①Neutropenia due to cancer chemotherapy and other reasons;
②Neutropenia due to chemotherapy for acute leukemia.
【R&D and Commercial Production of WHITE-C】
In 1990, an efficiently and stably expressed G-CSF engineered cell line was constructed;
In 1992, preclinical pilot-scale production processes and preclinical animal trials were successfully completed;
In 1994, clinical trial application was submitted;
In 1998, the phase I/II clinical trial approved by the Bureau of Drug Policy & Administration of Ministry of Health was completed;
In 1999, the new drug certificate issued by the Ministry of Health was obtained;
In 2000, trial production was conducted and various tests by the National Institutes for Food and Drug Control were passed;
In 2001, the approval for formal production was obtained;
In 2009, supplementary approval was obtained for the prefilled syringe;
In 2017, pegylated human granulocyte colony-stimulating factor for injection was approved for research and development.