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].
瑞科生物(02179) - 2021 - 年度财报