=6&type=section&id=%E6%A5%AD%E5%8B%99%E6%91%98%E8%A6%81) The company is focusing on its respiratory vaccine portfolio, prioritizing the development of its RSV candidate while ensuring financial sustainability through operational efficiency - The company's core strategy is to build a leading global respiratory vaccine portfolio using its validated Trimer-Tag technology platform[21](index=21&type=chunk) - The company will prioritize resources for the development of its proprietary bivalent PreF RSV vaccine candidate, SCB-1019, with full Phase I results expected by the end of 2024[21](index=21&type=chunk) - The company will continue measures to ensure financial sustainability, including improving operational efficiency and maintaining robust cash flow management[21](index=21&type=chunk) [Product Pipeline and Business Review](index=9&type=section&id=%E7%94%A2%E5%93%81%E7%AE%A1%E7%B7%9A%E8%88%87%E6%A5%AD%E5%8B%99%E5%9B%9E%E9%A1%A7) Details the progress of the product pipeline, highlighting positive RSV candidate data, commercial readiness of the influenza vaccine, and exploration of other opportunities [RSV Vaccine Candidate (SCB-1019)](index=10&type=section&id=RSV%E5%80%99%E9%81%B8%E7%96%AB%E8%8B%97%20(SCB-1019)) The bivalent RSV candidate SCB-1019 demonstrated encouraging immunogenicity and safety in its Phase I trial, showing competitive potential - SCB-1019 is a bivalent RSV vaccine candidate developed using the Trimer-Tag platform, with its Phase I clinical trial initiated in Australia[14](index=14&type=chunk) Preliminary Immunogenicity Data for SCB-1019 in Older Adults (28 Days Post-Vaccination) | Antibody Type | SCB-1019 Group GMT (IU/mL) | Placebo Group GMT (IU/mL) | | :--- | :--- | :--- | | RSV-A Neutralizing Antibody | Up to 7,906 | 1,078 | | RSV-B Neutralizing Antibody | Up to 46,674 | 12,185 | - SCB-1019 was **well-tolerated**, with adverse events generally mild and comparable to the placebo group, indicating a potential safety differentiation advantage[16](index=16&type=chunk) [AdimFlu-S (Quadrivalent Influenza Vaccine)](index=11&type=section&id=AdimFlu-S%20(%E5%9B%9B%E5%83%B9%E6%B5%81%E6%84%9F%E7%96%AB%E8%8B%97)) The company holds exclusive distribution rights for AdimFlu-S in mainland China and completed batch release ahead of the flu season - The company completed the batch release for AdimFlu-S at the end of July 2024, **significantly earlier than the mid-September 2023 release**, helping to capture sales opportunities for the autumn/winter season[11](index=11&type=chunk)[16](index=16&type=chunk) [SCB-219M (CIT Treatment)](index=11&type=section&id=SCB-219M%20(CIT%E6%B2%BB%E7%99%82)) The company is actively exploring business development opportunities for SCB-219M, a treatment for chemotherapy-induced thrombocytopenia, following positive Phase I data - The company is actively seeking business development opportunities for SCB-219M and may initiate a Phase Ib clinical trial before the end of 2024[17](index=17&type=chunk) [COVID-19 Vaccine](index=12&type=section&id=%E6%96%B0%E5%86%A0%E7%96%AB%E8%8B%97) The company is prudently assessing market opportunities for its COVID-19 vaccine after the market in mainland China transitioned to a private-pay model - The COVID-19 vaccine market in mainland China transitioned to a private-pay model on July 15, 2024, and the company is evaluating its impact on future commercialization[18](index=18&type=chunk) [R&D, Manufacturing, and Other Developments](index=12&type=section&id=%E7%A0%94%E7%99%BC%E3%80%81%E7%94%9F%E7%94%A2%E5%8F%8A%E5%85%B6%E4%BB%96%E7%99%BC%E5%B1%95) The company maintains an internal R&D team and a GMP-compliant manufacturing facility, while continuing to streamline operations for efficiency - As of June 30, 2024, the company's internal R&D team consisted of 124 employees[18](index=18&type=chunk) - The company's proprietary manufacturing facility in Changxing, Zhejiang has obtained a Drug Manufacturing License (DML) for vaccines, supporting future product development including the RSV candidate[19](index=19&type=chunk) - The company continues to streamline its organization and scrutinize expenditures to address macroeconomic challenges and improve operational efficiency[20](index=20&type=chunk) [Financial Review](index=14&type=section&id=%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) Provides an in-depth analysis of financial performance, including negative revenue from sales returns, a sharp drop in other income, and significantly lower operating expenses [Revenue Analysis](index=15&type=section&id=%E6%94%B6%E5%85%A5) The company recorded negative revenue of approximately RMB 10.1 million due to higher-than-expected sales returns for its influenza vaccine, AdimFlu-S - The company recorded **negative revenue of RMB 10.1 million** during the period due to sales returns of the quadrivalent influenza vaccine AdimFlu-S[23](index=23&type=chunk) - Sales returns were higher than anticipated because an expected influenza outbreak in spring 2024 did not materialize, leading to lower-than-expected market demand[23](index=23&type=chunk)[124](index=124&type=chunk) [Expense Analysis](index=16&type=section&id=%E9%96%8B%E6%94%AF%E5%88%86%E6%9E%90) All major expense categories decreased significantly year-over-year, reflecting cost control measures such as team optimization and strategic R&D prioritization Year-over-Year Change in Expenses | Expense Item | H1 2024 (RMB'000) | H1 2023 (RMB'000) | YoY Change | | :--- | :--- | :--- | :--- | | Selling and Distribution Expenses | 6,684 | 22,511 | -70.3% | | Administrative Expenses | 42,075 | 109,468 | -61.6% | | R&D Expenses | 98,297 | 385,603 | -74.5% | | Other