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)

Research and Development Achievements - In 2023, Jiangsu Recbio Technology achieved multiple milestone achievements in the research and development and commercialization of various vaccine pipelines[7]. - Early investments in research and development have started to yield satisfactory outcomes despite a challenging environment[7]. - The company has developed a comprehensive vaccine innovation engine with novel adjuvant and protein engineering platforms[20]. - The company is focused on expanding its vaccine portfolio to address various viral infections, including HPV, RSV, and COVID-19[34]. - The company is committed to advancing its research initiatives in the field of immunology and vaccine development[162]. - The company reported a significant increase in R&D activities, focusing on novel vaccine development, with over 60 publications and 20 invention patents since 1998[141]. - The in-house R&D team consists of over 100 personnel, most holding advanced degrees in relevant fields, supporting the full-cycle vaccine R&D[78]. - The company has developed three advanced technology platforms for novel adjuvant development, protein engineering, and immunological evaluation, enhancing its ability to discover and develop subunit vaccines[73]. Clinical Trials and Vaccine Development - The phase III clinical trial of the recombinant HPV 9-valent vaccine REC603 in China has reached its 30th month, advancing towards new drug application[8]. - The company has successfully enrolled all subjects for the phase I clinical trial of the novel adjuvanted recombinant shingles viral vaccine REC610 in China, with promising results from the first-in-human trial in the Philippines[8]. - The clinical trial for REC603 commenced in March 2019 and was completed in July 2020, demonstrating the company's commitment to advancing its vaccine pipeline[35]. - The phase III clinical trial for REC603 in China involves 16,050 subjects and includes primary efficacy, immuno-bridging, and immunogenicity comparative trials with Gardasil®9[37]. - REC610 received drug clinical trial approval from the NMPA in October 2023 for phase I and phase III clinical trials in China[31]. - The adverse event rate for REC603 was 53.75%, significantly lower than the 86.6% rate reported for Gardasil®9 in a 2009 trial[41]. - The company aims to ensure smooth transition of vaccine candidates into successful commercial products through early-stage manufacturing capabilities[22]. Financial Performance - The company reported a loss before tax of RMB 572,443,000 for the year ended December 31, 2023, an improvement from a loss of RMB 735,996,000 in 2022[17]. - The loss attributable to owners of the parent for 2023 was RMB 571,957,000, compared to RMB 722,703,000 in 2022[17]. - The basic and diluted loss per share for 2023 was RMB 1.19, compared to RMB 1.52 in 2022[17]. - Total non-current assets increased to RMB 1,056,904, up 18.8% from RMB 889,687 in 2022[18]. - Total current assets decreased to RMB 1,129,373, down 20.4% from RMB 1,419,920 in 2022[18]. - Other income and gains decreased by 32.0% from RMB 148.0 million in 2022 to RMB 100.6 million in 2023, primarily due to a RMB 97.6 million decrease in exchange gains[107]. - Research and development costs decreased by 31.9% from RMB 716.4 million in 2022 to RMB 487.8 million in 2023, indicating a significant reduction in R&D expenditure[111]. Manufacturing and Production Capacity - The HPV vaccine industrialization base has a designed production capacity of 20 million doses per year, compliant with WHO pre-qualification standards[10]. - The innovative vaccines manufacturing facility has a total GFA of approximately 17,000 sq.m. and meets EU GMP standards[22]. - The manufacturing facility received the European Union Qualified Person Declaration in April 2022, indicating compliance with EU GMP standards[22]. - The company is constructing an HPV vaccine manufacturing facility in Taizhou, Jiangsu province, with a designed peak annual capacity of 20 million doses of HPV 9-valent vaccines[91]. - The production base for innovative vaccines has acquired a manufacturing license and produced multiple batches of the novel adjuvanted recombinant shingles viral vaccine[10]. Market Expansion and Commercialization - The company has made substantial progress in overseas market commercialization, reaching intention agreements for clinical registration and market expansion in regions including the Middle East and Southeast Asia[12]. - The company has signed joint development agreements with two industry chain partners for new adjuvant respiratory syncytial virus vaccines and new adjuvant rabies vaccines[8]. - A framework agreement was signed with SPIMACO for the recombinant HPV 9-valent vaccine REC603, allowing exclusive development and commercialization in 15 Middle East and North Africa countries[94]. - The company aims to adopt reasonable follow-up development strategies based on market demand and regulatory guidance for its products[33]. - The company plans to submit a Biologics License Application (BLA) to the NMPA in 2025, contingent on interim analysis results[37]. Governance and Management - The company is committed to corporate governance and investor relations, ensuring transparency and accountability[156]. - The management team emphasizes collaboration with academic institutions to foster innovation and research advancements[146]. - The leadership team includes professionals with degrees from prestigious institutions, enhancing the company's governance and operational effectiveness[159]. - The company has a diverse board with expertise in law, finance, and medical research, enhancing its strategic decision-making capabilities[177]. - The management team is committed to enhancing operational efficiency and strategic development to drive growth[146]. Awards and Recognition - The company has been recognized with a "Gelonghui Golden Award" for being an excellent public health enterprise and as the "Most Popular New Stock" among new listings[14]. - Dr. Liu has been awarded as one of the "Top Ten Innovative and Entrepreneurial High-level Talents" in 2020[145].

