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].