Expenses | 2,540 | 1,330,909 | -99.8% | - The decrease in administrative expenses was mainly attributable to lower salaries and benefits from organizational streamlining, as well as reduced consulting and depreciation fees[26](index=26&type=chunk) - The reduction in R&D expenses was primarily due to the completion of activities related to the COVID-19 vaccine SCB-2019 and the company's strategic focus on its respiratory vaccine portfolio[27](index=27&type=chunk) [Liquidity and Capital Management](index=19&type=section&id=%E6%B5%81%E5%8B%95%E8%B3%87%E9%87%91%E8%88%87%E8%B3%87%E6%9C%AC%E7%AE%A1%E7%90%86) The company maintains a net cash position with sufficient liquidity to sustain operations, despite a decrease in cash reserves and net current liabilities - As of June 30, 2024, the Group's cash and bank balances stood at **RMB 829.8 million**[35](index=35&type=chunk) - As of June 30, 2024, the Group was in a **net cash position**, making the gearing ratio not applicable[36](index=36&type=chunk) - As of June 30, 2024, the Group had **RMB 347.2 million** in time deposits pledged for bank credit facilities[36](index=36&type=chunk) [Other Information](index=22&type=section&id=%E5%85%B6%E4%BB%96%E8%B3%87%E6%96%99) [Shareholding Structure and Directors' Interests](index=22&type=section&id=%E8%82%A1%E6%AC%8A%E7%B5%90%E6%A7%8B%E8%88%87%E8%91%A3%E4%BA%8B%E6%AC%8A%E7%9B%8A) Discloses the shareholdings of directors, chief executives, and substantial shareholders, with executive directors Dr. Peng Liang and Mr. Guo Liang as controlling shareholders - Executive directors Dr. Peng Liang and Mr. Guo Liang are deemed to have a joint interest in each other's shares due to a concert party deed[40](index=40&type=chunk)[41](index=41&type=chunk) - Substantial shareholders (holding over 5%) include **JNRY (7.03%)**, **AUT-XXI (5.12%)**, **Shanghai Tianhe (5.40%)**, and Ms. Shibi Wang (indirectly holding 6.98% through controlled corporations)[42](index=42&type=chunk)[43](index=43&type=chunk) [Share Incentive Schemes](index=27&type=section&id=%E8%82%A1%E4%BB%BD%E6%BF%80%E5%8B%B5%E8%A8%88%E5%8A%83) The company operates Pre-IPO, RSU, and Post-IPO share incentive schemes to reward directors, employees, and consultants for their contributions - As of June 30, 2024, **1,852,817 share options** under the Pre-IPO Share Option Scheme remained outstanding[60](index=60&type=chunk) - As of June 30, 2024, **15,557,014 unvested Restricted Share Units** (RSUs) were outstanding under the RSU Scheme[72](index=72&type=chunk)[74](index=74&type=chunk) - As of June 30, 2024, **35,401,791 share options** under the Post-IPO Share Option Scheme remained outstanding[90](index=90&type=chunk)[91](index=91&type=chunk) [Use of Proceeds](index=40&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%85%E7%94%A8%E9%80%94) Details the utilization of net proceeds from the Global Offering and Placing, with funds primarily allocated to R&D and commercialization of the respiratory vaccine portfolio Use of Net Proceeds from the Global Offering (as of June 30, 2024) | Use of Proceeds (Post-reallocation) | Re-allocated Amount (RMB million) | Utilized Amount (RMB million) | Unutilized Amount (RMB million) | Expected Full Utilization Date | | :--- | :--- | :--- | :--- | :--- | | Development of RSV candidate SCB-1019 | 228.4 | 130.1 | 98.3 | Before June 2025 | | R&D for other pipeline candidates | 93.4 | 40.9 | 52.5 | Before June 2025 | | R&D for COVID-19 vaccine | 51.9 | 51.9 | 0 | Completed | | Working capital and other | 41.5 | 41.5 | 0 | Completed | - Net proceeds from the Placing amounted to approximately RMB 449 million, of which **RMB 416.6 million (92.8%)** had been used as of June 30, 2024, with the remainder expected to be used by December 2024[101](index=101&type=chunk)[102](index=102&type=chunk) [Interim Condensed Consolidated Financial Statements and Notes](index=43&type=section&id=%E4%B8%AD%E6%9C%9F%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) [Key Financial Statements](index=43&type=section&id=%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) Presents the unaudited interim consolidated statements, showing a net loss for the period and a net liability position on the balance sheet Core Financial Statement Data (as of June 30, 2024) | Statement Item | Amount (RMB'000) | | :--- | :--- | | **Income Statement (H1 2024)** | | | Loss for the period | (95,123) | | Basic loss per share | (0.08) yuan | | **Statement of Financial Position (Period-end)** | | | Total Assets | 1,797,271 | | Total Liabilities | 2,630,046 | | Total Equity (Deficit) | (832,775) | | Cash and cash equivalents | 458,774 | | **Cash Flow Statement (H1 2024)** | | | Net cash flow from operating activities | (157,926) | | Net cash flow from investing activities | (9,011) | | Net cash flow from financing activities | (111,887) | [Summary of Notes to Financial Statements](index=51&type=section&id=%E4%B8%AD%E6%9C%9F%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E8%B3%87%E6%96%99%E9%99%84%E8%A8%BB) Provides detailed explanations for key financial data, including the basis of preparation, contract liabilities, and related party transactions - Despite recording **net liabilities of RMB 833 million** as of June 30, 2024, the directors believe the company can operate as a going concern, considering non-cash-flow-generating contract liabilities and available financing[118](index=118&type=chunk) - **Contract liabilities of RMB 1.589 billion** primarily consist of an advance payment from GAVI for the SCB-2019 vaccine, for which GAVI has not yet exercised its purchase option[152](index=152&type=chunk) - The non-current portion of trade payables, approximately **RMB 508 million**, is owed to Dynavax for the purchase of CpG 1018 adjuvant, with a settlement period exceeding 12 months[151](index=151&type=chunk) - During the period, the company incurred office rental and utility expenses of **RMB 2.847 million** with related party Chengdu Tianhe[170](index=170&type=chunk)