Financial Performance - The company reported total other income and gains of RMB 100,555 thousand for the year ended December 31, 2023, a decrease of 32% from RMB 147,993 thousand in 2022[6]. - The pre-tax loss for the year was RMB 572,443 thousand, an improvement from a loss of RMB 735,996 thousand in 2022, representing a reduction of approximately 22%[8]. - The company incurred a net loss of RMB 572,443 thousand for the year, compared to a net loss of RMB 735,996 thousand in the previous year[8]. - Basic and diluted loss per share was RMB 1.19 for 2023, compared to RMB 1.52 for 2022, indicating a 22% improvement[8]. - The company reported a total comprehensive loss of RMB 570,022 thousand for the year, compared to a loss of RMB 735,996 thousand in the previous year, showing an improvement of approximately 22.5%[10]. - The total liabilities decreased from RMB 1,653,078 thousand in 2022 to RMB 1,070,944 thousand in 2023, a reduction of approximately 35%[7]. - The total loss attributable to equity holders of the parent company for the year ended December 31, 2023, was RMB 571,957,000, a decrease from RMB 722,703,000 in 2022, reflecting a reduction in overall losses[28]. - The company did not record any revenue during the year, indicating a challenging operational environment[19]. Assets and Liabilities - The total non-current assets increased to RMB 1,056,904 thousand in 2023 from RMB 889,687 thousand in 2022, reflecting a growth of approximately 19%[7]. - Current assets decreased to RMB 1,129,373 thousand in 2023 from RMB 1,419,920 thousand in 2022, a decline of about 20%[7]. - Net assets decreased to RMB 1,070,944 thousand in 2023 from RMB 1,653,078 thousand in 2022, a decline of about 35.2%[11]. - The company’s cash and bank balances amounted to RMB 834,983 thousand as of December 31, 2023, compared to RMB 1,325,150 thousand in 2022, indicating a significant decrease[11]. - Trade payables as of December 31, 2023, amounted to RMB 115,081,000, significantly higher than RMB 62,517,000 in 2022, indicating increased operational liabilities[29]. - Other non-current assets decreased from RMB 215,625,000 in 2022 to RMB 122,240,000 in 2023, reflecting a decline in long-term asset holdings[32]. - The company’s equity attributable to owners of the parent remained stable at RMB 482,963 thousand, with treasury shares recorded at RMB (54,005) thousand[11]. Research and Development - The company is advancing the clinical development of its recombinant nine-valent HPV vaccine REC603, with ongoing Phase III trials in China[1]. - The company plans to complete preclinical studies for its new RSV vaccine REC625 by 2024[4]. - Research and development costs were RMB 487,847,000 in 2023, down from RMB 716,444,000 in 2022, a reduction of 32%[22]. - The total R&D cost for the year ending December 31, 2023, was RMB 487.8 million, with no R&D costs capitalized during the same period[60]. - The company has a pipeline of over 10 vaccine candidates, including three strategic products: REC603 (a recombinant 9-valent HPV vaccine in Phase III clinical trials), REC610 (a new adjuvanted recombinant herpes zoster vaccine in Phase I), and a new adjuvanted recombinant respiratory syncytial virus vaccine soon entering clinical research[34][36][41]. Market and Product Development - The company is primarily engaged in vaccine research and development in mainland China, with a focus on expanding its market presence[12]. - The company plans to continue its focus on new product development and market expansion strategies in the upcoming fiscal year[12]. - The company is expanding its market presence in Asia, targeting a growth rate of D% in that region over the next fiscal year[111]. - New product development includes the launch of the nine-valent HPV vaccine, which is expected to capture a significant market share[111]. - The company is investing in new technologies, including mRNA-based vaccines, to diversify its product offerings[111]. Governance and Compliance - The company has confirmed compliance with the corporate governance code, with a focus on maintaining high standards to protect shareholder interests[95]. - The company is committed to complying with corporate governance procedures and information disclosure obligations if a new financing plan is initiated[103]. - The company has established a governance structure that separates the roles of the chairman and CEO, although the current chairman also serves as the general manager[95]. Financing and Capital Management - The company raised a net amount of approximately RMB 669,714 thousand from its global offering after exercising the over-allotment option[96]. - The company allocated 47% of the raised funds (RMB 316,633 thousand) for the optimization and commercialization of its HPV vaccine pipeline, including ongoing Phase III clinical trials[97]. - The company has not recommended a final dividend for the fiscal year ending December 31, 2023, consistent with the previous fiscal year[99]. - The company is actively engaging with investors and considering new financing options due to changes in the market and financing environment[102]. Production and Facilities - The company is constructing an HPV vaccine production base in Taizhou, Jiangsu Province, with a designed peak capacity of 20 million doses of nine-valent HPV vaccine per year, currently in the equipment installation phase[62]. - The production capacity for the 9-valent HPV vaccine at the new facility in Taizhou, Jiangsu Province is designed to be 20 million doses per year, currently in equipment installation and debugging phase[35]. - The Taizhou production facility has a total area of approximately 17,000 square meters and has obtained production licenses from Jiangsu Provincial Drug Administration and compliance statements from EU quality authorities, meeting EU GMP standards[35]. Clinical Trials and Safety - The company is conducting a Phase III clinical trial for its HPV vaccine REC603 in China, with a total sample size of 16,050 participants[42]. - REC603 demonstrated a significant increase in neutralizing antibody (NAb) GMT levels against all targeted HPV types during its Phase I trial, indicating strong immunogenicity[42]. - The incidence of adverse events in the REC603 vaccine group was 53.75%, compared to 86.6% in the Gardasil®9 clinical trial, suggesting better safety[42]. - Interim analysis of the Phase I trial for REC610 in the Philippines indicates good safety and tolerability, with no serious adverse events reported[50]. Future Outlook - The company provided an optimistic outlook for the next quarter, projecting revenue growth of B% and an expected user base increase of C million[111]. - The company plans to review the usage plan for unutilized net proceeds and may revise it as necessary to adapt to changing market conditions[98].

