NK Max 'SNK01' Receives GMP Approval from Japan's Ministry of Health, Labour and Welfare

NKMAX announced on the 16th that it has received pharmaceutical manufacturing (GMP) approval from the Japanese Ministry of Health, Labour and Welfare for its domestic manufacturing facility of the natural killer (NK) cell therapy 'SNK01.'

NKMAX logo
Photo by NKMAX

With this GMP facility registration, NKMAX can now culture SNK01 at its domestic facility and send it to Japan without establishing a separate factory in Japan. NKMAX has completed consultations with medical institutions in regions such as Tokyo, Osaka, and Fukuoka for the commercialization of SNK01 and is coordinating the SNK01 administration schedule for patients awaiting treatment.

Last month, NKMAX presented the final results of the Phase 1 clinical trial of SNK01 at the Clinical Trials on Alzheimer's Disease (CTAD) conference in the United States, demonstrating safety and efficacy against Alzheimer's disease. Measurement of the Alzheimer's Disease Composite Score (ADCOMS) confirmed therapeutic effects in 90% of patients, and no adverse effects related to SNK01 administration were observed.

Additionally, the company emphasized that SNK can be used alone or in combination for various cancer types. In June, at the American Society of Clinical Oncology (ASCO), interim results on the combination effect of SNK01 in Phase 1/2a clinical trials for tyrosine kinase inhibitor (TKI) refractory non-small cell lung cancer were announced. When gemcitabine + carboplatin or gemcitabine + carboplatin + cetuximab were administered together with SNK01, meaningful efficacy was confirmed with a disease control rate (DCR) of 100%, including 3 partial responses (PR) and 9 stable disease (SD) cases among 12 patients. No SNK01-related adverse effects were observed, confirming safety as well.

Japan is considered the largest regenerative medicine market in the Asia region. The Korea Health Industry Development Institute forecasts that the Japanese regenerative medicine market will grow to over 1.6 trillion yen (approximately 13.73 trillion KRW) by 2030. Unlike in Korea, in Japan, immune cell therapies such as NK cells can be administered based on a physician's judgment, which is expected to generate sales.

Park Sang-woo, CEO of NKMAX, stated, "We plan to expand the treatment scope not only for Alzheimer's and cancer but also for patients with autoimmune diseases and stroke by strengthening research cooperation with Japanese medical professionals." He added, "NK cells can attack abnormal cells such as virus-infected cells and cancer cells, and the highly cytotoxic SNK01 is expected to prevent various diseases."