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It is precisely because of the small number of manufacturers, clinical supply is relatively short, therefore, the market competition is not sufficient.
October 2019, led by the National Health and Care Commission, the First List of Encouraging Generic Drugs included Tlars.
, The Dilasirox is an oral iron chelating agent.
, it binds to a compound with trivalent iron ions in a 2:1 ratio, and discharges the iron ions overloaded in the patient's body in the form of faeces, thereby reducing the storage of iron in the body. Developed by Novartis in 2005 and approved by the FDA,
, its product, Exjade, is primarily used to treat patients with chronic iron overload caused by blood transfusions aged 2 and over, and chronic iron overload treatment for patients aged 10 and over with non-transfusion-dependent thalassemia (NTDT).
Enrig, the first FDA-approved, conventionally used oral iron chelating agent, has now been approved in more than 80 countries worldwide, and its global sales in 2018 were $1,099 million, according to Novartis's annual report, which fell to $975 million in 2019 due to global sales (see chart below).
thalassemia is an inherited hemolytic anemia disease caused by gloatin gene defects leading to hemoglobin alpha and beta peptide chain synthesis disorders.
the hemoglobin dysfunction, resulting in patients have to rely on frequent blood transfusions to meet the body's normal physiological function needs, to ensure quality of life, but due to the lack of iron discharge mechanism, long-term blood transfusion caused the body iron deposited too much in the heart, liver, pancreas and other organs, resulting in organ damage, and thus life-threatening.
, therefore, patients with thalassemia who depend on blood transfusions need regular iron treatment.
studies have shown that patients can live to less than 10% of the age of 25 if they are not treated with iron chelation for long-term blood transfusions.
thalassemia is clinically most common with alpha-ground poverty and beta-ground poverty, posing a serious threat to the life and health of patients.
, named after the first discovery in the Mediterranean, is actually widespread in many parts of the world, including the south-east and south of the country.
according to the China Thalassemia Blue Book published in 2015, there are about 300,000 patients with intermediate and heavy thalassemia in China, at a rate of 10% per year.
China's Guidelines for the Diagnosis and Treatment of Heavy Beta Thalassemia (2017 Edition) recommended tiraros as one of the drugs of iron.
the decentralized tablet type has the advantage of oral absorption fast, 1 time a day convenience, for patients who need long-term iron treatment, to a certain extent, it is conducive to ensure that patients have a better compliance.
2019, the Tiranos are included in the national health insurance catalogue, the current winning bid price is 71.62 yuan per piece (125mg specification).
looking at the market pattern of the product, has been listed only the original research company, declared only 2 listed companies, Kangchen pharmaceutical products have a certain first-mover advantage.
in addition, the market of the product to a certain extent to solve the problem of clinical drug shortage, improve the Chinese thalassemia patients with iron drug accessibility.
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