Reyon Pharmaceutical is strengthening the competitiveness of 'NG101', a gene therapy for wet age-related macular degeneration (wet AMD) co-developed with Elysigen (formerly Neuracle Genetics). The company plans to reaffirm its unrivaled efficacy by disclosing additional data from the Phase 1/2a clinical trial in the second half of this year. Furthermore, it is pursuing indication expansion into dry AMD, which represents a significantly larger market size. Consequently, the Chungju Smart Plant is projected to elevate its status as the exclusive global manufacturing base for NG101. The company aims to maximize its growth potential through innovative biopharmaceuticals while sustaining the continuous growth of its chemical drug business.
Reyon Pharmaceutical announced on the 26th that its chemical segment sustained profitability in the first quarter of this year, recording a revenue of 26.4 billion KRW and an operating profit of 2.7 billion KRW. Annual operating profit for the chemical segment has been steadily increasing, rising from 4.6 billion KRW in 2023 to 5.6 billion KRW in 2024, and reaching 8.3 billion KRW in 2025. However, impacted by investments in the biopharmaceutical business, including the Chungju Smart Plant, the company recorded an overall operating loss of 6.7 billion KRW for the first quarter of this year. Despite these large-scale biopharmaceutical investments, the company continues to maintain a positive EBITDA trend.
Reyon Pharmaceutical expects the fruits of its long-term biopharmaceutical investments to materialize in earnest starting this year. In particular, the gene therapy NG101 is drawing immense interest from both domestic and international industry circles, as a novel drug pipeline capable of delivering long-term therapeutic effects with just a single administration.
Earlier this month, Reyon Pharmaceutical presented Phase 1/2a clinical data for NG101 at ARVO 2026, held in Denver, USA. During the 52-week follow-up period for subjects in the low-dose cohort, the average number of injections was 1.1 times, representing a staggering 89% reduction in injection frequency compared to conventional treatments, which averaged 9.8 injections per year. Eighty-three percent of all subjects (5 out of 6) maintained their vision with one or fewer additional injections over the 52 weeks. Notably, the subjects enrolled in this clinical trial are all real-world wet AMD patients who previously required injections roughly once a month.
In the second half of this year, Reyon Pharmaceutical plans to release additional follow-up data spanning 12 months or longer for NG101. The company is also preparing to disclose data for the mid-dose and high-dose cohorts. Given that the previously released low-dose cohort data demonstrated an 89% reduction in injection frequency, intense industry attention is focused on the upcoming outcomes for the mid- and high-dose cohorts.
As the Phase 1/2a clinical trial for NG101 progresses smoothly, the role of the Chungju Smart Plant, an infrastructure investment driven by Reyon Pharmaceutical since 2017, is coming into the spotlight. Following its completion in 2021, the Chungju Smart Plant secured KGMP certification in August 2023, followed by a dedicated GMP certification for biopharmaceutical contract manufacturing in November 2024. The facility is fully equipped to handle end-to-end production—from raw materials to finished drug products—for plasmid DNA (pDNA), viral vectors, and mRNA. Moving forward, it will take full charge of the exclusive global manufacturing of NG101.
In November 2024, NG101 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). This designation enables the company to communicate closely with the FDA to apply for accelerated approval following Phase 2, and priority review upon the completion of Phase 3.
The global wet AMD treatment market is projected to expand from 9 trillion KRW in 2023 to 23 trillion KRW by 2031. Concurrently, the market for wet AMD gene therapies is anticipated to surge from 700 billion KRW in 2026 to 7 trillion KRW by 2031.
An official from Reyon Pharmaceutical stated, "The Phase 1/2a clinical trial for NG101 is being conducted on real-world patients. Having demonstrated unrivaled efficacy in the low-dose cohort, it is drawing significant attention as a fundamental, disease-modifying treatment capable of reliably treating wet AMD with a single administration." The official added, "We plan to disclose more detailed data at upcoming international conferences in the second half of this year."
The official further emphasized, "NG101 is a pipeline possessing high scalability, with plans for indication expansion into dry AMD treatments. This year will mark the inaugural year where the growth prospects of Reyon Pharmaceutical's innovative biopharmaceutical business tangibly materialize."
