江蘇瑞科生物技術股份有限公司 章程 第一章 總則 江蘇瑞科生物技術股份有限公司 章程 二〇二五年十一月 | 目錄 | | --- | | 第一章 | 總則 | | 1 | | --- | --- | --- | --- | | 第二章 | | 經營宗旨和範圍 | 4 | | 第三章 | 股份 | | 4 | | 第一節 | | 股份發行 | 4 | | 第二節 | | 股份增減和回購 | 10 | | 第三節 | | 股份轉讓 | 11 | | 第四節 | | 股票及股東名冊 | 13 | | 第四章 | | 股東和股東大會 | 14 | | 第一節 | | 股東 | 14 | | 第二節 | | 股東大會的一般規定 | 16 | | 第三節 | | 股東大會的召集 | 19 | | 第四節 | | 股東大會的提案與通知 | 21 | | 第五節 | | 股東大會的召開 | 23 | | 第六節 | | 股東大會的表決和決議 | 26 | | 第五章 | | 董事會 | 31 | | 第一節 | | 董事 | 31 | | 第二節 | | 董事會 | 32 | | 第六章 | | 總經理及其他高級管理人員 | ...

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。 Jiangsu Recbio Technology Co., Ltd. 江蘇瑞科生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2179） 關於變更註冊資本完成工商登記及換領營業執照及修訂公司章程的公告 茲提述江蘇瑞科生物技術股份有限公司（「本公司」）日期分別為2024年11月11 日、2024年12月24日、2025年1月9日、2025年2月27日、2025年7月23日及2025 年10月16日的公告（「該等公告」）以及日期均為2024年12月5日的2024年第一次臨 時股東大會通告及通函（「該通函」），內容有關（其中包括）建議定向發行內資股及 建議授權董事會及其授權人士辦理定向發行內資股有關事宜的詳情。除文義另有 所指外，本公告所用詞彙與該通函所界定者具有相同涵義。 如該等公告所述，本公司已收到中國證監會《關於同意江蘇瑞科生物技術股份有 限公司向特定對象發行股票註冊的批 ...

Core Viewpoint - The company has received an expansion approval for its drug production license from the Jiangsu Provincial Drug Administration, allowing it to produce a recombinant shingles vaccine and related adjuvant components, enhancing its capabilities in the field of preventive biological products [1] Group 1: License Expansion Details - The company, Jiangsu Ruike Biotechnology Co., Ltd., has been granted an expansion of its drug production license with the number Su20210057 [1] - The license is effective from November 5, 2025, and will remain valid until November 14, 2026 [1] - The new production addresses include facilities for the recombinant shingles vaccine (CHO cells) and adjuvant components, with specific production lines for both the vaccine and the adjuvant [1] Group 2: Production Facilities - The new production site for the recombinant shingles vaccine includes a production line for CHO cell raw liquid and an adjuvant production line [1] - Additional facilities include a warehouse and laboratory functions at a new address in Taizhou, Jiangsu Province [1] - The adjuvant component, monophosphoryl lipid A (MPL), will also have dedicated production lines at the specified locations [1]

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。 Jiangsu Recbio Technology Co., Ltd. 江蘇瑞科生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2179） 自願性公告 本公司取得重組帶狀疱疹疫苗《藥品生產許可證》增項 本公告由江蘇瑞科生物技術股份有限公司（「本公司」，連同其附屬公司，統稱為 「本集團」）自願作出。本公司董事會（「董事會」）欣然宣佈，近日本公司已獲得江 蘇省藥品監督管理局頒發的《藥品生產許可證》增項批准，新增重組帶狀疱疹疫苗 （CHO細胞）及相關佐劑成份的生產範圍（「本次增項」）。本次增項標誌着本集團在 預防用生物製品領域的研發與生產能力實現進一步拓展，為後續藥品上市註冊奠 定堅實基礎。 1 • 企業名稱：江蘇瑞科生物技術股份有限公司 • 許可證編號：蘇20210057 • 發證機關：江蘇省藥品監督管理局 • 生效日期：2025年11月05日 • 有效期至：2026年11月1 ...

第 1 頁 共 11 頁 v 1.1.1 | | | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 江蘇瑞科生物技術股份有限公司 呈交日期: 2025年11月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 內資股 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 154,824,311 RMB | | | 1 RMB | | 154,824,311 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 154,824,311 RMB | | | 1 RMB | | 154, ...

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。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2179） 關於完成定向發行內資股之繳款及驗資的公告 本公司欣然宣佈，截至本公告日期，本次發行之募集資金已繳足，並已由根據中 國法律設立的驗資機構審驗並出具驗資報告。 本公司將根據內幕消息條文及╱或上市規則的要求就本次發行的進展在需要時作 出進一步公告。 Jiangsu Recbio Technology Co., Ltd. 股東及有意投資者於買賣本公司證券時務請審慎行事。 江蘇瑞科生物技術股份有限公司 承董事會命 江蘇瑞科生物技術股份有限公司 主席 茲提述江蘇瑞科生物技術股份有限公司（「本公司」）日期為2024年11月11日、 2024年12月24日、2025年1月9日、2025年2月27日及2025年7月23日的公告以及 日期為2024年12月5日的通函（「該等公告及通函」），內容有關（其中包括）本公司 建議定向發行內資股及其相關事宜，以及關於 ...

