The first domestic long-acting interferon was successfully listed in the R&D process for 14 years.

The first domestic long-acting interferon was successfully listed in the R&D process for 14 years.

September 26, 2016 Source: China Economic Net

Recently, the new drug “Pegigin” (PEG interferon α2b injection), which was developed by Xiamen Tebao Biotechnology Co., Ltd., was officially approved by the State Food and Drug Administration, and obtained the drug registration approval and new drug certificate. It is reported that this is the first domestically produced bio-innovative drug approved by the State Administration of Taxation in 2016.

According to the relevant person in charge of the Fujian Food and Drug Administration, “Pei Gebin” has completely independent intellectual property rights, and its exclusive 40kDY polyethylene glycol modification technology has a global patent. The clinical indication of this breed is viral hepatitis, which is the first domestically produced long-acting interferon, which broke the monopoly of similar foreign products and filled the domestic gap.

It is reported that the variety was established in 2002, submitted for clinical application in 2007, obtained clinical approval in 2009, submitted for listing in 2013, and was approved in 2016. The research and development process lasted for 14 years. Since the project was declared clinically, the Fujian Provincial Bureau has attached great importance to providing a full range of tracking services for enterprises. The Drug Registry has implemented fast acceptance, fast preliminary examination, fast verification, quick review and fast reporting for each stage of the product declaration. Five fast service, efforts to help enterprises solve the problems in the declaration, and communicated with the State Administration for many times, so that the variety received the special review procedure of the Drug Evaluation Center of the State Administration of China, which saved at least 8 months of review time. In July 2015, Tebao Biotech successfully passed the pre-marketing on-site inspection, GMP certification and registration inspection organized by the State Administration of Inspection and Quarantine, especially since the “September 22 Announcement”, the project was included in the clinical checklist. In order to ensure that the clinical quality of the project is in line with the clinical verification standards of the State Administration of Taxation, the Fujian Provincial Drug Registration Office organized four verification teams to go to more than a dozen clinical institutions across the country for verification, to help enterprises improve the quality of self-examination, and finally passed smoothly. The verification of the clinical data of the State Administration of Taxation has taken a crucial step in the approval of the variety.

On September 13th, the “Pigbin” GMP certification was officially published on the Internet. It is expected that the GMP certificate will be available in October and will be officially put into production, and the drug will be listed before the end of this year.

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