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R&D

R&D

Biosimilar Pipeline

Biologics Pipeline

Product	Major indications	Cell Line/ Manufacturing Process Dev.	Pre-clinical	Clinical Phase I	Clinical Phase III	Lunching	Note
EPO	Anemia	Lunching(KR, MY, KSA, PH, TR)					Second biosimilar EPO in the world Compliance with the EMA biosimilar EPO guidelines Promotion for Halal certification in progress by Duopharma, Malaysia Registered the biosimilar EPO in Thailand(24.09)
Factor Ⅷ	Hemophilia A	Approval global Phase III clinical trial					Compliance with EMA Factor Ⅷ Guideline Completed the PGA40(rhFVIII) Phase I clinical trial (2020.09) Received the approval of PGA40(rhFVIII) Phase III clinical trial from MFDA (2021.09) Promoting domestic and international technology transfer
Aflibercept	Macular degeneration, etc.	Completed non-clinical trial					Promotion of joint development and technology transfer with European or Japanese partners Confirmation of excellent quality equivalence between the reference drug EYLEA® and the Pangen’s biosimilar Patent application for therapeutic composition Completed preclinical trials (2020.09)
Anti-SFTSV Ab	SFTS	In non-clinical trial					The world's first treatment for tick-borne severe fever with thrombocytopenia syndrome Completion of production cell line and process technology (2020.08) Korea Disease Control and Prevention Agency, National Institute of Health Research Service (23.06~25.04)
G-CSF	Neutropenia	Completed non-clinical trial					First biosimilar Lenograstim product in the world Compliance with EMA biosimilar G-CSF Guideline Multinational joint clinical trial is being designed.

* Other protein treatments, antibody treatments, etc. are under development