Pharmacosmos A/S, a Denmark-based industry leader for developing and marketing medicines for the treatment of iron deficiency, said its Monofer, a new generation of innovative intravenous iron for the treatment of iron deficiency and iron-deficiency anemia, will soon be officially available to Chinese patients.

The drug was the first innovative intravenous iron approved in China since 2005, when the National Medical Products Administration approved it in February for the treatment of iron deficiency and iron-deficiency anemia in adult patients who have an intolerance to oral iron, have had an unsatisfactory response to oral iron, or when there is a clinical need to deliver iron rapidly.

The drug also is expected to expand the use of IV iron across multiple therapeutic areas in China, as iron-deficient anemia is a frequent condition for patients across various therapeutic areas.

The Chinese market of intravenous iron for the treatment of iron deficiency and iron deficiency anemia is one of the largest in the world, with a general prevalence of about 20 percent among Chinese, some research showed.

Chinese biotech company EdiGene Inc announced on Monday the Center for Drug Evaluation of the China National Medical Products Administration has approved the company's Investigational New Drug application for ET-01, a CRISPR/Cas 9 gene-editing therapy for patients with transfusion dependent β-thalassemia, a blood disease characterized by severe anemia and a lifelong dependence on red blood cell transfusions that can lead to iron overload.

But the development of therapeutic CD47 antibodies has been hampered by hematologic side-effects, such as severe anemia, because of the binding of CD47 on red blood cells.

AstraZeneca China announced on Tuesday that new anemia drug roxadustat has received approval from the National Medical Products Administration.

China has become the first country worldwide to approve the oral anemia treatment hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

According to the NMPA approval, roxadustat is to be used in the treatment of anemia caused by chronic kidney disease (CKD) in patients who are dialysis-dependent (DD).

There are over 120 million CKD patients in China, and anemia is one of the complications of CKD, occurring at a rate of up to 98.2 percent in patients on dialysis, according to medical journals Lancet and Chinese Journal of Nephrology.

If anemia is not controlled, it increases cardiovascular risks, as well as mortality in patients on dialysis, and may affect patients' mental health and social functions, imposing a heavy burden on patients, their families and society.

According to clinical data in China, roxadustat can effectively increase and keep hemoglobin in dialysis patients with anemia caused by CKD, AstraZeneca said.

The development of roxadustat ends a long period in which there were no new drugs developed by a new mechanism for the treatment of CKD-caused anemia, said Chen Xiangmei, member of the Chinese Academy of Engineering and head of the PLA Institute of Kidney Diseases.

A renal anemia medication, which is being developed locally in China, was displayed at the expo.

In 2017, the Chinese Center for Disease Control and Prevention released an evaluation report about the project and the overall indicators seem to exceed our expectations, especially on anemia improvement and an increase of children’s height.

A charity program initiated by China Soong Ching Ling Foundation, with support from AstraZeneca and FibroGen, was officially launched in Beijing on Sunday, aiming to increase the accessibility of innovative drugs to Chinese anemia patients.

The program will provide free Roxadustat capsules, the world's first-in-class new drug for the treatment of anemia caused by chronic kidney disease in patients who are dialysis-dependent, a major breakthrough for 30 years in the treatment of anemia.

The Roxadustat donation program plans to cover 30,000 CKD patients with anemia who are dialysis-dependent.

Anemia is a common complication of CKD, especially in patients with end-stage renal disease.

Despite a lack of current national figures, a report published in 2012 in internationally reputed medical journal Lancet showed on average one out of every 10 Chinese adults has CKD, and another report in 2013 published on Chinese Journal of Nephrology said anemia is a common complication of CKD, and among patients with the end-stage renal disease, the incidence of anemia is as high as 98.2 percent.

In December, the National Medical Products Administration approved Roxadustat, a drug developed by AstraZeneca and FibroGen, as a new treatment for anemia caused by chronic kidney disease in patients dependent on dialysis.

Last month, China became the first country to approve Roxadustat, a first-in-class treatment for anemia caused by chronic kidney disease in patients who are dialysis-dependent, co-developed by AstraZeneca China and FibroGen China.

Roxadustat, a domestically developed first-in-class Class 1 medicine, has received approval from the National Medical Products Administration, making China the first country that has greenlighted the oral medicine used for treatment of anemia caused by chronic kidney disease.

Roxadustat has been approved to treat anemia in patients who are dialysis-dependent.