Walvax Biotechnology's RSV mRNA vaccine gets clinical trial approval

Walvax Biotechnology, alongside Fudan University, Shanghai BlueMag Biopharmaceuticals, and its subsidiaries, announced that its jointly developed respiratory syncytial virus (RSV) mRNA vaccine has received Clinical Trial Approval Notices from China's National Medical Products Administration. The approval allows for clinical trials of the preventative biological product against RSV-induced lower respiratory tract disease. The company has three years from the approval date to enroll the first subject, after which the approval will lapse.

The vaccine, developed on an independently established mRNA platform, aims to stimulate an immune response to prevent RSV infections. Its design incorporates highly conserved sequences of the F protein from prevalent Chinese RSV-A strains over the past decade, with proprietary mutations to stabilize the pre-fusion trimeric F protein conformation.

Globally, three RSV vaccines are already on the market, including GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mRESVIA. As of the 2023-2024 period, global RSV vaccine sales were approximately $4 bn, while no RSV vaccines have yet been approved for market in China. The company noted that this clinical trial approval would not significantly impact its current year's financial performance.