Providing innovative and affordable medicines
for all patients
  • Discovery

    ● Naïve human phage display library(1.5×1010

    ● Synthetic humanised llama VHH library(2x1012

    ● Immunized llama VHH library(107~ 108

    ● Hybridomas

    ● Humanisation and affinity maturation

    ● Fc engineering and thermal stability optimization

    ● Bispecific antibody engineering platform

  • Pre-clinical Study

    ● >70 types of in-house developed animal models covering 18 human tumors

    ● >50 types of human tumour xenograft mouse models

    ● >10 types of PBMC humanised xenograft mouse models and CD34+ humanized model 

    ● 8 types of syngeneic mouse models

  • Cell Line Construction

    ● High-titer cell line construction platform

    ● Unique chromatin opening element

    ● Automatic and efficient transgene technique and data integration capability

    ● High-throughput cell line screening

  • Upstream Process Development

    ● Proprietary cell culture media

    ● Perfusion cell culture process development


  • Downstream Process Development

    ● High-throughput technology platform

    ● Continuous manufacturing technology

  • Formulation Development

    ● Drugability study

    ● Formulation development

    ● Lyophilisation process development

    ● Fill/finish process development

    ● Pre-filled syringe product development

    ● High-concentration formulation and fill/finish process development

  • Analytical Process Development

    ● QbD based drug product quality study platform

    ● Primary & higher-order structure characterisation

    ● Purity analysis and product variant profiling

    ● Bioactivity and immunogenicity analysis

    ● Process residuals and potential pollution analysis

    ● Process comparability and analytical similarity study platform

    ● Extractable & Leachable risk assessment platform

    ● In vitro pharmacological study platform

    ● PAT on-line quality monitoring 

    ● Biomarker platform


    Quality Management

    ● In line with the quality standards of EU, US and China

    ● China GMP certified

    ● EU GMP certified

  • Investigational New Drug Application

    ● Global regulatory affairs team

    ● In-depth knowledge of registration paths for different markets

    ● clinical trial approvals obtained in different countries and regions including US, Ukraine, the Philippines etc.

  • Clinical Development

    ● Conducting or conducted 20+ clinical trials globally

    ● Multiple international Phase 3 clinical trials conducted or ongoing

    ● Compliance with GCP 

  • New Drug Application

    ● First biosimilar approved and launched in China— HLX01

    ● NDAs of HLX02 and HLX03 accepted by NMPA and assigned to  priority review list