GI Innovation

GI Innovation Inc. (Korean: (주)지아이이노베이션) is a South Korean biopharmaceutical company headquartered in Songpa-gu, Seoul. Founded in 2017, the company focuses on research and development of innovative new drugs, particularly immuno-oncology and allergy treatments, using its proprietary GI-SMART™ platform technology. The platform enables the discovery and production of bispecific fusion proteins, a class of engineered biologics designed to simultaneously target multiple disease pathways. The company's pipeline includes several clinical-stage candidates. GI-101 and GI-102 are immuno-oncology agents; GI-101A is a CD80-IgG4-IL2v2 fusion protein being studied in combination with pembrolizumab (Keytruda) for advanced solid tumors, including urothelial carcinoma. GI-301 is an allergy treatment, and additional programs target metabolic diseases and fibrosis. GI Innovation has entered into licensing and collaboration agreements with major pharmaceutical companies, including Simcere in China and Yuhan Corporation in South Korea, and has received Fast Track Designation from the U.S. FDA for GI-101A and GI-102. GI Innovation listed on the KOSDAQ market on March 30, 2023. The company has pursued financing through convertible bonds, rights offerings, and third-party allotment capital increases to fund its clinical development programs. It maintains a scientific advisory board comprising prominent oncologists from South Korea, Australia, and the United States. The company's strategy is summarized as the "3S" approach: Science, Strategy, and Speed.

GI Innovation Inc. was founded in 2017 in South Korea. The company established its headquarters in Songpa-gu, Seoul, and focused on developing innovative biologics using its proprietary GI-SMART™ platform, which enables the discovery and production of bispecific fusion proteins for immuno-oncology and other therapeutic areas. In 2019, GI Innovation licensed GI-101 to Simcere, a leading Chinese pharmaceutical company, in a deal valued at approximately 900 billion Korean won. In 2020, the company licensed GI-301 to Yuhan Corporation in a deal valued at approximately 1.4 trillion Korean won. These out-licensing agreements provided significant validation of the company's platform technology and non-dilutive funding. GI Innovation continued to advance its pipeline through preclinical and clinical development. In 2022, the company received approval for its KOSDAQ listing preliminary review in December, and on March 30, 2023, it successfully listed on the KOSDAQ market. In October 2023, GI Innovation licensed GI-301 to Maruho Co., Ltd. for the Japanese market in a deal worth 29.8 billion Korean won. In November 2023, the company received the Minister of Health and Welfare Award as an innovative pharmaceutical company. In 2024, GI Innovation raised 10 billion won through convertible bonds and 10 billion won through a third-party allotment rights offering, securing a total of 20 billion won. The company also signed a supply agreement with MSD (Merck & Co.) in August 2024 for a combination trial of GI-102 with Keytruda (pembrolizumab). In June 2024, GI-102 received Orphan Drug Designation from the U.S. FDA for advanced and metastatic sarcoma. In November 2024, GI-102 and GI-128 were selected for the National New Drug Development Project (KDDF). In 2025, GI Innovation continued to expand its clinical programs. In January 2025, the company signed an MOU with Ranovamedicine for a GI-102 + ADC combination therapy for pancreatic cancer. In February 2025, GI-301 received a European material patent. In May 2025, the company signed an MOU with Progen for anti-aging research and advanced to the semifinals of the XPRIZE Healthspan competition. In June 2025, GI-108 received a U.S. material patent, and GI-301 received a U.S. material patent based on high sialic acid content. In July 2025, GI Innovation signed an MOU with AimedBio for glioblastoma research collaboration on GI-102. In September 2025, GI-102 received FDA Fast Track Designation. In October 2025, GI-301 received Korean MFDS IND approval for a Phase 2 clinical trial. In November 2025, the company received Australian approval for a Phase 2a clinical trial for XPRIZE. In 2026, GI Innovation achieved several milestones. In February 2026, GI-102 received Australian IND approval for a Phase 1/2 trial as monotherapy (IV, SC) and in combination (Keytruda, Enhertu). In March 2026, the company signed its first clinical supply agreement with Johnson & Johnson for prostate cancer combination therapy, and received U.S. FDA approval for a GI-102 clinical trial amendment (direct comparison with Keytruda) and a GI-101A clinical trial amendment. In April 2026, GI-102 received Korean MFDS approval for a clinical trial amendment (direct comparison with Keytruda) and U.S. IND approval for a GI-102 + pacritinib combination Phase 1b/2a trial. In May 2026, GI-102 + pacritinib combination Phase 1b/2a received Korean MFDS IND approval, and GI-101A was selected for an oral presentation at ASCO 2026 (Phase 1 trial). In August 2026, GI-101A received FDA Fast Track Designation for metastatic urothelial carcinoma, and the company advanced to the finals of the XPRIZE Healthspan competition. As of 2026, GI Innovation continues to develop its pipeline of immuno-oncology and allergy drugs, with a focus on bispecific fusion proteins and combination therapies. The company's scientific advisory board includes prominent oncologists such as Bang Young-joo, Moon Han-lim, Georgina Long, Igor Puzanov, Mario Sznol, and Kim Seok-ran.

• Company founded

• GI-101 licensed to Simcere (China) for ~900 billion KRW

• GI-301 licensed to Yuhan Corporation for ~1.4 trillion KRW

• KOSDAQ listing preliminary review approved

• Listed on KOSDAQ

• GI-301 licensed to Maruho (Japan) for 29.8 billion KRW

• GI-102 received FDA Orphan Drug Designation for sarcoma

• Supply agreement with MSD for GI-102 + Keytruda combination trial

• GI-102 received FDA Fast Track Designation

• First clinical supply agreement with Johnson & Johnson for prostate cancer combination therapy

• GI-101A received FDA Fast Track Designation for metastatic urothelial carcinoma

Next-generation innovative drug developer leveraging proprietary bispecific fusion protein platform technology.

• GI-101

  Immuno-oncology drug candidate, CD80-IL2v fusion protein

• GI-101A

  Next-generation immuno-oncology drug, CD80-IgG4-IL2v2 fusion protein, in combination with Keytruda

• GI-102

  Immuno-oncology drug candidate, CD80-IL2v3 fusion protein

• GI-301

  Allergy treatment, high sialic acid content

• GI-108

  Anti-CD73-IL2v immunocytokine for advanced solid tumors

• GI-128

  PD-L1 x LILRB1/2/4 bispecific antibody as a macrophage engager

1. 1GI Innovation official websitegi-innovation.com
2. 2GI Innovation historygi-innovation.com
3. 3GI Innovation scientific advisory boardgi-innovation.com
4. 4GI Innovation R&D capabilitiesgi-innovation.com
5. 5Wikidata entrywikidata.org
6. 6Wikipedia (Korean)ko.wikipedia.org