Chinagene Tech has submitted a marketing authorisation application to its China homeland's Centre for Drug Evaluation (CDE) for ZVS101e, a recombinant AAV2-mediated CYP4V2 gene augmentation therapy developed with Peking University Third Hospital for Bietti crystalline corneoretinal dystrophy (BCD) caused by biallelic CYP4V2 mutations. The Phase III trial randomised 31 patients to a single subretinal injection of 7.5×10¹⁰ viral genomes per eye and 32 to an untreated control; at week 24, 35% of treated patients gained at least 15 letters of best-corrected visual acuity (BCVA) versus 3% of controls (p=0.001), with a 10-letter between-group difference in mean BCVA change (11.5 vs 1.5, p<0.001), favourable MLMT and full-field stimulus threshold shifts, and no serious treatment-related adverse events.

ZVS101e holds US orphan drug and RMAT designations, China NMPA breakthrough therapy and priority review status, and is one of only three CYP4V2 gene therapies in global development alongside Vitalgen's VGR-R01, which was filed in China in June 2026.

BCD affects an estimated 60,000 to 140,000 patients in China alone, typically causing blindness by age 40 with no approved therapy, making ZVS101e a potential first-in-indication asset with a clear unmet-need narrative. The one-time subretinal administration model fits established AAV retinal commercialisation logistics seen with Luxturna, and a China approval would position Chinagene for regional licensing or manufacturing partnerships rather than immediate global launch.