江蘇瑞科生物技術股份有限公司 章程 第三條 公司的發起人為以下四十八方：泰州元工科技合夥企業（有限 合夥）、上海超瑞醫藥科技合夥企業（有限合夥）、北京君聯晟 源股權投資合夥企業（有限合夥）、南京招銀現代產業貳號股權 投資基金（有限合夥）、LYFE Niagara River Limited、深圳市富 海新材二期創業投資基金合夥企業（有限合夥）、深圳盈科進投 資管理合夥企業（有限合夥）、深圳市紅杉瀚辰股權投資合夥企 業（有限合夥）、珠海君聯永碩股權投資企業（有限合夥）、SCC Growth VI Holdco C (HK) Limited、深圳富海雋永二號創業投 資企業（有限合夥）、連雲港瑞百泰醫藥科技合夥企業（有限合 夥）、江蘇疌泉中衛騰雲醫藥健康產業投資基金（有限合夥）、 上海濟玥企業管理合夥企業（有限合夥）、上海濟軒企業管理諮 詢合夥企業（有限合夥）、寧波梅山保稅港區浩金致同股權投資 合夥企業（有限合夥）、祥峰（廈門）投資合夥企業（有限合夥）、 泰州中國醫藥城一類新藥研發投資基金合夥企業（有限合夥）、 贛州浩金致遠股權投資中心（有限合夥）、瀏陽沃陽健康產業投 1 二〇二五年八月 | 目錄 | | --- ...

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。 2 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） 關於變更經營範圍及修訂公司章程 完成工商登記及換領營業執照的公告 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2025年5月21日及 2025年6月20日的公告以及日期均為2025年5月30日的年度股東大會通告及通函 （「該通函」），內容有關（其中包括）建議變更經營範圍及建議修訂公司章程及相關 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。 本公司於2025年6月20日召開年度股東大會，審議通過了該通函提述的(1)關於 建議變更本公司經營範圍的議案；及(2)關於建議修訂公司章程的議案（「該等議 案」）。建議變更經營範圍將自市場監督管理部門頒發新營業執照當日起生效， 而修訂後的公司章程將自建 ...

第 1 頁 共 11 頁 v 1.1.1 | 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 | 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 | 普通股 | 股份類別 | | ...

Core Viewpoint - The company has signed a product licensing cooperation agreement with Indian BE Company for the restructuring of the nine-valent HPV vaccine REC603, granting exclusive rights for development, production, and commercialization in India and in tender markets led by UNICEF and PAHO [1] Group 1 - The company has received an upfront payment for the collaboration [1] - The company will receive milestone payments based on the progress of the collaboration [1] - The company will also earn royalties based on annual net sales [1]

Industry Overview - Vaccines are essential biological products for preventing and controlling infectious diseases, representing a core defense in public health systems [1][5] - The Chinese vaccine industry is experiencing rapid growth, with the market size projected to increase from 306.22 billion yuan in 2015 to 1,762.19 billion yuan in 2024, and expected to exceed 300 billion yuan by 2031 [1][5] Industry Chain - The upstream of the vaccine industry includes raw material supply, such as microcarriers, human serum albumin, and packaging materials [3] - The midstream involves vaccine research and production, with key players including Sinopharm, Sinovac, CanSino, Zhifei, and Watson [3] - The downstream consists of vaccine distribution and consumption, reaching end consumers through health service centers and medical institutions [3] Current Industry Status - As of December 31, 2024, 47 companies in China have received vaccine batch approvals, totaling 543 million doses, with a decrease of 5.6% compared to 2023 [7] - The most approved vaccines in 2024 were influenza and rabies vaccines, each exceeding 80 million doses, accounting for 30% of total approvals [9] Market Competition - The Chinese vaccine market is characterized by a diverse competitive landscape, with local companies like Sinopharm and Zhifei rising against foreign giants like Merck and Pfizer [11] - Zhifei has achieved significant growth in international markets, with a 300% increase in exports of its WHO-precertified 23-valent pneumococcal polysaccharide vaccine [11] - Innovative companies like CanSino and Watson are making breakthroughs in mRNA and recombinant protein vaccines, enhancing their market presence [11][12] Future Trends - Technological innovation is driving the vaccine industry forward, with new platforms like mRNA and gene-engineered vaccines emerging [17] - The adult vaccine market is growing, with a 45% increase in HPV vaccine uptake in 2024, indicating a shift in public health awareness [18] - Chinese vaccine companies are expanding internationally, with over 2.5 billion doses of COVID-19 vaccines supplied abroad, focusing on markets in Africa and Southeast Asia [19]

Core Insights - The market for shingles vaccines in China has experienced rapid growth due to an aging population and increased public health awareness, with the market size expected to reach 5.6 billion yuan by 2024 after a recovery from a significant drop in 2021 [1][13] - The incidence of shingles is notably high among individuals aged 50 and above, driving sustained demand for vaccines [1][13] - The public's awareness of shingles and its prevention is gradually increasing, further propelling the market's growth [1][13] Industry Overview - Shingles vaccines are designed to prevent shingles, a disease caused by the reactivation of the Varicella-Zoster Virus, which initially causes chickenpox [2][4] - The industry chain includes upstream raw material suppliers, midstream vaccine developers and manufacturers, and downstream logistics and healthcare providers [4] Development History - The shingles vaccine industry in China has evolved from non-existence to local innovation, with the first imported vaccine, GSK's Shingrix, approved in 2019 [6][9] - The launch of the first domestic live attenuated shingles vaccine by Baike Biological in January 2023 marked a significant milestone, expanding the eligible age group for vaccination [6][9] - The market is now characterized by competition between imported