Financial Performance - The company reported a revenue of RMB 829.8 million for the six months ended June 30, 2024, a significant decrease of approximately 96.7% compared to RMB 2,510.8 million for the same period in 2023[1]. - The company's total income decreased from RMB 2,510.8 million for the six months ended June 30, 2023, to RMB 67.1 million for the same period in 2024, a reduction of RMB 2,443.7 million[24]. - For the six months ended June 30, 2024, the company reported a revenue of negative RMB 10.1 million, primarily due to sales returns of the quadrivalent influenza vaccine AdimFlu-S[23]. - The group reported a loss attributable to equity holders of the parent company of RMB (95,123,000) for the six months ended June 30, 2024, compared to a profit of RMB 650,624,000 for the same period in 2023[66]. - The total comprehensive loss for the period was RMB 107,811,000, a stark contrast to the total comprehensive income of RMB 671,837,000 in the previous year[45]. Expenses and Cost Management - The cash and bank balances decreased from RMB 1,095.5 million as of December 31, 2023, to RMB 829.8 million as of June 30, 2024, primarily due to cash outflows from operations and loan repayments[2]. - Research and development expenses decreased by approximately 75% from RMB 385.6 million for the six months ended June 30, 2023, to RMB 98.3 million for the same period in 2024, as related activities for SCB2019 were completed[3]. - Administrative expenses were reduced by about 62% from RMB 109.5 million for the six months ended June 30, 2023, to RMB 42.1 million for the same period in 2024, due to staff reductions and other cost-saving measures[2]. - Sales and distribution expenses decreased from RMB 22.5 million to RMB 6.7 million, a reduction of RMB 15.8 million, mainly due to optimized staffing to improve efficiency[25]. - Employee compensation and benefits decreased from RMB 152.8 million for the six months ended June 30, 2023, to RMB 56.5 million for the six months ended June 30, 2024[29]. Clinical Development and Research - The company is the first in China to independently develop a PreF bivalent RSV candidate vaccine, which has entered clinical trial stages[4]. - The company announced the completion of the first cohort enrollment in the Phase I clinical trial for its RSV candidate vaccine (SCB-1019) in December 2023[5]. - Initial results from Phase I trials for young adults and elderly groups showed positive immunogenicity and safety data in April and June 2024[5]. - The company aims to advance its proprietary bivalent PreF RSV candidate vaccine development, expecting to obtain comprehensive Phase I clinical trial results by the end of 2024[21]. - SCB-1019 demonstrated good overall tolerability, with mild local and systemic adverse events comparable to the placebo group, and no serious adverse events were observed[14]. Product Development and Market Strategy - The company has established an exclusive distribution agreement for AdimFlu-S with a local partner, enabling faster market access and distribution in mainland China[6]. - The company completed the batch approval for AdimFlu-S by the Chinese National Medical Products Administration, facilitating quicker market entry before the autumn-winter vaccination season[6]. - SCB-219M is a bispecific Fc fusion protein for treating chemotherapy-induced thrombocytopenia (CIT), with plans to initiate Phase Ib clinical trials by the end of 2024[7]. - The company is focused on building a leading respiratory vaccine product portfolio based on its validated Trimer-Tag platform[21]. - The company is committed to developing a leading respiratory vaccine product portfolio to meet the unmet needs in preventing severe respiratory infections[12]. Financial Position and Liabilities - Total assets decreased from RMB 2,101.4 million as of December 31, 2023, to RMB 1,797.3 million as of June 30, 2024[34]. - Total liabilities decreased from RMB 2,834.3 million as of December 31, 2023, to RMB 2,630.0 million as of June 30, 2024[34]. - The group reported a net liability of RMB 832,775,000 as of June 30, 2024, compared to RMB 732,833,000 at the end of 2023[46]. - The company anticipates no cash outflow related to contract liabilities of RMB 1,589,092,000 in the next twelve months, indicating a potential for improved cash flow management[48]. - The company has sufficient cash and cash equivalents to meet operational needs, supported by available bank financing[49]. Government Grants and Other Income - Other income and gains for the six months ended June 30, 2024, amounted to RMB 67.148 million, compared to RMB 2.511 million for the same period in 2023, indicating a substantial increase[55]. - Government grants received for supporting R&D activities and the purchase of property, plant, and equipment amounted to RMB 33.952 million for the six months ended June 30, 2024[55]. - The government grant recognized in profit or loss for the year decreased from RMB 1,000,000 in 2023 to RMB (1,851,000) in 2024[76]. Corporate Governance and Compliance - The company has adopted the corporate governance code and has complied with its principles and provisions during the reporting period[79]. - The audit committee has reviewed the unaudited condensed consolidated financial statements for the six months ended June 30, 2024[80].

