FFuzkk Atlas of China
#8Official Top 100

Hengrui Pharma

江苏恒瑞医药股份有限公司

#8

Oncology, ADC and high-potencyChemical medicines and finished dosage formsBiologics

Manufacturing profile

Oncology, ADC and high-potency
Chemical medicines and finished dosage forms
Biologics

Region: Jiangsu

Selection basis

The company is included in the official 2024 ranking of the 100 largest Chinese pharmaceutical-industry enterprises by main-business revenue.

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1Raw-material receipt and identification
  2. 2Dispensing, blending and granulation
  3. 3Tableting, encapsulation or solution preparation
  4. 4Packaging and labelling
  5. 5HPLC, GC, KF, ICP/AAS, dissolution and stability QC
  6. 6Cell bank or microbial seed
  7. 7Upstream culture or fermentation
  8. 8Clarification and chromatography
  9. 9UF/DF, formulation and sterile filtration

Relevant FUZKK packages

ADC / Conjugated Biologics QC SuiteGlobal API & Biosimilars QC SuiteChina: national essential medicines QC packageLumex QC SuiteLabEx QC Suite

Product/API utilities

ADC Aggregation MonitorADC Drug Antibody Ratio AnalyzerADC Free Payload QuantifierADC Linker Stability ProfilerADCRelease Readiness CheckerAssay & Impurities Result ReviewerResidual Host Cell DNA Quality CheckerResidual Host Protein Checker

Lumex — instrumental QC

CE Glycosylation ProfilerCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Peptide Map ValidatorGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt RhLabWare CDS Bridge ConnectorContent Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation Checker

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerLC-MS Confirmation Quality CheckerSterility Test Membrane Filtration Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerContent Uniformity Quality CheckerDissolution Apparatus 1 & 2 Quality CheckerStability Condition Monitoring Quality CheckerBiologic Aggregate Size Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerData Integrity Security CheckerRelease Readiness CheckerSupplier Evaluation CheckerCalibration Status CheckerChange Control Impact CheckerRequirement Traceability Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand the scope.

Mapping boundary

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Methodology