Company Information

Major Milestones

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2021

5Month
  • BioGend submitted Investigational Device Exemption (“IDE”) application to U.S. FDA
4Month
  • April 21, 2021. BioGend submitted the application for importing permit of 「“RevoCart” One-Step Autologous Cartilage Repair System」to China National Medical Products Administration.
2Month
  • “RECOMBINANT POLYPEPTIDES, COMPOSITIONS, AND METHODS THEREOF” Patent related to our products associated with Osteoinductive factor (OIF) was granted from USPTO.
1Month
  • BioGend acquired self-paid price for RevoCart one-step autologous cartilage repair system.

2020

12Month
  • BioGend Therapeutics Co., Ltd. (stock code: 6733) held a performance presentation before stock listing on December 22, 2020
11Month
  • “RECOMBINANT POLYPEPTIDES AND NUCLEIC ACID MOLECULES, COMPOSITIONS AND METHODS OF MAKING AND USES THEREOF” Patent related to our products associated with Osteoinductive factor (OIF) was granted from European Patent Office (EPO).
11Month
  • “RECOMBINANT POLYPEPTIDES, COMPOSITIONS, AND METHODS THEREOF” Patent related to our products associated with Osteoinductive factor (OIF) was granted from Taiwan Intellectual Property Office (TIPO).
10Month
  • “RECOMBINANT POLYPEPTIDES AND NUCLEIC ACID MOLECULES, COMPOSITIONS AND METHODS OF MAKING AND USES THEREOF” Patent related to our products associated with Osteoinductive factor (OIF) was granted from USPTO.
4Month
  • BiG009 “RevoCart One-step Autologous Cartilage Repair System” has received the premarket approval (Certificate No. 006689) from the TFDA.

2019

12Month
  • BiG009 RevoCart Clinical Evaluation Report was accepted by the FDA.
11Month
  • Obtained the“Scientific and Technological Business Opinion”letter issued by Bureau of Industry, Ministry of Economic Affairs.
9Month
  • Additional investment in Osteopharma, Inc., Japan increasing the share holding from 16 to 43%.
8Month
  • “RECOMBINANT POLYPEPTIDES AND NUCLEIC ACID MOLECULES, COMPOSITIONS, AND METHODS OF MAKING AND USES THEREOF” Patent related to our products associated with Osteoinductive factor (OIF) was granted from Taiwan Intellectual Property Office (TIPO).
7Month
  • 1.BiG-009, RevoCart has completed the data analysis of the pivotal trial indicating the outcome measures were met.
    2.The contract manufacturer of BiG-009, RevoCart has passed the GMP inspection and accreditation by the TFDA.
6Month
  • The major protein used in BiG-001 and BiG-006 to stimulate bone regeneration received a patentable ruling related to active ingredients from the Taiwan Intellectual Property Office.
6Month
  • Completed registration at the TPEx Emerging Stock Board
4Month
  • Applied to TPEx Emerging Stock Board to issue the stock public offering, effective April 3, 2019.
2Month
  • Issued 12,000,000 new shares at TWD 10 per share for employee purchase, increasing the paid-in capital to 820 million TWD.

2018

10Month
  • Issued 14,289,300 new shares at TWD 30 per share increasing the paid-in capital to 700 million TWD.
6Month
  • BiG-001 received the conditional approval from the TFDA for an IDE clinical study.
4Month
  • BiG-009, RevoCart completed the enrollment of the last patient required in the pivotal clinical trial.
3Month
  • Completed merge with Exactech Taiwan; issued 5,710,700 new shares at TWD 10 per share, increasing the paid-in capital to 557,107,000 TWD

2017

12Month
  • Merged with Exactech Taiwan with a stock-for-stock transaction, and the merging date was December 31, 2017.
10Month
  • BiG-001, Osteoinductive Bone Graft for Fracture Fixation, and BiG-006, Osteoinductive Bone Graft for Spinal Fusion, met the qualification requirement in the Act For The Development Of Biotech And New Pharmaceuticals Industry.
8Month
  • Made a strategic investment in Excactech Taiwan and obtained 81% of shares.
5Month
  • Completed a new round of fundraising by issuing 25 million shares at TWD 10 per share, increasing the paid-in capital to 500 million TWD.

2016

7Month
  • Obtained the right to the osteoinductive factor from Osteopharma, Inc., Japan; made a strategic investment in exchange of 16% of shares
7Month
  • BioGend incorporated with the capital of 250 million TWD

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