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Recently, China NMPA official website shows that 1 new type of new drug in Zhejiang Pharmaceutical, HAIBO MAIBU TABLETS is approved in China for primary high cholesterolemia.
Haibo Maibu Tablets is a 1-class new drug, which is independently developed by China Haizheng Pharmaceutical, is a cholesterol absorbing inhibitor acting on Nieman Pech C1 1 (Niemann-Pick C1-Like1, NPC1L1) protein surface on the surface of intestinal and hepatocytes. Receptor, selectively inhibit cholesterol absorption, thereby reducing the transport of cholesterol in the small intestine to the liver, so that the reservoirs of liver cholesterol are reduced, and the liquid cholesterol is increased.
In October 2012, Haibo Maibu Tablets was clinically batch. In September 2018, Haizheng announced the completion of HAIBO MAIBU TABLETS (HS-25) single medicine 3 clinical trials.
374 subjects of single medicine III test group, relatively placebo group, mainly results in LDL-C (Fas set) and -16.0% (PPS episodes), no statistical studies of adverse reactions and placebo Differences, short-term and long-term medication safety; 255 subjects in the intermediate joining III test, for the combined with atherosclerosis cardiovascular disease and other hazardous diseases, often do not reach the target value in the treatment of statin High cholesterol metamormia patient, based on 10 mg atorvastatin, add HAIBO MAIBU or atorvastatine dose, FAS set analysis, LDL-C Haibo MAIBU reduces -16.4% (PPS set It was -16.8%, subgroup analysis - 18.4%), atorvastin decreased - 6.8% (PPS set was -7.7%, subgroup analysis - 8.7%), and the difference in inter-group was statistically significant (P <0.0001).
In terms of safety, the incidence of adverse reactions in HAIBO MAIBU and atorvastatin is 7.9% and 13.6%, and the HAIBO MAIBU has general adverse events, and the frequency of adverse reactions is lower than the atorvastatin trend.
In addition, HAIBO MAIBU has developed with the atorvastatin retrieving "multi-center, random, double blind double simulation, two doses of HAIBO MAIBU (HS-25) combined with aorvastatin to treat high cholesterolemia. Sexual clinical research is still in progress, and further evaluates the efficacy and safety of Haish wheat cloth combined with atorvastatin in the treatment of high cholesterol.
According to the Insight database, there is currently the same kind of drugs in China, it is mainly used in Zetia®, which is mainly used for primary high cholesterol hypermia, homozygous families, high cholesterolemia (HOFH) and homozygous grains blood. Treatment of disease (or phytosteric disease), approved in China in 2006.
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