Eusol Biotech Co., Ltd.


Chairman: HongJen Chang, MD, MS, MPH
Year Established: March 16th, 2005
Tel: 886-2-2718-5128 (Corporate), 886-2-2299-4836 (Plant)
Fax: 886-2-2718-3118 (Corporate), 886-2-2299-6026(Plant)
Corporate Address: 6F., No.135, Sec.3, Minsheng E. Rd., Songshan Dist., Taipei 10546, Taiwan.
          Manufacturing Plant Address:5F., No.9, Wuquan Rd., Wugu Dist., New Taipei City 24886, Taiwan



Company Overview

Milestones

1. Since its establishment in March 2005, Eusol Biotech has been mainly engaging in advancing R&D and the manufacturing technologies toward the ultimate marketing Commercialization of the prospective recombinant human acidic fibroblast growth factor (rhFGF1) product that possess to certain clinical efficacy.

2. The manufacturing plant of Eusol Biotech, which locates in a standard factory building at New Taipei Industrial Park (WuGu Industrial Park), has been certified as a PIC/S GMP facility for biopharmaceutical API manufacture and any relevant contract-manufacture services by Taiwan regulatory authority. 

3. A Pivotal phase Ⅱ clinical trial of rhFGF1 for the repairs of traumatic spinal cord and spinal nerves was conducted at Taipei Veterans General Hospital and, subsequently, its study report was accepted by MOH for the conclusion of the clinical trial in January, 2011.  During this trial, clinical samples of rhFGF1 were supplied by the Company. Thereafter, Taipei Veterans General Hospital has been continuously gaining TFDA’s approval to treat additional patients with the Company’s rhFGF1 under special authorization.

Present Status

The Company has submitted the FEGENN® NDA to TFDA of Ministry of Health and Welfare for the marketing approval in R.O.C.