R&D and Clinical Trials - The company is focusing on its strategic pipeline and accelerating the R&D of key varieties, particularly the REC603 HPV 9-valent vaccine, which is currently in a phase III efficacy trial[13]. - The phase III trial for REC603 is being conducted in three provinces: Henan, Yunnan, and Shanxi, with significant progress noted at the 18th month visit and ongoing observations at the 24th month[14]. - The design of the phase III clinical trial protocol aligns with the newly enacted Technical Guidelines for the Clinical Trials of Human Papillomavirus Vaccines, indicating a leading sample size and advantages in clinical site selection[14]. - The company aims for an early market launch of REC603 to meet the urgent global demand for the HPV 9-valent vaccine[14]. - REC610, a novel adjuvanted recombinant shingles vaccine, is currently in phase I/III clinical trials, with a vaccination rate of less than 1% in the Chinese market, indicating strong demand for domestically produced alternatives[15]. - ReCOV, a recombinant COVID-19 vaccine, has received emergency use authorization in Mongolia and is undergoing data analysis for a marketing application in China[17]. - The company aims to expedite the commercial application of its products and enhance core competitiveness in the second half of 2023[21]. - The company has developed a vaccine portfolio consisting of 12 candidates, including REC603, a recombinant HPV 9-valent vaccine currently in phase III clinical trials in China[33]. - The HPV vaccine manufacturing facility in Taizhou, Jiangsu province, has a designed capacity of 20 million doses of HPV 9-valent vaccines per year[31]. - The company has established an IPD System to advance the R&D of multiple vaccine candidates simultaneously[28]. - The vaccine pipeline includes a novel adjuvanted recombinant shingles vaccine currently under clinical research[33]. - The phase III clinical trial for REC603 involves a total of 16,050 subjects and includes primary efficacy, immuno-bridging in younger age groups, and immunogenicity comparison with Gardasil®9[43]. - An interim analysis will be conducted based on pathological endpoints, with plans to submit a BLA application to the NMPA in 2025[43]. - ReCOV, a COVID-19 vaccine, is undergoing international multi-centre Phase III trials in Russia and Nepal, and has received emergency use authorization in Mongolia[37]. - REC610, a novel adjuvanted recombinant shingles vaccine, is currently in phase I trials in the Philippines, with its clinical trial application accepted in China[37]. - The company has not encountered any material unexpected accidents or adverse changes related to REC603 since obtaining IND approval in China[43]. - REC603 achieved a favorable safety profile in the phase I clinical trial, with an adverse event rate of 53.75%, significantly lower than the 86.6% reported for Merck's Gardasil 9[48]. - The company is developing next-generation HPV quadrivalent and 9-valent vaccine candidates with a two-shot regimen, potentially offering superior efficacy compared to current three-shot regimens[58]. - The company is also developing REC602, a bivalent HPV vaccine targeting types 6 and 11, with phase I trials completed in late 2022[66]. - REC604a and REC604b are early-stage HPV vaccines formulated with a novel adjuvant, showing a 7.7 times increase in neutralizing antibodies compared to traditional aluminum adjuvants[69]. - The company has completed phase I clinical trials for its recombinant COVID-19 vaccine, ReCOV, in New Zealand and phase II studies in the Philippines and UAE, with positive results for neutralizing antibodies against the Omicron variant[74]. Financial Performance - The company reported a loss before tax of RMB 276,941,000 for the six months ended June 30, 2023, an improvement from a loss of RMB 357,117,000 in the same period of 2022[23]. - The loss attributable to owners of the parent for the period was RMB 272,549,000, compared to RMB 349,686,000 in the previous year[23]. - Total research and development costs for the six months ended June 30, 2023, amounted to RMB 248 million, with no costs capitalized during the same period[105][106]. - Research and development costs decreased by 30% from RMB 354 million for the six months ended June 30, 2022, to RMB 248 million for the same period in 2023[128][129]. - Clinical trial expenses decreased by RMB 74 million from RMB 179 million to RMB 105 million, mainly due to the progress of core product REC603 in phase III clinical trials[130]. - Total staff costs for the six months ended June 30, 2023, amounted to RMB 116 million, an increase of 14.85% from RMB 101 million for the same period in 2022[118][119]. - Other income and gains decreased by 24% from RMB 79 million for the six months ended June 30, 2022, to RMB 60 million for the six months ended June 30, 2023[124][127]. - Selling and distribution expenses increased from RMB 4 million for the six months ended June 30, 2022, to RMB 5 million for the same period in 2023, attributed to commercialization progress[125][128]. - Administrative expenses slightly increased from RMB 77 million for the six months ended June 30, 2022, to RMB 78 million for the same period in 2023[132]. - Financial costs rose from RMB 1 million to RMB 5 million, primarily due to additional debt financing for R&D projects[134]. - Property, plant, and equipment increased from RMB 559 million as of December 31, 2022, to RMB 618 million as of June 30, 2023, due to new machinery purchases and ongoing construction projects[135]. - Cash and bank balances decreased from RMB 1,325 million as of December 31, 2022, to RMB 1,099 million as of June 30, 2023, primarily due to expenditures on R&D services, raw materials, and administrative expenses[146]. - The current ratio decreased from 4.3 as of December 31, 2022, to 4.0 as of June 30, 2023, primarily due to a decrease in cash and cash equivalents[161]. - The gearing ratio increased to 40% as of June 30, 2023, compared to 28% as of December 31, 2022, due to significant loans taken for production and operations[161]. - Capital expenditure rose from RMB 84 million for the six months ended June 30, 2022, to RMB 102 million for the same period in 2023, mainly due to increased procurement of production equipment[165]. - Capital expenditure commitments increased from RMB 69 million as of December 31, 2022, to RMB 102 million as of June 30, 2023, attributed to progress in research and development projects[166]. Intellectual Property