Meridigen Biotech Co., Ltd. (Meridigen) is dedicated to developing mesenchymal stem cells (MSCs)-based technologies from manufacturing, characterization, storage, to drug discoveries. Moreover, we have been acquiring other avant-garde technologies, such as machine learning and artificial intelligence, to strive toward invention of smart medical products for the improvement of innovation and precision of medicine. Meridigen’s MSC drugs strictly follow the international standard of Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice (PIC/S GMP). Whereby, we have optimized the large-scale manufacturing process, from the raw materials to the final products. It also complies with TFDA’s regulations “Guideline on human cell-based medicinal products” and “Guidelines on the clinical applications of human cell-based medicinal products”. Besides, the manufacturing process has many steps of tests that have been referred to the drug regulatory of FDA, MFDS (Korea), and EU, to ensure the quality of our products is following the GMP standard of these developed countries.
Meridigen was founded in Taiwan, yet with an aim to harbor the world. Being led by the founder John Hsuan (Min-Chih Hsuan) and Chairman Yogi Hsuan, the company has been actively contributed and expanded to the stem cell industry, establishing the largest bank for placenta and umbilical cord derived stem cells in the Chinese world. Meridigen targets this niche market in cooperation with cross- straits industry and academics, to push precision medicine to another level and to discover the potential of stem cell drugs. We strive toward the launch of our stem cell drugs that can benefit the global well-beings of mankind.
Our History
2019 |
Patent granted in Taiwan for pharmaceutical composition for treating chronic obstructive pulmonary disease and method thereof. |
The review for UMC119-06 (COPD) IND has been approved by Taiwan FDA. |
Patent granted in Korea for biomarker EphA2 used for characterizing mesenchymal stem cells. |
Patent granted in Japan for biomarker EphA2 used for characterizing mesenchymal stem cells. |
The review for UMC119-06 (COPD) IND has been approved by USFDA. |
The review for UMC119-06 (AIS) IND has been approved by Taiwan FDA. |
The review for UMC119-06(AIS) IND has been completed by USFDA. |
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2018 |
Patent granted in Singapore for biomarker EphA2 used for characterizing mesenchymal stem cells. |
Second patent granted in Taiwan for biomarker EphA2 used for characterizing mesenchymal stem cells. |
The review for UMC119-01 IND has been completed by Taiwan FDA. |
Patent granted in China for biomarker EphA2 used for characterizing mesenchymal stem cells. |
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2017 |
The review for UMC119-01 IND has been completed by USFDA. |
Filed for the Investigational New Drug (IND) to TFDA. |
Completed toxicological testing of the MSC drug UMC119-01 in animal models. |
Patent granted in Taiwan for biomarker EphA2 used for characterizing mesenchymal stem cells. |
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2016 |
Completed the drug efficacy testing of the MSC drug UMC119-01 in animal models. |
Patent granted in USA for biomarker EphA2 used for characterizing mesenchymal stem cells. |
Revalidated for the 2015 Taiwan Intellectual Property Management System. |
Obtained the certificate of pharmaceutical manufacturer from Dept. of Health, New Taipei City. |
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2015 |
Selected by Centre for Drug Evaluation of Taiwan as the “Index case” that receives regulatory counselling services. |
Selected by IDB-MOE for the “IP management taking root plan” and “counselling services for IP strategies”. |
Funded by Dept. of Economics Development-Taipei City for the project “Development of pre-clinical processes for applied stem cell therapeutics”. |
Meridigen Pharmaceuticals Factory completed. |
Our pharmaceutical factory was approved by the Econ Development Dept. of New Taipei City Government. |
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2014 |
Qualified by IDB-MOE as Biotech and New Pharmaceutical Company. |
Collaborated with National Chiao Tung University for stem cell research. |
Started constructing the PIC/S GMP-standardized factory. |
Awarded by Industrial Development Bureau(IDB) as a model for Taiwan Intellectual Property Management System. |
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2013 |
R&D Laboratory established in Neihu. |
Meridigen Biotech Co., Ltd. acquired the Da-Chan Umbilical Cord Cell Bank and renamed as Meribank. |
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2011 |
Meridigen Biotech Co., Ltd. established. |
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