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Zensun’s Neucardin HF drug fast-tracked by FDA

  • Categories:Portfolio News
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  • Time of issue:2019-08-29
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(Summary description)ZensunScienceandTechnology’sfirst-in-classbiologicagentNeucardinhasbeengrantedfasttrackdesignationfromtheUSFoodandDrugAdministration(FDA).InOctober2018,ChinaZhongjiInvestmentjoinedinZensun. Neucardini

Zensun’s Neucardin HF drug fast-tracked by FDA

(Summary description)ZensunScienceandTechnology’sfirst-in-classbiologicagentNeucardinhasbeengrantedfasttrackdesignationfromtheUSFoodandDrugAdministration(FDA).InOctober2018,ChinaZhongjiInvestmentjoinedinZensun. Neucardini

  • Categories:Portfolio News
  • Author:
  • Origin:
  • Time of issue:2019-08-29
  • Views:4
Information

Zensun Science and Technology’s first-in-class biologic agent Neucardin has been granted fast track designation from the US Food and Drug Administration (FDA). In October 2018, China Zhongji Investment joined in Zensun.

 


Neucardin is a recombinant human neuregulin-1 fragment and is the main heart failure (HF) drug for Zensun. Unlike other HF drug therapies, Neucardin does not promote vasodilation, but works directly on the myocardial structure and function.

The drug works by targeting the ErbB2/ErbB4 receptor in cardiac myocytes, to reverse cardiac remodelling and decrease all-cause mortality.

Zensun, a biopharmaceutical company specializing in HF and cancer treatments, is developing a variety of drugs with novel targets. If Neucardin gains approval, this would be their first marketed drug, and would represent a new treatment strategy in HF.


The company has started Phase III trials in China with Neucardin and is about to embark on a Phase III trial in the US. Zensun hope to get National Medical Products Administration (NMPA) and FDA approval. Neucardin is also being trialled in HF-REF and is also in Phase II trials for HF-PEF. Both are areas of unmet need, with the latter having no specifically approved treatment on the market to date.
 

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