[Edaily Reporter Kim Jinsoo ] With the establishment of an institutional framework that will enable advanced regenerative medicine treatments using autologous natural killer (NK) cells to be carried out more swiftly in South Korea, Vaxcell-Bio Therapeutics(323990)is expected to be the biggest beneficiary. This is also expected to benefit GC CELL(144510)(GC Cell) and Chabiotech Co.,Ltd.(085660).

Ministry of Health and Welfare Adjusts Risk Level for Advanced Regenerative Medicine Using Autologous Immune Cells to “Low Risk”

On the 26th

,

the

Ministry of Health and

Welfare

adjusted

the

risk level for advanced regenerative medicine utilizing autologous immune cells,

such as autologous NK cells, from “medium risk”

to “low risk

.” As a result, medical professionals can now apply for treatment plans without having to conduct preliminary advanced regenerative medicine clinical studies, which typically take about 2–3 years.

The risk levels for advanced regenerative medicine are defined in Article 2 of the Advanced Regenerative Bio Act and Article 4 of the Enforcement Decree of the Advanced Regenerative Bio Act. Risk levels are broadly categorized into high, medium, and low.

Clinical research and treatments with uncertain effects on human life and health or those posing a high risk are classified as high-risk; those that may have adverse effects on human life and health and require significant caution are classified as medium-risk; and those with well-known effects on human life and health and minimal risk are classified as low-risk.

When a treatment is reclassified from medium-risk to low-risk, the most significant change is the exemption from prior clinical trial requirements. For medium-risk treatments, safety and efficacy data must first be obtained through clinical trials, and based on this data, the treatment can be used only after a review of the treatment plan. In other words, treatment is provided to patients only after a review process for therapies for which safety and efficacy evidence has been accumulated through clinical trials and other means.

In contrast, low-risk treatments can bypass the clinical trial phase and proceed directly to treatment following a treatment plan review. Consequently, advanced regenerative medicine utilizing autologous immune cells, such as NK cells, stands to gain approximately two to three years in development time. Furthermore, once efficacy and safety are demonstrated through clinical trials for advanced regenerative medicine, providers can apply for advanced regenerative medicine treatment authorization and bill for the associated costs. Unlike clinical trials, where costs must be borne entirely by the provider, revenue is generated through treatment fees.

The government has streamlined the procedures for advanced regenerative medicine utilizing autologous immune cells, such as NK cells, while maintaining safety management standards. Even if the risk level is adjusted downward, cultured autologous immune cells must be manufactured, supplied, and used at cell processing facilities licensed for advanced biopharmaceutical manufacturing, taking into account the technical expertise, quality, and safety of the technology.

Vaxcell-Bio Therapeutics Expected to Be the Biggest Beneficiary

Following this risk classification adjustment, it is expected that not only will access to treatment for patients with rare and intractable diseases improve, but NK cell-based advanced regenerative medicine treatments will also become significantly more widespread. Some in the biotech industry predict that this could serve as an opportunity to expand domestic treatment demand among patients who previously received NK cell therapy overseas, such as in Japan.

The biotech industry believes these regulatory changes will further expand the role of companies with cell manufacturing capabilities. Vaxcell-Bio Therapeutics, which is developing anti-cancer immunotherapies, is cited as one of the companies expected to benefit.

Vaxcell-Bio Therapeutics has developed VCB-1102, an autologous NK cell-based therapy for advanced hepatocellular carcinoma, and achieved groundbreaking results in its Phase 2a clinical trial, with an objective response rate (ORR) of 68.75%, a disease control rate (DCR) of 100%, and a median overall survival (mOS) of 24.05 months.

Following the expansion and construction of state-of-the-art GMP production facilities in 2024, the company obtained a license for the manufacture of advanced biopharmaceuticals in 2025, thereby establishing a manufacturing and supply system for NK cells required for advanced regenerative medicine. Consequently, it has also secured a foundation for advanced regenerative medicine treatments and contract development and manufacturing (CDMO) in collaboration with medical institutions.

Building on the clinical experience gained in hepatocellular carcinoma, Vaxcell-Bio Therapeutics is also moving to expand its indications to small cell lung cancer and pancreatic cancer. Industry observers anticipate that this risk adjustment will have a positive impact on accelerating the practical clinical application of NK cell-based advanced regenerative medicine and expanding its indications in the future.

Furthermore, companies in the immune cell therapy and advanced regenerative medicine sectors—such as GC CELL(144510)(GC Cell) and Chabiotech Co.,Ltd.(085660) —are also expected to benefit from these regulatory improvements. Among them, Vaxcell-Bio Therapeutics, which possesses clinical experience with NK cells, a manufacturing license for advanced biopharmaceuticals, and research capabilities in advanced regenerative medicine, is regarded as one of the companies most directly linked to these regulatory changes.

A bioindustry official stated, “This risk adjustment is a policy that enhances patients’ access to treatment while expanding the commercialization foundation for the domestic advanced regenerative medicine industry,” adding, “In particular, cooperation between companies with cell manufacturing capabilities and medical institutions is likely to become even more active.”