ReCOV – Recombinant Bicomponent COVID-19 Vaccine

ReCOV is a recombinant COVID-19 vaccine developed by the Company comprehensively using its core technology platforms, including its novel adjuvant, protein engineering and immunological evaluation platforms, and the adjuvant used therein is its self-developed novel adjuvant BFA03. Since it obtained the first clinical trial approval in April 2021, the Company has conducted multiple clinical trials in countries including New Zealand, the Philippines, the UAE, China, Russia and Nepal, achieving several complete clinical research results. ReCOV was granted the emergency use authorization in Mongolia in 2023. Currently, there is no ongoing clinical trial for this project worldwide. Given the relatively low global demand for COVID-19 vaccines at present, continuing to advance the subsequent registration and commercialization of this project may not yield favorable economic and social benefits. The Company will no longer make new rounds of clinical development for COVID-19 vaccine projects developed against the existing strains, but will reasonably allocate resources based on the future development plans for respiratory combination vaccines, the market, policy environment and other factors. As there are adjustments in the business plans for COVID-19 vaccine projects, upon in-depth analysis and prudent consideration, the Company decides to deregister its subsidiary, Wuhan Recogen, which was established to conduct the R&D of mRNA COVID-19 vaccine. At the same time, the Company will continuously pay attention to and keep track of the mRNA vaccine technology.

During the Reporting Period, the Company established a complete and systematic quality system for large-scale commercial production of vaccines at its vaccine manufacturing facility in Taizhou City, Jiangsu Province based on the COVID-19 vaccine project. The factory meets both Chinese and European Union (EU) GMP standards and has obtained a Chinese vaccine production license.It has consistently received the EU Qualified Person Declaration issued by a Qualified Person (QP) for several years. The factory has a track record of successful large-scale batch production, which is of great value in advancing the subsequent development and industrialization of the Company’s recombinant shingles vaccine REC610 and bivalent recombinant respiratory syncytial virus vaccine REC625.