The barrier to clinical entry for advanced regenerative medicine using patients' own immune cells, such as autologous natural killer (NK) cells, is set to be sharply lowered. With the elimination of preliminary clinical study procedures that once took several years, access to treatment for patients with rare and intractable diseases is expected to improve, and Korea's NK cell therapy market is poised to enter a phase of full-fledged growth. The industry expects demand for advanced regenerative medicine institutions and cell contract development and manufacturing (CDMO) to rise, and that over the long term, demand for overseas treatment in countries such as Japan will be absorbed domestically.
According to the Ministry of Health and Welfare's advanced regenerative medicine portal on the 17th, a total of 65 advanced regenerative medicine clinical studies had been approved as of June this year. Of these, low-risk studies numbered just 13 (20%), while medium-risk studies totaled 30 and high-risk studies 22, meaning medium- and high-risk projects accounted for 80% of the total. This indicates that most of Korea's advanced regenerative medicine clinical studies are currently subject to regulations requiring preliminary clinical studies ahead of actual treatment.
Against this backdrop, the Ministry of Health and Welfare recently adjusted the risk level of advanced regenerative medicine involving autologous immune cell culture, following a resolution by the Deliberation Committee on Advanced Regenerative Medicine and Advanced Biopharmaceuticals. Treatment using patients' own immune cells, including autologous NK cells, has been downgraded from "medium risk" to "low risk."
The biggest change is the removal of the mandatory preliminary clinical study. Previously, high-risk and medium-risk treatments could apply for a treatment plan only after demonstrating safety and efficacy through preliminary clinical studies. Going forward, however, treatment plans can be submitted for deliberation directly, based on existing clinical results and literature. The industry expects the period until actual patient treatment to be shortened by up to 2-3 years. In particular, as the use of advanced regenerative medicine in clinical settings expands, access to treatment for patients with rare and intractable diseases is expected to improve.
Advanced regenerative medicine is a medical technology that uses human cells and other materials to regenerate and restore damaged tissues and functions, or to treat and prevent disease. Representative examples include cell therapy, gene therapy, and tissue engineering therapy. While conventional pharmaceuticals focus on relieving symptoms, advanced regenerative medicine aims at fundamental treatment that restores or replaces damaged cells and tissues to a normal state.
The industry expects this deregulation to increase the practice of advanced regenerative medicine at tertiary general hospitals. This is because currently approved studies are being conducted mainly at large hospitals such as Seoul Asan Medical Center, Seoul National University Hospital, Severance Hospital, Samsung Medical Center, and CHA Bundang Medical Center. As the burden of preliminary clinical studies is reduced, hospitals with existing clinical experience are expected to actively pursue treatment plan applications, leading to a rapid increase in actual treatment cases.
Domestic cell therapy developers are also expected to benefit from the institutional improvement. As the application of autologous immune cell therapy expands while quality and safety standards for cell culture remain unchanged, the competitiveness of companies equipped with GMP production facilities and manufacturing capabilities is expected to become more pronounced. The industry expects companies that operate cell supply and contract development and manufacturing (CDMO) businesses alongside therapeutic development to be the biggest beneficiaries of this institutional improvement.
CHA Biotech (085660) expects clinical research and treatment application of its autologous NK cell therapy to accelerate. The company is pursuing advanced regenerative medicine research for recurrent glioblastoma using its autologous NK cell therapy "CHANK-101," as well as expansion into various solid tumors including primary glioblastoma. "This institutional improvement will speed up the progress of related clinical research," a CHA Biotech official said. "Centered on our subsidiary Matica Biolabs, we also expect to expand our cell and gene therapy (CGT) CDMO business in line with rising cell manufacturing demand from medical institutions and biotech ventures."
GC Cell (144510) expects the scope of use for "Immuncell-LC Inj.," Korea's first approved autologous immune cell-based liver cell carcinoma treatment, to widen. The company is currently expanding its allogeneic CAR-NK and NK cell therapy portfolio, and having built production infrastructure capable of everything from research and development to manufacturing and supply based on its own GMP manufacturing facility, it also expects to expand collaboration with medical institutions and its CDMO business. "GC Cell has built a production base spanning the entire cycle from research and development to manufacturing and supply, along with core CDMO infrastructure," a GC Cell official said. "This institutional improvement will broaden the scope of use for approved drugs and serve as an opportunity to invigorate Korea's advanced regenerative medicine ecosystem and create new business models."
Vaxcell-Bio (323990) is expected to accelerate cell supply and expansion into new indications. Leading with its autologous NK cell anticancer immunotherapy "VCB-1102," the company is conducting clinical trials for advanced liver cell carcinoma and is also pursuing indication expansion into small cell lung cancer and pancreatic cancer. Having obtained an advanced biopharmaceutical manufacturing license last year and established a production system capable of everything from NK cell manufacturing to supply, the company also expects to expand cell supply needed for future advanced regenerative medicine treatment, as well as joint treatment with medical institutions and cell contract development and manufacturing (CDMO) business.
SMT Bio expects that, based on its NK cell activity assessment and donor screening technologies, it will be able to expand its business into a precision medicine platform utilizing these capabilities if autologous NK cell therapy expands going forward. "We plan to build an autologous NK cell-based precision medicine platform using our NK cell activity assessment and donor screening technologies, and to expand into various indications," a company official said.
