Eusol Biotech Co., Ltd. adhering to the concept of sustainable management, is committed to the development of innovative treatments to meet the unmet medical need in the nervous system disease and injury. The primary focus is on improving treatment of spinal cord and peripheral nerve injury. It is aimed to help people to recover from nerve injury and to improve their quality of life by restoring functional activity and independence. New indication development is also undergoing. The investigational product ES135 (rhFGF1) is a recombinant human acidic fibroblast growth factor. It has been patented in Taiwan, EU, China and the United States as a curative molecule with medicinal applications. Eusol has been collaborating with the medical team of the Neural Regeneration Center at Taipei Veterans General Hospital (TVGH) and has completed Phase 1 and Phase 2 clinical studies. Currently, a multicenter pivotal phase 3 clinical trial has been recruiting subjects. ES135 is produced by Eusol’s manufacturing facility located in the New Taipei City Industrial Park (WuGu Industrial Park). The site provides biopharmaceutical API manufacturing and is approved by the PIC/s GMP standard as a pilot plant which aims in product optimization, strict control of product quality, commitment to process improvement and implementation of the quality management system. In addition to the ES135, Eusol is also developing a 3-in-1 new dosage form SM-1 as a sleep aid. It is designed to be a new formulation in combination of sequential release of 3 drugs to improve sleeping quality for people with insomnia. We currently have completed a phase 3 clinical study in the US.
Since early 2021, we foresee that the global epidemic will not end in the short term, the growing demand for epidemic prevention products will continue. A task force including epidemic prevention, medical treatment, pharmaceutical information law, as well as international drug marketing experts, has been set up in due course to help fight the epidemic.
|2005||EUSOL was established.|
|2006||Eusol R&D Department was setup at Innovation Center of National Yang-Ming University.|
|2006||Pilot Plant was set up at Wu-Gu District in New Taipei Industrial Park.|
|2008||Eusol’s Wugu manufacturing site was certified by Taiwan Health Authority as a GMP pilot plant for production of biological drug substance.|
|2011||TFDA approved the TVGH “Compassionate use” program to treat 100 SCI patients with Eusol’s Investigational new drug ES135. This program has been completed in August 2014.|
|2017||Acquired 100% equity in subsidiary Sequential Medicine Ltd for developing SM-1 as sleeping aid|
|2018||ES135 Multi-Center Phase 3 pivotal clinical trial in spinal cord injury was initiated in Taiwan.|
|2018||Completion of one of the SM-1 phase 3 clinical trials in the US|
|2020||Conducting another small scale SM-1 clinical trial in the US|