On May 29th, the Phase II clinical trial of the freeze-dried respiratory syncytial virus vaccine (code: NR222) independently developed by Namixin Biotechnology was officially launched in Guilin, Guangxi. NR222 is the first domestically approved clinical freeze-dried mRNA RSV vaccine. This experiment is hosted by the Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, and the experimental site is located at the Guilin Center for Disease Control and Prevention. The launch ceremony was presided over by Mo Yi, Director of the Vaccine Clinical Research Institute of Guangxi Center for Disease Control and Prevention and Project PI. Dr. Qian Zhikang, co-founder and Chief Scientific Officer of Namixin Biotechnology, delivered a speech. Shi Chaohui, Director of Guilin Center for Disease Control and Prevention, and Mo Zhaojun, General Manager of Shanghai Stenm Pharmaceutical, respectively delivered important speeches.

NR222 is developed based on the LNP mRNA platform and AI assisted sequence optimization platform technology independently owned by Namixin Biotechnology, and enhances the immunogenicity and structural stability of preF antigen through unique amino acid sequence design. The vaccine development adopts freeze-drying technology, effectively solving the problems of poor thermal stability and the need for low-temperature/ultra-low temperature storage and transportation of mRNA vaccine water injection type. It is expected to be stably stored at 2-8 ℃ for ≥ 36 months, greatly improving product accessibility. Preclinical trial data shows that NR222 exhibits high antibody levels in mouse immunogenicity tests, and the antibody levels of subtype A and subtype B are comparable, demonstrating strong potential for cross neutralization protection. In the cotton mouse virus challenge test, it was further confirmed that this variety can induce high valent A and B neutralizing antibodies, with good virus protection effect and no vaccine induced disease enhancement effect. In head to head non clinical studies with already marketed recombinant protein vaccines, it has shown superior virus suppression effects. The Phase I clinical trial (clinical trial registration number CTR20251101) showed no serious adverse events or particularly concerning adverse events related to the vaccine 30 days after immunization, and overall safety was good. Immunogenicity data shows that humoral and cellular immunity exhibit strong immunogenicity at 14 and 30 days after immunization, supporting further phase II clinical trials.

RSV is a common respiratory infection pathogen with high infectivity and widespread prevalence worldwide. RSV infection is an important factor causing respiratory death in infants, young children, and the elderly. At the same time, people who have been infected with RSV still have the possibility of reinfection with RSV. At present, clinical specific treatment methods are relatively limited, and vaccination is the key to prevention and control. There is currently no effective RSV vaccine approved for market in China. This Phase II clinical trial will recruit 375 healthy subjects, using a randomized, blinded, placebo-controlled design. On site training will be provided by Han Yanbin, Chief Physician of the Autonomous Region Center for Disease Control and Prevention, Mo Yi, Principal Investigator, Chen Junji, Research Coordinator, and Feng Zhengli, Quality Control Team, on clinical research quality management standards, clinical trial protocol design, implementation protocol requirements, and quality control to ensure that this project strictly follows GCP standards and clinical trial protocol execution.

Founded in May 2021, Namixin Biotechnology is an innovative biotechnology enterprise dedicated to the research and development of new vaccines and drugs in the mRNA field. Throughout its history, the company has adhered to the research and development philosophy of "AI driven, source innovation", focusing on disease areas with clear unmet clinical needs, and committed to building an mRNA technology platform with sustained innovation capabilities.

About Namixin

In April 2026, Chengdu Kanghua Biological Products Co., Ltd. (stock code: 300841. SZ) announced that it would acquire 100% control of Namixin Biotechnology through installment subscription of newly added registered capital and equity transfer. Subsequently, as the Shanghai R&D center of Kanghua Biotechnology, Namixin Biotechnology will operate and upgrade its vaccine innovation strategy through the collaboration between Sichuan and Shanghai.