Zesheng Technology: Nicardipine® receives US patent for its indication in treating dilated cardiomyopathy
Recently, Zeshen Technology, a company invested in by China Zhongji Investment, announced that its investigational new drug, Nukaidine, a world-first innovation, has been granted a US patent (Patent No. US10561709) for its indication in Heart Failure with preserved Ejection Fraction (HFpEF, diastolic heart failure). Previously in China, the Phase II clinical study of Nukaidine® for diastolic heart failure has also passed the ethical review of the research group leader unit and is about to start patient enrollment after completing the genetic administration approval. The invention patent granted this time involves the application of Neuregulin-1 in the preparation of drugs for preventing, treating, or delaying heart failure with preserved ejection fraction (diastolic heart failure), as well as the use method of the said drugs. This invention patent also provides a method for preventing, treating, or delaying heart failure with preserved ejection fraction (diastolic heart failure), including the use of drugs containing Neuregulin-1 protein in special populations suffering from or at risk of the disease.
Since its establishment, Zeshen Technology has always attached importance to the protection of intellectual property rights, and has carried out strict global intellectual property protection and patent layout for innovative achievements, forming a comprehensive and meticulous patent protection network. Obtaining the US patent authorization will help the company maintain its core technological advantages, secure the future commercial development status of its core products in global target markets, and further enhance its core competitiveness.
Regarding Heart Failure with preserved Ejection Fraction (
HFpEF, diastolic heart failure) Heart failure is the terminal stage and major cause of death of various cardiovascular diseases, characterized by high incidence and mortality rates. It is one of the most serious global public health problems, with more than 23 million patients worldwide. Heart failure with preserved ejection fraction (diastolic heart failure) accounts for about half of the number of patients with chronic heart failure. Currently, international guidelines generally recognize that there is a lack of sufficient evidence-based medical evidence for the treatment of diastolic heart failure, and there is an urgent clinical need for effective therapeutic drugs.
About Nukaidine
® (recombinant human Neuregulin-1) Nukaidine® (recombinant human Neuregulin-1) is an investigational recombinant protein drug independently developed by Zeshen Technology and globally pioneered for the treatment of chronic heart failure, including heart failure with reduced ejection fraction (systolic heart failure) and heart failure with preserved ejection fraction (diastolic heart failure).
Its innovative mechanism of action is to activate the ErbB2/ErbB4 receptor tyrosine kinase expressed in cardiomyocytes to regulate gene and protein expression, promote sarcomere reorganization, increase myocardial contraction/relaxation, and reverse ventricular remodeling.
Completed clinical trials have preliminarily demonstrated that Nukaidine® can improve cardiac function in patients with chronic systolic heart failure, improve long-term prognosis, and show a downward trend in the risk of death in heart failure patients, especially a significant reduction in the risk of death in target patients (NYHA II-III grade, NT-proBNP ≤ 1600 fmol/mL).
Preclinical studies on the indication of diastolic heart failure show that Nukaidine
® can improve the energy metabolism of the heart in model animals, improve calcium ion cycling in cardiomyocytes during contraction/relaxation in model animals, maintain the integrity of contractile/relaxation functional units, and increase the compliance of the left ventricle in heart failure animals. These effects are directly involved in regulating myocardial relaxation. Therefore, Nukaidine® has the potential to become a first-in-class international innovative drug for the treatment of diastolic heart failure and fill the international gap in the relevant field. Recently, Nukaidine® (recombinant human Neuregulin-1) has also completed a survival clinical trial. After retrospective analysis, the trial data showed that in addition to the previously discovered conclusion that the lower the baseline NT-proBNP [Note 1] in the overall subject group, the greater the survival benefit, it was newly found that Nukaidine showed a significant survival benefit in a large subgroup of the population. This will be beneficial to the subsequent clinical development strategy of Nukaidine®, and is expected to further increase the target medication population.
Background information:
Zeshen Technology is a biopharmaceutical high-tech enterprise that is driven by the needs of the international pharmaceutical market and based on innovative research, dedicated to the research and development of original innovative drugs with independent intellectual property rights. Founded in 2000 by overseas returnees, it mainly engages in the research and development of original innovative drugs, improved new drugs, and medical devices. Its product R&D pipeline focuses on three therapeutic areas: cardiovascular, oncology, and energy metabolism. Products such as recombinant human Neuregulin-1 are first-in-class, globally innovative drugs.
In October 2018, China Zhongji Investment completed its investment in Zeshen Technology. Previously, Zeshen Technology has introduced well-known strategic investment institutions such as Zhangjiang Kechuang Investment, Morningside Venture Capital, Kimstone Investment, Guoxin Venture Capital, China Yujia Capital, and Hanfu Capital. China Zhongji Investment is optimistic about the development prospects of the healthcare industry and will continue to increase its investment in sub-sectors such as biopharmaceuticals and medical services.
2018年10月，China Zhongji Investment)完成对泽生科技的投资。此前，泽生科技已引入张江科投、晨兴资本、金石投资、国投创业、中钰资本、汉富资本等知名战略投资机构。China Zhongji Investment)看好大健康领域的发展前景，将继续加大在生物制药、医疗服务等细分领域的投资力度。