Pipeline Development and Commercialization - Clover Biopharmaceuticals has achieved significant progress in its pipeline development and has entered its commercialization phase in 2023, focusing on innovative vaccines to improve global health[9]. - The company has two authorized vaccines: a COVID-19 booster vaccine and a quadrivalent seasonal influenza vaccine, with sales expected to reach approximately $2.5 billion in the second half of 2023 in the US and European markets[9]. - The RSV vaccine, utilizing proprietary mutation technology and the Trimer-Tag platform, has the potential to become one of the best RSV vaccines globally, with a market potential exceeding $10 billion[9]. - Clover Biopharmaceuticals has completed the BLA submission for the quadrivalent influenza vaccine in Brazil, marking a strategic step towards commercial opportunities in the Southern Hemisphere respiratory vaccine market[10]. - The company is actively seeking domestic and international partnerships for mid-to-late stage respiratory and pediatric vaccine products to enrich its product portfolio[13]. - The company aims to maximize its commercial potential in the respiratory vaccine market, including the RSV vaccine, through strategic resource allocation and operational optimization[12]. - The company announced the successful enrollment of the first subjects in the Phase I clinical trial for the RSV candidate vaccine SCB-1019, developed using the Trimer-Tag technology platform[26]. - The quadrivalent seasonal flu vaccine AdimFlu-S (QIS) was launched in 28 provinces in China, with an exclusive distribution agreement established with National Biotechnology Co., Ltd.[26]. - The company submitted a Biologics License Application for the seasonal flu vaccine in Brazil, aiming for commercialization upon approval[26]. - The company announced an exclusive agreement with National Biotechnology in February 2023 to distribute the quadrivalent influenza vaccine AdimFlu-S in mainland China[30]. - The company plans to leverage its Trimer-Tag platform for the commercial production of SCB-1019 at its Changxing facility, which has received GMP certification[34]. - The company aims to achieve a year-round sales cycle for its seasonal influenza vaccine by expanding into the Southern Hemisphere market with the approval of AdimFlu-S in Brazil[37]. Financial Performance - Revenue for the year ended December 31, 2023, was RMB 39.3 million, attributed to the commercial launch of SCB-2019 and the quadrivalent seasonal flu vaccine in China[16]. - Other income and gains increased significantly to RMB 2,571.4 million from RMB 23.2 million in the previous year, mainly due to the recognition of RMB 2,540.5 million from CEPI funding[16]. - The net loss for the year narrowed to RMB 138.5 million from RMB 2,451.9 million, driven by increased other income and reduced R&D and administrative expenses[19]. - The adjusted net loss, excluding share-based compensation, was RMB 85.0 million compared to RMB 2,356.9 million in the previous year[21]. - The company achieved a gross profit of RMB 24.2 million, with a sales cost of RMB 15.0 million[47]. - Administrative expenses were reduced by approximately 52% to RMB 198.8 million from RMB 410.2 million, due to workforce reductions and cost-saving measures[17]. - R&D expenses decreased by about 56% to RMB 649.9 million from RMB 1,465.3 million, as related activities for SCB-2019 were largely completed[19]. - Other expenses increased from RMB 593.7 million in 2022 to RMB 1,811.9 million in 2023, primarily due to inventory provisions of RMB 1,697.4 million[57]. - Financial costs rose from RMB 5.9 million in 2022 to RMB 18.7 million in 2023, an increase of 216.9%[58]. - Total current assets decreased from RMB 4,389.9 million in 2022 to RMB 1,899.5 million in 2023[63]. - Total liabilities decreased from RMB 5,362.8 million in 2022 to RMB 2,834.3 million in 2023[63]. - Cash and bank balances decreased from RMB 1,856.5 million in 2022 to RMB 1,095.5 million in 2023, a reduction of 41%[64]. - As of December 31, 2023, the company's reserves available for distribution from the share premium account, after deducting accumulated losses, amount to approximately RMB 1,579.7 million, down from RMB 4,183.4 million in 2022[153]. - The company did not recommend the payment of a final dividend for the year ended December 31, 2023[149]. Operational Efficiency and Cost Management - Operational efficiency has improved, with operating expenses reduced by over 50% year-on-year, and the full-time employee count decreased to 387 while retaining core talent[12]. - Administrative expenses decreased by approximately 52% from RMB 410.2 million in 2022 to RMB 198.8 million in 2023, mainly due to reductions in employee salaries and benefits[51]. - Research and development expenses were reduced from RMB 1,465.3 million in 2022 to RMB 649.9 million in 2023, reflecting a strategic focus on efficiency[47]. - Employee salaries and benefits dropped from RMB 386.6 million in 2022 to RMB 236.3 million in 2023, a decrease of 38.8%[56]. - Clinical trial expenses fell from RMB 413.0 million in 2022 to RMB 196.5 million in 2023, a decline of 52.5%[56]. Leadership and Governance - The company has a strong leadership team with extensive experience in the pharmaceutical and biotechnology sectors[104]. - The management team includes Dr. Liang Peng, who has over 25 years of experience in the pharmaceutical industry and has been with the group since its inception[76]. - The management team includes individuals with extensive backgrounds in the pharmaceutical and biotechnology sectors, enhancing strategic decision-making[88]. - The board includes independent directors