- Partner Elisigen unveils the 44-week clinical results of the mid-dose cohort for 'NG101' for the first time at ASRS.
- Proven to reduce wet macular degeneration injection frequency by 90% even at an ultra-low dose—less than 10% of competitors' doses.
- Reyon Pharmaceutical secures exclusive manufacturing rights, greenlighting advanced GMP commercial production at its new Chungju plant.
'NG101', a next-generation pipeline co-developed by Reyon Pharmaceutical and its partner Elisigen, has unveiled overwhelming clinical data at the world's largest retina congress, significantly boosting expectations for their global commercialization partnership.
Reyon Pharmaceutical announced on July 20 that its partner, Elisigen, successfully presented the 44-week results of the mid-dose group (Cohort 2) from the Phase 1/2a clinical trial of 'NG101'—a gene therapy for wet age-related macular degeneration (wAMD)—at the American Society of Retina Specialists (ASRS 2026).
Celebrating its 44th anniversary this year, ASRS 2026 is the world's largest retina congress where leading ophthalmologists and researchers from across the globe gather to share the latest clinical data. The presentation drew significant attention from the global industry as it was delivered by Dr. Peter Kertes, a professor at the University of Toronto and a world-renowned authority in ophthalmology who serves as a Principal Investigator (PI) for the NG101 clinical trial.
The 44-week data of the mid-dose cohort (Cohort 2) disclosed at this congress, following the 52-week results of the low-dose cohort (Cohort 1) announced in May, once again demonstrated the excellent safety and strong dose-dependent response (increased efficacy with higher doses) of NG101.
According to the presented data, patients treated with the mid-dose of NG101 showed a dramatic therapeutic effect, with a 90% reduction in the frequency of additional anti-VEGF (vascular endothelial growth factor) injections. This signifies that NG101 could serve as a disruptive, "one-time treatment" alternative for macular degeneration patients who previously endured the burden of repeated intraocular injections 8 to 10 times a year.
Notes from previous clinical results indicate that the mid-dose cohort exhibited superior efficacy in vision improvement and macular structure-related indicators compared to the low-dose cohort, proving a distinct trend of efficacy improvement in correlation with dose escalation.
Furthermore, these results are evaluated to hold immense commercial value as they were achieved at an extremely low dose compared to global competitors. The dosage administered to the NG101 mid-dose group is merely 2.3% to 10% of that of competitors. This breakthrough is attributed to Elisigen's proprietary 'CAT311 promoter' platform technology, which induces high gene expression even at exceptionally low doses.
Given that AAV (adeno-associated virus) gene therapies generally carry a higher risk of adverse events as the dosage increases, the fact that NG101 demonstrated powerful efficacy at an ultra-low dose with zero Serious Adverse Events (SAEs) or Dose-Limiting Toxicities (DLTs) observed positions it to secure an unrivaled safety advantage upon entering the global market.
With this clinical success, Reyon Pharmaceutical's Chungju plant—which holds exclusive rights for global production and supply—is expected to accelerate its preparations for full-scale operations. Under the joint development agreement signed with Elisigen in 2020, Reyon Pharmaceutical will manufacture the entire volume of NG101 at its state-of-the-art Chungju bio-plant GMP facility to supply the global market once commercialized.
The characteristic of NG101 delivering exceptional efficacy even at ultra-low doses can maximize cost competitiveness during mass production. Consequently, Reyon Pharmaceutical's Chungju plant is anticipated to play a pivotal role in leaping forward as a global gene therapy manufacturing hub.
An official from Reyon Pharmaceutical stated, "Through this ASRS presentation, the innovative value and global commercialization potential of NG101 have been scientifically proven. If we successfully secure the 24-week results of the high-dose group (Cohort 3), which are scheduled to be presented at the American Academy of Ophthalmology (AAO) this October, discussions regarding Phase 2b entry and global licensing-out (L/O) will gain further momentum."
The official added, "Based on close cooperation with our partner Elisigen, we will support the remaining clinical schedules without a hitch, while making every effort to prepare for the commercial production of the gene therapy based on the advanced GMP production facilities at our Chungju plant."
