Walvax Biotech Wins NMPA Approval for mRNA and Recombinant COVID-19 Vaccines

China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has received clinical trial approvals from the National Medical Products Administration (NMPA) for two novel coronavirus vaccines: an mRNA vaccine co-developed with Fudan University and Shanghai RNACure Biopharma, and a recombinant vaccine developed in-house by its subsidiary Shanghai Zerun Biotech.

Vaccine Details

  • mRNA Vaccine (S Protein Chimera):
    • Designed for 2019-nCoV variants, encoding a full-length S protein chimera.
    • Developed via partnership with Fudan and RNACure, covering major immune escape mutations.
    • Preclinical data show safety, efficacy, and cross-neutralization against VOCs like Omicron.
  • Recombinant Vaccine (CHO Cells):
    • Based on the prototype vaccine, with cross-neutralization ability against Omicron.
    • Received clinical approval in Mali in February 2022.

Strategic Outlook
Walvax’s mRNA vaccine leverages a broad-spectrum platform targeting emerging variants, while the recombinant vaccine expands its global pipeline. The NMPA approvals mark progress in China’s efforts to combat COVID-19 evolution.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry