Professionalism, Innovation, and Collaboration — Our Core Values Driving Medigen Forward

  • 2024
    • Obtained IND approval from the Taiwan FDA to initiate a Phase I/II clinical trial using allogeneic Magicell-NK cell therapy for patients with pancreatic ductal adenocarcinoma or bile duct cancer.
    • Obtained approvals from Taiwan MOHW for the use of autologous GDT (gamma delta T) cell therapy at Taichung Tzu Chi Hospital, Changhua Christian Hospital, Chi Mei Hospital (Liouying), and Taipei Municipal Wanfang Hospital under the Regulations Governing the Application of Specific Medical Examination Techniques and Medical Devices (commonly referred to in Taiwan as the Special Regulation).
  • 2023
    • Medigen's first autologous GDT (gamma delta T) cell therapy program submitted under the Special Regulation has been approved by Taiwan MOHW.
    • Obtained approvals from Taiwan MOHW for the use of Medigen's Magicell-NK cell therapy at MacKay Memorial Hospital, Chang Bing Show Chwan Memorial Hospital and Show Chwan Memorial Hospital under the Special Regulation.
    • Obtained approvals from Taiwan MOHW for the use of autologous GDT (gamma delta T) cell therapy at Shin Kong Wu Ho-Su Memorial Hospital, Show Chwan Memorial Hospital, Chang Bing Show Chwan Memorial Hospital and Hualien Tzu Chi Hospital under the Special Regulation.
  • 2022
    • Obtained approvals from Taiwan MOHW for the use of Medigen's Magicell-NK cell therapy at Taipei Municipal Wanfang Hospital and Taichung Tzu Chi Hospital under the Special Regulation.
  • 2021
    • Obtained IND approval from the Taiwan FDA to initiate a Phase I clinical trial using autologous Magicell-NK cell therapy for patients with colon cancer.
    • Obtained approvals from Taiwan MOHW for the use of Medigen's autologous Magicell-NK cell therapy at Da-Lee Jen-Ai Hospital, Changhua Christian Hospital, Shin Kong Wu Ho-Su Memorial Hospital, En Chu Kong Hospital, Central Clinic & Hospital, and Taipei Medical University Hospital under the Special Regulation.
  • 2020
    • Medigen's first autologous NK cell therapy program submitted under the Special Regulation has been approved by Taiwan MOHW.
    • Completed the Phase I clinical trial of OBP-301 for liver cancer conducted in Taiwan and South Korea in collaboration with Oncolys BioPharma Inc.
    • Obtained approvals from Taiwan MOHW for the use of Medigen's Magicell-NK cell therapy at E-Da hospital, Hualien Tzu Chi Hospital, and Chi Mei Hospital (Liouying) under the Special Regulation.
    • Out-licensed the ccPCR patents to a third party for applications in the detection of human infectious diseases.
  • 2019
    • Out-licensed OBP-301, developed in collaboration with Oncolys BioPharma Inc., to Chugai Pharmaceuticals Co., Ltd.
    • Established a partnership with MEDINET Co., Ltd., a publicly listed company in Japan, and obtained an exclusive license for Gamma Delta T (GDT) immune cell therapy in Taiwan.
  • 2017
    • Completed the Clinical Study Report (CSR) for the Phase III trial of PI-88.
  • 2016
    • Out-licensed OBP-301, developed in collaboration with Oncolys BioPharma Inc., to Jiangsu Hengrui Medicine Co., Ltd.
  • 2014
    • Acquired 67.92% of the shares of Winston Medical Supply Co., Ltd., making Winston a subsidiary of Medigen.
    • Subsidiary Winston Medical Supply Co., Ltd. obtained PIC/S GMP certification.
  • 2012
    • Established subsidiary Medigen Vaccine Biologics Corp.
    • Sold the shares of subsidiary Shanghai Haoyuan Biotech to PerkinElmer, Inc. (USA)
    • Received approval from the China FDA to conduct a Phase III clinical trial of PI-88.
    • Signed a collaborative R&D agreement with Taipei Veterans General Hospital.
  • 2011
    • Medigen Biotechnology Corp. (stock code: 3176) completed its initial public offering (IPO) on the Taipei Exchange (TPEx).
    • Received Taiwan FDA approval to conduct a Phase III clinical trial of PI-88.
  • 2010
    • Acquired the full global rights to PI-88 for the treatment of liver cancer.
    • Signed a licensing agreement with Taiwan National Health Research Institutes (NHRI) for influenza vaccines.
  • 2009
    • HLA high-resolution typing kits approved by the U.S. FDA.
    • Signed a collaborative agreement with Taiwan National Health Research Institutes (NHRI) to develop a novel H1N1 influenza vaccine.
    • Collaborated with Taiwan National Health Research Institutes (NHRI) to develop cell-culture-based vaccine technology.
    • Completed the out-license of the ccPCR intellectual property to a third party.
  • 2008
    • Signed a strategic alliance agreement with Oncolys BioPharma Inc. to jointly develop OBP-301, an oncolytic virus therapy for cancer.
    • Obtained laboratory accreditation from the American Society for Histocompatibility and Immunogenetics (ASHI).
  • 2007
    • Received Taipei Biotech Awards – Gold Award for Technology Transfer for the PI-88 project.
    • Won the Gold Award in the Taiwan Biomedical Industry Startup Competition.
    • Established subsidiary TBG Biotechnology Corp.
    • Obtained Taiwan FDA approval, ISO 13485 certification, and EU CE marking for HLA nucleic acid testing kit.
    • Entered the blood screening market in China through the acquisition of Shanghai Haoyuan Biotech Co., Ltd.
    • Signed collaborative R&D agreements with the College of Medicine, National Taiwan University, and Academia Sinica to jointly develop innovative technologies.
  • 2006
    • Relocated the company headquarters to the Nangang Software Park in Taipei City.
    • Completed the Phase II clinical trial of PI-88.
    • Received the Taipei Biotech Awards – Silver Award for Technology Transfer for the“Immune Killer Cell”out-licensing project.
  • 2003
    • Received approval from the Taipei Exchange (TPEx) to be listed on the Emerging Stock.
    • Received approval from the Taiwan MOHW to conduct a Phase II clinical trial of PI-88 for liver cancer.
  • 2002
    • Received approval from the Securities & Futures Institute to launch a public offering.
  • 2001
    • Initiated the Phase I clinical trial of PI-88.
  • 1999
    • Medigen Biotechnology Corp. established.