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Biotech & Drug DiscoveryKOSDAQ 09570036 trials

Genexine, Inc.

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KOSDAQ-listed biotech that launched the anemia drug EFESA (GX-E4) in Indonesia and co-develops the growth hormone candidate GX-H9 with China's TJ Bio.

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Business overview

Source: DART corporate disclosure

Founded in 1999 and listed on KOSDAQ in 2009, Genexine develops antibody-fusion protein therapeutics and gene therapy vaccines. Its anemia treatment for chronic kidney disease, EFESA (GX-E4, efepoetin alfa), completed Phase 3 trials across Indonesia, Korea, Malaysia, the Philippines, Thailand, Taiwan, and Australia, received its first marketing approval in Indonesia in October 2023, launched there in April 2024, and was submitted for approval in Korea in November 2024. Its immuno-oncology candidate GX-I7 and DNA vaccine GX-188E are being tested in combination with checkpoint inhibitors such as Keytruda and Opdivo, while its long-acting growth hormone candidate GX-H9 is in Phase 3 trials conducted through an open-innovation partnership with China's TJ Bio.

Products & technology

  • EFESA (GX-E4, efepoetin alfa)Anemia treatment for non-dialysis chronic kidney disease patients

Clinical trials

data.go.kr

36 MFDS clinical trial authorisations · 2012–2024 (Phase 1 14 · Phase 2 9 · Phase 1b 4 · Phase 1/2 4 · Phase 3 3)

  • Phase 1GX-E42024-05-28

    1 trial site

  • Phase 3GX-E42023-11-23

    5 trial sites

  • Phase 2GX-I72021-11-10

    3 trial sites

  • Phase 3GX-E42021-03-31

    9 trial sites

  • Phase 1GX-19/GX-19N2021-01-29

    2 trial sites

  • Phase 1/2aGX-19/GX-19N2020-12-11

    6 trial sites

  • Phase 1bGX-I72020-08-07

    1 trial site

  • Phase 1/2aGX-19/GX-19N2020-06-11

    2 trial sites

  • Phase 1GX-P12020-03-31

    2 trial sites

  • Phase 1GX-2002019-09-10

    2 trial sites

  • Phase 1/2GX-I72019-05-27

    1 trial site

  • Phase 1/2GX-I72018-11-30

    12 trial sites

Show 24 more
  • Phase 1bGX-I72018-09-20

    2 trial sites

  • Phase 1GX-2002018-06-22

    3 trial sites

  • Phase 3GX-E42018-03-13

    2 trial sites

  • Phase 1bGX-I72018-03-09

    5 trial sites

  • Phase 1bGX-I72017-12-27

    3 trial sites

  • Phase 1/2GX-188E2017-06-14

    9 trial sites

  • Phase 1/2GX-302017-05-22

    10 trial sites

  • Phase 1GX-022017-01-25

    1 trial site

  • Phase 1GX-I72016-11-30

    4 trial sites

  • Phase 1GX-I72016-06-01

    1 trial site

  • Phase 2GX-188E2016-03-17

    9 trial sites

  • Phase 2GX-H9 (hGH-hyFc)2016-02-22

    3 trial sites

  • Phase 2GX-G32016-02-16

    3 trial sites

  • Phase 1GX-0512015-07-06

    1 trial site

  • Phase 2GX-188E2015-01-08

    4 trial sites

  • Phase 1GX-E42014-10-21

    1 trial site

  • Phase 2GX-H9 (hGH-hyFc)2014-09-19

    8 trial sites

  • Phase 2GX-188E2014-03-11

    4 trial sites

  • Phase 1GX-0512014-02-21

    1 trial site

  • Phase 1GX-188E2014-01-08

    1 trial site

  • Phase 2GX-E42013-11-22

    15 trial sites

  • Phase 2HB-1102013-11-05

    1 trial site

  • Phase 1GX-G32013-06-26

    1 trial site

  • Phase 1GX-188E2012-05-30

    1 trial site

R&D and key agreements

Source: DART corporate disclosure

GX-I7 · 말기고형암, 교모세포종, 삼중음성유방암, 미만성거대B세포림프종 등 · 임상1b~2상(다수 병용임상) · Improves tumor-associated lymphopenia and enhances antitumor T-cell immunity; combined with Keytruda, Avastin, Temodal, and Kymriah in various trials

GX-188E · HPV16/18 유래 자궁경부암·두경부암 · 임상1b~2상 · HPV DNA vaccine combined with GX-I7 and checkpoint inhibitors Keytruda/Opdivo

GX-H9 · 성인·소아 성장호르몬 결핍증 · 성인 임상2a상, 소아 임상3상(TJ Bio) · Long-acting growth hormone dosed weekly or biweekly; Phase 3 conducted with China's TJ Bio via open innovation

GX-G3 · 호중구감소증(항암제 투여 비골수성 종양) · 임상2상(ILKOGEN) · Improved efficacy and safety versus PEGylated G-CSF

GX-G6 · 제2형 당뇨병 · 임상3상(CSPC) · Long-acting GLP-1 receptor agonist

GX-P1 · 자가면역질환, 뇌염증질환 · 임상1~1b상 · Mechanism based on inducing T-cell immune tolerance

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Sources and updates

Company basics
Korea Exchange · DART
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Compiled from disclosure filings
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Measured 2026-08-13

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