August 11, 2025 - NEUREGEN Biotech (NEUREGEN) announced FDA Investigational New Drug (IND) approval for its pioneering NRG-103 injection – the world's first in situ transdifferentiation-based gene therapy for glioblastoma (GBM). This milestone accelerates the development of a potential paradigm-shifting treatment for one of oncology's most aggressive cancers.
InnoStar: Delivering the Non-Clinical Foundation for Success
As NEUREGEN's trusted Non-clinical CRO partner, InnoStar provided end-to-end analytical and safety support critical to this IND approval. Our comprehensive service package included:
- Specialized Intracranial Dosing Studies: Utilizing proprietary techniques for precise CNS delivery in GLP models.
- Regulatory-Grade Study Execution: Full compliance with NMPA, FDA & ICH guidelines within our dual-certified (NMPA/FDA) GLP facilities.
- Global Submission Support: Integrated data packaging for FDA IND application.
InnoStar congratulates NEUREGEN on this historic achievement. We are honored to be the non-clinical engine powering revolutionary therapies from lab to clinic.
