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The AAV gene therapy, under co-development of Reyon Pharmaceutical and Neuracle Genetics, has received approval for phase 1/2a clinical trials in Canada

-Reyon Pharmaceutical secures exclusive production and supply rights for raw materials and finished products worldwide through the 2020 joint development agreement for gene therapy (NG101) for wet age-related macular degeneration (wAMD).

-Initiation of clinical trials in 3Q23 Expand clinical trials to the United States in the future

Reyon Pharmaceutical (Representative Directors: Jung SoonOck, Yoo Yonghwan) announced on the 2nd that the company had received approval from the Ministry of Health of Canada for phase 1/2a clinical trial of ‘NG101’, gene therapy for wet age-related macular degeneration (wAMD) jointly developed with its partner, biotech venture company Neuracle Genetics (CEO Kim Jong-mook).

In 2020, the two companies signed a joint development agreement for ‘NG101’, a new adeno-associated virus (AAV) vector-based gene therapy drug whose main target indication is wAMD.

Under this agreement, Reyon Pharmaceutical has secured worldwide exclusive production rights and supply rights for this treatment's raw materials and finished products. The company plans to proceed from clinical sample production to commercial production in its Chungju bio plant.

According to Grand View Research, in 2022, the global AMD market will grow at an average annual rate of 6.9% to expand to $18 billion (KRW 24.1 trillion) in 2030 from $9.8 billion (approximately KRW 13.2 trillion) in 2021. (Note 1)

Patients are reluctant to undergo treatment with currently approved wAMD antibody therapies because they must be administered intraocularly every two to four months.

NG101 is a treatment for wAMD using adeno-associated virus (AAV) as a vector, designed to optimize gene expression and sustain its structure. In addition to such characteristics, NG101 is delivered to the patient subretinally, possibly producing a significant therapeutic effect even with a relatively small amount of treatment and minimal inflammation and side

Also, this treatment is likely to improve the quality of life of wAMD patients by enabling fundamental treatment of the disease with long-term effects with just a single administration.

Kim Jong-mook, the CEO of Neuracle Genetics, said, "With this clinical trial approval, we are a step closer to presenting a new alternative AAV gene therapy," and "We will continue to do our utmost best to develop safe and effective treatments."

Yoo Yonghwan, Representative Director of Reyon Pharmaceutical, "Through the approval of the clinical trial of NG101, jointly developed with Neuracle Genetics, Reyon Pharmaceutical has finally leaped into a comprehensive biopharmaceutical production platform for commercial production from pDNA to virus-based gene therapy." "We are eager to show tangible results soon from the joint development pipeline currently underway with various companies," he said.

Meanwhile, Reyon Pharmaceutical continually expands discussions on joint pipeline development and CDMO business with many biopharmaceutical companies based on its advanced biopharmaceutical production facility, Chungju Plant.

(Note 1) Age-related Macular Degeneration Market Report, Grand View Research Inc., 2022