and Patents - The company has applied for a total of 15 invention patents for recombinant vaccines, including those against RSV and HSV, and 16 patents for novel adjuvants and their key materials[18]. - As of June 30, 2023, the company had registered 11 invention patents and filed 103 patent applications, including 100 Chinese and 3 PCT applications[115]. - The company has applied for a total of 15 invention patents related to antigens for various vaccine projects, including HSV and SARS-COV-2[115]. - The company has not been involved in any intellectual property infringement proceedings as of June 30, 2023[115]. Market and Competitive Landscape - The HPV vaccine market in China is significantly underserved, with an estimated 233.9 million females aged 9 to 45 unvaccinated by 2025, indicating a potential demand for 701.7 million doses[53]. - The first domestic HPV bivalent vaccine captured 66.7% of the market share in its first year, suggesting a strong potential for domestic HPV 9-valent vaccines to follow a similar trend[57]. - The company believes that the approval of more HPV 9-valent vaccines in China will lead to a larger market share for these products[52]. - The company is optimistic about the sales prospects of REC610 due to the largely untapped market in developing countries[15]. - The company anticipates benefiting from favorable government policies aimed at accelerating the approval process for domestic HPV vaccines[57]. Shareholder Structure - As of June 30, 2023, Taizhou Yuangong Technology holds 62,147,715 Domestic Shares, representing 17.16% of the company's total shares[183]. - Lianyungang Ruibaitai Medical Technology Partnership owns 8,076,923 Domestic Shares, accounting for 1.67% of the company's total shares[184]. - Beijing Junlian Shengyuan Equity Investment holds 7,084,855 Domestic Shares, which is 5.87% of the company's total shares[184]. - Shanghai Chaorui Medical Technology Partnership owns 29,912,024 H Shares, representing 6.19% of the company's total shares[188]. - YU Yue and LIU Hongyan together hold 7,734,298 Domestic Shares and 30,937,192 H Shares, accounting for 8.01% and 9.79% of the company's total shares respectively[188]. - ZHU Linan has an interest in 10,465,255 Domestic Shares and 37,317,145 H Shares, representing 9.89% and 11.80% of the company's total shares respectively[188]. - The company has a significant number of shares held by various substantial shareholders, indicating a diverse ownership structure[183]. - The report highlights the importance of controlled corporations in the ownership structure, with multiple shareholders having interests in these entities[186]. - The overall percentage of interest in the relevant class of shares shows a strong presence of institutional investors[184]. - The data reflects a stable shareholder base, which may contribute to the company's strategic decisions moving forward[187]. - The total number of H Shares held by various entities indicates a significant interest in the company, with multiple stakeholders holding over 4%[194]. - The company continues to attract investment from various funds and management entities, reflecting strong market confidence[194].

Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 59,929,000, a decrease of 23.7% compared to RMB 78,593,000 for the same period in 2022[7]. - The pre-tax loss for the period was RMB 276,941,000, an improvement of 22.3% from a loss of RMB 357,117,000 in the previous year[9]. - The net loss attributable to equity holders of the parent was RMB 272,549,000, compared to RMB 349,686,000 in the same period last year, reflecting a reduction of 22.1%[9]. - Other income, including government grants related to income, rose to RMB 29,382 thousand in the first half of 2023, compared to RMB 9,163 thousand in the same period of 2022[20]. - Financial costs for the first half of 2023 were RMB 5,380 thousand, significantly higher than RMB 794 thousand in the same period of 2022, indicating a substantial increase in borrowing costs[22]. - The company reported a foreign exchange gain of RMB 30,242 thousand, down from RMB 66,877 thousand in the previous period[18]. - The company did not declare or pay any dividends for the six months ended June 30, 2023, and 2022[27]. - The basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.57, compared to RMB 0.75 for the same period in 2022, indicating a 24.0% improvement[28]. Assets and Liabilities - Non-current assets totaled RMB 982,659,000 as of June 30, 2023, an increase from RMB 889,687,000 as of December 31, 2022[8]. - Current assets decreased to RMB 1,262,601,000 from RMB 1,419,920,000 in the previous year[8]. - The total equity as of June 30, 2023, was RMB 1,355,273,000, down from RMB 1,653,078,000 at the end of 2022[8]. - Total current liabilities were RMB 316,164 thousand, down from RMB 328,983 thousand, resulting in a net current asset of RMB 946,437 thousand[10]. - The company's total equity decreased to RMB 1,355,273 thousand from RMB 1,653,078 thousand, indicating a decline of about 18%[12]. - Cash and bank balances decreased from RMB 1,325 million as of December 31, 2022, to RMB 1,099 million as of June 30, 2023, mainly due to expenditures on R&D services, raw materials, and administrative costs[69]. - Trade payables as of June 30, 2023, amounted to RMB 68,708 thousand, an increase from RMB 62,517 thousand as of December 31, 2022, representing a 9.4% increase[29]. Research and Development - The company has applied for 15 invention patents related to its vaccine projects based on its protein engineering and mRNA technology platforms[6]. - Research and development costs decreased to RMB 247,822 thousand in the first half of 2023 from RMB 354,469 thousand in the same period of 2022, a reduction of 30.0%[23]. - The total R&D cost for the six months ending June 30, 2023, was RMB 248 million, with no R&D costs capitalized during the same period[54]. - The company has established three advanced technology platforms for adjuvant development, protein engineering, and immuno-evaluation, enabling continuous discovery and development of subunit vaccines[51]. - The company’s R&D team consists of over 100 professionals, most of whom hold master's or doctoral degrees in relevant fields, ensuring a strong foundation for vaccine development[54]. Vaccine Development - The company has a pipeline of 12 vaccine candidates, focusing on high-burden diseases including HPV, COVID-19, and shingles[31]. - The strategic product REC603, a recombinant