Changchun Research Institute is the biosimilar R&D center established by Huisheng Bio in Changchun. It is responsible for product development, registration application and post-marketing research of biosimilar projects. There are nearly 50 professional R&D personnel, of which more than 90% have bachelor's degrees or above. Their majors cover molecular biology, microbial fermentation and purification, pharmaceutical preparation, drug analysis, drug registration and project management.
Changchun Research Institute boasts advanced laboratories capable of supporting genetically engineered cell construction, microbial and mammalian cell fermentation and culture, isolation and purification, and formulation research. These laboratories also meet diverse instrumental and biochemical analyses, as well as testing requirements for cell viability. Through years of development and technological accumulation, Changchun Research Institute has accumulated extensive experience in synthetic biology, encompassing multi-system high-level expression of microorganisms, continuous microbial culture, protein and peptide drug isolation and purification, structure identification, formulation development, and quality control.
Since its establishment, the company has successfully completed process development, quality research, and registration applications for more than ten insulins, including insulin degludec and insulin aspart, as well as peptide drugs. Several of these biopharmaceuticals have received marketing approval from the National Medical Products Administration (NMPA). Furthermore, the company has successfully developed and marketed a variety of key biopharmaceutical intermediates and bio-tool enzymes, achieving fruitful project results.
