PEGylation of recombinant human interferon α 2B injection will be approved in clinical

According to the website of the State Food and Drug Administration (CFDA) on May 12, the status of pegylated recombinant human interferon α 2B injection (hereinafter referred to as "long-acting interferon") of nine kinds of biological products applied for clinical application by Anke biology has been changed to "approved - to be certified" The product is approved for clinical use, and the company will start clinical trials as soon as it gets the clinical approval, the company said to the big smart news agency Long acting interferon is a heavy new drug declared by Anke biology in February 2012 As a green channel approval variety, it was originally expected to be approved for clinical use last year, but the clinical expectation was delayed because the product had been required to supplement information The above people said that the product has just been approved for clinical use and will not have a substantial impact on performance in the short term, but as a high-end dosage form, long-term interferon will undoubtedly be a major good for the company after it is finally approved for listing The main indications of interferon are viral hepatitis, tumor and acute infectious disease, which can be divided into long-term type and common type It is understood that in 2013, the domestic interferon sales scale exceeded 4 billion yuan, among which, the imported long-acting interferon of foreign giants Roche and Schering plough was in a monopoly position, with the sales amount accounting for more than 60%, and there was no precedent for long-acting dosage form approval in China At present, among the domestic enterprises applying for long-term interferon, Xiamen Tebao, a subsidiary of Tonghua Dongbao (600867 SH), has the fastest progress and is expected to be the first to be approved for listing Compared with the oligopoly of long-term dosage form, the domestic common interferon has a fierce competition At present, the common dosage form accounts for less than 40% of the domestic interferon sales amount, but there are more than 30 domestic production enterprises, fighting fiercely As one of them, the product's revenue last year was 111 million yuan, a year-on-year increase of 17.58%, and its gross profit rate fell 3.27% year-on-year, encountering growth bottleneck.