WuXi Biologics
Shanghai, CN · Wuxi, CN
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
83.7
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
✓ Press (20)
✓ EMA GMP (3)
✓ MHRA GMP (1)
Quick Facts: WuXi Biologics
- Signal Score
- 83.7/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- Shanghai, CN · Wuxi, CN
- Modalities
- CAR-T, Cell Therapy, AAV, ADC, Monoclonal Antibody
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About WuXi Biologics
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates3 on record
MHRA GMP Certificates1 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCAR-T, Cell Therapy, AAV, ADC, Monoclonal Antibody
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: WuXi AppTec
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: WuXi AppTec
Financial assessment: 68.0/100
Capacity
71.0
2 manufacturing sites
Broad modality coverage (5 modalities)
Regulatory milestones (9 articles)
Sites: Shanghai, CN, Wuxi, CN
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
Recent Press20 articles
2 manufacturing sites
Broad modality coverage (5 modalities)
Regulatory milestones (9 articles)
WuXi Biologics EMA GMP Compliance 3 certificates
2024-10
2024-10
2024-08
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 35282/IMP13104/00001 | Wuxi Biologics Ireland Limited | Ireland | 2024-10-11 | COMPLIANT |
| 35282/M13105/00001 | Wuxi Biologics Ireland Limited | Ireland | 2024-10-11 | COMPLIANT |
| DE_NW_03_GMP_2025_0079 | WuXi Biologics Germany GmbH | Germany | 2024-08-23 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 06, 2026
WuXi Biologics MHRA GMP Compliance 1 certificates
2025-08
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 52290 Insp GMP 52290/19113162-0001[H] | WUXI BIOLOGICS CO LIMITED | CN-214092 | 2025-08-12 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Jul 06, 2026
Recent News 20 articles
WuXi Biologics Releases 2025 Sustainability Report, Advancing Sustainable Growth and Improving Healthcare Access - The Manila Times
WuXi Biologics Releases 2025 Sustainability Report, Advancing Sustainable Growth and Improving Healthcare Access The Manila Times
Assessing WuXi Biologics (SEHK:2269) Valuation As Undervaluation Narrative Gains Traction - simplywall.st
Assessing WuXi Biologics (SEHK:2269) Valuation As Undervaluation Narrative Gains Traction simplywall.st
Assessing WuXi Biologics (SEHK:2269) Valuation As Undervaluation Narrative Gains Traction - simplywall.st
Assessing WuXi Biologics (SEHK:2269) Valuation As Undervaluation Narrative Gains Traction simplywall.st
WuXi Biologics Secures MFDS GMP Certification For Three Key Manufacturing Facilities - BioPharma APAC
WuXi Biologics Secures MFDS GMP Certification For Three Key Manufacturing Facilities BioPharma APAC
WuXi Biologics Completes Structure of Chengdu Microbial Manufacturing Site - Contract Pharma
WuXi Biologics Completes Structure of Chengdu Microbial Manufacturing Site Contract Pharma
WuXi Biologics Chengdu Microbial Commercial Manufacturing Site Achieves Structural Completion and Key Equipment Arrival - Yahoo! Finance Canada
WuXi Biologics Chengdu Microbial Commercial Manufacturing Site Achieves Structural Completion and Key Equipment Arrival Yahoo! Finance Canada
WuXi Biologics Chengdu Microbial Commercial Manufacturing Site Achieves Structural Completion and Key Equipment Arrival - Yahoo Finance
WuXi Biologics Chengdu Microbial Commercial Manufacturing Site Achieves Structural Completion and Key Equipment Arrival Yahoo Finance
WuXi Biologics Achieves Structural Completion and Key Equipment Arrival At Chengdu Microbial Commercial Manufacturing Site - marketscreener.com
WuXi Biologics Achieves Structural Completion and Key Equipment Arrival At Chengdu Microbial Commercial Manufacturing Site marketscreener.com
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics - Eastern Progress
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics Eastern Progress
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics - marketscreener.com
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics marketscreener.com
WuXi Biologics Secures MFDS GMP Certification For Three Key Manufacturing Facilities - BioPharma APAC
WuXi Biologics Secures MFDS GMP Certification For Three Key Manufacturing Facilities BioPharma APAC
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics - The Manila Times
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics The Manila Times
WuXi Biologics Secures MFDS GMP Certification For Three Key Manufacturing Facilities - BioPharma APAC
WuXi Biologics Secures MFDS GMP Certification For Three Key Manufacturing Facilities BioPharma APAC
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics - Yahoo Finance
WuXi Biologics Receives South Korea MFDS GMP Certification to Enable Commercial Manufacturing of Bispecific Antibody Therapeutics Yahoo Finance
WuXi Biologics Recognized by Morningstar Sustainalytics as Industry and Regional ESG Leader for Sixth Year - PR Newswire
WuXi Biologics Recognized by Morningstar Sustainalytics as Industry and Regional ESG Leader for Sixth Year PR Newswire
WuXi Biologics Recognized as ESG Leader by Morningstar Sustainalytics - Contract Pharma
WuXi Biologics Recognized as ESG Leader by Morningstar Sustainalytics Contract Pharma
WuXi Biologics Recognized by Morningstar Sustainalytics as Industry and Regional ESG Leader for Sixth Year - ADVFN
WuXi Biologics Recognized by Morningstar Sustainalytics as Industry and Regional ESG Leader for Sixth Year ADVFN
A Look At WuXi Biologics (SEHK:2269) Valuation After Securing ISO 13485:2016 Certification - simplywall.st
A Look At WuXi Biologics (SEHK:2269) Valuation After Securing ISO 13485:2016 Certification simplywall.st
WuXi Biologics Achieves ISO 13485 Certification, Signifying Strong Capabilities in Drug-Device Combination Product Development and Manufacturing - The Manila Times
WuXi Biologics Achieves ISO 13485 Certification, Signifying Strong Capabilities in Drug-Device Combination Product Development and Manufacturing The Manila Times
WuXi Biologics Garners ISO 13485 Certification for Drug-Device Combination Product Manufacturing - Contract Pharma
WuXi Biologics Garners ISO 13485 Certification for Drug-Device Combination Product Manufacturing Contract Pharma
Frequently Asked Questions About WuXi Biologics
Does WuXi Biologics hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA and 1 MHRA GMP certificates for WuXi Biologics.
What is WuXi Biologics's CDMO Signal Score?
WuXi Biologics has a Signal Score of 84/100, based on quality, operations, financial stability, and capacity data.
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