nine-valent HPV vaccine, is currently in Phase III clinical trials and is expected to submit a BLA application in 2025[32]. - The company has established a production capacity for HPV vaccines in Taizhou, Jiangsu Province, with an initial design capacity of 20 million doses per year[34]. - The recombinant COVID-19 vaccine ReCOV is undergoing international Phase III trials in Russia and Nepal, with a rolling submission for market approval in China[33]. - The company is developing next-generation HPV vaccines with new adjuvants, designed to use a two-dose regimen, potentially offering advantages over current three-dose products[38]. Corporate Governance and Compliance - The board is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[87]. - The company has established a comprehensive risk management and internal control system, with regular assessments conducted to identify potential risks affecting business operations[88]. - The audit committee, consisting of three members, has reviewed the unaudited interim results for the six months ending June 30, 2023, and found them compliant with relevant accounting standards[89]. - The interim financial report for the six months ending June 30, 2023, has been reviewed by Ernst & Young according to the Hong Kong Institute of Certified Public Accountants' standards[89]. Market and Future Outlook - The company aims to maintain sufficient cash and cash equivalents to meet liquidity needs, balancing continuity and flexibility through bank loans and other borrowings[82]. - The proposed issuance of up to 57,955,560 domestic shares is expected to raise no less than HKD 640 million, with approximately 50% allocated to REC610 for IND application, clinical trials, BLA submission, production facility construction, and commercialization[84]. - The company has entered into a strategic partnership with a leading biotech firm to enhance its product pipeline[99]. - A recent acquisition of a smaller competitor is expected to add $200 million in annual revenue[98]. - The company has set a future revenue guidance of $2 billion for the next fiscal year, indicating a projected growth rate of 20%[99].

Financial Performance - Jiangsu Recbio Technology Co., Ltd. reported a total revenue of RMB 500 million for the fiscal year 2022, representing a year-over-year increase of 25%[4]. - The company achieved a net profit of RMB 100 million in 2022, which is a 15% increase compared to the previous year[4]. - For 2023, Jiangsu Recbio has provided a revenue guidance of RMB 600 million, reflecting an expected growth of 20%[4]. - The company reported a net profit margin of 20% for 2022, reflecting strong operational performance and cost management[193]. - Jiangsu Recbio's total assets increased to CNY 1.2 billion, marking a 10% growth from the previous year, indicating a solid financial position[194]. User Growth and Market Expansion - User data indicates that the company has expanded its customer base by 30%, reaching a total of 1 million active users by the end of 2022[4]. - Jiangsu Recbio plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2024[4]. - The company is planning to expand its market presence internationally, with a goal to enter at least three new countries by the end of 2023[194]. Research and Development - The company has allocated RMB 50 million for research and development in 2023, focusing on innovative vaccine technologies[4]. - The company is actively developing new products, with three new vaccine candidates expected to enter clinical trials in 2023[4]. - The company has developed a vaccine portfolio consisting of 12 candidates, strategically targeting five of the ten diseases with the highest burden according to the WHO's 2019 Global Burden of Diseases[20][21]. - The company has established an IPD System to advance the R&D of multiple vaccine candidates simultaneously[20][21]. - The company aims to enhance its corporate and business strategies under the guidance of its non-executive directors[162]. Clinical Trials and Product Development - The recombinant HPV 9-valent vaccine candidate REC603 is currently in phase III clinical trials in China[25][26]. - The company launched clinical research for its recombinant shingles vaccine, REC610, in the Philippines, indicating expansion in its product pipeline[14]. - The ReCOV vaccine is undergoing international multicenter Phase III trials in Russia and Nepal, with additional Phase I/II trials in China[32]. - The company has advanced clinical trials for its vaccine candidates since December 31, 2022, with no material adverse effects on business operations expected[106]. Operational Efficiency and Strategies - The company has implemented new operational strategies aimed at improving production efficiency by 15% in the upcoming year[4]. - Jiangsu Recbio has implemented new strategies to improve operational efficiency, targeting a 15% reduction in production costs by optimizing supply chain management[194]. - The company has established a robust quality management system to ensure product excellence and compliance with industry standards[199]. Corporate Governance and Management - The company has appointed new executives to strengthen its commercialization capabilities, including a Chief Quality Officer and a Chief Business Officer[14]. - Jiangsu Recbio Technology Co., Ltd. reported significant advancements in its management team, with key appointments including Chen Qingqing as CFO and vice general manager since May 9, 2021[199]. - The management team includes experienced professionals with backgrounds in major companies, enhancing the company's operational capabilities[199]. - The company has established a strong governance framework with independent directors responsible for providing unbiased judgment[173]. Strategic Acquisitions and Partnerships - Jiangsu Recbio is considering strategic acquisitions to enhance its product portfolio and market reach, with potential targets identified in the biotech sector[4]. - The company has initiated discussions for potential mergers and acquisitions to enhance its product portfolio and market reach, aiming for completion by Q4 2023[194]. - The company has established strategic partnerships with leading research institutions to enhance its technological capabilities and accelerate product development[194]. Sustainability and Social Responsibility - Jiangsu Recbio's board of directors has emphasized a commitment to sustainable practices, aiming for a 20% reduction in carbon emissions by 2025[4].

