WuXi Biologics

Shanghai, CN · Wuxi, CN
CAR-T Cell Therapy AAV ADC Monoclonal Antibody
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
Sponsorsno 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

general 2026-04-29
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
general 2026-04-28
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
general 2026-04-28
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
regulatory 2026-04-25
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
general 2026-04-24
WuXi Biologics Completes Structure of Chengdu Microbial Manufacturing Site - Contract Pharma
WuXi Biologics Completes Structure of Chengdu Microbial Manufacturing Site  Contract Pharma
general 2026-04-24
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
general 2026-04-24
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
general 2026-04-24
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
regulatory 2026-04-23
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
regulatory 2026-04-23
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
regulatory 2026-04-23
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
regulatory 2026-04-23
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
regulatory 2026-04-23
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
regulatory 2026-04-23
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
regulatory 2026-04-17
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
general 2026-04-17
WuXi Biologics Recognized as ESG Leader by Morningstar Sustainalytics - Contract Pharma
WuXi Biologics Recognized as ESG Leader by Morningstar Sustainalytics  Contract Pharma
regulatory 2026-04-17
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
general 2026-04-16
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
general 2026-04-15
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
general 2026-04-15
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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