公司沿革

·獲醫藥品查驗中心CDE指標案件輔導
Received CDE indicator case guidance from the Pharmaceutical Inspection Center

·台灣 (TFDA) 正式核准長聖的新藥CAR001(CAR-T)進行Phase I/IIa臨床試驗
Taiwan Food and Drug Administration (TFDA) has officially approved Ever-Supreme's new drug CAR001 (CAR-T) for Phase I/IIa clinical trials.

·國立臺灣大學醫學院附設醫院於2023年2月6日獲衛福部核准第4期實體癌自體免疫樹突細胞治療
On February 6, 2023, the National Taiwan University Hospital received approval from the Ministry of Health and Welfare for Phase IV autologous immune dendritic cell therapy for solid tumors.

·榮獲第8屆經濟部國家產業創新獎
Awarded the 8th National Industrial Innovation Award by the Ministry of Economic Affairs

·榮獲2023傑出生技產業獎-金質獎
Awarded the 2023 Outstanding Biotechnology Industry Award - Gold Medal

·美國食品藥物管理局 (FDA) 正式核准長聖的新藥CAR001(CAR-T)進行Phase I/IIa臨床試驗
The U.S. Food and Drug Administration (FDA) has officially approved Ever-Supreme's new drug CAR001 (CAR-T) for Phase I/IIa clinical trials.

·長聖生技受邀於總統府與總統接見，共同慶賀與分享「傑出生技產業獎」獎項
Ever-Supreme was invited to the Presidential Office to meet with the President and jointly celebrate and share the "Outstanding Biotechnology Industry Award".

·長聖受邀「總統接見110年度傑出生技產業獎獲獎單位」，肯定長聖國際生技在細胞療法的成就
Ever-Supreme was invited to a "Presidential Meeting with Recipients of the 2021 Outstanding Biotechnology Industry Award," recognizing Chang Sheng International Biotechnology's achievements in cell therapy.

·與中國附醫共同合作，經衛福部特管辦法核准以gamma-delta T治療第四期實體癌
In collaboration with China Medical University Hospital, and with approval from the Ministry of Health and Welfare under special regulations, gamma-delta T therapy was developed to treat stage IV solid tumors.

·與中國附醫共同合作，經衛福部特管辦法核准以DC-CIK治療第一期至第三期肺癌之經標準治療無效
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's Special Management Regulations, DC-CIK therapy was used to treat stage I to III lung cancer patients who had failed standard treatments.

·正式上櫃掛牌
Officially listed on the over-the-counter market

·第一家上櫃公司以最短時間被MSCI列入成分股
The first company listed on the over-the-counter market was included in the MSCI index in the shortest possible time.

·CAR001(CAR-T)可異體治療實體癌新藥研究獲國際頂尖期刊JITC刊登
Research on CAR001 (CAR-T) allogeneic therapy for solid tumors has been published in the top international journal JITC.
·榮獲Taiwan Bio Awards傑出生技產業獎：潛力標竿獎
Awarded the Taiwan Bio Awards Outstanding Biotechnology Industry Award: Potential Benchmark Award

·與中國附醫共同合作，經衛福部特管辦法核准以CIK治療第四期實體癌
In collaboration with China Medical University Hospital, CIK therapy for stage IV solid tumors has been approved by the Ministry of Health and Welfare under special regulations.

·榮獲第18屆國家新創獎企業新創獎(精準免疫幹細胞療法：雙基因修飾臍帶間質幹細胞治療實體癌症)
Awarded the 18th National Innovation Award for Enterprise Innovation (Precision Immunotherapy Stem Cell Therapy: Dual-Gene Modified Umbilical Cord Mesenchymal Stem Cells for the Treatment of Solid Cancers)

·榮獲經濟部A+企業創新研發淬鍊計畫之 補助於ADCV01治療GBM
Awarded a grant from the Ministry of Economic Affairs' A+ Enterprise Innovation and R&D Refinement Program for ADCV01 treatment of GBM.

·CAR001獲日本專利
CAR001 obtains Japanese patent

·TFDA 通過UMSC01 一期急性腦中風臨床試驗案
TFDA approves UMSC01 Phase I acute stroke clinical trial case

·FDA 通過UMSC01 一期急性腦中風臨床試驗案
FDA approves UMSC01 Phase I acute stroke clinical trial

·與中國附醫共同合作，經衛福部特管辦法核准以DC-CIK治療第四期實體癌
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's Special Management Regulations, DC-CIK therapy was used to treat stage IV solid tumors.

