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Biotech & Drug DiscoveryKOSDAQ 0283002 approvals

Multi-business group in healthcare, biotech, and shipbuilding, developing the oral anticancer drug rivoceranib and the cholangiocarcinoma therapy RLY-4008.

As of 2026-10-08, HLB Co.,LTD. has 2 US FDA clearances/approvals on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded in 1985 and listed on KOSDAQ in 1996, the company operates three business segments: healthcare, biotech, and shipbuilding. In biotech, it holds the oral angiogenesis-inhibiting TKI rivoceranib and the cholangiocarcinoma drug RLY-4008 (lirafugratinib) licensed from Relay Therapeutics. Rivoceranib's NDA was submitted to the US FDA in May 2023, and the company acquired its global ex-China patent rights from Advenchen Laboratories for USD 22M and its China patent rights from SFFT Developing for USD 20M, both in September 2020.

Products & technology

  • body care deviceMedia-commerce consumer product
  • plant-based melatonin ODFMedia-commerce consumer product

Regulatory approvals

openFDA

1 US FDA drug approvals · 2026 / 1 US FDA 510(k) · 2025

  • FDA drugSubsidiary: Elevar Therapeutics, Inc.LYRFIGTU2026-09-23
    FDA drug approval · NDANDA220425
  • FDASterilized Eol Auto Lancet; Sterilized Eol Lancet Plus2025-01-13
    510(k) · TraditionalGeneral, Plastic SurgeryK243533

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

리보세라닙(Rivoceranib) · 간세포암 1차 치료(캄렐리주맙 병용) · 임상3상 결과 발표, FDA NDA 제출 · Oral TKI targeting angiogenesis; Phase 3 results for 1st-line hepatocellular carcinoma (with camrelizumab) announced Sep 2022; FDA NDA submitted May 2023; final results presented at ASCO Jun 2024

RLY-4008(리라푸그라티닉) · 담관암 · 라이선스 도입, 혁신신약 지정 · Global exclusive license-in from Relay Therapeutics in Dec 2024; granted Breakthrough Therapy designation

Key disclosures

KRX KIND via OpenDART

Patents

KIPRIS · applicant-matched
Show 26 more patents

AI reads

MAA server logs · IP-verified
44
Times AI engines pulled HLB Co.,LTD.'s records

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Last 30 days
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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 7, 2026

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Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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