August 11, 2025-Neuregen Therapeutics (Neuregen) announced that its in-house designed innovative NRG-103 injection, the world's first therapeutic product based on in situ trans-differentiation technology for glioblastoma, has recently received the Investigational New Drug (IND) Clearance from the U.S. Food and Drug Administration (FDA).

Glioblastoma is the most common and most aggressive primary brain tumor, characterized by highly aggressive growth and significant genetic heterogeneity, which makes it difficult to treat clinically. Almost 100% of cases recur, leading to extremely low long-term survival rates. Current treatment options remain limited, highlighting an urgent need for the development of new therapies.

NRG-103 injection is a groundbreaking innovative therapy targeting glioblastoma developed by Neuregen based on its globally leading in situ trans-differentiation technology platform. To address the biological complexity and current treatment limitations of glioblastoma, NRG-103 injection employs a dual mechanism design of ' in situ trans-differentiation with oncolytic virus as vector and immunotherapy'. The specially disigned oncolytic viruse vectors selectively multiply in and kill most of the tumor cells while bring in the genes of in situ trans-differentiation factors, which then converts the residual tumor cells into non-proliferative cells through in situ trans-differentiation, fundamentally addressing issues of tumor escape and recurrence. This cutting-edge in situ trans-differentiation technology was recognized with a national Disruptive Award in 2024.

In April 2025, NRG-103 injection received FDA Orphan Drug Designation. And before that, NRG-103’s preclinical data was presented at AACR 2024 poster exhibition, and an ongoing investigator-initiated clinical trail (IIT) of NRG-103 injection in China has demonstrated encouraging safety and efficacy signals, laying a solid foundation for the upcoming formal clinical trials. Now as globally the first in situ trans-differentiation therapy for glioblastoma  that received the FDA IND Clearance, it marks a significant milestone for this rising and revolutionary technology. It highlights Neuregen's technological and innovative product development prowess, and establishes the company's leading position in this promising field.