and domestic vaccines, with expectations for a surge in domestic vaccine approvals in the coming years [6][9] Market Dynamics - The number of vaccine approvals has increased significantly, with Baike Biological's vaccine receiving 22 approvals in the first three quarters of 2023, indicating strong market performance [9] - The domestic vaccine market is expected to grow rapidly, driven by aging demographics and improved public health policies [9][11] Key Companies - Baike Biological has established itself as a leader in the shingles vaccine market, with a revenue of 883 million yuan in 2023, although it is projected to decline to 251 million yuan in 2024 [17] - Wantai Biological, another key player, reported a revenue of 5.511 billion yuan in 2023, down 50.73% from the previous year, and is expected to generate 2.245 billion yuan in 2024 [19] Future Trends - Domestic vaccines are anticipated to dominate the market due to their competitive pricing and alignment with local needs [21] - The improvement of health insurance policies is expected to enhance vaccine accessibility and increase public willingness to get vaccinated [22] - The development of multivalent and combination vaccines is becoming a significant trend, aiming to provide broader protection and improve vaccination efficiency [23]

Industry Overview - In 2024, the biopharmaceutical industry faced a complex situation with both challenges and opportunities, emphasizing the importance of developing first-class vaccines to protect human health [14]. Company Strategy and Goals - The company aims to create value and accumulate development potential during economic recession, focusing on the value release of its core products [14]. - Recbio is expected to submit the marketing application for its first strategic product in 2025, marking a significant milestone for the company [28]. - The company was recognized in the "2024 TOP10 China Listed Pharmaceutical Companies in ESG Competitiveness," reflecting its commitment to sustainable development [23]. - Recbio established the "Recbio College" to support employee education and integration of education, talent, industry, and innovation chains [24]. Clinical Trials and Vaccine Development - In 2024, Recbio's phase III clinical trial of the recombinant HPV 9-valent vaccine REC603 progressed well, completing the 36-month observation and initiating the 42-month observation [15]. - The phase I clinical study of REC610, a novel adjuvanted recombinant shingles vaccine, showed strong gE-specific immune response comparable to Shingrix®, with 24,640 subjects enrolled in the phase III trial in China within two months [15]. - 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 marketing application submission by December 31, 2025 [48][50]. - The novel adjuvanted recombinant shingles vaccine, REC610, received clinical trial approval in October 2023, with Phase III trials initiated in October 2024 and expected marketing approval by November 30, 2026 [52]. - The bivalent recombinant respiratory syncytial virus vaccine, REC625, is scheduled for completion of preclinical studies in 2025 [52]. - The novel adjuvanted recombinant HPV 9-valent vaccine, REC604c, was submitted for clinical trial application in February 2025 and accepted by the NMPA [52][53]. - The company is developing multiple vaccine candidates, including those for hepatitis B, herpes simplex, and influenza, with various adjuvant systems [50][52]. - The company emphasizes the importance of HPV vaccines in preventing cervical cancer, which is primarily caused by high-risk HPV types [53]. - The company is developing several early-stage vaccines, including REC609 for human cytomegalovirus, REC629 for hepatitis B virus, and REC630 for therapeutic hepatitis B virus, utilizing advanced technology platforms [108][109][110]. Financial Performance - The company reported a loss before tax of RMB 561,897,000 in 2024, a slight improvement from RMB 572,443,000 in 2023 [33]. - Loss per share for 2024 was RMB 1.16, compared to RMB 1.19 in 2023, indicating a reduction in losses [33]. - Total non-current assets increased to RMB 1,285,103,000 in 2024 from RMB 1,056,904,000 in 2023, representing a growth of 21.5% [34]. - Total current assets decreased to RMB 655,129,000 in 2024 from RMB 1,129,373,000 in 2023, a decline of 42% [34]. - Total current liabilities rose significantly to RMB 839,420,000 in 2024, up from RMB 444,235,000 in 2023, marking an increase of 88.9% [34]. - Net current assets turned negative at RMB (184,291,000) in 2024 compared to RMB 685,138,000 in 2023, indicating a substantial decline [34]. - Total (deficit)/equity decreased to RMB 529,324,000 in 2024 from RMB 1,070,944,000 in 2023, reflecting a drop of 50.7% [34]. Manufacturing and Production Capabilities - The HPV vaccine industrialization base can produce up to 20 million doses of the recombinant HPV 9-valent vaccine annually, complying with Chinese and international GMP standards [21]. - The innovative vaccines manufacturing facility, completed in November 2021, spans approximately 17,000 sq.m. and has received production licenses from Jiangsu MPA [41][43]. - The vaccine manufacturing facility in Taizhou