Heyuan Bio Announces Third IND Application for Fast CAR-T Candidate HY001N Accepted by NMPA for Refractory Idiopathic Inflammatory Myopathy

Recently,Juventas Announces Its Rapid Platform-Prepared CAR-T (Fast CAR-T)of HY001NNew Drug Clinical Trials (IND) application, received on June 11, 2026The National Medical Products Administration (NMPA) has officially accepted the application for the proposed treatment of adult patients with refractory idiopathic inflammatory myopathies (IIM).

This isThe third IND submitted by HY001N. Previously, on September 30, 2025,HY001N submitted its first IND to the NMPA, andGranted clinical implicit approval in December of the same year for the treatment ofAutoimmune Hemolytic Anemia (AIHA) with Failure of at Least Three Lines of Therapy; June 5, 2026，HY001N submitted the second IND to the NMPA.

HY001N is aJuventas Innovative Rapid PreparationCD19-targeted CAR-T cells developed using the NexT technology platform,Enabling T cells to specifically recognize and eliminate pathogenic B cells through gene editing, thereby blocking autoimmune responses at the source.

According to Juventas Biotechnology's disclosure,HY001N is an innovative, rapidly prepared product by Juventas BiotechnologyThe first candidate drug of the NexT technology platform.

Rapid PreparationThe NexT technology platform can reduce the ex vivoThe expansion culture procedure reduces the manufacturing time for CAR-T cells in the facility from 9–14 days to under 2 days, shortening patient wait times by 50% to as little as 10 days, and significantly lowering production costs compared with existing manufacturing technologies. Furthermore,The significantly increased proportion of Tnaïve cells in rapidly manufactured CAR-T products lays the foundation for their efficacy and safety.