Clinical approval of pegylated recombinant human interferon α 2B injection in Anke

On the evening of May 22, an kebio announced that the company's self-developed and characteristic pegylated recombinant human interferon α 2B injection was approved by the State Food and Drug Administration for clinical trials and began to enter the stage of clinical trials Pegylated recombinant human interferon α 2B injection, also known as "long-acting interferon", is a modification of recombinant human interferon α 2B by PEGylation technology, which prolongs its half-life in human blood, reduces injection frequency and improves patients' compliance This product is the upgrading product of the company's leading product recombinant human interferon α 2B injection, which belongs to the company's heavyweight new drug It was originally expected to be approved for clinical use last year, but the clinical expectation was delayed because the product was required to supplement information It is understood that the main indications of interferon are viral hepatitis, tumor and acute infectious diseases, which are divided into long-acting and common types 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, 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 The pegylated recombinant human interferon α 2B injection still needs clinical research, and the product can only be put into market after passing the clinical research.