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Biotech & Drug DiscoveryKOSDAQ 358570Orphan Drug1 approvals5 trials

GI Innovation Inc.

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Biotech company developing fusion-protein immuno-oncology and allergy therapeutics, listed on KOSDAQ since 2023.

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Business overview

Source: DART corporate disclosure

Founded in 2017 and listed on KOSDAQ in 2023, GI Innovation is a biotech company developing next-generation immunotherapies based on fusion protein technology. Its core pipeline includes the immuno-oncology candidates GI-101 and GI-102, the allergy treatment GI-301, and the metabolic immuno-oncology candidate GI-108, discovered and produced through its proprietary GI-SMART™ platform (SMART-Selex™ and SMART-cLego™). The company has completed three global licensing deals, including GI-101 to China's Simcere Pharmaceutical for USD 790 million, GI-301 to Yuhan Corporation for KRW 1,409 billion (global rights excluding Japan) plus a further USD 221 million Japan-rights deal in October 2023, along with a co-development clinical agreement with MSD (Merck & Co.).

Regulatory approvals

1 Orphan Drug designations · 2025

  • OrphanGI-102(CD80-IgG4 Fc-IL2v3)2025-01-15
    Orphan Drug designation · in development20240237740

Clinical trials

data.go.kr

5 MFDS clinical trial authorisations · 2021–2026 (Phase 1/2 3 · Phase 2a 1 · Phase 1/2a 1)

  • Phase 1/2GI-1022026-05-29

    2 trial sites

  • Phase 2aGI-1022026-02-23

    1 trial site

  • Phase 1/2aGI-1082024-12-11

    3 trial sites

  • Phase 1/2GI-1022023-02-20

    6 trial sites

  • Phase 1/2GI-1012021-04-21

    9 trial sites

R&D and key agreements

Source: DART corporate disclosure

GI-101 · 면역항암 · 임상 · Selected for a KRW 7 billion clinical program grant from the Korea Drug Development Fund (KDDF) and named to the 2020 National R&D Excellence 100 list.

GI-102 · 면역항암 · 임상 · Selected for a KRW 6.4 billion clinical program grant from the Korea Drug Development Fund (KDDF).

GI-301 · 알레르기 · 임상 · Licensed out global rights excluding Japan to Yuhan Corporation at the preclinical stage, followed by an additional licensing deal for Japan development and commercialization rights in October 2023.

GI-108 · 대사면역항암 · 임상 · Selected for a KRW 2 billion preclinical program grant from the Korea Drug Development Fund (KDDF).

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Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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