By Fineline Cube 
Everest Medicines Limited (HKG: 1952) announced today that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its universal, off‑the‑shelf therapeutic oncology vaccine EVM14 for Injection. The IND clearance follows the U.S. Food and Drug Administration (FDA) approval of the same clinical trial in March 2025, positioning EVM14 for accelerated global development.
Product Profile
- EVM14 – a next‑generation, mRNA‑based therapeutic vaccine developed on Everest’s proprietary platform.
- Universal Design – targets five tumor‑associated antigens (TAAs), enabling broad applicability across multiple squamous malignancies.
- Indications – designed for treatment of squamous cell carcinomas, specifically squamous non‑small cell lung cancer (sq‑NSCLC) and head‑and‑neck squamous cell carcinoma (HNSCC).
Development Milestones
| Milestone | Date | Impact |
|---|---|---|
| FDA IND Approval | March 2025 | Validated global safety and efficacy profile; opened U.S. clinical pathway. |
| NMPA IND Approval | October 13 2025 | Enables launch of Phase 1/2 trials in China; expands patient access. |
| Platform Validation | 2024‑2025 | Demonstrated robust immunogenicity against all five TAAs in pre‑clinical models. |
Strategic Significance
- First‑in‑Class Therapeutic Vaccine – EVM14 represents the first universal, off‑the‑shelf mRNA vaccine targeting multiple TAAs in squamous cancers.
- Market Potential – With an estimated $20 billion+ global market for squamous NSCLC and HNSCC, EVM14 could capture a significant share of unmet therapeutic needs.
- Accelerated Pathway – Dual FDA and NMPA approvals accelerate the path toward global Phase 3 studies, positioning Everest for a leadership role in the oncology vaccine arena.
About Everest Medicines
Everest Medicines Limited is a Hong Kong‑listed (HKG: 1952) biotechnology company focused on the discovery, development, and commercialization of innovative mRNA therapeutics. The company’s platform enables rapid, scalable vaccine development for cancer and infectious diseases.-Fineline Info & Tech