Lotte Biologics
Incheon, KR · Syracuse, NY
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
83.7
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (20)
○ EMA GMP
○ MHRA GMP
Quick Facts: Lotte Biologics
- Signal Score
- 83.7/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100
- Headquarters
- Incheon, KR · Syracuse, NY
- Modalities
- Biologics, AAV
- Active Programs
- No ClinicalTrials.gov matches confirmed — 1 partnership announcement in press
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Lotte Biologics
Korean conglomerate entering biologics CDMO. $1.6B investment.
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. 1 partnership announcement 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.
Partnership Announcements (from press monitoring)
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
71.0
2 manufacturing sites
Strong partnership activity (9 articles)
Regulatory milestones (3 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 (9 articles)
Regulatory milestones (3 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 May 20, 2026
Recent News 20 articles
Lotte Group chief makes first inspection tour of U.S. bio campus since 2023 acquisition - MSN
Lotte Group chief makes first inspection tour of U.S. bio campus since 2023 acquisition MSN
Lotte Group chief makes first inspection tour of U.S. bio campus since 2023 acquisition - MSN
Lotte Group chief makes first inspection tour of U.S. bio campus since 2023 acquisition MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate - MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate - MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate - MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate - MSN
Lotte Biologics inks agreement with Ottimo Pharma on antibody drug candidate MSN
Lotte Group chief makes first inspection tour of U.S. bio campus since 2023 acquisition - MSN
Lotte Group chief makes first inspection tour of U.S. bio campus since 2023 acquisition MSN
Lotte Biologics to showcase SoluFlex Link ADC platform at AACR 2026 - koreabiomed.com
Lotte Biologics to showcase SoluFlex Link ADC platform at AACR 2026 koreabiomed.com
LOTTE Biologics, Ottimo Pharma Sign Antibody Manufacturing Contract - Contract Pharma
LOTTE Biologics, Ottimo Pharma Sign Antibody Manufacturing Contract Contract Pharma
LOTTE Biologics Secures Partnership with a Japan-Based Global Pharmaceutical Companyobal Pharmaceutical Company - businesskorea.co.kr
LOTTE Biologics Secures Partnership with a Japan-Based Global Pharmaceutical Company Businesskorea
Lotte Biologics Signs Contract Development and Manufacturing Agreement for Anticancer Drug with Japanese Pharmaceutical Company - 아시아경제
Lotte Biologics Signs Contract Development and Manufacturing Agreement for Anticancer Drug with Japanese Pharmaceutical Company 아시아경제
Lotte Biologics secures Japan CDMO deal to advance cancer drug development - CHOSUNBIZ - Chosunbiz
Lotte Biologics secures Japan CDMO deal to advance cancer drug development - CHOSUNBIZ Chosunbiz
Lotte Biologics Signs Contract Development and Manufacturing Agreement for Anticancer Drug with Japanese Pharmaceutical Company - 아시아경제
Lotte Biologics Signs Contract Development and Manufacturing Agreement for Anticancer Drug with Japanese Pharmaceutical Company 아시아경제
Lotte Biologics Signs CDMO Deal With Japanese Pharma Firm for Cancer Drug - en.sedaily.com
Lotte Biologics Signs CDMO Deal With Japanese Pharma Firm for Cancer Drug Seoul Economic Daily
Lotte Biologics Signs CDMO Deal With Japanese Pharma Firm for Cancer Drug - Seoul Economic Daily
Lotte Biologics Signs CDMO Deal With Japanese Pharma Firm for Cancer Drug Seoul Economic Daily
LOTTE BIOLOGICS Signs CDMO Deal With U.S. Oncology Biotech Company - thelec.net
LOTTE BIOLOGICS Signs CDMO Deal With U.S. Oncology Biotech Company thelec.net
Lotte Biologics Inks U.S. Oncology Antibody Manufacturing Deal - Businesskorea
Lotte Biologics Inks U.S. Oncology Antibody Manufacturing Deal Businesskorea
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
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
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
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