I. 法定/註冊股本變動 公司名稱: 江蘇瑞科生物技術股份有限公司 呈交日期: 2025年10月2日 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 第 1 頁 共 11 頁 v 1.1.1 | | | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 非上市外資股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 12,000,000 | RMB | | | 1 RMB | | 12,000,000 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 12,000,000 | RMB | | | 1 RMB | | 12,000,000 | | 1. 股份分類 | 普通 ...

Financial Performance - Revenue for the six months ended June 30, 2025, was RMB 10,899,000, compared to no revenue in the same period of 2024[14] - Other income and gains decreased to RMB 12,102,000 from RMB 35,701,000 year-on-year, representing a decline of approximately 66.1%[14] - Loss before tax for the period was RMB 339,573,000, compared to a loss of RMB 249,636,000 in the previous year, indicating an increase in loss of approximately 36%[14] - Total equity dropped to RMB 177,634,000 from RMB 529,324,000, reflecting a decrease of approximately 66.5%[15] - The total research and development costs for the six months ended June 30, 2025, amounted to RMB 299.6 million, with no costs capitalized during the same period[117] - Employee costs for the six months ended June 30, 2025, were RMB 96.2 million, slightly down from RMB 96.4 million for the same period in 2024[131] - Selling and distribution expenses decreased by 46.7% from RMB 1.5 million for the six months ended June 30, 2024, to RMB 0.8 million for the six months ended June 30, 2025, attributed to a reduction in marketing department headcount[139] - Research and development costs increased by 46.0% from RMB 205.2 million for the six months ended June 30, 2024, to RMB 299.6 million for the six months ended June 30, 2025, driven by increased clinical trial expenses[140] - Administrative expenses decreased by 12.6% from RMB 54.7 million for the six months ended June 30, 2024, to RMB 47.8 million for the six months ended June 30, 2025, due to a decrease in labor costs from reduced staff[148] Asset and Liability Management - Total non-current assets as of June 30, 2025, were RMB 1,261,034,000, down from RMB 1,285,103,000 at the end of 2024[15] - Total current assets decreased significantly to RMB 281,657,000 from RMB 655,129,000, a decline of approximately 57.0%[15] - Cash and bank balances decreased by 76.8% from RMB 456.5 million as of December 31, 2024, to RMB 106.1 million as of June 30, 2025, mainly due to expenditures on R&D services, raw materials, and equipment[161] - The company's net current assets decreased by 225.4% from RMB -184.3 million as of December 31, 2024, to RMB -599.8 million as of June 30, 2025, primarily due to increased current liabilities and decreased cash and bank balances[172] - Total interest-bearing bank loans and other borrowings as of June 30, 2025, were RMB 829.3 million, with RMB 510.2 million classified as current borrowings maturing by June 30, 2026[179] - The current ratio decreased from 0.78 as of December 31, 2024, to 0.32 as of June 30, 2025, mainly due to an increase in current liabilities[180] - The gearing ratio increased to 88.5% as of June 30, 2025, compared to 72.7% as of December 31, 2024, attributed to a decrease in cash and bank balances[180] Vaccine Development and R&D - The company is currently conducting phase III clinical trials for its strategic products, including the recombinant shingles vaccine REC610 and the recombinant HPV 9-valent vaccine REC603[17] - The company has developed a comprehensive vaccine innovation engine with multiple technology platforms to enhance its R&D capabilities[18] - The vaccine portfolio consists of more than 10 candidates, including a bivalent recombinant respiratory syncytial virus vaccine that is about to enter clinical research[17] - The company aims to advance the R&D of multiple vaccine candidates simultaneously through its established IPD system[18] - The company has developed a comprehensive vaccine innovation engine, including platforms for novel adjuvants, protein engineering, immune evaluation, and process development, enabling the discovery and development of innovative vaccines[20] - The HPV vaccine manufacturing facility in Taizhou City has a designed capacity of 20 million doses per year and is currently in pilot production to support the BLA application in China[22][24] - The innovative vaccine manufacturing facility based on CHO cell expression systems was completed in November 2021 and has a total area of approximately 17,000 sq.m[22][24] - The vaccine portfolio includes over 10 candidates targeting significant global disease burdens, including a novel adjuvanted recombinant shingles vaccine and a recombinant HPV 9-valent vaccine currently in phase III clinical trials in China[23][25] - The company has established an IPD system to advance multiple vaccine candidates simultaneously, following the OPTI vaccine development concept[20] - The recombinant influenza virus vaccine and bivalent recombinant respiratory syncytial virus vaccine are about to enter the clinical research stage[23][25] - The company has successfully acquired a vaccine production license issued by Jiangsu MPA for its innovative vaccine manufacturing facility[22][24] - The vaccine pipeline includes candidates for COVID-19 and hepatitis B virus, showcasing the company's diverse research and development efforts[28] Clinical Trials and Regulatory Approvals - The recombinant HPV 9-valent vaccine, REC603, is currently in the pivotal stage of phase III clinical trial in China, with a clinical analysis report expected by August 31, 2025, and product marketing application to be submitted by December 31, 2025[2] - The novel adjuvanted recombinant shingles vaccine, REC610, received drug clinical trial approval in October 2023, with phase III trials initiated in October 2024 and marketing approval expected by November 30, 2026[4] - The phase III clinical trial for REC603 involves a total of 16,050 subjects and includes primary efficacy, immuno-bridging, and immunogenicity comparative trials[38] - The company will not pursue further clinical development for the ReCOV COVID-19 vaccine due to low global demand, reallocating resources towards respiratory combination vaccines instead[35] - The clinical analysis report for the shingles vaccine is expected by September 30, 2025, with a marketing application to be submitted by December 31, 2025[4] - The IND approval for REC603 was obtained in July 2018, allowing direct phase III trials in China after phase I data[37] - The company anticipates submitting a BLA application for REC603 in 2026 when conditions are met[39] - REC603's phase III clinical trial involves a total sample size of 16,050 participants, adhering to the guidelines set by the National Medical Products Administration[40] - The phase I clinical trial of REC603 demonstrated a significant increase in neutralizing antibody geometric mean titer (NAb GMT) against all target HPV types[42] - The adverse event rate in the phase I clinical trial of REC603 was 53.75%, significantly lower than the 86.6% rate reported for Gardasil®9[44] Manufacturing and Quality Control - The manufacturing facility has received the EU Qualified Person Declaration for several consecutive years, ensuring compliance with international standards[22] - The vaccine manufacturing facility in Taizhou City has established a quality system that meets both Chinese and EU GMP standards, supporting the production of REC610 and REC625[84] - The company has established a comprehensive quality system for large-scale commercial production of vaccines at its facility in Taizhou, Jiangsu, which complies with both Chinese and EU GMP standards[89] - The facility has a successful track record of large-scale batch production, which is crucial for the development and industrialization of the recombinant shingles vaccine REC610 and the bivalent recombinant respiratory syncytial virus vaccine REC625[89] Strategic Partnerships and Market Development - The company has established an international business development team to commercialize its vaccine candidates in international markets, focusing on collaborations with foreign governments and multinational companies[124] - A product licensing cooperation agreement has been entered into with the Indian biopharmaceutical company Biological E for the recombinant HPV 9-valent vaccine REC603, which includes upfront payments and milestone payments based on cooperation progress[124] - The company plans to accelerate R&D, clinical trials, and commercialization of vaccine candidates, and strengthen international strategies through "going-out" and "bringing-in" approaches[133] - The company aims to concentrate resources on marketing HPV 9-valent vaccines and recombinant shingles vaccines to ensure timely market entry[134] - The company is actively planning subsequent pipelines and conducting preclinical studies within resource capabilities[134]