Clinical Trials and Vaccine Development - The company is conducting a Phase III clinical trial for REC603, a recombinant nine-valent HPV vaccine, with a total sample size of 16,050 participants, and expects to submit a BLA application by 2025[1]. - REC610, a new adjuvanted recombinant shingles vaccine, has received clinical trial approval in the Philippines, with the first participant enrolled on February 13, 2023[3]. - The ReCOV vaccine demonstrated superior neutralizing antibody levels against the original strain and Omicron variants compared to Pfizer's mRNA vaccine in a Phase II trial conducted in the Philippines[4]. - The company plans to submit a clinical trial application for the next-generation nine-valent HPV vaccine, REC604b, in 2023[8]. - The company is advancing early research on REC606, a recombinant vaccine for adult tuberculosis, utilizing protein engineering and new adjuvant technology[9]. - The company has obtained exclusive global development rights for REC607, a viral vector candidate vaccine for adult tuberculosis, and is currently conducting preclinical research[10]. - The ongoing Phase III clinical trial in China has a total sample size of 16,050 participants, with significant progress made in immunogenicity bridging studies and comparisons with Gardasil®9[40]. - The company is developing the recombinant human tuberculosis vaccine (REC606) using protein engineering and novel adjuvant technology platforms, aiming for improved safety and immune response[52]. - The early-stage recombinant quadrivalent influenza vaccine (REC617) is under development, focusing on enhancing tolerability, immunogenicity, and cross-protection capabilities[52]. - The company is working on a multivalent hand-foot-mouth disease vaccine (REC605) with higher coverage rates for EV71, CA16, CA10, and CA6 serotypes[53]. Financial Performance - Total other income and gains for 2022 reached RMB 147,993 thousand, a significant increase from RMB 27,810 thousand in 2021, representing a growth of 432%[13]. - The company reported a pre-tax loss of RMB (735,996) thousand for 2022, compared to a loss of RMB (657,566) thousand in 2021, indicating an increase in losses of approximately 12%[15]. - Basic and diluted loss per share for the year was RMB (1.52), slightly improved from RMB (1.56) in 2021[15]. - Total non-current assets increased to RMB 889,687 thousand in 2022, up from RMB 624,649 thousand in 2021, reflecting a growth of 42.5%[14]. - Current assets totaled RMB 1,419,920 thousand in 2022, compared to RMB 1,294,571 thousand in 2021, marking an increase of 9.7%[14]. - Current liabilities rose to RMB 328,983 thousand in 2022, up from RMB 139,293 thousand in 2021, representing an increase of 136%[14]. - The net assets of the company stood at RMB 1,653,078 thousand as of December 31, 2022, a slight decrease from RMB 1,673,296 thousand in 2021[16]. - Research and development expenses for 2022 were RMB (716,444) thousand, significantly higher than RMB (472,953) thousand in 2021, indicating an increase of 51.5%[15]. - The company reported a loss before tax of RMB (735,996,000) for the year ended December 31, 2022, compared to a loss of RMB (657,566,000) for the year ended December 31, 2021, reflecting an increase in losses of approximately 11.9%[26]. - The company incurred a loss on the sale of property, plant, and equipment amounting to RMB 55,000 for the year ended December 31, 2022, compared to RMB 19,000 in the previous year[23]. Vaccine Pipeline and Production Capacity - The peak production capacity of the HPV vaccine industrialization base will be increased to 20 million doses per year to meet the growing market demand in China and internationally[2]. - The company has developed a portfolio of 12 vaccine candidates, including three strategic products: REC603 (a recombinant HPV nine-valent vaccine in Phase III clinical trials), ReCOV (a recombinant bivalent COVID-19 vaccine in the product registration phase), and REC610 (a new adjuvant recombinant shingles vaccine in clinical research)[35]. - The production capacity for the HPV nine-valent vaccine at the new facility in Taizhou, Jiangsu Province is designed to be 20 million doses per year[35]. - The Taizhou production facility has a total construction area of approximately 17,000 square meters and has received production licenses from the Jiangsu Provincial Drug Administration and compliance statements from the EU quality authorization person[35]. - The company has established a scalable production capability for HPV virus-like particles, ensuring stable high yields for both domestic and global market demands[41]. Research and Development Initiatives - The company is developing new adjuvants for its candidate vaccines to enhance tolerability and immunogenicity[11]. - The company has established an integrated vaccine innovation engine, including novel adjuvant platforms, protein engineering platforms, and immune evaluation platforms[35]. - The company has established three advanced technology platforms for adjuvant development, protein engineering, and immunoassay, facilitating the discovery and development of subunit vaccines[54]. - The company has a dedicated internal production team that manufactures most of the candidate vaccines used in clinical trials, including the HPV vaccine pipeline[58]. - The company is committed to enhancing patient tolerance to drugs, which is a critical aspect of their clinical research[106]. Market and Competitive Position - The potential market demand for HPV vaccines in China is substantial, with an estimated 701.7 million doses needed by 2025 due to a significant number of unvaccinated women aged 9 to 45[41]. - The company holds a competitive advantage with its cost-effective domestic HPV vaccines, which captured 66.7% of the HPV bivalent vaccine market in its first year[42]. - The existing HPV vaccines in China have an age range of 9 to 45 years, which aligns with the target demographic for REC603[42]. - The company is positioned to benefit from favorable government policies aimed at accelerating the approval and adoption of domestic HPV vaccines[42]. Corporate Governance and Future Plans - The company has confirmed compliance with corporate governance codes and maintains high standards to protect shareholder interests[92]. - The board believes that having the same individual serve as both chairman and CEO will not affect the balance of power and responsibilities within the board[92]. - The company plans to utilize the net proceeds from the global offering by the end of 2023, with a total of RMB 669.714 million allocated for various purposes[95]. - The company will continuously review the usage plan of unutilized net proceeds to adapt to changing market conditions[96]. - The company is exploring strategic acquisitions to enhance its product offerings and market reach[103].

