On September 10, 2026, Walvax Biotechnology announced that its wholly-owned subsidiary, Yuxi Walvax, had received the Drug Registration Certificate for its "COVID-19 mRNA Vaccine" issued by the National Medical Products Administration (NMPA). The vaccine was jointly developed by Fudan University, RNACure, Guangzhou Laboratory and Walvax Biotechnology, making it the first mRNA vaccine in China to be approved for marketing through iterative development on an mRNA platform technology strategy.
This approval marks a new stage in the industrialization of mRNA technology in China, and represents an important milestone in RNACure's continued advancement of core technology innovation and the translation of research achievements into products.
Collaborative Innovation: Translating Research into Vaccine Products
As an enterprise supported by Fudan University for the translation of mRNA vaccine technologies, RNACure plays an important role in connecting scientific innovation with industrial application.
Since 2021, with the support of the Ministry of Science and Technology, the National Health Commission, the National Development and Reform Commission, relevant Shanghai municipal authorities and Fudan University, RNACure has worked closely with research teams and industrial partners to advance vaccine R&D and technology iteration, jointly driving the translation of research results into vaccine products.
From early-stage research and process development to clinical advancement and industrial translation, bringing an innovative vaccine to market requires continuous alignment across many stages. By combining scientific exploration with engineering development, RNACure has continuously accumulated experience in underlying technologies, processes and quality management during joint development, providing support for product development and building reusable platform capabilities for its subsequent pipeline.
This approval is the shared achievement of long-term collaboration and sustained effort by all parties, and reflects the value of industry-academia-research collaboration in bringing innovative results to market.
Deepening Underlying Technologies to Build a Full-Chain mRNA Platform
Since its founding, RNACure has continued to cultivate core underlying mRNA technologies. Centered on three technology directions — mRNA molecular engineering, delivery systems and immune regulation — the company has established a portfolio of more than one hundred core intellectual property assets, and has independently built full-chain mRNA platform capabilities covering drug discovery, process development, quality control, clinical development and large-scale manufacturing. The company's Baoshan pilot production base has also established a standardized, scalable and customizable chemistry, manufacturing and controls (CMC) platform, providing end-to-end support for process optimization, production scale-up and clinical sample manufacturing of mRNA drugs.
(RNACure Baoshan Pilot Production Base)
At the same time, RNACure is actively exploring deep integration of AI technologies with RNA drug R&D to continuously improve drug design, delivery optimization and R&D efficiency. The company has developed proprietary novel delivery systems and a personalized neoantigen algorithm system, and is advancing the construction of an mRNA drug R&D and clinical application system driven by the twin engines of AI and automation.
Building on these capabilities, RNACure's R&D and application exploration has expanded beyond infectious disease vaccines into oncology, personalized therapy, cell therapy, anti-aging and rare diseases, laying the foundation for extending mRNA technology to more disease scenarios.
Taking Approval as a New Starting Point to Expand mRNA Applications
The successful approval of this COVID-19 mRNA vaccine has accumulated important experience for RNACure's subsequent product development and provides a new starting point for the continued expansion of its platform capabilities.
At present, the company's respiratory syncytial virus (RSV) mRNA vaccine and freeze-dried herpes zoster mRNA vaccine have obtained clinical trial approvals; its personalized cancer vaccine (PCV) has entered investigator-initiated trials (IIT); and multiple programs, including in vivo CAR-T and a hepatitis B virus (HBV) therapeutic vaccine, have entered the development preparation stage supporting clinical trial applications or study initiation (IND/IIT-enabling).
From preventive vaccines to therapeutic drugs, and from universal products to personalized regimens, RNACure is leveraging reusable and iterable underlying technologies to continue exploring the potential of the mRNA platform across different application scenarios.
Looking ahead, RNACure will continue to deepen its core underlying mRNA technologies, continuously improve its technology platform system, strengthen the deep integration of AI, automation and intelligent manufacturing in innovative drug R&D, keep expanding the application scenarios of RNA technology in disease prevention and treatment, and strive to build an mRNA innovative drug platform company with global influence.
