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].
瑞科生物(02179) - 2024 - 年度财报