Everest Medicines (HKEX 1952.HK), a China-based biopharmaceutical company, announced on Sunday that it has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for EVM14, a Tumour-Associated Antigen (TAA) vaccine.

EVM14 is the company's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, which is claimed to mark a significant milestone in its efforts to develop innovative mRNA therapeutics in oncology.

EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens.

Rogers Yongqing Luo, Everest Medicines chief executive officer, said: "With FDA IND approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our 'dual-engine' strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation. Through our clinically validated and fully-integrated mRNA platform, we have realised synergies with our 'AI-powered' pipeline, underscoring Everest's leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalised cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China's mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilised its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimisation. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modelling."