The National Assembly, convened on January 1st, has successfully passed the amendment to the law on advanced regenerative medicine and the safety and support of advanced biopharmaceuticals, commonly referred to as the Regenerative Medicine Law. This landmark development raises optimism for an increased scope of "advanced regenerative medicine" treatments for patients grappling with severe, rare, and incurable diseases.

Under the jurisdiction of the Ministry of Health and Welfare (MOHW), the Regenerative Medicine Law introduces a system for advanced regenerative medicine treatment, expanding the range of clinical research subjects. To ensure safety, the treatment targets are restricted to patients suffering from severe, rare, and incurable diseases. The enforcement of the Regenerative Medicine Law is scheduled for one year after promulgation.

In preparation for the full implementation date, one year after promulgation, a MOHW official has stated, "We plan to thoroughly revise and expand the safety management system for ongoing advanced regenerative medicine clinical research."

Despite the implementation of the Regenerative Medicine Law in August 2020, industry insiders highlight its exclusive use for research purposes, limited patient eligibility, and challenges faced by patients in claiming treatment expenses abroad for cell and gene therapies.

Chabiotech and NKMax, both actively engaged in developing cell and gene therapies in South Korea, express approval of the proposed amendments. A representative from Chabiotech asserts, "With the passage of the Regenerative Medicine Law amendment through the National Assembly, not only research subjects but also patients can now receive regenerative medical services." The spokesperson emphasizes that the amendment opens avenues for patients with severe, rare, and incurable diseases to access advanced regenerative medicine treatments.

NKMax announces the utilization of their NK cell therapy (SNK) for tailored treatments, specifically for patients with severe, rare, and incurable diseases like cancer and Alzheimer's disease in South Korea, following the passage of the Regenerative Medicine Law amendment.

The Advanced Regenerative Medicine Industry Association (CARM) also weighs in on the amendment, mentioning, "Following the passage of the Regenerative Medicine Law amendment by the National Assembly, we are currently gathering opinions from companies to ensure that their views are reflected in the subsequent enactment of the Regenerative Medicine Law enforcement decree." They plan to officially announce their position in February.

Industry insiders view the recent amendment to the Regenerative Medicine Law as the commencement of a new era for advanced regenerative medicine treatments in South Korea. This development provides fresh treatment opportunities for patients with rare and incurable diseases, serving as a foundation for leading biotech companies to increase investments and pursue global ventures. The expanded opportunities in clinical research are expected to stimulate investment activity in this field. Additionally, it is regarded as a positive development for pharmaceutical companies developing cell and gene therapies, although continuous monitoring and follow-up clinical studies remain necessary for safety and efficacy verification.