with diverse backgrounds, ensuring robust governance and oversight[95]. - The board of directors includes two executive directors, three non-executive directors, and four independent non-executive directors, ensuring a diverse governance structure[115]. - The company has a strong board with members possessing extensive experience in vaccine development and pharmaceutical management, enhancing its strategic direction[93]. Research and Development - Positive clinical trial data for targeted therapy for chemotherapy-induced thrombocytopenia (CIT) has been announced, showcasing the company's strong and diverse R&D capabilities[13]. - SCB-219M, a new drug candidate for treating chemotherapy-induced thrombocytopenia, has shown positive preliminary safety and efficacy data in its Phase I clinical trial[36]. - The company plans to initiate Phase Ib clinical trials for SCB-219M in 2024, targeting patients with chemotherapy-induced thrombocytopenia[41]. - The company has completed five Phase I clinical trials in China and Australia for its oncology candidate products, but further development is currently on hold pending strategic evaluation[30]. Market Presence and Strategic Initiatives - The company is focused on expanding its market presence and enhancing its product pipeline through strategic leadership and innovation[93]. - The company is actively expanding its market presence and product offerings through strategic initiatives and potential acquisitions[88]. - The company has established partnerships and may seek strategic alliances or licensing arrangements in the future, although the realization of such benefits is uncertain[126]. - The company has established a strong customer relationship to achieve immediate and long-term goals, emphasizing customer satisfaction and quality control measures[138]. Risks and Compliance - The company faced significant risks related to clinical development, regulatory approvals, and commercialization of candidate products, which could severely impact business operations[123]. - The dynamic regulatory pathway for COVID-19 vaccines presents ongoing challenges that could lead to unforeseen delays[123]. - The company is committed to complying with environmental regulations and has not faced any significant adverse impacts from complaints or incidents during the reporting period[124]. - The company relies on third-party CROs for clinical trials, and any failure on their part could severely hinder regulatory approval and commercialization efforts[126]. Share Capital and Equity Plans - The total number of issued shares as of December 31, 2023, is 1,296,289,733[171]. - The maximum number of shares available for the pre-IPO share option plan is 25,947,096 shares[179]. - The pre-IPO share option plan is effective from the date of adoption until the day before the listing date[182]. - The exercise price for each share option will not be less than the par value of one share[181]. - The total number of stock options granted under the pre-IPO stock option plan is 1,929,317, representing 0.15% of the total shares issued[186]. - The restricted share unit plan allows for a total of 77,350,000 shares to be granted, which is approximately 5.96% of the total issued share capital[192]. - The company aims to incentivize qualified participants through the restricted share unit plan for their contributions to the group[189].

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 39.3 million, generated from the commercial launch of SCB-2019 and the quadrivalent seasonal influenza vaccine in China[125]. - The group reported a revenue of RMB 39,255 thousand for 2023, with a gross profit of RMB 24,241 thousand[101]. - The total comprehensive loss for the year was RMB 138.5 million, a significant improvement from RMB 2.45 billion in the previous year[170]. - The net loss for the year decreased from RMB 2,451.9 million to RMB 138.5 million, attributed to the recognition of CEPI funding and a reduction in R&D and administrative expenses[128]. - The adjusted net loss, excluding share-based compensation, was RMB 85.0 million for the year ended December 31, 2023, compared to RMB 2,356.9 million in 2022[130]. - The group incurred a loss before tax of RMB 138,539 thousand in 2023, significantly improved from a loss of RMB 2,451,903 thousand in 2022[101]. - The company's administrative expenses decreased by RMB 211.4 million or approximately 52% to RMB 198.8 million for the fiscal year ending December 31, 2023, mainly due to reductions in employee salaries and benefits[175]. - Research and development expenses for 2023 amounted to RMB 649,885 thousand, a decrease from RMB 1,465,324 thousand in 2022[101]. Cash Flow and Financial Position - As of December 31, 2023, the group recorded a net liability of RMB 732,833,000 and a cumulative loss of RMB 9,640,268,000[79]. - The group's cash and cash equivalents amounted to RMB 735,864,000, indicating sufficient operational funds for the next twelve months[79]. - The group's cash and bank balances decreased from RMB 1,856.5 million as of December 31, 2022, to RMB 1,095.5 million as of December 31, 2023, primarily due to ongoing R&D investments and operating expenses[191]. - Total current assets as of December 31, 2023, amounted to RMB 1,899.5 million, including cash and cash equivalents of RMB 1,095.5 million[191]. - Total current liabilities as of December 31, 2023, were RMB 2,277.0 million, including contract liabilities of RMB 1,577.8 million[192]. - The group is in a net cash position as of December 31, 2023, making the debt-to-equity ratio not applicable[88]. - The group has pledged fixed deposits totaling RMB 343.4 million to secure bank loans[90]. Trade and