Caninized and Felinized Biologics, Five Pipelines
We carry both obesity pipelines through approval ourselves; the other three are available for out-licensing once POC is in hand.
Development Status
Development Stage
- Candidate
- Cell Line
- CMC / Preclinical
- Clinical POC
- Approval
- Candidate
- Cell Line
- CMC / Preclinical
- Clinical POC
- Approval
All pipelines are in cell line development and not yet approved. Timelines aren't shown on this page.
Our Pipelines
Our Pipelines
Canine obesity · Caninized GLP-1 receptor agonist · once-weekly subcutaneous (target product profile)
See Detail
Feline obesity · Felinized GLP-1 receptor agonist
See Detail
HER2-positive canine mammary tumour · Caninized anti-HER2 antibody
See Detail
Canine atopic dermatitis · Caninized anti-IL-31 / IL-13 bispecific
See Detail
Canine obesity and metabolic disease · GLP-1 / GIP dual agonist
See DetailRegulatory Strategy
A Parallel Regulatory Strategy for Korea, the US and the EU
KR · APQA
Veterinary drug approval under MAFRA, with requirements aligned up front through APQA pre-submission consultation.
US · FDA-CVM
The veterinary route from INAD to NADA. Some antibody products may fall to USDA-CVB rather than FDA-CVM, so jurisdiction is confirmed product by product. A partner can lead or share the filing in their region.
EU · EMA-CVMP
Regulation (EU) 2019/6, following VICH GL9 (GCP), GL40 (biologics quality) and GL43 (target animal safety). Biotechnology-derived products take the centralised route: a CVMP opinion at the EMA, then a Commission decision.
Korea, the US and the EU are the starting point. Our dossier is built to VICH guidelines, so we can pursue approval wherever a partner already operates.
Every programme is in development and pre-approval. Product properties, including dosing interval and efficacy endpoints, are development targets and have not been established in vivo. Technical, market and development detail is available under an executed CDA.