Everest Medicines Secures NMPA Approval for EVM14 Tumor-Associated Antigen Cancer Vaccine
Tuesday, October 14, 2025
Everest Medicines, a biopharmaceutical company focused on innovative therapeutics, has received approval from China’s National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) cancer vaccine. This approval marks a significant milestone in the company’s development of therapeutic mRNA cancer vaccines. EVM14 is now the company’s first internally developed mRNA cancer vaccine to receive IND approvals from both China’s NMPA and the U.S. Food and Drug Administration (FDA).
EVM14 is an off-the-shelf therapeutic mRNA vaccine formulated with mRNA encoding five TAAs. It is designed to treat a range of squamous cell carcinomas, including squamous non-small cell lung cancer (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC). The vaccine previously received IND clearance from the FDA in March 2025.
The vaccine’s design allows it to induce immune memory and potentially prevent tumour recurrence. Preclinical studies have shown dose-dependent antigen-specific immune responses, significant tumour growth inhibition in multiple models, and enhanced efficacy when combined with immune checkpoint inhibitors.
The approval from the NMPA is expected to accelerate clinical development in both China and the U.S., with ongoing global multicentre trials generating data to support potential future indication expansion. The Phase I trial will primarily evaluate safety and tolerability, while secondary endpoints will assess preliminary efficacy. A broad expression profile of the five target genes has been observed in 96% of sq-NSCLC and 97% of HNSCC patients, highlighting an unmet medical need in these populations.
EVM14 is manufactured at Everest’s Jiashan facility, with the first GMP clinical trial batch released in June 2025. Clinical trials will be conducted at multiple centres including NEXT Oncology Virginia, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center in the U.S., and Shanghai Chest Hospital in China.
The vaccine is administered via intramuscular injection as a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) formulation. After administration, the mRNA is taken up by antigen-presenting cells, translated into target antigens, and presented to T cells. Activated T cells then migrate to tumour tissue to recognise and eliminate cells expressing the target antigens.
This approval strengthens Everest Medicines’ leadership in therapeutic cancer vaccines and supports the advancement of novel immuno-oncology therapies for multiple tumour types.
Source: prnewswire.com
