China Approves Walvax's Third mRNA COVID-19 Vaccine Targeting Omicron JN.1
核心洞察
China's NMPA approved a COVID-19 (搜索) mRNA vaccine from Yuxi Watson Biotechnology (搜索), a wholly-owned Walvax Biotechnology (搜索) subsidiary, for adults aged 18 and above.
The vaccine targets the Omicron JN.1 strain and is Walvax's third successive mRNA COVID-19 (搜索) iteration built on its proprietary mRNA platform.
Each 0.15 mL dose contains 30 micrograms of JN.1 spike-encoding mRNA in a lipid nanoparticle delivery system, with design and process unchanged from prior generations.
China's National Medical Products Administration (搜索) has approved a COVID-19 (搜索) mRNA vaccine developed by Yuxi Watson Biotechnology (搜索) Co., Ltd., a wholly-owned subsidiary of Yunnan-based Walvax Biotechnology (搜索) Co., Ltd. (SZSE: 300142), for prevention of COVID-19 in adults aged 18 years and above. The product carries National Drug Approval Number S20260070 and targets the Omicron JN.1 strain, making it the third successive mRNA COVID-19 vaccine iteration developed on Walvax's proprietary mRNA platform.
The approved vaccine is given as a 0.15 mL injection containing 30 µg of mRNA encoding the SARS-CoV-2 Omicron JN.1 spike (S) protein, formulated in a lipid nanoparticle delivery system. Its mRNA molecular design, manufacturing process and formulation are unchanged from the two prior generations, the S protein chimera vaccine and the Omicron XBB.1.5 variant vaccine, apart from the antigen-encoding mRNA sequence. The LNP-formulated mRNA directs host cells to produce the JN.1 S protein antigen, stimulating neutralizing antibody and T cell responses without introducing live virus. Walvax said the platform's modularity, swapping only the antigen-encoding sequence while retaining the same architecture, process and quality system, allows future strain updates based on WHO or Chinese public-health recommendations.
The approval adds a domestically developed mRNA option to China's COVID-19 (搜索) vaccine landscape, which has historically been dominated by inactivated and recombinant protein vaccines. Walvax reported that global mRNA COVID-19 vaccine sales exceeded USD 6 billion in 2025. Beyond COVID-19, the company said its mRNA platform has produced clinical trial approvals for a respiratory syncytial virus mRNA vaccine and a freeze-dried herpes zoster mRNA vaccine, while therapeutic programs including tumor vaccines and in vivo CAR-T remain preclinical. Walvax said the approval is not expected to have a material impact on its financial performance in the current year.
Source: allsci.com