2138太阳集团(中国)有限公司-Official website

【Indications】

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.