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Congratulations | NeoCura’s IND Application for Personalized Neoantigen mRNA Cancer Vaccine Approved


On March 10, 2025, NeoCura announced that its Investigational New Drug (IND) application for XH001, a personalized neoantigen mRNA cancer vaccine independently developed by the company, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

Preclinical studies have demonstrated that the XH001 vaccine significantly enhances tumor-specific T-cell immune responses by integrating high-throughput sequencing with AI-driven algorithms to identify highly immunogenic neoantigens. This marks the first IND acceptance in China for a personalized neoantigen vaccine developed using AI technology, signifying a new era of precision and intelligent tumor immunotherapy in the country.

Levostar Biotech has been deeply engaged in the field of mRNA technology, dedicated to providing comprehensive end-to-end solutions from research and development to manufacturing for industry partners. As a key partner of NeoCura,Levostar played a crucial role in the development and submission of the XH001 vaccine, particularly in the characterization and analysis of the mRNA formulation.

We sincerely congratulate NeoCura on this milestone achievement and look forward to deepening our collaboration to drive the "accessibility revolution" in tumor immunotherapy, bringing more efficient and affordable innovative treatments to patients worldwide!

About NeoCura

NeoCura is a high-tech enterprise focused on RNA-based innovative drug development, leveraging AI technology. The company has established a multi-omics big data collection platform and a comprehensive biological omics database, utilizing AI and bioinformatics for in-depth drug target discovery and fully automated drug design. Additionally, NeoCura has built a leading RNA drug manufacturing center in China to support its pipeline development and clinical needs.