Source: Medical Geography
Medical Network December 27th, on December 18th, the National Food and Drug Administration (NMPA) is the first in the world to approve AstraZeneca and its partner Fibrogen's new anemia drug Roxadustat (rostastat, capsule. Trade name: Ai Ruizhuo ), making Chinese patients ahead of other countries to benefit from the drug.
Roxadustat is the first small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat renal anemia by mimicking one of the substrates of prolyl hydroxylase (PH). Acid to inhibit PH enzyme, affecting the role of PH enzyme in maintaining the balance of hypoxia-inducible factor (HIF) production and degradation rate, so as to achieve the purpose of correcting anemia. HIF not only increases the expression of erythropoietin, but also increases the expression of erythropoietin receptors and proteins that promote iron absorption and circulation. In short, it promotes erythropoiesis and improves iron absorption and utilization by regulating the expression of genes such as erythropoietin and iron metabolism, thereby improving the level of red blood cells.
In both OLYMPUS and ROCKIES trials, Roxadustat reached the primary endpoint: a statistically significant improvement in baseline median Hb (hemoglobin) levels from week 28 to week 52.
The two trials differed in two main areas: in OLYMPUS, patients with chronic kidney disease did not rely on dialysis, and the control group received placebo; while the ROCKIES trial involved dialysis-dependent patients and Roxadustat and Alfa-Ipoetin (Epoetin alfa, a natural erythropoietin analog) was compared.
Akebia is also developing a HIF-PHI or hypoxia-inducible factor prolyl hydroxylase inhibitor. The approval of Roxadustat gave FibroGen and AstraZeneca a first-mover advantage. Regardless of chronic kidney disease (CKD) or dialysis patients, Roxadustat can effectively increase hemoglobin levels without being affected by the inflammatory state of the patient. It is currently only available for CKD dialysis dependent patients. The number of people with CKD anemia in China is estimated to be about 500,000.
AstraZeneca and partner Fibrogen are further analyzing the results of the trial and hope to expand the range of label indications in 2019.
CKD-related anemia can have a very large impact on patients. Oral drugs for HIF-PHI renal anemia are easier to manage and safer than erythropoietin (EPO) drugs (the current EPO drugs increase the risk of cardiovascular events), and some patients even take high doses of EPO drugs. There is no response, and they urgently need effective treatment. In the United States, Roxadustat's new drug application is expected to be accepted in the first half of 2019 and may be approved after 6 to 10 months.
The rapid launch of Roxadustat also attracted interest from major pharmaceutical companies such as AstraZeneca. AstraZeneca has invested heavily in the rise of China's pharmaceutical industry, which is currently the second largest pharmaceutical company in the UK by sales. The approval and sales of Roxadustat will help promote AstraZeneca's establishment and consolidation of the kidney disease business in China.
Roxadustat has been approved to demonstrate that NMPA is accepting and reviewing new drug applications faster and faster. AstraZeneca has twice been a beneficiary of the accelerated approval process, and its anticancer drugs, Lynparza (Olaparib) and Tagrisso (Osimertinib), were approved within a year of receiving priority review.
So far, AstraZeneca's success in China is mainly due to its respiratory drugs, such as Pulmicort (Budesonide, Budesonide), but the company hopes to promote drug sales in oncology and kidney disease.
In addition to AstraZeneca, other multinational pharmaceutical companies, including Novartis and Sanofi, who love the Chinese market, sell new drugs developed elsewhere in China and also conduct collaborative research and development in China.
Lilly and Hutchison China Medical Technology Co., Ltd. (Huangye Pharmaceutical, Chi-Med) cooperated to deepen the development of anticancer drugs (Fruquintinib, furazolinib. Trade name Elunate / Aiyoute) is the first to discover, develop and The approved drug was approved by NMPA for the treatment of colorectal cancer on September 5. Since then, the developer plans to push it to the US and European markets. Like Roxadustat, Fruquintinib was first recognized as a milestone in the biomedical industry in China.
Contact: Ms. Tian
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