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Biotech & Drug DiscoveryKOSDAQ 174900Orphan Drug1 approvals1 trials

Founded in 2010 and KOSDAQ-listed in 2017, AbClon Inc. develops the HER2-targeting antibody AC101 (HLX22) via its NEST discovery platform.

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Business overview

Source: DART corporate disclosure

Founded in 2010 by Korean and Swedish scientist groups and listed on KOSDAQ in 2017, AbClon Inc. is a biotech venture developing antibody therapeutics. The company operates the NEST antibody discovery platform and the AffiMab bispecific antibody platform, with its lead pipeline being the HER2-targeting antibody AC101 (HLX22). AbClon licensed AC101's China rights to Shanghai Henlius Biotech for USD 16.5 million (about KRW 18.8 billion) in 2016, transferred full global rights in 2018, and completed first-patient dosing in a global Phase 3 trial for metastatic gastric cancer in the US in July 2025.

Products & technology

  • AC101 (HLX22)HER2-targeting antibody for HER2-positive gastric/GEJ cancer and breast cancer

Regulatory approvals

1 Orphan Drug designations · 2025

  • OrphanNespe-cel (자가혈액유래 CD19 표적 CAR-T 세포, AT101)2025-09-17
    Orphan Drug designation · in development20250156335

Clinical trials

data.go.kr

1 MFDS clinical trial authorisations · 2021 (Phase 1/2 1)

  • Phase 1/2AT1012021-12-28

    7 trial sites

R&D and key agreements

Source: DART corporate disclosure

AC101 (HLX22) · HER2 양성 위암·위식도접합부암(G/GEJ) · 글로벌 임상 3상(미국) · FDA approved Phase 3 IND (May 2024); Japan approved Phase 3 for metastatic gastric cancer (Oct 2024); first patient dosed in US Phase 3 (Jul 2025).

AC101 (HLX22) · HER2 저발현 유방암(엔허투 병용) · 임상 2상 · First patient dosed Apr 2025 in Phase 2 combining AC101 with Enhertu for HER2-low breast cancer.

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

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