City, Jiangsu Province, has established a complete quality system for large-scale commercial production, meeting both Chinese and EU GMP standards, and has a successful track record of large-scale batch production [107]. - The company has completed the construction of its HPV vaccine manufacturing facility in Taizhou, Jiangsu Province, which has a designed peak annual capacity of 20 million doses of HPV 9-valent vaccines [144]. Research and Development - Total research and development costs for the year ended December 31, 2024, amounted to RMB 476.1 million, with no costs capitalized during the same period [139]. - The company has developed four advanced technology platforms: novel adjuvant development, protein engineering, immunological evaluation, and process development, which enhance vaccine discovery and development [137]. - The in-house R&D team consists of over 100 personnel, most holding master's or doctoral degrees in relevant fields, ensuring a strong foundation for vaccine R&D [132]. - The company has established a systematic approach to vaccine development, integrating novel adjuvant development, protein engineering, and immunological evaluation [118]. Market and Competitive Landscape - There are significant opportunities for REC603 as it is the only domestic HPV 9-valent vaccine currently in development, which can prevent approximately 90% of cervical cancer cases [66]. - The first domestic HPV bivalent vaccine captured 66.7% of China's HPV bivalent vaccine market in its first year, despite being approved in 2019, while the first imported vaccine was approved in 2016 [72][76]. - The HPV 9-valent vaccine is expected to follow a similar trend in pricing as domestic products tend to be more cost-effective compared to global counterparts [72][76]. - The Chinese government has implemented favorable policies for domestic HPV vaccine developers, which the company expects to benefit from in the future [72][76]. Organizational Changes and Efficiency - The company has reorganized its clinical development, process development, and quality analysis departments to improve management efficiency and operational profitability [138]. - The number of research and development staff has decreased following organizational optimization, while efficiency has improved [138]. International Business Development - The company plans to build an international business development team to commercialize its vaccine candidates in international markets, with agreements signed with several countries for the development and commercialization of the recombinant HPV 9-valent vaccine REC603 [148]. Employee and Social Responsibility - The company has implemented training programs for employees and complies with social insurance and housing provident fund contributions as per PRC laws [153].

Financial Performance - The company reported total other income and gains of RMB 61,644 thousand for the year ended December 31, 2024, a decrease of 38.7% compared to RMB 100,555 thousand in 2023[8]. - The pre-tax loss for the year was RMB 561,897 thousand, slightly improved from a loss of RMB 572,443 thousand in 2023, representing a reduction of 9.6%[8]. - The net loss attributable to equity holders of the parent was RMB 562,389 thousand, compared to RMB 571,957 thousand in the previous year, indicating a decrease of 1.0%[8]. - Total revenue for the year ended December 31, 2024, was RMB 61,644,000, a decrease of 38.7% compared to RMB 100,555,000 in 2023[10]. - Research and development expenses for 2024 were RMB 476,124,000, slightly reduced from RMB 487,847,000 in 2023, indicating a decrease of 2.8%[10]. - The basic and diluted loss per share for the year was RMB 1.16, slightly improved from RMB 1.19 in 2023[10]. - The net asset value decreased to RMB 529,324,000 in 2024 from RMB 1,070,944,000 in 2023, a decline of 50.6%[12]. - Employee costs totaled RMB 187.9 million for the year ended December 31, 2024, down 17.4% from RMB 227.6 million for the year ended December 31, 2023[83]. - Administrative expenses decreased by 24.1% to RMB 109.1 million for the year ended December 31, 2024, from RMB 143.8 million for the year ended December 31, 2023, primarily due to personnel optimization[88]. - Sales and distribution expenses decreased by 69.4% to RMB 2.6 million for the year ended December 31, 2024, from RMB 8.5 million for the year ended December 31, 2023, mainly due to a reduction in sales personnel[87]. Assets and Liabilities - The total non-current assets increased to RMB 1,285,103 thousand in 2024, up by 21.5% from RMB 1,056,904 thousand in 2023[9]. - Current assets decreased significantly to RMB 655,129 thousand, down 42.0% from RMB 1,129,373 thousand in 2023[9]. - Current liabilities rose to RMB 839,420 thousand, an increase of 89.0% compared to RMB 444,235 thousand in 2023[9]. - Cash and cash equivalents decreased to RMB 319,040,000 in 2024 from RMB 834,983,000 in 2023, with bank cash at RMB 327,271,000 and pledged deposits at RMB 8,231,000[37]. - Trade payables and notes payable totaled RMB 59,789,000 at the end of 2024, a decrease from RMB 115,081,000 in 2023, with RMB 41,603,000 due within one year[34]. - The current ratio decreased