By Fineline Cube 
China‑based Northeast Pharmaceutical Group Co., Ltd. (SHE: 000597) has announced that its chimeric antigen receptor T‑cell therapy, DCTY0801 Injection, has received clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for patients with recurrent or progressive high‑grade brain gliomas expressing the EGFRvIII mutant antigen.
Targeted CAR‑T Platform
DCTY0801 Injection is engineered to recognize the EGFRvIII mutation, a tumor‑specific antigen absent from normal tissues. Approximately 30 % of glioblastoma cases harbor this mutation, yet therapeutic options targeting EGFRvIII in brain gliomas remain scarce. By delivering a CAR‑T construct that homes in on EGFRvIII, Northeast Pharma aims to provide a novel treatment avenue for this aggressive malignancy.
Regulatory Milestones and Future Outlook
The NMPA’s approval to conduct trials marks a significant regulatory milestone, building on the product’s earlier Orphan Drug Designation by the U.S. Food and Drug Administration in May 2023. With trial initiation underway, the company anticipates generating pivotal clinical data that could accelerate the path to broader therapeutic access for patients with EGFRvIII‑positive gliomas.
Key Takeaways
- Northeast Pharma secures NMPA approval for DCTY0801 Injection.
- The therapy targets the EGFRvIII antigen, present in ~30 % of glioblastoma cases.
- Upcoming trials will evaluate safety and efficacy in a high‑grade brain glioma population.-Fineline Info & Tech