Another long-lasting EPO was approved in the domestic EPO market competition is becoming more intense
Last Update: 2020-06-17
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Recently, Concord Fermentation Kirin Co., LtdDayibotin alpha injection application (JXSS190005/6/7/8/9) in nMPA status changed to "in approval", which means that another long-acting EPO drug will soon be approved in Chinachronic kidney disease (CKD) is the most common major chronic disease after cardiovascular and diabetic disease in China, with a prevalence rate of 10.8%According to a large-scale cross-sectional survey of Chinese adults conducted between September 2009 and September 2010, published in The Lancet in March 2012, it is estimated that there are about 120 million CKD patients in ChinaAnemia is a common complication of CKD, with anaemia rates of 98.2% and 52.0% in dialysis and non-dialysis CKD patients, respectively, accelerating the progression of chronic kidney disease, increasing the risk of death, and significantly affecting the quality of life of patientsfor a long time, the treatment of renal anemia has relied on exogenous injection recombinant human erythropoietin (rHuEPO) and auxiliary iron supplementationHowever, in recent years, a new drug for the treatment of renal anemia, namely rosasta, is the world's first small molecule low-molecule low-oxygen induced factor prosaica hydroxylase inhibitor (HIF-PHI), promotes red blood cell production by promoting endogenous erythropoietin production, improves iron regulation, and overcomes the adverse effects of inflammation on hemoglobin and hemoglobin production by lowering ferritinThe drug was approved in 2018 for the treatment of anemia in CK dialysis patients, and then by NMPA in 2019 for the treatment of non-dialysis-dependent chronic kidney disease (NDD-CKD) anemia, achieving full coverage for patients with renal anemiaDarbepoetin alfa is a long-acting recombinant human erythropoietin (EPO) developed in 1996 by Japan's Concord Kirin Pharmaceuticals and Amgen, which is a long-term mechanism for achieving longer semi-life and continuous erythropoietin-producing activity by partially modifying the amino acid sequence of human erythropoietin and adding new sugar chains to its moleculesthe drug was listed in the United States in 2001 (the product is called Arnesp, which is owned by Amjin) and in Japan in 2007 (the product is called Espo, which is owned by Concord Fermentation Kirin Co., Ltd.)In the U.S., Arnesp generated $41.5 million in sales in the year it went public, and sales more than doubled ninefold in its second year of public offering, to about $420 million, reaching a peak of $4.12 billion in 20062007, a series of studies suggested that Aranesp promotes tumor growth and increases the risk of death in cancer patientsThat has raised questions across the united States, including the U.SSenate, about the safety of the "heavy bomb" drug, which has led insurance companies and Medicare to remove Aranesp (cancer chemotherapy) from the reimbursement list, but subsequent studies have shown that Aranesp does not accelerate deaths in cancer patientsDespite this, Aranesp's sales began to decline, falling to $1,911 million in 2013according to the insight database, Dayapotin alpha has registered three clinical trials in China, of which two clinical trials registered by Concord Fermented Kirin Co., Ltdare anaemic The indications of amgen registered clinical trials are anemia caused by first-line chemotherapy for advanced non-small cell lung cancer, which amsifying has not yet been reported Japan Concord Fermentation Kirin Co., Ltd first submitted a listing application for Dayapotin alpha in 2015, but withdrew the listing application in 2016 during a self-checking of clinical trial data In 2019, Japan Concord Kirin Co., Ltd will re-submit its listing application for Dayipotin Alpha According to clinical trials registered with the drug in China, the reported indications are: renal anemia in the implementation of hemodialysis, including alternative recombinant recombinant people to treat anemia in patients with hemodialysis however, dayaperin alpha future market prospects in the domestic market is not very clear, the domestic EPO market, mainly to domestic enterprises, such as Shenyang Sansheng Pharmaceutical "Ibio" and "Sebor", North China Pharmaceutical Jintan "heart drink", Shanghai Kirin Yipeng Pharmaceuticals "Li hetreasure", Shanghai Kaimao biopharmaceutical "Yibao", the "Snow", the "snow up" According to data from 22 cities in China, the amount of EPO drug use in China in 2014 was 357 million yuan, and there were more than a dozen production enterprises involved in EPO in the sample hospital market Among the top five enterprises are: Shenyang Sansheng Pharmaceuticals (242 million yuan, accounting for 67.7%), North China Pharmaceuticals (the amount of drug use is 21.84 million yuan, accounting for 6.1%), Shanghai Kirin Yipeng Pharmaceutical (the amount of drug use is 19.92 million yuan, accounting for 5.6%), Shanghai Kaimao Biopharmaceuticals (the amount of drug use is 12.55 million yuan, or 3.5%) and Ha Pharmaceutical Group (drug amount of 12.122 million yuan), accounting for 12.12 million yuan) , Sansheng Pharmaceuticals still has a large market share in the domestic EPO market, and it is understood that sales of its two recombinant products, Ibio and Sebor, increased by 5.8% in the first half of 2019, accounting for 41.3% of the market share in addition, Roche has launched a long-lasting EPO in China, namely methicin recombinant human erythropoietin, the product is called MesinLo The author believes that Dayipotin alpha in order to occupy a place in the domestic EPO market, in addition to virtue of long-term advantages, but also in the price concessions to cover more patients.
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