Xiamen Tebao new drug pegylated interferon α - 2b injection is the first in China to be approved soon

According to the information on CFDA's website on November 5, Tonghua Dongbao (600867 SH), a joint-stock company of Xiamen Tebao, will enter the GMP field inspection this month Industry insiders predict that the product will become the first imitation in China after being approved, with a market scale of more than one billion It is worth mentioning that the on-site inspection of GMP is a necessary link for the approval and listing of drugs At present, the drug in the drug evaluation center (CDE) of the State Food and drug administration has been in the link of formulating the inspection scheme for the on-site inspection of the certification center, and it is expected to enter the on-site inspection of drug registration in the near future According to the registration and application progress of similar drugs, the product is expected to be approved for production within half a year According to the public information, pegylated interferon α - 2b injection is a kind of biological product, which is used to treat chronic hepatitis B and C Among the similar products in the world, only Schering plough's recombinant human interferon α - 2b (trade name "Intron-A", ganleneng, listed in 1991) and Roche's long-acting interferon polyglycosylated α - 2A (trade name "Pegasys", listed in 2005) jointly occupy more than half of the hospital's anti hepatitis B interferon market It is worth mentioning that there are about 45 million hepatitis C carriers and 120 million hepatitis B carriers in China Pegylated interferon α - 2b injection is a national major new drug creation and clinical research project during the 12th Five Year Plan period It was declared to be listed in January 2014 Xiamen Tebao has obtained patent authorization from nearly 30 countries, including the United States, Europe, Japan, Australia and China Shenwan Hongyuan research report pointed out that Xiamen Tebao will be the first generic drug of pegylated interferon α - 2b injection It is expected that no domestic drug of the same kind will be listed in three years, and it will enjoy the space of import substitution for a long time Because of the huge number of patients with chronic hepatitis C and chronic hepatitis B in China, this is a new breed with a billion income scale According to the public information, Tonghua Dongbao holds 34.41% of the shares of Xiamen Tebao, which is mainly engaged in the research and development of genetic engineering technology and the industrialization of biomedicine In addition to pegylated interferon α - 2b injection, there are three class I biological products, namely y-pegylated recombinant human granulocyte stimulating factor injection, y-pegylated recombinant human growth hormone injection and y-pegylated recombinant human interferon α 2A injection, which are in phase II clinical research stage.