Deferred Income - Trade payables totaled RMB 752,876,000 as of year-end 2023, a decrease from RMB 856,964,000 in 2022, reflecting a reduction of approximately 12.1%[2]. - Deferred income from CEPI amounted to RMB 44,364,000 in 2023, down from RMB 2,496,900,000 in 2022, indicating a significant decrease of approximately 98.2%[5]. - The company confirmed recognition of deferred income of RMB 2,540,497,000 (equivalent to USD 389,865,000) in 2023, as all conditions related to CEPI funding were met[11]. - As of December 31, 2023, the deferred revenue balance was RMB 17,414,000, which includes cash grants of RMB 11,733,000 from CEPI for several work packages pending CEPI approval, and the value of certain donated vials from previous years amounting to RMB 5,681,000[13]. - The company decided to abandon remaining vials related to the CEPI donation agreement, resulting in a write-off of RMB 58,787,000 in deferred income[12]. Corporate Governance and Compliance - The company has adopted the principles and provisions of the corporate governance code, ensuring high standards of corporate governance to protect shareholder interests and enhance company value[17]. - The audit committee, consisting of three independent non-executive directors, is responsible for overseeing the financial reporting process and internal control systems[22]. - The company has confirmed that there were no violations of the standard code by employees during the reporting period[19]. - The company has not purchased, sold, or redeemed any of its shares during the reporting period[20]. Research and Development - The company announced significant progress in product development, including the initiation of Phase I clinical trials for the RSV candidate vaccine SCB-1019[131]. - The company has developed a diverse pipeline of candidate vaccines aimed at preventing various diseases, leveraging its strong R&D and commercialization capabilities[137]. - The RSV candidate vaccine SCB-1019 has successfully completed the enrollment of the first batch of participants in its Phase I clinical trial in Australia[143]. - The company plans to continue prioritizing resources to accelerate the development of the RSV candidate vaccine to capture high-growth market opportunities[167]. - The company aims to address unmet medical needs in the treatment of malignant ascites and pleural effusion through its TRAIL-trimer candidate product SCB-313[141]. Market and Commercialization - The company has established an exclusive agreement for the distribution of the quadrivalent influenza vaccine AdimFlu-S in mainland China, showcasing its commercial capabilities[139]. - The AdimFlu-S (QIS) vaccine was launched in 28 provinces in China as of September 2023, following an exclusive distribution agreement with a local partner[132]. - The commercialization of seasonal influenza vaccines will expand to Brazil once approved, targeting the Southern Hemisphere's influenza season, which is the second largest seasonal influenza vaccine market globally[155]. - The company plans to commercialize SCB-1019 using the same Trimer-Tag platform as its COVID-19 vaccine, with production set to occur at its Changxing facility, which has passed multiple GMP inspections[152]. Future Outlook - The expected timeline for the use of the remaining proceeds includes a focus on expanding commercialization capabilities for respiratory vaccine products, including seasonal flu and COVID-19 vaccines, by June 2024[60]. - The company emphasizes that the expected timeline for the use of proceeds is based on the best estimates of future R&D progress and market conditions, which may change[31]. - The company plans to allocate 65.0% of the net proceeds for the R&D, production, and commercialization of core products and related products[27].

Share Issuance and Ownership - The company has issued a total of 1,294,002,733 shares as of June 30, 2023[4][20] - Longpan Fund III holds a beneficial ownership of 35,152,768 shares, representing 2.72% of the total shares[7] - The beneficial ownership of certain individuals is 82,022 shares, representing 0.006% of the total shares[2] - The company's share capital as of June 30, 2023, was RMB 836 thousand, with 1,294,002,733 ordinary shares issued[143] Share Option and Restricted Share Unit Plans - The maximum number of shares that can be granted under the Pre-IPO Share Option Plan is 25,947,096 shares[18] - The Pre-IPO Share Option Plan is effective from the adoption date until the day before the listing date[19] - The company has issued restricted share units and share options to directors under the Restricted Share Unit Plan and Post-IPO Share Option Plan[3][4] - The company granted 4,988,000 restricted share units to 105 employees at zero cost under the Restricted Share Unit Plan[48] - As of June 30, 2023, 5,013,534 restricted share units had vested and 3,429,004 had lapsed under the Restricted Share Unit Plan[48] - The company had 20,256,959 unvested restricted share units under the Restricted Share Unit Plan as of June 30, 2023[48] - The company granted 5,013,534 restricted share units during the six months ended June 30, 2023, resulting in a transfer of RMB 20,197 thousand from the share-based compensation reserve to share premium[144] - The company issued 18,850,500 stock options during the six months ended June 30, 2023, with a weighted average exercise price of USD 0.2322 per option[149] - The company had 55,625,659 outstanding stock options as of June 30, 2023, with a weighted average exercise price of USD 0.4787 per option[149] - The total number of shares available for issuance under the post-IPO share option plan is 115,751,136, representing approximately 8.94% of