Walvax Unit Receives China Approval for Third-Generation COVID-19 mRNA Vaccine

On the evening of September 10, 2026, Walvax Biotechnology announced that its wholly owned subsidiary, Yuxi Walvax Biotechnology Co. , Ltd. , received on that day a Drug Registration Certificate issued by the National Medical Products Administration for a COVID-19 mRNA vaccine. The vaccine is the company's third-generation COVID-19 mRNA vaccine, developed iteratively under its mRNA platform technology strategy, with an antigen sequence designed based on the spike protein of the Omicron JN. 1 strain. It is intended for people aged 18 and above to prevent disease caused by SARS-CoV-2 infection.

The company previously developed a first-generation vaccine, a COVID-19 variant vaccine (spike protein chimera), and a second-generation iterative vaccine, a COVID-19 variant vaccine (Omicron XBB. 1.5), which together validated the mRNA platform technology. Following the issuance of the Drug Registration Certificate for this vaccine, research and development and drug registration work related to the first- and second-generation COVID-19 mRNA vaccines has ended concurrently. The research project was listed as a key supported project by the Ministry of Science and Technology, the National Development and Reform Commission, and the Yunnan Provincial Department of Science and Technology, among others. The announcement cited data showing that global sales of mRNA COVID-19 vaccines exceeded 6 billion US dollars in 2025.

Walvax Biotechnology is a high-tech enterprise engaged in the research, development, production, and sale of human vaccines and other biotechnology products. It is the first company in China and the second globally to independently develop and successfully launch a 13-valent pneumococcal conjugate vaccine, and the second in China and the fourth globally to independently develop and successfully launch an HPV vaccine. The company currently has eight proprietary vaccine products in 14 specifications on the market, with products exported to 28 countries and regions.

Its 2026 interim report showed first-half operating revenue of RMB 834 million, down 27.72% year on year; net profit attributable to shareholders of the listed company of RMB 54.1922 million, up 25.56% year on year; and net profit after deducting non-recurring gains and losses of RMB 94.9448 million, up 233.81% year on year. The company disclosed that the revenue decline was mainly due to a change in the biological products tax rate from 3% to 13% under the new value-added tax law, as well as lower domestic vaccine product revenue. In the first half, vaccine product sales revenue was RMB 816 million, accounting for 97.84% of total operating revenue; overseas business revenue was approximately RMB 243 million, up 13.64% year on year. Since the start of 2026, Walvax Biotechnology's share price began the year at around RMB 11 and had risen by about 20% cumulatively as of September 10. On August 20, the stock hit the daily limit, rising 20% in a single day, and continued to rise the next day, touching a year-to-date high of RMB 16.97. On September 10, 2026, the share price was RMB 13.00, giving a market capitalisation of RMB 20.792 billion.