1 Jiangsu Recbio Technology Co., Ltd. 江蘇瑞科生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2179） 董事會提名委員會工作細則 第一章 總則 第一條 為規範江蘇瑞科生物技術股份有限公司（以下簡稱「公司」）董事及高 級管理人員的產生，優化董事會組成，完善公司治理結構，根據《中 華人民共和國公司法》（以下簡稱「《公司法》」）、《香港聯合交易所有 限公司證券上市規則》（以下簡稱「《上市規則》」）、《上市規則》附錄 十四所載的《企業管治守則》等法律、法規、規範性文件和H股發行 後適用的《江蘇瑞科生物技術股份有限公司章程》（以下簡稱「《公司 章程》」），依照董事會決議，公司特設立董事會提名委員會，並結合 公司實際，制定《江蘇瑞科生物技術股份有限公司董事會提名委員會 工作細則》（以下簡稱「本細則」）。 第二條 董事會提名委員會是公司董事會按照《公司章程》下設的董事會專門 工作機構，主要職責是對公司董事（包括獨立非執行董事）及高級管 理人員的選擇、選擇標準和程序進行研究並向董事會提出意見和建 議。 第三條 本細則所稱的高級管理人員是指公司的總經理、副總 ...

第 1 頁 共 11 頁 v 1.1.1 | 1. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 內資股 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | | 法定/註冊股本 | | | 上月底結存 | | | 154,824,311 | RMB | | | 1 RMB | | | 154,824,311 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | | 0 | I. 法定/註冊股本變動 | 3. 股份分類 | 普通股 | 股份類別 | H | 於香港聯交所上市 (註1) | 是 | | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02179 | 說明 | | | | | 2. 股份分類 | 普通股 | 股份類別 ...