from 2.5 as of December 31, 2023, to 0.78 as of December 31, 2024, primarily due to an increase in bank loans and other borrowings due within one year[103]. - The debt-to-capital ratio increased to 72.7% as of December 31, 2024, from 51.0% as of December 31, 2023, due to the growth in bank and other loan financing[103]. - Total interest-bearing bank loans and other borrowings amounted to RMB 878.3 million as of December 31, 2024, with RMB 499.4 million being short-term borrowings due in 2025[103]. Vaccine Development and Clinical Trials - The company is conducting a Phase III clinical trial for its nine-valent HPV vaccine REC603, with plans to submit a BLA application in 2025[3]. - REC610, a new adjuvanted recombinant shingles vaccine, has completed participant enrollment and vaccination in its Phase III trial, with 24,640 subjects recruited across 18 research centers[4]. - The company plans to complete preclinical studies for REC625, a bivalent recombinant respiratory syncytial virus vaccine, by 2025[5]. - The ReCOV vaccine project has been halted for further clinical development due to low global demand for COVID-19 vaccines, with a focus on reallocating resources based on future market conditions[6]. - The company has a pipeline of over 10 vaccine candidates, including three strategic products: REC603 (a recombinant nine-valent HPV vaccine in Phase III clinical trials), REC610 (a new adjuvanted recombinant shingles vaccine in Phase III clinical trials in China), and a bivalent recombinant respiratory syncytial virus vaccine soon entering clinical research[41][43]. - The company aims to submit the Biologics License Application (BLA) for REC603 by 2025, following the completion of the Phase III trial and interim analysis[50]. - The HPV vaccine is expected to achieve clinical analysis report by August 31, 2025, and submit for market approval by December 31, 2025[48]. - The new adjuvanted recombinant quadrivalent HPV vaccine (REC604a) has received clinical trial approval from the Chinese regulatory authority[48]. - The recombinant shingles vaccine (REC610) has been granted clinical trial approval, with Phase III trials set to start in October 2024[48]. - The bivalent recombinant respiratory syncytial virus vaccine (REC625) is planned to complete preclinical research by 2025[48]. Research and Development - The company has established a comprehensive vaccine innovation engine, including platforms for adjuvant development, protein engineering, immune evaluation, and process development, enabling the discovery and development of innovative vaccines[41]. - The R&D team consists of over 100 professionals, most of whom hold master's or doctoral degrees in relevant fields[75]. - The company has developed advanced technology platforms for adjuvant development, protein engineering, and immune evaluation, facilitating the discovery of subunit vaccines[70]. - The company has implemented an IPD system to manage the entire lifecycle of vaccine candidates and allocate R&D resources effectively[76]. - The company is focused on improving the immunogenicity of its vaccine candidates[137]. - The company is actively engaged in research and development of new technologies and products to strengthen its competitive position[134]. - The company is exploring the development of early-stage HPV vaccines (REC604a and REC604c) using a novel adjuvant, which may enhance immunogenicity compared to traditional aluminum adjuvants[59]. Corporate Governance and Financial Strategy - The company has adopted a corporate governance code to ensure shareholder interests and enhance corporate value since its listing[119]. - The board of directors has approved the issuance of shares to strengthen the company's financial structure and improve profitability and risk resistance[115]. - The company aims to optimize its financial structure and ensure sustainable development through the new share issuance[116]. - The share issuance is subject to approval from the China Securities Regulatory Commission[116]. - The company has confirmed compliance with the standard code of conduct for securities trading during the reporting period[118]. - The company is committed to maintaining high standards of corporate governance and transparency[133]. - The company has established a product investment decision-making and review body to guide its strategic direction[132]. Market Presence and Strategic Initiatives - The company is focused on expanding its market presence and enhancing its product pipeline through strategic initiatives[134]. - The company has signed framework agreements with countries including Saudi Arabia, Argentina, Russia, Indonesia, and South Africa for the development and commercialization of the recombinant nine-valent HPV vaccine REC603[81]. - The company has initiated the construction of an international business development team to facilitate the commercialization of its candidates in overseas markets[81]. - The company is under the supervision of the Jiangsu Provincial Drug Administration for its product approvals[132]. - CEPI is a foundation that funds independent research projects to develop vaccines for emerging infectious diseases[135].

