- Reyon Pharmaceutical holds exclusive global manufacturing and supply rights for NG101, taking full charge of commercial GMP manufacturing.
- An 89% reduction in injection frequency over 52 weeks following a single administration confirms its innovative value as a 'one-shot treatment' for wet age-related macular degeneration (wet AMD).
- Selected as a ‘Hot Topic’ by the ARVO Program Committee, gaining recognition for its academic and clinical significance.

Reyon Pharmaceutical has moved one step closer to commercialization by disclosing overwhelming clinical data on the global stage for 'NG101', a co-developed gene therapy for wet age-related macular degeneration (wet AMD).

Reyon Pharmaceutical announced on the 7th that its joint development partner, Elisigen (formerly Neuracle Genetics), participated in ARVO 2026—the world's largest ophthalmology congress, held in Denver, USA, from May 3 to 7—and presented the 52-week results for the low-dose cohort (Cohort 1) of the Phase 1/2a clinical trial of NG101.

ARVO is a prestigious scientific conference attended by over 10,000 ophthalmology researchers, clinicians, and global pharmaceutical and biotech industry representatives from more than 75 countries, and is evaluated as one of the most influential international societies in the field of ophthalmology and visual science. Notably, this presentation was selected as a 'Hot Topic' by the ARVO Program Committee, being recognized as a major study with profound academic and clinical significance.

The most notable aspect of this presentation was, by far, the "overwhelming efficacy of the long-term follow-up results in the low-dose cohort." According to the detailed data released, subjects in the low-dose cohort (Cohort 1) required regular anti-VEGF injections averaging 9.8 times per year in the year prior to participating in the trial. However, during the 52-week follow-up period after NG101 administration, the frequency of injections drastically decreased to an average of 1.1 times. This represents a staggering reduction of approximately 89% in administration frequency compared to conventional treatments.

Innovative achievements were also confirmed in patient-specific responses. Eighty-three percent of all subjects (5 out of 6) maintained their vision with only one or fewer additional injections over the 52 weeks. Remarkably, 50% (3 out of 6) did not require a single additional injection throughout the entire year. Furthermore, key metrics such as Best-Corrected Visual Acuity (BCVA) and Central Retinal Thickness (CST) remained stable, and excellent safety was proven as no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) were observed.

These breakthrough clinical achievements are drawing even more attention in conjunction with the steep growth of the global market that NG101 will enter. According to market reports, the global market for wet AMD treatments is expected to grow from approximately $6.7 billion (about 9 trillion KRW) in 2023 to approximately $16.6 billion (about 23 trillion KRW) by 2031, at a compound annual growth rate (CAGR) of 12.1%. In particular, the AAV-based wet AMD gene therapy market is cited as a core sector anticipated to witness an overwhelming growth rate, surging from approximately $500 million (about 700 billion KRW) in 2026 to approximately $4.9 billion (about 7 trillion KRW) by 2031, with a CAGR of roughly 59.6%.

Through the joint development agreement signed with Elisigen in 2020, Reyon Pharmaceutical secures exclusive global manufacturing and supply rights for NG101. In particular, Reyon Pharmaceutical's Chungju Smart Plant, equipped with state-of-the-art facilities, will serve as the core hub responsible for manufacturing global commercial volumes of NG101 in the future.

The Chungju plant houses Korea's only facility dedicated to E. coli fermentation-based pDNA production and has also completed the development of animal cell culture-based AAV process technology. Consequently, it is expected to become the only facility in Korea capable of providing one-stop production for both plasmid DNA (pDNA) and AAV. Reyon Pharmaceutical is already playing a pivotal role by manufacturing the AAV-use pDNA for the Phase 2 clinical trial of NG101. Securing superior pDNA productivity compared to foreign biotech firms is expected to provide a foundation for NG101 to gain a stable and cost-effective supply advantage in the global competitive landscape.

An official from Reyon Pharmaceutical emphasized, "As the innovative therapeutic efficacy of NG101 has been proven through this ARVO 2026 presentation, interest from the global ophthalmology community is immensely high." The official added, "Reyon Pharmaceutical will concentrate its top-tier GMP manufacturing capabilities to ensure the successful commercialization of NG101 and, using this as a stepping stone, firmly solidify our position as a global gene therapy manufacturing hub."

Meanwhile, NG101 has currently completed dosing for all 20 subjects, and the company plans to secure the Phase 1/2a clinical trial interim report in the third quarter of 2026. Taking this data as a turning point, both companies strategize to accelerate discussions for global Phase 2b entry and technology licensing (licensing out) to derive substantial business results.

Furthermore, Reyon Pharmaceutical maintains a solid strategic partnership as the largest shareholder of Elisigen. Moving forward, the company plans to promote mutual growth by co-developing various new pipelines in the gene therapy sector in addition to NG101.