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Human Granulocyte Colony-stimulating Factor Injection
Since its introduction into the market in 1999, WHITE-C has been clinically applied for more than 20 years, with a wide range of evidence-based applications, topping the list of domestic similar products in terms of export volume. As strict in-house control quality standards are followed, WHITE-C is not only in line with Chinese Pharmacopoeia, but also European Pharmacopoeia.
Drug description

【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.

Drug description
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