the total issued shares as of the latest practicable date[192] - The exercise price of restricted share units is zero[188] - The company's restricted share units vest in two schedules: 25% on the first anniversary of the grantee's employment start date or on December 1, 2023, with the remaining vesting monthly over the next three years[186] Corporate Governance - The company has established an audit committee composed of three independent non-executive directors[14] - The company continues to regularly review and monitor corporate governance practices to ensure compliance with the Corporate Governance Code[12] - The company has adopted a policy on "inside information" to fulfill its responsibilities under the Securities and Futures Ordinance and Listing Rules[8] - The company has disclosed changes in director information since April 20, 2023, in accordance with Listing Rule 13.51B (1)[9] Financial Performance and Expenses - The company achieved a turnaround from a loss of RMB 1,136.1 million in the first half of 2022 to a profit of RMB 650.6 million in the first half of 2023, primarily due to CEPI funding recognized as other income and a 50% reduction in R&D and administrative expenses[76] - Administrative expenses decreased significantly by RMB 115.8 million, or 51%, from RMB 225.3 million in the first half of 2022 to RMB 109.5 million in the first half of 2023, primarily due to workforce reductions and cost-saving measures[75] - R&D expenses decreased from RMB 855.3 million in the first half of 2022 to RMB 385.6 million in the first half of 2023, reflecting a reduction in research and development activities[72] - Other expenses increased significantly from RMB 65.1 million in the first half of 2022 to RMB 1,330.9 million in the first half of 2023, primarily due to inventory provisions[72] - Cash and bank balances decreased to RMB 1,522,872 thousand as of June 30, 2023, compared to RMB 1,856,513 thousand as of December 31, 2022[82] - Other income and gains increased significantly to RMB 2,510.8 million for the six months ended June 30, 2023, primarily due to RMB 2,494.1 million received from CEPI[84] - Other expenses increased to RMB 1,330.9 million for the six months ended June 30, 2023, mainly due to a provision for inventory (mostly raw materials) of RMB 1,236.7 million[86] - Adjusted profit for the period was RMB 674,468 thousand for the six months ended June 30, 2023, compared to a loss of RMB 1,072,218 thousand for the same period in 2022[88] - The company reported a net profit of RMB 650,624 thousand for the six months ended June 30, 2023, compared to a net loss of RMB 1,136,085 thousand in the same period last year[138] - The company's total comprehensive income for the six months ended June 30, 2023, was RMB 671,837 thousand, compared to a total comprehensive loss of RMB 1,103,133 thousand in the same period last year[139] - The company's adjusted net profit for the six months ended June 30, 2023, was RMB 674,468 thousand, compared to an adjusted net loss of RMB 1,072,218 thousand in the same period last year[139] - The company's deferred revenue balance as of June 30, 2023, was RMB 117,826 thousand, including RMB 53,221 thousand in cash funding from CEPI and RMB 64,605 thousand for certain vials donated by CEPI in previous years[140] - The company's revenue from SCB-2019 (CpG 1018/Aluminum Adjuvant) since its commercial launch in China in February 2023 was RMB 0.3 million as of June 30, 2023[171] - Other income and gains increased by RMB 2,499.0 million to RMB 2,510.8 million for the six months ended June 30, 2023, primarily due to the recognition of RMB 2,494.1 million in funding from CEPI[172] - Sales and distribution expenses related to the launch of commercial sales activities were RMB 22.5 million for the six months ended June 30, 2023[173] - The company's other expenses increased by RMB 1,265.8 million to RMB 1,330.9 million for the six months ended June 30, 2023, mainly due to a provision for inventory (mostly raw materials) of RMB 1,236.7 million[176] - The company's financial costs increased by RMB 9.5 million to RMB 11.7 million for the six months ended June 30, 2023, mainly due to increased interest expenses on bank loans[177] - The company provides adjusted profit/loss as supplementary information, which is not required by IFRS but is considered useful for shareholders and potential investors[178] Employee Compensation and Benefits - Restricted stock units granted to Wu Jing totaled 2,123,254 units as of January 1, 2023, with 303,324 units traded during the reporting period[29] - Wu Peng held 1,213,303 restricted stock units as of January 1, 2023, with 173,320 units traded during the reporting period[29] - Ralf Leo Clemens had 485,331 restricted stock units as of April 18, 2021, with 103,932 units traded from January 15, 2023, to June 15, 2023[29] - Short-term employee benefits totaled RMB 26,711 thousand for the six months ended June 30, 2023[54] - Share-based compensation expenses were RMB 17,882 thousand for the six months ended June 30, 2023[54] - Post-employment benefits amounted to RMB 3,162 thousand for the six months ended June 30, 2023[54] - Total remuneration paid to key management personnel was RMB 47,755 thousand for the six months ended June 30, 2023[54] - The fair value of share options granted to directors and employees under the Post-IPO Share Option Scheme was RMB 16,275,000 for the six months ended June 30, 2023[158] - The company recognized share-based compensation expenses of RMB 15,125,000 for the six months ended June 30, 2023[158] - As of June 30, 2023, the company had unexercised share options with exercise prices ranging from HKD 0.001 to HKD 7.300 