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Hisun Pharmaceutical's Class 1 new drug "Haibo Maibu Tablets" was approved for listing

 Last Update: 2021-08-16
 Source: Internet
 Author: User

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On June 25, the official website of NMPA showed that Zhejiang Hisun Pharmaceutical's Class 1 new drug "Haibo Mebu Tablets" was approved for marketing for primary hypercholesterolemia

Haibo Maibu Tablet (formerly known as Haize Maibu) is a class 1 new drug independently developed by Hisun Pharmaceuticals.

Hezeimibe was approved for clinical use in October 2012.

A total of 374 subjects were enrolled in the single-agent phase III trial.

In terms of safety, the incidence of adverse reactions of Hezemibe and atorvastatin was 7.

In addition, the "multi-center, randomized, double-blind, double-simulation, and controlled observation of two doses of Hezeimibe (HS-25) combined with atorvastatin in the treatment of hypercholesterolemia" developed by Hezemibe and atorvastatin The efficacy and safety clinical study is still in progress, and the efficacy and safety of Hezemibu combined with atorvastatin in the treatment of hypercholesterolemia will be further evaluated

According to the Insight database, the current domestic marketed similar drug is ezetimibe (ZETIA®), which is mainly used for primary hypercholesterolemia, homozygous familial hypercholesterolemia (HoFH) and homozygous sitosterolemia (Or phytosterolemia) treatment, approved for marketing in China in 2006

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