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Human Interferon α1b for Injection
The first α1b interferon in the world using Chinese gene for cloning and expression, which makes its clinical use consistent with the natural antiviral status of Chinese population. It has high purity, good stability, stronger antiviral activity and immune regulation ability, and lower neutralization antibody production rate and drug antigenicity.
Drug description

【Indications】

① Viral diseases and some malignant tumors;

② Chronic hepatitis B, hepatitis C and hairy cell leukemia;

③ Viral diseases such as herpes zoster, condyloma acuminata, epidemic hemorrhagic fever and respiratory syncytial virus pneumonia in children;

④ Malignant tumors such as chronic myelogenous leukemia, melanoma and lymphoma.


【R&D and Commercial Production of SINOGEN】

In 1982, the Institute of Virology, Chinese Academy of Preventive Medicine (one of the shareholders participating in the establishment of Shenzhen Kexing Bioproducts Co., Ltd., a subsidiary of Kexing Biopharm) successfully constructed a genetically engineered human α1 interferon strain with commercially significant expression;


In 1985, Shanghai Institute of Biological Products (one of the shareholders participating in the establishment of Shenzhen Kexing Bioproducts Co., Ltd.), Ministry of Health, completed the study on whole processes from high-density engineered strain fermentation, product extraction to purification, and made the product into a preparation for injection;


In 1989, the clinical trial of genetically engineered human α1 interferon for injection was conducted with certain clinical effects achieved, and the application for a trial production license was submitted;


In 1992, the new drug certificate issued by the Ministry of Health was obtained.


In 1993, the pilot production of interferon samples was completed, and three consecutive batches of product samples were tested by the National Institute for the Control of Pharmaceutical and Biological Products;


In 1994, the approval number for trial production was obtained;


In 1996, the approval number for formal production was obtained, and the new drug belonged to Class I biological products; it was known as the first genetically engineered innovative drug in China with high clinical recognition and popularity.


In 2014, the capacity of interferon α1b expanded fivefold.


Drug description