and exercise periods from 2022 to 2033[156] - As of December 31, 2022, the company had 23,711,497 unvested restricted share units under the Restricted Share Unit Plan[160] - The weighted average closing price of shares before the vesting date of restricted share units during the reporting period was HKD 1.99[187] Fair Value Measurements - The fair value of financial assets measured at fair value through profit or loss was RMB 14,452 thousand as of June 30, 2023[37] - No significant transfers between Level 1 and Level 2 fair value measurements occurred during the period[39] - The fair value of financial assets measured at fair value through profit or loss was RMB 14,452 thousand[58] - The fair value of financial assets measured at fair value through profit or loss was RMB 13,929 thousand[58] Vaccine Development and Commercialization - The company completed registration applications for its COVID-19 vaccine in one Southeast Asian country and one Latin American country in the first half of 2023[95] - The company plans to disclose more preclinical data and development plans for its RSV PreF vaccine in the second half of 2023[96] - The company announced an exclusive agreement with Adimmune Corporation to distribute AdimFlu-S (QIS) in mainland China, the only imported quadrivalent seasonal influenza vaccine approved for individuals aged three and above[89][103] - The company has completed initial internal commercial capability building to support the commercialization of AdimFlu-S (QIS) and partnered with Keyuan Trading to maximize its access and commercial success[90] - The company's Trimer-Tag technology platform is the only one globally that uses a human-derived trimerization tag to produce recombinant covalent trimerized fusion proteins[98] - The company is focusing on building a leading respiratory vaccine portfolio, including seasonal influenza, COVID-19, RSV, and PCV vaccines[102] - AdimFlu-S (QIS) is expected to be commercially launched in mainland China in the second half of 2023, with production starting in Q1 2023 and importation planned for Q3 2023[104] - The company aims to be among the first in China to enter human clinical trials for the RSV PreF vaccine, with more preclinical data and development plans to be disclosed in the second half of 2023[105] - SCB-1019, an RSV candidate vaccine, is being developed without oil-in-water emulsion adjuvants, potentially offering industry-leading safety and tolerability, including for infant populations[107] - The company completed COVID-19 vaccine registration applications in one Southeast Asian country and one Latin American country in the first half of 2023, with regulatory reviews ongoing[108] - SCB-219M, a candidate vaccine for XBB variant, is expected to release interim Phase 1 clinical trial data in Q4 2023[109] - The company anticipates at least one additional vaccine licensing deal in 2023 to expand its mid-to-late stage pipeline, focusing on PCV and pediatric vaccines[110] - The company’s COVID-19 vaccine has been launched in 28 provinces in China, covering over 95% of the population, demonstrating strong commercialization and market access capabilities[118] - The company’s proprietary production base in Zhejiang Changxing has established commercial-scale production capabilities for COVID-19 vaccines and passed multiple GMP inspections[132] - The company's COVID-19 vaccine has been launched in 28 provinces in China, covering over 95% of the population[182] - The company is developing a new generation of COVID-19 vaccines targeting the XBB.1.5 variant, with development expected to be completed in the second half of 2023[183] - The RSV vaccine candidate utilizes the Trimer-Tag platform, positioning the company as a leading RSV vaccine developer in China and globally[179] - SCB-1019 will be commercially produced at the Changxing facility, which has passed multiple GMP reviews and obtained a vaccine production license from the Chinese National Medical Products Administration[181] - The company is transitioning into a commercial-stage biopharmaceutical company, focusing on expanding its product and vaccine candidate portfolio for long-term sustainable development[185] Operational Expenses and Leasing - Office leasing and utility expenses in Chengdu Tianhe amounted to RMB 1,977 thousand for the six months ended June 30, 2023[51] - The company's lease liability with Chengdu Tianhe was RMB 5,984,000 as of June 30, 2023[165] Financial Statements and Reporting - The board of directors approved the issuance of the interim condensed consolidated financial information on August 22, 2023[41] - Cash and bank balances decreased by RMB 333.6 million to RMB 1,522.9 million as of June 30, 2023, primarily due to commercial capacity expansion and ongoing R&D activities[113] - R&D expenses decreased by 55% to RMB 385.6 million in the first half of 2023, as activities related to SCB-2019 (CpG 1018/aluminum adjuvant) were largely completed[115] - The company's total equity as of June 30, 2023, was RMB 8,589,440 thousand, including RMB 8,588,636 thousand in share premium[144]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告 全部或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責 任。 Clover Biopharmaceuticals, Ltd. 三 葉 草 生 物 製 藥 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：2197） 截 至2023年6月30日 止 六 個 月 中 期 業 績 公 告 及 更 改 所 得 款 項 用 途 董事會欣然公佈本集團於報告期的未經審核簡明綜合業績，連同2022年同期的 比較數字。該等中期業績已由審核委員會及本公司核數師安永會計師事務所 審閱。 於本公告內，「我們」指本公司，及倘文義另有所指，本集團。本公告所載的若 干金額及百分比數字已作四捨五入調整，或已四捨五入至小數點後一位或兩 位。本公告任何表格、圖表或其他地方所示總額與所列數額總和的任何差異乃 因四捨五入所致。 財務摘要 截至 截至 2023年 2022年 6月30日 12月31日 人民幣千元 人民幣千元 （未經審核） （經審核） 現金及銀行結餘 1,522,872 1,8 ...

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]