·協助TFDA辦理模擬查廠
Assisting TFDA in conducting mock factory inspections

·榮獲第十七屆國家新創獎(樹突細胞免疫治療惡性腫瘤之精準創新技術)
Awarded the 17th National Innovation Award (Precision Innovation Technology for Dendritic Cell Immunotherapy of Malignant Tumors).
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's Special Management Regulations, BMSCs were used to treat osteoarthritis.

·與中國附醫共同合作，經衛福部特管辦法核准以BMSC治療退化性關節炎
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's Special Management Regulations, BMSCs were used to treat osteoarthritis.

·與中國附醫共同合作，經衛福部特管辦法核准以CIK治療血液惡性腫瘤
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's Special Management Regulations, CIK therapy was developed to treat hematological malignancies.

·通過TFDA查廠，取得TFDA批准樹突細胞疫苗(ADCV01)治療惡性腦瘤2期臨床試驗
Through a factory inspection by the TFDA, TFDA approval was obtained for a Phase 2 clinical trial of the dendritic cell vaccine (ADCV01) for the treatment of malignant brain tumors.
·榮獲經濟部A+企業創新研發淬鍊計畫之補助於UMSC01治療心肌梗塞
Received a grant from the Ministry of Economic Affairs' A+ Enterprise Innovation and R&D Refinement Program for UMSC01 treatment of myocardial infarction

·與中國附醫共同合作，經衛福部特管辦法核准以樹突細胞治療第四期實體癌
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's special management regulations, dendritic cell therapy was used to treat stage IV solid cancer.

·與中國附醫共同合作，經衛福部特管辦法核准以樹突細胞治療經標準治療無效的第一至第三期實體癌
In collaboration with China Medical University Hospital, and with the approval of the Ministry of Health and Welfare's Special Management Regulations, dendritic cell therapy was used to treat stage I to III solid cancers that had failed standard treatment.

·UMSC01獲美國專利
UMSC01 was granted a US patent.

·取得美國FDA核准得以進行異體幹細胞(UMSC01)治療心肌梗塞臨床1期試驗
FDA approval has been obtained to conduct a Phase 1 clinical trial of allogeneic stem cell therapy (UMSC01) for the treatment of myocardial infarction.

取得專屬授權：
Obtain exclusive authorization:
·中風鼠腦內移植人類臍帶間質幹細胞對於功能及結構上的修復
Transplantation of human umbilical cord mesenchymal stem cells into the brains of stroke-stricken rats for functional and structural repair

·通過TFDA查廠並取得核准，得以進行異體幹細胞(UMSC01)心肌梗塞臨床1期試驗
After undergoing a factory inspection and obtaining approval from the TFDA, we were able to conduct a Phase I clinical trial of allogeneic stem cells (umsc01) for myocardial infarction.

取得專屬授權：
Obtain exclusive authorization：
·(CAR001)HLA-G嵌合抗原受體治療、核酸、受體表達質體、受體表達之用途及醫藥組合物(CAR-T)
(CAR001) HLA-G chimeric antigen receptor therapy, nucleic acids, receptor expression plasmids, receptor expression applications and pharmaceutical compositions (CAR-T)

取得專屬授權：
Obtain exclusive authorization:
·樹突狀細胞腫瘤疫苗及其製備方法
Dendritic cell tumor vaccine and its preparation method
·用於評估多形性膠質母細胞瘤患者適用以樹突狀細胞腫瘤疫苗為基礎的免疫治療之方法及預測經治療後的存活率之方法
Methods for evaluating the suitability of dendritic cell tumor vaccine-based immunotherapy in patients with glioblastoma multiforme and for predicting post-treatment survival.
·表現IGF1R之幹細胞治療腦損傷及幹細胞的應用技術
Stem cell therapy for brain injury exhibiting IGF1R and the application technology of stem cells

取得專屬授權：
Obtain exclusive authorization:
·表現IGF1R之幹細胞治療心肌梗塞及幹細胞的應用
Stem cell therapy for myocardial infarction and the application of stem cells with IGF1R expression

·長聖國際生技成立
Ever Supreme Bio Technology Established.