Milestones

Completed liver cancer clinical trials and obtained conditional drug approval from the U.S. FDA.
Initiated the preclinical trial for Chimeric Antigen Receptor (CAR).
Recognized as one of the top 10 clinical trial companies in Asia by Life Sciences Review Magazine.

Completed the application process for the Phase II clinical trial of liver cancer in Taiwan under the U.S. ODD and IND programs.
Applied for clinical trial approval from the Taiwan Ministry of Health and Welfare and initiated clinical trials in collaboration with 13 medical centers and major hospitals in Taiwan (ongoing enrollment).
Lukas Biomedical, under the "Administrative Regulation on Special Medical Instruments and Inspection Techniques", has obtained approval from the Ministry of Health and Welfare for cytokine-induced killer (CIK) cell therapy for "Stage I to III solid tumors that are unresponsive to standard treatment" and "Stage IV solid tumors." The approved collaborating hospitals include Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital, Chi Mei Hospital, Pan Chiao Chung Hsing Hospital, and Shin Kong Wu Ho-Su Memorial Hospital.
Awarded the 4th Golden Ship Award for Innovative Services by the General Chamber of Commerce of the Republic of China.
Won the DEMO DAY Award from the Tai-Fu Startup Association.
FreshO2 partnered with Arata Co., Ltd. (JP-2733, Japan’s largest wholesaler in the field of daily goods and cosmetics) to enter the Japanese cosmetics market.

Lukas's GTP laboratory in Xizhi was approved as a cell processing unit (CPU) by the Ministry of Health and Welfare under the Administrative Regulation on Special Medical Instruments and Inspection Techniques (approval number: TP109C019).
Lukas's LuLym-T (Autologous Activated Lymphocytes; ATL) passed the FDA's investigational new drug (IND) review for Phase II clinical trials under orphan drug designation (ODD) for liver cancer.
Lukas Biomedical, together with Hualien Tzu Chi Hospital, has received official approval from the Ministry of Health and Welfare for the implementation of autologous immune cell (CIK) therapy for Stage IV solid tumors.
Launched a "Circulating Tumor Cell (CTC) Test" service.
Won the 24th Symbol of National Quality (SNQ) Mark and National Biotechnology & Medical Care Quality Award.

Obtained FDA orphan drug designation and pre-IND status for liver cancer.
Signed memorandums of understanding and collaboration agreements with Taipei Veterans General Hospital, Keelung Chang Gung Memorial Hospital, Tri-Service General Hospital, and Far Eastern Memorial Hospital.
Public offering and listing on the Emerging Stock Market.

Completed the construction of the GTP laboratory in Xizhi, and waited for the certification by the Ministry of Health and Welfare.
Applied for a treatment program under the "Administrative Regulation on Special Medical Instruments and Inspection Techniques" in collaboration with Shin Kong Wu Ho-Su Memorial Hospital, Hualien Tzu Chi Hospital, and Chi Mei Hospital Liouying, and submitted the application to the Ministry of Health and Welfare.

Approved to conduct Phase I/II clinical trials for oral cancer in Taiwan.
Collaborated with Taipei Veterans General Hospital for the first clinical trial of T-cell combined chemo-radiotherapy in Taiwan.
Passed orphan drug review in the U.S. and obtained FDA clinical approval.
Developed techniques for culturing dendritic cells, natural killer cells, and novel tumor-antigen T cells to complement T-cell therapeutics.
Merged with Galilee Biotech Incorporation.
Constructed a national-level GTP laboratory in Xizhi.
Established FreshO2, a biotech cosmetic brand, and developed online and offline channels for biotech skincare products as part of the brand's health and wellness portfolio.

Applied for the first clinical Pl/Plla trial of immune cells combined with chemo-radiotherapy for oral cancer in Taiwan.
Obtained authorization from Japan's Lymphotec Inc. for the use of its immunocellular therapy technology in the U.S.

Completed the technology transfer with Japan for the first clinical trial of T cells in Taiwan.
Invested in the subsidiary Grand Zone International Biomedical Inc.