mRNA Vaccine Progress Review (January–March)

As an emerging force in the field of vaccines, mRNA vaccines have garnered significant attention since their inception due to their unique mechanism of action and numerous advantages. From shining during the COVID-19 pandemic to ongoing exploration in the prevention and treatment of various diseases, their development progress remains a focal point in the pharmaceutical world. Between January and March 2025, the mRNA vaccine field made steady advancements, achieving key breakthroughs across several projects.

iNeST by BioNTech and Roche

On January 6, the top-tier medical journal Nature Medicine published the Phase I clinical research progress of the personalized mRNA neoantigen vaccine Autogene Cevumeran (iNeST), co-developed by BioNTech and Roche. This vaccine activates patient-specific T-cell immune responses and demonstrated significant safety and preliminary anti-tumor activity in treating advanced solid tumors. With a poor prognosis and limited traditional treatments, this progress opens new avenues for cancer immunotherapy. Future research will focus on expanding sample sizes and optimizing combination therapies to further validate its clinical value.

Abogen Biosciences' VZV mRNA Vaccine

On January 24, Abogen Biosciences' IND application for its varicella-zoster virus (VZV) mRNA vaccine (AFN1204 injection) was accepted by the CDE. It is intended to prevent herpes zoster caused by VZV infection. Herpes zoster is triggered by reactivation of latent VZV and characterized by clusters of vesicles along unilateral peripheral nerves, often accompanied by severe neuralgia. This mRNA vaccine aims to induce a specific immune response against VZV and could become a powerful new tool for prevention.

Walvax Biotechnology's HSV-2 mRNA Vaccine

Also on January 24, Walvax Biotechnology announced via investor platform that its clinical trial application for an HSV-2 (Herpes Simplex Virus Type 2) mRNA vaccine was approved. HSV-2 primarily causes genital herpes, a common sexually transmitted disease with high recurrence and no cure. With mRNA technology, Walvax aims to develop a vaccine that can prevent infection and reduce recurrence risk — a significant step forward in this vaccine field domestically.

Lican Biotech’s Tumor Neoantigen mRNA Vaccine

In early February, Lican Biotech's LK101 injection, a tumor neoantigen mRNA vaccine, received IND approval from the U.S. FDA. This marks the first Chinese-developed mRNA cancer vaccine to go overseas. It uses AI algorithms to predict tumor neoantigens and completes target screening within 48 hours. Phase I trials have shown significant anti-tumor activity.

CSPC’s Herpes Zoster mRNA Vaccine

On February 6, CSPC's subsidiary, Jushi Biotech, received approval from the CDE to conduct clinical trials for SYS6017 (Herpes Zoster mRNA Vaccine), making it the fourth such vaccine approved for trials in China. CSPC's past experience in COVID-19 mRNA vaccine development lends credibility to this endeavor, potentially offering more options to patients and enriching the domestic mRNA vaccine pipeline.

China’s First mRNA Flu Vaccine

On February 21, China’s first mRNA flu vaccine was officially approved by the NMPA for Phase I clinical trials. Targeting the H3N2 strain, its production cycle is only two months — significantly shorter than traditional flu vaccines. Preclinical trials showed an 85% immune response rate against H3N2, and the first batch of 300 volunteers has completed vaccination. If clinical trials go well, it could greatly enhance flu prevention efforts.

Everest Medicines’ mRNA Cancer Vaccine EVM16

On March 6, Everest Medicines announced that the first patient was dosed at Peking University Cancer Hospital in the clinical trial of EVM16, its novel mRNA personalized cancer vaccine. Powered by AI to identify tumor neoantigens, the EVM16CX01 trial aims to evaluate its safety, tolerability, immunogenicity, and preliminary efficacy in patients with advanced or recurrent solid tumors. Personalized cancer vaccines represent a cutting-edge direction in oncology, and this move brings new hope for patients.

Moderna’s First mRNA Cancer Vaccine Expected by 2027

On March 5, Moderna announced at an investor conference that it aims to launch the world’s first mRNA cancer vaccine by 2027. Used in combination with checkpoint inhibitors, the vaccine reduced recurrence or death risk by 44% in a Phase II trial for melanoma (when combined with Keytruda). Three Phase III trials are underway, covering melanoma, non-small cell lung cancer, and squamous cell carcinoma. Moderna’s strong foundation in mRNA tech and its COVID-19 success position it well for this breakthrough.

China’s First Novel Tuberculosis mRNA Vaccine

On March 24, China's first self-developed novel tuberculosis mRNA vaccine began clinical trials, with the first subject vaccinated at Beijing Chest Hospital. This marks a major breakthrough in infectious disease prevention using mRNA. Animal studies showed the vaccine’s protective effect is over 20 times greater than both traditional BCG and the well-known M72 subunit vaccine, indicating great potential.

From infectious disease prevention like flu and herpes zoster to cancer treatment, mRNA vaccine progress in the first quarter of 2025 showcases robust and promising development across the board.