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 ...

Group 1 - The company reported an increase in revenue to RMB 10.9 million for the six months ending June 30, 2025, compared to no revenue in the same period of 2024, primarily due to income generated from granting intellectual property licenses [1] - Research and development costs rose by 46.0% to RMB 299.6 million for the same period, up from RMB 205.2 million in the previous year, driven by increased clinical trial expenses and other factors [1] - Clinical trial expenses increased from RMB 71.6 million to RMB 95.9 million, mainly due to the REC610 entering Phase III clinical trials at the end of 2024 [1] Group 2 - The company's vaccine portfolio strategically covers eight major disease areas, including HPV and respiratory syncytial virus, with over 10 candidate vaccines [2] - The company is conducting a Phase III clinical trial for REC603 in China and has completed the 42-month follow-up, with plans to submit a BLA application in 2026 [2] - Future strategies include accelerating the development and commercialization of candidate vaccines, enhancing research capabilities, and pursuing internationalization through "going out" and "bringing in" strategies [2]

Core Viewpoint - 瑞科生物-B (02179) reported a significant increase in revenue for the first half of 2025, primarily due to income generated from granting intellectual property licenses, despite a substantial loss for the period [1] Financial Performance - Revenue from continuing operations reached 10.899 million RMB, compared to none in the same period last year [1] - The loss attributable to equity holders of the parent company was 341 million RMB, representing a year-on-year increase of 36.7% [1] - Basic loss per share was 0.71 RMB [1]

Group 1 - The company reported a revenue of 10.899 million yuan for the first half of 2025, compared to no revenue in the same period last year [1] - The loss attributable to the parent company increased to 341 million yuan, representing a year-on-year increase of 36.7% [1] - The basic loss per share was 0.71 yuan [1] Group 2 - The increase in revenue was primarily due to income generated from granting intellectual property licenses during the period [1]

Financial Performance - For the six months ended June 30, 2025, the company reported revenue of RMB 10,899 thousand, compared to no revenue in the same period of 2024[9] - Other income and gains decreased to RMB 12,102 thousand from RMB 35,701 thousand year-on-year, representing a decline of approximately 66.1%[9] - The company recorded a pre-tax loss of RMB 339,573 thousand, which is an increase of 36% compared to a pre-tax loss of RMB 249,636 thousand in 2024[9] - The net loss for the period was RMB 340,653 thousand, compared to a net loss of RMB 249,636 thousand in the previous year, indicating a year-on-year increase of 36.4%[9] - Basic and diluted loss per share was RMB 0.71, compared to RMB 0.52 in the same period of 2024[9] Assets and Liabilities - The total non-current assets amounted to RMB 1,261,034 thousand, a slight decrease from RMB 1,285,103 thousand as of December 31, 2024[10] - Current assets decreased significantly to RMB 281,657 thousand from RMB 655,129 thousand, indicating a reduction of approximately 57.0%[10] - The total current liabilities increased to RMB 881,452 thousand from RMB 839,420 thousand, reflecting a rise of about 5.0%[10] - The total equity decreased to RMB 177,634 thousand from RMB 529,324 thousand, showing a decline of approximately 66.5%[10] - The net current liabilities reached RMB 599,795,000, compared to RMB 184,291,000 in the previous year, indicating a substantial increase in financial pressure[12] Research and Development - The company is advancing its product pipeline, including the REC603 HPV vaccine, with plans to submit a BLA application in 2026 following interim analysis[3] - Research and development costs increased to RMB 299,582,000 for the six months ended June 30, 2025, compared to RMB 205,222,000 in 2024, reflecting a growth of 45.8%[27] - The company is focused on developing innovative vaccines, with a pipeline that includes over 10 candidates, including the strategic products REC610 and REC603, both in Phase III clinical trials[40] - The company has established a comprehensive vaccine innovation engine, which includes advanced platforms for adjuvant and protein engineering, enabling the development of innovative vaccines[41] - The company has developed advanced technology platforms for adjuvant development, protein engineering, and immunological evaluation, facilitating the discovery of subunit vaccines[70] Clinical Trials and Product Development - REC603, the core product, is currently in the critical phase of the Phase III clinical trial in China, with a total sample size of 16,050 participants[48] - The new adjuvant recombinant quadrivalent HPV vaccine (REC604a) has received clinical trial approval from the National Medical Products Administration[46] - The recombinant zoster vaccine (REC610) has also received clinical trial approval and is set to initiate Phase III trials in October 2024[46] - The bivalent recombinant respiratory syncytial virus vaccine (REC625) is expected to complete preclinical research by 2025[46] - The company plans to submit the Biologics License Application (BLA) for REC603 by 2026, following the completion of the Phase III trial and interim analysis[49] Financial Strategy and Capital Management - The company has received approval from the China Securities Regulatory Commission to issue shares to Yangtze River Pharmaceutical Group for a total consideration of RMB 800,000,000, expected to be completed by September 30, 2025[17] - The company has secured unused credit facilities totaling RMB 130,000,000, available until June 30, 2026, to support its operational needs[17] - The company plans to issue up to 143,112,702 domestic shares at a subscription price of RMB 5.59 per share to enhance its business development and financial structure[115] - Approximately RMB 800 million is expected to be raised from the share issuance, with about 70% allocated to the shingles vaccine project and 30% for working capital[116][118] - The company aims to maintain sufficient cash and cash equivalents to meet its working capital needs and mitigate cash flow volatility[113] Market Position and Future Outlook - The company operates primarily in the vaccine research and development sector within mainland China, with no significant revenue from other regions reported[14] - The company is focusing on expanding its vaccine portfolio to address various viral infections, including HPV and respiratory viruses, to meet market demand[46] - The company reported a significant increase in revenue, with a year-over-year growth of 25% in Q2 2023[136] - The company projects a revenue guidance of $500 million for Q3 2023, reflecting a 20% growth from Q2 2023[136] - Future outlook remains positive, with anticipated growth driven by new product launches and market expansion strategies[136]