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).

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.

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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.

Zensun is also planning to initiate Phase I clinical trials in treating acute myocardial infarction (AMI). These are supported by the prior data from Neucardin’s HF trials showing that it is well tolerated. The drug only showed serious adverse effects in two patients (13%) while also showing improvements in cardiac function. This is the second time Zensun has filed a New Drug Application (NDA) to the NMPA for Neucardin. The first time was in 2012 but the NDA was not approved due to the patient sample size being too small.

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GlobalData believes that Neucardin has big potential in the market due to the impact that the drug has shown in improved quality of life for patients. Key opinion leaders (KOLs) have often commented on the lack of HF therapies that focus on quality of life. This is something they place a high value on as the condition is ultimately progressive. If approved, AstraZeneca’s Farxiga (dapagliflozin) and Novartis’s Entresto are likely to be the main competitors that Neucardin will face.

Zensun’s Chief Executive Officer Zhou Mingdong has said that the company expects a commercial collaboration with established pharmaceutical players, which could greatly increase the success of Neucardin across the major world markets.