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The Drug Review Center (CDE) of the State Drug Administration of China announced the information, Huahai Pharmaceutical subsidiary Huabo Bio and Huaotai Biological jointly declared HB0017 injection seiscored obtained a clinical implied license, indications for moderate to severe plaque psoriasis.
HB0017 is a monoclonal antibody that targets IL-17 and belongs to a new class 1 drug, which is the first time the drug has been approved for clinical use in China.
IL-17 is one of the star targets and has spawned a number of heavyweight innovations.
IL-17, known as Interleukin-17, was discovered by scientists in the 1990s.
later studies have shown that IL-17 is an important inflammatory factor that plays an important role in the pathology of a variety of autoimmune diseases, including psoriasis, psoriasis arthritis and mandatory spina bifida.
based on these important findings, IL-17 has become an important therapeutic target for this disease and has spawned a number of heavy-duty innovations.
HB0017 is a monoclonal antibody developed by Huahai Pharmaceuticals with IL-17 as a target for the treatment of psoriasis, psoriasis arthritis and mandatory spina bifida.
April 2020, the drug has been approved by the U.S. FDA for clinical trials of the new drug.
this is the first time HB0017 has been approved for clinical in China, targeting the indications of moderate to severe plaque-like psoriasis.
but the CDE website information shows that Huahai Pharmaceuticals has submitted three clinical trialapplications for HB0017 injections, meaning the drug is also expected to be approved for future clinical studies on other indications.
, several drugs targeting IL-17 have been approved worldwide, including Novartis's IL-17A monoanti-resisting (SkucciYu, secukinumab), Lilly Lilly and Company's IL-17A antagonist Topaz (Ichizumab), Valeant Pharmaceuticals, developed a single anti-I-Il-17A receptor.
, according to company earnings, Cucci U-Singa's global sales in 2019 were $3.551 billion, while The Cucci Zuma was $1.37 billion.
in China, only two IL-17 targeted drugs have been approved for sale in China: one is Novartis's good-natured, has been approved for the treatment of adult patients with moderate to severe plaque-like psoriasis, adult patients with severe spinal adenosis (AS) who have been treated with poor efficacy;
congratulate Huahai Pharmaceuticals IL-17 mono-anti-HB0017 approved clinical, hope that the drug research smoothly, to provide patients with more treatment options.
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