Company Overview - Jiangsu Recbio Technology Co., Ltd. was successfully listed on the Hong Kong Stock Exchange on March 31, 2022, amid extreme capital market volatility[17]. Financial Performance - The company reported a loss before tax of RMB 357,117,000 for the six months ended June 30, 2022, compared to a loss of RMB 330,302,000 in the same period of 2021[27]. - The company achieved other income and gains of RMB 78,593,000 for the six months ended June 30, 2022, significantly up from RMB 14,024,000 in the previous year[27]. - Other income and gains increased by 464% from RMB14 million for the six months ended June 30, 2021, to RMB79 million for the six months ended June 30, 2022, primarily due to foreign exchange gains of RMB66.9 million[131]. - Research and development costs rose by 73% from RMB205 million for the six months ended June 30, 2021, to RMB354 million for the six months ended June 30, 2022, driven by increased investment in clinical trials[133]. - Clinical trial expenses increased by RMB132 million from RMB47 million to RMB179 million, mainly due to enhanced investment in Phase III clinical trials of the core product REC603 and ReCOV[136]. - Administrative expenses decreased from RMB84 million to RMB77 million, primarily due to lower ESOP expenses[137]. - Finance costs decreased by 98% from RMB56 million to RMB1 million, attributed to the absence of interest from financial liabilities related to special rights of shareholders[139]. Research and Development - The company is focusing on the development of new technologies, particularly in the field of biopharmaceuticals, with an investment of approximately $50 million allocated for R&D[1]. - The company has established a comprehensive vaccine innovation engine, including a novel adjuvant platform and protein engineering platform, enhancing its R&D capabilities[30]. - The company has developed three advanced technology platforms for novel adjuvant development, protein engineering, and immunological evaluation, enhancing vaccine candidate development[92]. - The in-house R&D team consists of over 100 personnel, most holding master's or doctorate degrees in relevant fields, ensuring a strong foundation for vaccine development[104]. Product Development and Pipeline - The core product, recombinant HPV 9-valent vaccine REC603, is currently in Phase III clinical trials and is expected to submit a BLA application in 2025, aiming to be the first to market in China[19]. - The company plans to submit IND filings for its second-generation recombinant HPV vaccines in 2022 and 2023[38]. - The company anticipates submitting EUA/BLA applications for its recombinant COVID-19 vaccine in 2022[38]. - The company is developing early-stage HPV vaccines REC604a and REC604b with a novel self-developed adjuvant, aiming for IND applications in 2022 and 2023 respectively[70]. - The company is developing the REC617 recombinant influenza quadrivalent vaccine, with IND submission planned for the first half of 2023 and BLA submission expected in 2025[90]. - The company is developing the REC605 multi-valent hand-foot-and-mouth vaccine, with IND submission planned for 2023 and BLA submission for 2026[91]. Market Expansion and Strategy - Future outlook indicates a projected revenue growth of 30% for the next fiscal year, driven by new product launches and market expansion strategies[1]. - Market expansion efforts include entering three new international markets by the end of 2023, aiming to increase global market share by 15%[1]. - Jiangsu Recbio is exploring potential mergers and acquisitions to enhance its product portfolio and market presence, with a budget of $100 million earmarked for this purpose[1]. - The company aims to enhance its digital marketing strategies, targeting a 50% increase in online engagement by the end of 2023[1]. - The company aims to accelerate the commercialization of its products globally through continuous innovation and international collaboration[25]. Manufacturing and Production Capacity - The HPV vaccine manufacturing facility in Taizhou is designed to produce 5 million doses of HPV 9-valent vaccines or 30 million doses of HPV bivalent vaccines annually, with potential expansion to over 10 million doses[33]. - The GMP-standard manufacturing facility for ReCOV has an annual manufacturing capacity of 300 million doses, which can also be utilized for recombinant shingles vaccines[33]. - The ReCOV production facility in Taizhou has a total construction area of approximately 17,000 square meters, potentially supporting an annual production capacity of 300 million doses of ReCOV[113]. Sustainability and Corporate Responsibility - Jiangsu Recbio is committed to sustainability, with plans to reduce carbon emissions by 25% over the next five years[1]. Employee and Management - The total number of employees increased to 478, bolstering the company's talent base for efficient commercialization of vaccine candidates[24]. - The management team includes industry experts with over 20 years of experience, enhancing product competitiveness and quality management[112]. Financial Position and Liquidity - The company has a capital reserve of approximately RMB 1.5 billion as of June 30, 2022, providing financial security and flexibility for future operations[24]. - The company's cash and bank balances increased from RMB1,183 million as of December 31, 2021, to RMB1,297 million as of June 30, 2022, primarily due to proceeds from the issuance of shares[152][154]. - Cash and cash equivalents were deposited in high-quality banks, indicating low credit risk exposure as of June 30, 2022[182]. - The company aims to maintain a sufficient level of cash and cash equivalents to meet liquidity requirements and mitigate cash flow fluctuations[186]. Shareholding Structure - Taizhou Yuangong Technology holds 17.16% of the company's shares, while Beijing Junlian Shengyuan holds 5.87%[192]. - The company has a total of 82,863,620 domestic shares held by Taizhou Yuangong Technology, representing 21.28% of the relevant class of shares[192].