Company Overview - Jiangsu Recbio Technology Co., Ltd. is incorporated in the People's Republic of China with stock code 2179[1]. - The interim report for 2024 includes financial highlights and management discussion and analysis sections[3]. - The report contains interim condensed consolidated statements of profit or loss and other comprehensive income, financial position, changes in equity, and cash flows[3]. Corporate Governance - The company has appointed new executive and non-executive directors as of May 8, 2024, including Dr. Liu Yong as the chairman[5]. - The audit committee for the second session of the board includes Dr. Xia Lijun as chairman, with other members appointed on May 8, 2024[6]. - The remuneration and appraisal committee is chaired by Professor Yuen Ming Fai, with members appointed on May 8, 2024[6]. - The nomination committee is also chaired by Dr. Liu Yong, with members appointed on May 8, 2024[6]. - The company has a joint company secretary, Ms. Chen Qingqing, appointed on June 18, 2024[6]. - The H share registrar for the company is Computershare Hong Kong Investor Services Limited[8]. - The interim report provides a comprehensive overview of the company's corporate governance and financial status[3]. Financial Performance - For the six months ended June 30, 2024, the company reported a loss before tax of RMB 249,636,000, an improvement from a loss of RMB 276,941,000 in the same period of 2023, representing a decrease of approximately 9.5%[13]. - Loss attributable to owners of the parent for the six months ended June 30, 2024, was RMB 249,135,000, compared to RMB 272,549,000 in the same period of 2023, indicating a reduction of approximately 8.6%[13]. - Total current assets decreased to RMB 795,359,000 as of June 30, 2024, from RMB 1,129,373,000 as of December 31, 2023, a decline of about 29.6%[14]. - The net current assets as of June 30, 2024, were RMB 113,716,000, a significant decrease from RMB 685,138,000 as of December 31, 2023[14]. - Other income and gains decreased by 40.4% from RMB 59.9 million for the six months ended June 30, 2023, to RMB 35.7 million for the same period in 2024, primarily due to a decrease in foreign exchange gains and interest income[103]. - Selling and distribution expenses decreased by 72.2% from RMB 5.4 million for the six months ended June 30, 2023, to RMB 1.5 million for the six months ended June 30, 2024, mainly due to a reduction in headcount in the marketing department[105]. - Research and development costs decreased by 17.2% from RMB 247.8 million for the six months ended June 30, 2023, to RMB 205.2 million for the six months ended June 30, 2024, attributed to lower clinical trial expenses[108]. - Administrative expenses decreased by 30.0% from RMB 78.1 million for the six months ended June 30, 2023, to RMB 54.7 million for the six months ended June 30, 2024, mainly due to reduced labor expenses[110]. - Finance costs increased by 68.5% from RMB 5.4 million for the six months ended June 30, 2023, to RMB 9.1 million for the six months ended June 30, 2024, primarily due to additional debt financing[115]. Asset and Liabilities - Total non-current assets increased to RMB 1,263,356,000 as of June 30, 2024, compared to RMB 1,056,904,000 as of December 31, 2023, reflecting a growth of about 19.5%[14]. - Property, plant, and equipment increased by 21.5% from RMB 840.8 million as of December 31, 2023, to RMB 1,021.9 million as of June 30, 2024, mainly due to construction projects for the HPV industrialization base[116]. - Cash and bank balances decreased by 34.4% from RMB 912.4 million as of December 31, 2023, to RMB 598.1 million as of June 30, 2024, mainly due to expenditures on R&D services and administrative costs[124]. - Trade payables decreased by 40.6% from RMB 115.1 million as of December 31, 2023, to RMB 68.3 million as of June 30, 2024, mainly due to payments for R&D and inventory procurement[125]. - Other payables and accruals increased by 33.2% from RMB 268.1 million as of December 31, 2023, to RMB 357.2 million as of June 30, 2024, mainly due to increased purchases of industrialization-based equipment[125]. - The company's cash and bank balances decreased by 34.4% from RMB 912.4 million as of December 31, 2023, to RMB 598.1 million as of June 30, 2024, primarily due to expenditures on R&D services, raw materials, equipment, and administrative expenses[127]. - Net current assets decreased by 83.4% from RMB 685.1 million as of December 31, 2023, to RMB 113.7 million as of June 30, 2024, mainly due to reduced cash and bank balances and increased current liabilities from bank loans[130]. - Lease liabilities decreased by 17.7% from RMB 19.2 million as of December 31, 2023, to RMB 15.8 million as of June 30, 2024, due to rent payments related to right-of-use assets[128]. - The total interest-bearing bank loans and other borrowings amounted to RMB 681.3 million as of June 30, 2024, with