Lotte Biologics

Incheon, KR · Syracuse, NY
Biologics AAV
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02
82.9
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ✓ Press (20) ○ EMA GMP ○ MHRA GMP

Quick Facts: Lotte Biologics

Signal Score
82.9/100 (as of 2026-04-02)
Quality Compliance
100.0/100
Headquarters
Incheon, KR · Syracuse, NY
Modalities
Biologics, AAV
Active Programs
No ClinicalTrials.gov matches confirmed — 7 partnership announcements in press
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

Signal Score & Pillar Breakdown

Quality Compliance 100.0
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2024-09-19)
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 7 partnership announcements found in press monitoring.
Programs — no verified data
Sponsors— no verified data
ModalitiesBiologics, AAV
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 68.0
Parent company: Lotte Group
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Lotte Group
Financial assessment: 68.0/100
Capacity 68.0
2 manufacturing sites
Strong partnership activity (8 articles)
Sites: Incheon, South Korea, Syracuse, NY
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
Recent Press20 articles
2 manufacturing sites
Strong partnership activity (8 articles)

FDA Inspection History

2024-09
NAI VAI OAI
Date Site Type Observations Classification
2024-09-19 East Syracuse, New York Drug Quality Assurance No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

Recent News 20 articles

general 2026-04-01
Lotte Biologics Inks U.S. Oncology Antibody Manufacturing Deal - Businesskorea
Lotte Biologics Inks U.S. Oncology Antibody Manufacturing Deal  Businesskorea
Source →
general 2026-04-01
Lotte Biologics Signs CDMO Deal With U.S. Cancer Biotech for Antibody Drug Substance - ajupress.com
Lotte Biologics Signs CDMO Deal With U.S. Cancer Biotech for Antibody Drug Substance  aju press
Source →
general 2026-04-01
Lotte Biologics signs CDMO deal with U.S. firm for antibody drug substance - Yonhap News Agency
Lotte Biologics signs CDMO deal with U.S. firm for antibody drug substance  Yonhap News Agency
Source →
general 2026-04-01
Lotte Biologics Wins Antibody Production CDMO Contract With U.S. Oncology Biotech - 서울경제신문
Lotte Biologics Wins Antibody Production CDMO Contract With U.S. Oncology Biotech  Seoul Economic Daily
Source →
general 2026-04-01
Lotte Biologics signs US antibody deal, links Syracuse and Korea hubs - CHOSUNBIZ - Chosunbiz
Lotte Biologics signs US antibody deal, links Syracuse and Korea hubs - CHOSUNBIZ  Chosunbiz
Source →
general 2026-04-01
Lotte Biologics Signs Antibody CDMO Agreement with US Oncology Biotech Company - 아시아경제
Lotte Biologics Signs Antibody CDMO Agreement with US Oncology Biotech Company  asiae.co.kr
Source →
general 2026-04-01
Lotte Biologics Wins Antibody Production CDMO Deal With U.S. Oncology Firm - Seoul Economic Daily
Lotte Biologics Wins Antibody Production CDMO Deal With U.S. Oncology Firm  Seoul Economic Daily
Source →
partnership 2026-03-26
LOTTE Biologics Receives 2026 CDMO Leadership Awards - Businesskorea
LOTTE Biologics Receives 2026 CDMO Leadership Awards  Businesskorea
Source →
general 2026-03-26
Lotte Biologics Wins Global CDMO Award, Proves Competitiveness in Four Years - 서울경제신문
Lotte Biologics Wins Global CDMO Award, Proves Competitiveness in Four Years  en.sedaily.com
Source →
general 2026-03-26
Lotte Biologics Wins Global CDMO Award, Proves Competitiveness in Four Years - 서울경제신문
Lotte Biologics Wins Global CDMO Award, Proves Competitiveness in Four Years  Seoul Economic Daily
Source →
general 2026-03-25
Samsung Bio and Lotte Bio court CDMO deals at New York DCAT Week - CHOSUNBIZ - Chosunbiz
Samsung Bio and Lotte Bio court CDMO deals at New York DCAT Week - CHOSUNBIZ  Chosunbiz
Source →
general 2026-03-18
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations - BioSpace
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations  BioSpace
Source →
general 2026-03-18
Lotte Biologics boosts talent, builds Songdo plant, confronts Korea dual-listing risk - CHOSUNBIZ - Chosunbiz
Lotte Biologics boosts talent, builds Songdo plant, confronts Korea dual-listing risk - CHOSUNBIZ  Chosunbiz
Source →
general 2026-03-17
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations - Business Wire
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations  Business Wire
Source →
partnership 2026-03-13
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - ANTARA News
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities  ANTARA News
Source →
partnership 2026-03-09
Lotte Biologics seeks global partnerships at DCAT Week - The Korea Herald
Lotte Biologics seeks global partnerships at DCAT Week  The Korea Herald
Source →
partnership 2026-03-09
Lotte Biologics to seek CDMO partnerships at DCAT Week 2026 - koreabiomed.com
Lotte Biologics to seek CDMO partnerships at DCAT Week 2026  koreabiomed.com
Source →
partnership 2026-03-09
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - ANI News
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities  ANI News
Source →
partnership 2026-03-09
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - PR Newswire
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities  prnewswire.com
Source →
partnership 2026-03-09
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - Bolsamania
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities  Bolsamania
Source →
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