NK Max "Passage of Cheomsaengbeop Amendment... Boost to Clinical Trials and Commercialization"

As the amendment to the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act (ARMA) passed the National Assembly plenary session, NKMAX announced on the 2nd that it will accelerate domestic commercialization.

The National Assembly held a plenary session and approved the law under the jurisdiction of the Ministry of Health and Welfare, the "Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act," on the 1st.

The domestic ARMA was enacted in August 2020. However, it could only be used for research purposes for patients with rare and intractable diseases. Additionally, treatment costs could not be charged. Because of this, patients had to travel abroad to receive cell and gene therapies.

The recent amendment to ARMA introduced an advanced regenerative medical treatment system and expanded the scope of clinical research subjects. Accordingly, once safety is ensured, patients with severe, rare, and intractable diseases can receive advanced regenerative medical treatment domestically.

NKMAX aims to boost clinical research to accelerate domestic commercialization. Leading with its U.S. subsidiary NKGen Biotech, the company is conducting clinical trials targeting severe, rare, and intractable diseases using its NK cell therapy (SNK). NKMAX has already demonstrated safety and efficacy in clinical trials for solid tumors and Alzheimer's disease.

Furthermore, NKMAX has completed preparations for the commercialization of NK cell therapy in both Korea and Japan. In November last year, it received GMP (Good Manufacturing Practice) approval from the Japanese Ministry of Health, Labour and Welfare. Domestically, it can target patients with severe, rare, and intractable diseases, while in Japan, it can target a broader range of patients and practitioners. Currently, it is undergoing IRB (Institutional Review Board) review at local hospitals in Japan and plans to begin patient treatment immediately upon approval. NKMAX also plans to expand its GMP facilities.

An NKMAX official stated, "With the passage of the ARMA amendment, SNK can now be used as a customized treatment for patients with severe, rare, and intractable diseases such as cancer and Alzheimer's disease in Korea," adding, "Since we already have GMP facilities, we expect visible sales of SNK in both Japan and Korea."