current borrowings of RMB 212.1 million maturing on June 30, 2025[137]. - The current ratio decreased from 2.5 as of December 31, 2023, to 1.2 as of June 30, 2024, primarily due to an increase in bank loans and other borrowings maturing within one year[137]. - The gearing ratio increased to 59.4% as of June 30, 2024, compared to 51.0% as of December 31, 2023, due to a significant amount of loans borrowed for production and operations[138]. Research and Development - The company has developed a vaccine portfolio consisting of more than 10 candidates, including three strategic products currently in various stages of clinical trials[16]. - The company is focused on the R&D of innovative vaccines, including HPV vaccine candidates, with ongoing clinical trials for its strategic products[16]. - The company has established a comprehensive vaccine innovation engine, including a novel adjuvant platform, protein engineering platform, and immunological evaluation platform, enhancing its R&D capabilities[17]. - The R&D team consists of over 100 personnel with expertise in immunology and related fields, supported by an Integrated Product Development (IPD) system that governs the entire vaccine development lifecycle[83][84]. - The company has established three advanced technology platforms: novel adjuvant development, protein engineering, and immunological evaluation, enabling the discovery and development of subunit vaccines[73][78][80]. - The company has the capability to conduct advanced immunological tests such as pseudoviral neutralization, ELISPOT, and ICS tests, making it one of the first in China to do so[80]. - Total research and development costs for the six months ended June 30, 2024, amounted to RMB 205.2 million, with no costs capitalized during the same period[89]. Vaccine Development - The HPV vaccine manufacturing facility in Taizhou City has a designed capacity of 20 million doses per year and is currently in the pilot production stage[18]. - REC603, a recombinant HPV 9-valent vaccine, is currently in phase III clinical trials in China, with a BLA application expected to be submitted to the NMPA in 2025[25]. - REC610 received clinical trial approval in October 2023 for phase I and phase III trials in China, with phase III expected to start in 2024[27]. - The vaccine pipeline includes a novel adjuvanted recombinant shingles vaccine in phase I and a bivalent recombinant respiratory syncytial virus vaccine about to enter clinical research[21]. - The company has completed the first-in-human clinical trial for REC610 in the Philippines[27]. - The company plans to allocate resources based on future development plans for respiratory combination vaccines and market conditions[28]. - The core product REC603 obtained umbrella IND approval from the NMPA in July 2018, allowing direct phase III trials in China[25]. - The clinical trial design for REC603 is randomized, double-blind, and placebo-controlled, which is considered the best strategy for confirming immunogenicity[32][33]. - The company is developing next-generation HPV vaccines with a two-shot regimen, potentially offering advantages over current three-shot regimens[43]. - The company aims to adopt a reasonable follow-up development strategy based on market demand and regulatory guidance for its vaccine candidates[48]. - The company has established a clear commercialization strategy for its clinical-stage vaccine candidates, including the recombinant HPV vaccine and recombinant shingles vaccine[95]. Market and Commercialization - A strategic cooperation agreement was signed with SPIMACO for the exclusive development, registration, and commercialization of the recombinant HPV 9-valent vaccine REC603 in 15 Middle Eastern and North African countries[94]. - The company plans to enter collaborations with foreign governments and organizations to commercialize its products internationally[94]. - The company aims to strengthen its international business development team to facilitate the commercialization of its products in overseas markets[95]. - The company plans to concentrate resources on the marketing of HPV 9-valent vaccines and recombinant shingles vaccines as soon as possible[101]. Shareholder Structure - The major shareholder, Taizhou Yuangong Technology Partnership, holds 62,147,715 Domestic Shares, representing approximately 17.16% of the Company[162]. - The company has multiple stakeholders with significant interests in both Domestic and H Shares, indicating a diverse ownership structure[164]. - The total number of H Shares held by various entities indicates a significant interest in the company, reflecting strong investor confidence[169]. - The company has a diverse shareholder base, with interests from various investment partnerships and corporations[175]. - The ownership structure of these partnerships indicates a complex network of financial relationships and investment strategies[190].

