● Naïve human phage display library（1.5×1010）
● Synthetic humanised llama VHH library（2×1012）
● Immunized llama VHH library（107~ 108）
● Hybridomas
● Humanisation and affinity maturation
● Fc engineering and thermal stability optimization
● Bispecific antibody engineering platform
● >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
● High-titer cell line construction platform
● Unique chromatin opening element
● Automatic and efficient transgene technique and data integration capability
● High-throughput cell line screening
● Proprietary cell culture media
● Perfusion cell culture process development
● High-throughput technology platform
● Continuous manufacturing technology
● Drugability study
● Formulation development
● Lyophilisation process development
● Fill/finish process development
● Pre-filled syringe product development
● High-concentration formulation and fill/finish 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
● In line with the quality standards of EU, US and China
● GMP-certificated by China, the EU, the U.S. regulatory agencies, as well as PIC/S participating members
● Global regulatory affairs team
● In-depth knowledge of registration paths for different markets
● Clinical approvals obtained in China, the US, the EU, Australia etc.
● Conducting or conducted 20+ clinical trials globally
● Multiple international Phase 3 clinical trials conducted or ongoing
● Compliance with GCP
● 19 Approved indications
● 3 Marketing applications (NMPA / EMA)
● 40+ Approved countries
● 2 ODDs (FDA & EC)
● First biosimilar approved and launched in China- HANLIKANG (rituximab)
● First Chinese mAb biosimilar launched in both the EU and China- HANQUYOU ( trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe)
