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 中期報告 2024 | --- | --- | |-------|--------------------------| | | | | | 目錄表 | | 2 | 公司資料 | | 4 | 財務摘要 | | 6 | 業務摘要 | | 7 | 管理層討論與分析 | | 21 | 其他資料 | | 43 | 中期簡明綜合損益表 | | 44 | 中期簡明綜合全面收益表 | | 45 | 中期簡明綜合財務狀況表 | | 47 | 中期簡明綜合權益變動表 | | 49 | 中期簡明綜合現金流量表 | | 51 | 中期簡明綜合財務資料附註 | | 76 | 釋義 | 公司資料 | --- | --- | |------------------------------|---------------------------------------| | 董事會 | 聯席公司秘書 | | 執行董事 | 王曉艷女士 | | 梁朋博士 （董事長） | 周慶齡女士 ...

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2024年6月30日止六個月 中期業績公告 董事會欣然公佈本集團截至2024年6月30日止六個月的未經審核簡明綜合業績， 連 同2023年 同 期 的 比 較 數 字。該 等 中 期 業 績 已 由 審 核 委 員 會 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 ...

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 ...

減 值 分 析 於 各 報 告 日 期 進 行。本 集 團 已 採 用 國 際 財 務 報 告 準 則 第9號規定的簡化方法就 預 期 信 貸 虧 損 計 提 撥 備，該 方 法 允 許 就 所 有 貿 易 應 收 款 項 使 用 全 期 預 期 虧 損 撥 備。本 公 司 董 事 認 為，就 貿 易 應 收 款 項 結 餘 而 言，其 產 生 的 預 期 信 貸 虧 損 極 小。於2023年12月31 日，並 無 就 貿 易 應 收 款 項 減 值 計 提 虧 損 撥 備。 12. 貿易應付款項 貿 易 應 付 款 項 於 年 末 根 據 發 票 日 期 的 賬 齡 分 析 如 下： | --- | --- | --- | --- | |---------------------|-------|----------------------|--------------------| | | | 2023 年 人民幣千元 | 2022 年 人民幣千元 | | 個月內 | | 156,119 | | | 6 至 個 月 | | 52,815 | 385,856 | | 6 12 年以上 | | 543,942 ...

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 ...

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 2022 年 度 報 告 頁次 目錄表 公司簡介 2 公司資料 3 首席執行官報告 5 財務摘要 7 業務摘要 9 管理層討論與分析 11 董事及管理層簡介 25 董事會報告 33 企業管治報告 60 環境、社會及管治報告 77 獨立核數師報告 111 綜合損益表 116 ...

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2022年12月31日止年度 全年業績公告 董事會欣然公佈本集團於報告期的經審核綜合業績，連同截至2021年12月31日止 年度的比較數字。本集團於報告期的綜合財務報表已由本公司審核委員會審閱， 並經本公司核數師安永會計師事務所審核。 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12月31日 2022年 2021年 人民幣千元 人民幣千元 ...

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 2022 中期報告 目錄表 頁次 公司資料2 財務摘要4 業務摘要6 管理層討論與分析9 其他資料 25 獨立審閱報告 35 中期簡明綜合損益表 36 中期簡明綜合全面收益表 37 中期簡明綜合財務狀況表 38 中期簡明綜合權益變動表 40 中期簡明綜合現金流量表 42 中期簡明綜合財務資料附註 44 釋義 66 公司資料 | --- | --- | |------------------------------------------|-----------------------------------------| | 董事會 | 聯席公司秘書 | | 執行董事 | Brian KREX 先生 | | 梁朋博士 （董事長） | 周慶齡女士 （香港公司治理公會資深會員） | | 梁果先生 | | | 非執行董事 | 註冊辦事處 | | 王曉東博士 | PO Box 309, Ugland House | | 呂東先生 | Grand Cayman, KY1-11 ...

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 2021 年度報告 頁次 目錄表 公司簡介2 公司資料3 首席執行官報告5 財務摘要7 業務摘要9 管理層討論與分析 11 董事及管理層簡介 27 董事會報告 37 企業管治報告 58 環境、社會及管治報告 73 獨立核數師報告 101 綜合損益表 106 綜合全面收益表 107 綜合財務狀況表 108 綜合權益變動表 110 綜合現金流量表 112 財務報表附註 114 三年財務摘要 185 釋義 186 公司簡介 我們是一家處於臨床試驗階段的全球生物製藥公司，致力於開發新型疫苗及生物療法。 我們的願景是通過變革性科學賦予人類更健康的未來。我們的使命是依託Trimer-TagTM技術平台和我們的生 產製造能力，發現、開發及商業化新型疫苗及生物療法。 自2007年成立以來，我們一直專注於尖端科學的轉化，以解決未被滿足的巨大醫療需求。我們源起Trimer- TagTM技術平台，在中國四川省的成都打造了自有的研發實力，在中國浙江省的長興建立了具備商業規模的生 產基地，在 ...