乐鱼在线

● 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 ● China GMP certified ● EU GMP certified

● 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 

● First biosimilar approved and launched in China - 汉利康^® (rituximab)

● First Chinese mAb biosimilar launched in both the EU and China - 汉曲优^® (Zercepac^® in the EU, trastuzumab)

● The Company’s first product indicated for autoimmune diseases - 汉达远^® (adalimumab)

● NDAs of serplulimab (anti-PD-1 mAb) - MSI-H, HLX04 (bevacizumab) and HLX01 (rituximab) - RA accepted by the NMPA for review