KAINOS MEDICINE, INC.
License-out focused drug developer behind the Parkinson's disease candidate KM-819 and the HIV therapy KM-023.
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Business overview
Source: DART corporate disclosureFounded in 2017 and listed on KOSDAQ in 2018, the company develops new drug candidates on a license-out business model. Its pipeline includes the Parkinson's disease drug KM-819, a multiple system atrophy (MSA) candidate, the HIV therapy KM-023, and the anticancer candidates IRAK4 and FAF1-novel delivery. KM-819 received FDA Phase 2 IND approval in the US, and its MSA indication received Korea Phase 2 IND approval from the MFDS in October 2025; KM-023, licensed to Chinese partner Jiangsu Aidea Pharm., saw ACC007 gain Chinese NDA approval in 2021 and ACC008 in 2023.
Products & technology
- ACC007 (Ainuovirine)HIV therapy
- ACC008 (Ainuomiti)HIV therapy, single-tablet combination (ACC007+TDF+3TC)
Clinical trials
data.go.kr4 MFDS clinical trial authorisations · 2015–2025 (Phase 2 2 · Phase 1 2)
- Phase 2KM-819정2025-10-20
2 trial sites
- Phase 2KM-819정2021-10-22
2 trial sites
- Phase 1KM-819정2016-10-21
1 trial site
- Phase 1KM-819정2015-12-29
1 trial site
R&D and key agreements
Source: DART corporate disclosureKM-819 · 파킨슨병 · 미국 FDA 임상2상 IND 승인, Part1a/1b 완료 · Developed via US subsidiary FAScinate; Phase 2 IND approved by FDA, Part 1a/1b completed, addressing FDA comments to proceed to Part 2
KM-819 (MSA 적응증) · 다계통위축증(MSA) · 한국 임상2상 IND 승인(2025.10) · Same compound as KM-819 for MSA; Korea Phase 2 IND approved by MFDS in Oct 2025; US clinical site expansion under discussion
KM-023 · 에이즈(HIV) · 기술이전 완료, 상업화 단계(파트너사) · Licensed to Jiangsu Aidea Pharm. for China (incl. Taiwan, Hong Kong) in 2014; global rights (ex-Korea) licensed in April 2023
IRAK4 · 혈액암(백혈병, 림프종) · 공동연구개발 및 기술이전 완료, 파트너사 후속연구 중단 · Co-development and license agreement with US-based Emmaus in 2021; Emmaus holds US/EU/UK commercial rights but follow-up research is paused due to its financial situation; company retains rights elsewhere
FAF1-novel delivery · 항암(적응증 미정) · 초기 후보물질 창출 연구단계 · Early hit-to-lead research completed; platform development and preclinical candidate selection ongoing
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Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-14
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