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Biotech & Drug DiscoveryKOSDAQ 0392004 approvals3 trials

KOSDAQ-listed drug developer whose out-licensed targeted lung cancer therapy has received approval from Korea's MFDS and the US FDA.

As of 2026-10-10, OSCOTECInc. has 4 Korean MFDS device approvals, 13 PubMed-indexed papers 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 1998 and listed on KOSDAQ in 2007, OSCOTEC is a research-driven new drug development and biotech company. It operates a synthetic new drug development business, a functional-materials and related-products business, and a dental bone-graft-material business, and currently has two synthetic drug candidates in clinical trials. Its out-licensed targeted therapy for lung cancer, licensed to a domestic pharmaceutical company, has been approved by Korea's MFDS and the US FDA as a first-line treatment, either as monotherapy or in combination.

Products & technology

  • Bone graft materials and membranesDental bone graft materials and membranes
  • Functional materialsHealth functional food ingredient materials

Regulatory approvals

data.go.kr

4 Korean MFDS device approvals · 1999–2014

  • MFDSBarrier, intra oral, resorbable2014-02-25
    Product approval · Class 4제허 14-482 호
  • MFDSBone graft material, animal source or other living things’ source2010-08-03
    Product approval · Class 4제허 10-771 호
  • MFDSBone graft material, syntheticRevoked2006-05-10
    Product approval · Class 4제허 06-318 호
  • MFDS치과용골이식재Revoked1999-12-10
    Product approval · Class 3제허 99-365 호

Clinical trials

data.go.kr

3 MFDS clinical trial authorisations · 2021–2026 (Phase 1 3)

  • Phase 1SKI-O-7032026-05-21

    2 trial sites

  • Phase 1OCT-5982025-11-18

    12 trial sites

  • Phase 1SKI-G-8012021-07-29

    4 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

합성 신약 후보물질(2종) · 임상시험 진행중 · Synthetic small-molecule candidates for arthritis and oncology indications, currently in clinical trials

표적항암제(폐암 치료물질) · 폐암 · 한국 식약처·미국 FDA 승인 · Out-licensed to a domestic pharmaceutical company; approved as first-line monotherapy or combination therapy

Key disclosures

KRX KIND via OpenDART
Show 20 more events

Publications

PubMed · affiliation-matched
Show 3 more publications

Patents

KIPRIS · applicant-matched
Show 86 more patents

AI reads

MAA server logs · IP-verified
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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 10, 2026

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Companies approved for the same productsBiotech & Drug Discovery

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

NIBEC CO., LTD.3 shared

Founded in 2004 and listed on KOSDAQ in 2011, NIBEC develops dental tissue regeneration biomaterials and peptide-based biomaterials.

DENTIS CO.,LTD2 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

METABIOMED.CO.,LTD2 shared

KOSDAQ-listed medical device company manufacturing synthetic bioresorbable suture yarn and dental root canal filling materials.

OSTEONIC Co., Ltd.2 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

CELLUMED CO., LTD.1 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

DIO Corporation1 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

Samyang Biopharm Corporation1 shared

Founded and KOSPI-listed in 2025, Samyang Biopharm develops medical devices, pharmaceuticals, and new drug candidates.

SHINHUNG CO.,LTD1 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

T&R Biofab Co., Ltd1 shared

Founded in 2013 and KOSDAQ-listed in 2018, T&R Biofab commercializes 3D bioprinting systems, bioinks, and biodegradable scaffolds.

AHNLAB,INC.100

KOSDAQ-listed integrated security company behind the V3 antivirus and AhnLab TrusGuard and XDR solutions.

Inventage Lab Inc.100

Drug delivery system company behind the long-acting injectable platform IVL-DrugFluidic and the LNP delivery platform IVL-GeneFluidic.

ORGANOIDSCIENCES LTD.100

Organoid-based biotech founded 2018, KOSDAQ-listed 2025, developing the ATORM-C regenerative therapeutic and ODISEI evaluation solution.

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

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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