[Performance Overview](index=1&type=section&id=Business%20and%20Financial%20Summary) [Business Summary](index=1&type=section&id=Business%20Summary) The company advanced core vaccine development, with REC603 (HPV) in late-stage Phase III and REC610 (Shingles) nearing Phase III, while ceasing COVID-19 vaccine development and repurposing facilities - The core product, recombinant nine-valent HPV vaccine (REC603), is undergoing 36-month follow-up visits in Phase III clinical trials, with BLA submission anticipated in **2025** upon meeting conditions, positioning it among the leading domestic candidates[1](index=1&type=chunk) - The novel adjuvant recombinant shingles vaccine (REC610) has completed final vaccinations in China Phase I clinical trials, demonstrating good safety, with Phase III clinical studies expected to commence in **2024**[2](index=2&type=chunk) - Due to low market demand, the company will not proceed with a new round of clinical development for the existing strain COVID-19 vaccine project (ReCOV) and will deregister related subsidiaries, but the established production base will be repurposed to advance the industrialization of shingles and RSV vaccines[4](index=4&type=chunk) [Financial Summary](index=3&type=section&id=Financial%20Summary) For the six months ended June 30, 2024, the company remained in the R&D investment phase with no primary operating revenue, reporting a narrowed loss of **RMB 249.6 million** compared to **RMB 276.9 million** last year, with improved basic loss per share of **RMB 0.52**, while total assets decreased and total liabilities increased, leading to a decline in total equity Key Financial Data for H1 2024 (Consolidated Statements) | Indicator | H1 2024 (RMB Thousand) | H1 2023 (RMB Thousand) | | :--- | :--- | :--- | | **Income Statement:** | | | | Other Income and Gains | 35,701 | 59,929 | | Loss for the Period | (249,636) | (276,941) | | Loss Attributable to Owners of the Parent | (249,135) | (272,549) | | Loss Per Share (RMB) | (0.52) | (0.57) | | **Balance Sheet (Period-End):** | **June 30, 2024** | **Dec 31, 2023** | | Total Assets | 2,058,715 | 2,186,277 | | Total Liabilities | 1,222,954 | 1,115,333 | | Total Equity | 835,761 | 1,070,944 | [Management Discussion & Analysis](index=12&type=section&id=Management%20Discussion%20%26%20Analysis) [Business Review and R&D Pipeline](index=12&type=section&id=Business%20Review) The company, an innovation-driven vaccine firm, strategically develops over 10 candidates across major disease areas, leveraging three core technology platforms, with REC603 (HPV) in Phase III and REC610 (Shingles) nearing Phase III, supported by GMP-compliant production and international partnerships - The company possesses over **10** vaccine candidates, strategically focusing on three key products: recombinant nine-valent HPV vaccine (REC603), novel adjuvant recombinant shingles vaccine (REC610), and bivalent recombinant respiratory syncytial virus vaccine[29](index=29&type=chunk)[30](index=30&type=chunk) - The company has established three core technology platforms—novel adjuvants, protein engineering, and immune evaluation—forming a 'golden triangle' synergy to support continuous vaccine innovation and development[29](index=29&type=chunk)[46](index=46&type=chunk)[50](index=50&type=chunk) - The company has established a WHO PQ-compliant HPV vaccine production base in Taizhou with a designed annual capacity of **20 million doses**, and an EU GMP-compliant innovative vaccine production base, laying the foundation for future commercial manufacturing[29](index=29&type=chunk)[52](index=52&type=chunk) - The company is actively advancing its internationalization strategy, having signed commercialization framework agreements for the nine-valent HPV vaccine REC603 with enterprises in multiple countries and regions, including Saudi Arabia, Argentina, and Russia[52](index=52&type=chunk) [HPV Vaccine Pipeline](index=14&type=section&id=HPV%20Vaccine%20Pipeline) HPV vaccines are the company's core pipeline, with flagship REC603 (nine-valent) in Phase III, expected for BLA submission in **2025**, demonstrating positive immunogenicity and safety, alongside development of bivalent and next-generation HPV vaccines - The core product REC603 (nine-valent HPV vaccine) Phase III clinical trial is undergoing its **36-month** follow-up visit, with BLA submission planned for **2025**, featuring a randomized, double-blind, placebo-controlled design strictly adhering to guidelines, and boasting China's largest sample size of **16,050** cases[34](index=34&type=chunk)[38](index=38&type=chunk) - REC603 utilizes the *Hansenula polymorpha* expression system, enabling high-yield and stable production of virus-like particles suitable for commercial manufacturing, and has demonstrated good safety, with an adverse event incidence rate of **53.75%** in Phase I clinical trials, lower than historical data for marketed products[35](index=35&type=chunk)[36](index=36&type=chunk) - The company is simultaneously developing bivalent HPV vaccines (REC601/REC602, Phase I completed) and next-generation HPV vaccines (REC604a/b) utilizing novel adjuvants, with REC604a having received clinical trial approval in China[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) [Shingles Vaccine Pipeline](index=18&type=section&id=Shingles%20Vaccine%20Pipeline) The novel adjuvant recombinant shingles vaccine REC610, having completed China