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Bio B2BEirGenix, Inc. 〉EG12014 Trastuzumab Biosimilar

EG12014 Trastuzumab Biosimilar

EG12014 Trastuzumab Biosimilar

The Phase 1 clinical trial for EG12014 is the first biosimilar Phase 1 trial completed by a Taiwanese company in Europe, performed in compliance with EMA and FDA biosimilar regulations.

Request for Collaboration
Overview
Eirgenix aims to commercialize the first biosimilar product manufactured in Taiwan for the global market.

Indication: HER2 Breast Cancer
Expected Product Launch: 2020
Status: Phase 1 completed, BE established between EG12014 / EU & US Herceptin

Advantages of EG12014
- The development of EG12014 follows EMA/FDA published guidance and past experience
- EirGenix clinical study set up is considered an asset while possessing unique attributes
- A profound similarity study has demonstrated EG12014 is highly similar to Herceptin® :

     -  Same amino acid sequence & physical-chemical characteristics             
     -  Similar biological properties
     -  Similar in vitro PD activity           
     -  Similar in vivo anti-tumor activities and PK profile
     -  Similar PK profile in human (Phase 1 clinical trial)            

- Through in-house medium development to achieve a competitive titer
- Pivotal trial and initial market launch material successfully produced at 1000L scale in house
- Post-approval scale-up planned at 2x2000L scale, supported by EirGenix new Zhubei facility
- No risk of patent infringement

 
Application
- Drug substance for combination treatment
- Drug substance for antibody drug conjugates (ADC)
 
Collaboration Options
Regional & global partnership for Trastuzumab biosimilar product development, phase 3 clinical trial, and commercialization.
Initial Contact -> Sign NDA -> Initial Discussion -> Sign LOI / MOU -> Partnership Discussion -> Sign Contract
 
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