new drug "conditionally approved for marketing" is a "fast path" set by the state to encourage drug innovation with clinical needs as the core and accelerate the marketing of urgently needed drugs with outstanding clinical value. In January 2020, the National Drug Review Center formally approved the application for conditional marketing of Zesheng Technology, requiring that the phase III survival rate confirmation clinical trial of Newland Green (Newcardin®) for injection should continue to be promoted. also suggested that Zesheng Technology conduct a phase 3 trial with cardiac function as the main efficacy indicator to support the conditional approval of drug application for conditional approval.
Recently, Zesheng Technology and the National Medical Products Review Center held a formal communication and exchange meeting to communicate and exchange on the statistical analysis data, important research results and the next research and development direction of the previously completed clinical trial of cardiac function (ZS-01-308 research). Based on the consensus of the Communication and Exchange Conference, Zesheng Technology will fully carry out a phase III trial of cardiac function with "significantly improving the response rate of left ventricular volume in the end-stage of systolic and end-diastolic left ventricular volume" as the main endpoint indicator. The specific communication and discussion results of the meeting will be disclosed after the minutes of the meeting between the two parties are determined, and the specific design and implementation of the ZS-01-308B test will be formulated based on the minutes of the meeting. The design of the
308B trial is based on the important research progress achieved in the 308 trials that have been completed: the "response rate of systolic and end-diastolic left ventricular volume" in the short term (30 days) after medication, and the Newcardin® group was significantly higher than that of the placebo group (P <> heart failure and , and the proportion of this incidence in the drug administration group was significantly higher than that of the placebo group with existing standard treatment.
[About Newcardin® (recombinant human Newcardin®)]
Newcardin® (recombinant human Newcardin®) is a world-first recombinant protein drug independently developed by Zesheng Technology and is used to treat diseases such as heart failure with reduced ejection fraction (systolic heart failure), ejection fraction retention heart failure ( diastolic heart failure ). Its innovative mechanism of action is to activate the tyrosine kinase expressed in cardiomyocytes, to regulate gene and protein expression, promote sarcomer recombination, increase myocardial contraction/diastolic, and reverse ventricular remodeling. Based on the above scientific discoveries, Zesheng Technology is committed to developing recombinant human Newland Green as the first biopharmaceutical to treat chronic heart failure by improving the structure and function of cardiomyocytes (the trade name is Newcardin®).
1 The completed clinical trial shows that Newcardin® can improve the heart function of patients with chronic systolic heart failure and improve long-term prognosis. There is a trend of reducing the risk of death in patients with heart failure, and can significantly reduce the mortality rate of patients with specific subgroups accurately determined by NT-proBNP (according to multiple large sample size studies and Zesheng clinical data, this target subgroup accounts for about 62.5% of patients with NYHA Grade II-III systolic heart failure). The post-hoc subgroup analysis of three independent survival benefit clinical trials showed that the annual reduction trend of all-cause mortality in the target patients was consistent and reproducible, with a relative decrease of 63.9%-86.1% (of which two analyses were statistically significant alone), and the combined analysis showed a relative decrease of 73.7%, which was extremely significant (P=0.0006).
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