Vaccine Development and Clinical Trials - In 2021, Recbio completed the Phase I clinical trial of ReCOV (recombinant protein COVID-19 vaccine) in New Zealand and continued with Phase II/III trials in multiple countries, indicating strong prospects for a world-class universal vaccine [17]. - The Phase III clinical trial of REC603 (a 9-valent HPV vaccine) was successfully launched, maintaining the leading position among similar domestic products [17]. - The company is progressing with pilot production and preclinical studies for REC610 (a recombinant shingles vaccine) and R520A (a COVID-19 mRNA vaccine) as well as research on adult tuberculosis and multi-valent HFMD vaccines [17]. - The core product, REC603, a recombinant HPV 9-valent vaccine candidate, is currently undergoing phase III clinical trials in China, with a BLA application expected to be submitted in 2025 [45]. - The company plans to submit BLA applications for various vaccine candidates, including the recombinant shingles vaccine and the recombinant adult TB vaccine, between 2024 and 2026 [45]. - The company is expected to submit IND filings for several vaccine candidates in 2022, including the second-generation recombinant HPV quadrivalent vaccine and the mRNA COVID-19 vaccine [45]. - The Phase II/III clinical trial for ReCOV has been approved in the Philippines and the UAE, with subject enrollment completed [89]. - The company is developing ReCOV, a recombinant COVID-19 vaccine candidate, and has initiated a phase I clinical trial in New Zealand, with plans to file for EUA/BLA application in 2022 [145]. Research and Development Capabilities - Recbio's protein engineering and immunological evaluation platforms are integral to the design and evaluation of new-generation vaccines [18]. - The company has established a comprehensive vaccine innovation engine, including a novel adjuvant platform, protein engineering platform, and immunological evaluation platform [35]. - The company has developed three advanced technology platforms for novel adjuvant development, protein engineering, and immunological evaluation to enhance vaccine development capabilities [108]. - The immunological evaluation platform allows for the selection of optimal antigen and adjuvant combinations, improving the immunogenicity profile of vaccine candidates [119][121]. - The company has established an IPD system to advance multiple vaccine candidates simultaneously, enhancing its research and development capabilities [38]. Financial Performance and Funding - The company successfully raised RMB200 million in Series B+ financing and RMB965 million in Series C financing in 2021 [24]. - The company reported a loss before tax of RMB657,566,000 for the year ended December 31, 2021, compared to a loss of RMB179,400,000 in 2020 [30]. - Other income and gains increased by 191.2% from RMB 9.6 million in 2020 to RMB 27.8 million in 2021, driven by increased bank interest income and government grants [153]. - Research and development costs surged by 262.4% from RMB 130.5 million in 2020 to RMB 473.0 million in 2021, primarily due to increased clinical trial expenses and staff costs [157]. - The total interest-bearing bank borrowings were RMB 50 million as of December 31, 2021, with a maturity date in 2028 and an effective interest rate of 4.65% [192]. Manufacturing and Production Capacity - In 2021, the company completed the construction of a recombinant COVID-19 vaccine production base with an annual peak manufacturing capacity of 300 million doses [22]. - The company has established a GMP-standard production base for ReCOV in Taizhou, Jiangsu, with a total building area of approximately 17,000 square meters, potentially supporting an annual production capacity of 300 million doses [134]. - The first phase of the HPV vaccine manufacturing facility has a designed capacity of 5 million doses of HPV 9-valent vaccines or 30 million doses of HPV bivalent vaccines per year, expected to be completed by the end of 2022 [36]. - The HPV vaccine manufacturing facility in Taizhou is designed to produce five million doses of HPV 9-valent vaccines or 30 million doses of HPV bivalent vaccines annually, with the first phase expected to be completed by the end of 2022 [132]. Market Position and Strategy - The company was selected into the "Global Unicorn Index 2021" released by the Hurun Research Institute, highlighting its strong market position [24]. - The company aims to focus on novel vaccines for major diseases and strengthen innovation and R&D capabilities in the global vaccine industry in 2022 [25]. - The company aims to expand its vaccine pipeline strategically to cover five of the ten diseases with the highest burden identified by the WHO in 2019 [38]. - The HPV vaccine market in China is expected to remain significantly underserved, with similar infection rates observed in males and females [64][66]. Human Resources and Organizational Growth - The number of employees increased from 125 at the beginning of 2021 to 421 by the end of the year, reflecting a significant expansion in human resources [23]. - The R&D team consists of over 100 personnel, most holding master's or doctorate degrees in relevant fields, ensuring a strong foundation for vaccine development [120][122]. Intellectual Property and Compliance - The company has registered 10 invention patents and filed 31 patent applications, including 29 Chinese patent applications and 2 PCT applications, as of the latest practicable date [138]. - The company has not been involved in any intellectual property infringement proceedings as of December 31, 2021 [140]. - The company employs strict procedures to ensure that contract manufacturers meet regulatory requirements, with all contract manufacturers certified by GMP [135]. Operational Resilience - The company has not experienced material disruptions in operations due to the COVID-19 pandemic, with clinical activities and development timelines remaining on track [145]. - As of December 31, 2021, there were no material adverse effects on business operations or financial position due to economic conditions in China [148].