Phase I with good safety, is expected to enter Phase III in **2024**, and previously showed comparable or numerically superior safety and immunogenicity against Shingrix® in a head-to-head FIH study - REC610's China Phase I clinical trial has completed final vaccinations for **180** subjects, demonstrating good safety with no SAEs reported, and based on these results, Phase III clinical studies are expected to commence in **2024**[41](index=41&type=chunk) - In a head-to-head FIH study against Shingrix® in the Philippines, REC610 induced gE-specific humoral and cellular immune responses comparable to, and numerically higher than, Shingrix®[41](index=41&type=chunk)[42](index=42&type=chunk) - REC610 incorporates the company's independently developed novel adjuvant BFA01, aiming to provide a domestic alternative for shingles prevention for approximately **700 million** people aged **40** and above in China[42](index=42&type=chunk) [Other Vaccine Pipelines](index=20&type=section&id=Other%20Pipelines) The company has pipelines in RSV, influenza, and cytomegalovirus, with bivalent RSV vaccine REC625 planned to complete preclinical studies in **2024**, and the suspended COVID-19 vaccine ReCOV project's production system will support other pipeline development - Preclinical studies for the bivalent recombinant RSV vaccine (REC625) have shown good immunogenicity, with preclinical research planned for completion in **2024**[43](index=43&type=chunk) - Due to low market demand, the recombinant COVID-19 vaccine (ReCOV) project has ceased a new round of clinical development, but the GMP-compliant production facilities established for this project will be utilized to support the subsequent development of products like REC610 and REC625[44](index=44&type=chunk) - The company has also strategically positioned several early-stage vaccine projects, including those for influenza, cytomegalovirus, hepatitis B, and herpes simplex virus[45](index=45&type=chunk) [Financial Review](index=26&type=section&id=Financial%20Review) In H1 2024, the company's loss narrowed to **RMB 250 million** due to controlled R&D and administrative expenses, but cash and bank balances decreased to **RMB 598 million**, current ratio dropped from **2.5** to **1.2**, and gearing ratio rose from **51.0%** to **59.4%**, indicating funding pressure Key Expense Item Changes | Expense Item | H1 2024 (RMB Million) | H1 2023 (RMB Million) | YoY Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 205.2 | 247.8 | -17.2% | | Administrative Expenses | 54.7 | 78.1 | -30.0% | | Selling and Distribution Expenses | 1.5 | 5.4 | -72.2% | - The decrease in R&D expenses is primarily due to core product REC603 entering the late-stage Phase III clinical follow-up phase, resulting in reduced clinical trial expenditures[58](index=58&type=chunk) - Cash and bank balances decreased from **RMB 912 million** at the end of **2023** to **RMB 598 million**, primarily utilized for R&D, industrialization construction, and administrative expenses[66](index=66&type=chunk)[70](index=70&type=chunk) - The gearing ratio increased from **51.0%** to **59.4%**, and the current ratio decreased from **2.5** to **1.2**, primarily due to increased bank borrowings and reduced cash[73](index=73&type=chunk) [Business Outlook and Strategy](index=26&type=section&id=Business%20Outlook) The company will prioritize the expedited market launch of nine-valent HPV and recombinant shingles vaccines, focusing on accelerating clinical and commercialization processes, strengthening R&D, optimizing structure, and building market competitiveness through international BD and industrial cooperation - The core strategy is to concentrate resources and prioritize the market launch of the nine-valent HPV vaccine and recombinant shingles vaccine[55](index=55&type=chunk) - Strengthen international business development (BD) capabilities to achieve greater breakthroughs in international markets and outbound commercial licensing[55](index=55&type=chunk) - Prepare for product commercialization by developing intelligent manufacturing, strengthening quality systems, and building a marketing network[55](index=55&type=chunk) [Other Information](index=32&type=section&id=Other%20Information) [Corporate Governance and Compliance](index=32&type=section&id=Corporate%20Governance) The company maintains high corporate governance standards, largely complying with the code, though the Chairman and CEO roles are combined (Dr. Liu Yong) for business efficiency, and the Audit Committee, along with Ernst & Young, has reviewed the interim financial results - The roles of Chairman and General Manager (CEO) are concurrently held by Dr. Liu Yong, constituting a deviation from Corporate Governance Code Provision C.2.1, which the Board believes benefits the company's business prospects and operational efficiency[83](index=83&type=chunk) - The Board confirms its responsibility for risk management and internal control systems, with no significant internal control deficiencies or reports of improper conduct identified during the reporting period[84](index=84&type=chunk) - The Audit Committee has reviewed the current period's results, and the interim financial report has been reviewed by Ernst & Young in accordance with relevant standards[85](index=85&type=chunk) - The Board does not recommend the payment of an interim dividend for the six months ended June 30, **2024**[85](index=85&type=chunk)