Recently, the 2024 VBEF Future Medical Ecology Exhibition Awards Dinner was held in Beijing. Zesheng Technology has been ranked as one of the top 100 future medical products in 2024 - China's Top 100 Innovative Pharmaceuticals and Biological Products by VB100, a well-known third-party research institution, Artery.com, and Eggshell Research Institute.
According to an article published by Nature Biotechnology, Zesheng Technology is one of the very few first-in-class R&D companies in China (Nature Biotechnology, 2019); Since its establishment in Zhangjiang Hi-Tech Park in 2000, the company has always been guided by cutting-edge technology, original innovation and unmet clinical needs, focusing on the research and development of the world's first innovative drugs. His scientific research work has received great attention from the international scientific community and industry, and his research results have been reported, cited, commented on or affirmed by scientific journals such as Nature, Nature Reviews, and Nature Biotechnology for many times. Zesheng has been supported by the national "11th Five-Year Plan", "12th Five-Year Plan" and "13th Five-Year Plan" major new drug creation national science and technology major projects, "863" major projects and other projects for nine times.
Zesheng Technology's core product Newcardine ® (recombinant human Nürgreen) is an international first-in-class drug for the fundamental treatment of heart failure by directly acting on cardiomyocytes and improving the structure and function of cardiomyocytes based on breakthrough innovation discoveries in the field of international heart failure treatment, and is about to enter the industrialization stage. The project is ahead of the international level, rare in China, has global independent intellectual property rights, and is aimed at nearly 30 million heart failure patients in the international market.
At present, Newcardine ® is in phase III clinical trials in China and the United States, and previous trials have fully demonstrated its efficacy in greatly improving patients' cardiac function and reducing mortality. Zesheng has confirmed a supplemental cardiac function study (trial ZS-01-308B) with the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, and can submit a conditional marketing application upon successful completion. The total sample size of the trial design was 198 cases, and as of May 8, 2024, 144 subjects have been enrolled in the trial.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the drug and has approved the protocol for the U.S./international multicenter clinical trial (ZS-01-307 trial) of Newcardine ®.
[About Newcardine ® (recombinant Nuring)]
Newcardine ® (recombinant human Nürlangring) is a recombinant protein drug independently developed by Zesheng Technology and the world's first for the treatment of 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. Based on the above scientific findings, the Company is committed to developing recombinant human Nurings as the first biologic drug for the treatment of chronic heart failure by improving the structure and function of cardiomyocytes (trade name proposed Newcardine ®).
[About the ZS-01-308B clinical trial of Newcardine ® in support of the conditional marketing application]
Trial ZS-01-308B is a multicenter, randomized, double-blind, placebo-controlled clinical study of the effect of recombinant human Nurings on cardiac function in patients with chronic systolic heart failure (COPD) with a primary endpoint of "substantial improvement in the response rate of left ventricular volume during systolic and end-diastolic phases" to evaluate the safety and efficacy of recombinant human Nürlangring at effective doses in patients with target heart failure. In this study, Fuwai Hospital, Chinese Academy of Medical Sciences and Beijing Chaoyang Hospital affiliated to Capital Medical University were the joint team leaders, Professor Zhang Jian, Director of the Heart Failure Center of Fuwai Hospital, and Professor Chen Mulei, Chief Physician of the Department of Cardiology of Chaoyang Hospital, were the national coordinating investigators, and the program was designed to enroll 198 patients in more than 90 research centers across the country, with 10 days of study medication and a follow-up period of 90 days. According to the minutes of the previous meeting between Zesheng Technology and the Drug Evaluation Center of the China Food and Drug Administration, after the success of the 308B trial, Zesheng Technology can apply for conditional approval of the new drug Newcardine ®.