The Zensun History

FIGURE 2 Treatment with rhNRG-1 attenuates serum-free, media-induced myofibrillar disorganization in neonatal myocytes. Neonatal myocytes were cultured in serum-free medium with or without the indicated doses of rhNRG-1 for 2 days. The actin cytoskeleton was stained with phalloidin (red/left panels), and striated muscle was stained using an anti-aactinin antibody conjugated to fluorescein isothiocyanate (FITC) (green/right panels).Neuregulin-1 KO mouse died at embryonic period. Pathological anatomy results showed abnormal heart development in the mutant mouse. (Liu, X, Zhou, M. et al. (1998). PNAS, 95(22), 13024-13029.)
Professor Kenneth Rchien reported similar results: the conditional kick out of ErbB2, which was the receptor of Neuregulin-1, would lead to dilated cardiomyopathy. Both of these studies showed that Neuregulin-1 played a very important role in the development of the heart and in maintaining normal heart functions.
In 1998,Sydney, Australia, Dr Mingdong Zhou, the director of cell signaling research center and an independent principal investigator made a great discovery in a molecular biology experiment: the signal protein molecule derived from human body, Neuregulin-1 (NRG-1), acts as an agonist to the ErbB3/4 receptor. It not only plays a crucial role in heart development, but also repairs the damaged cardiomyocyte structure, strengthens the attachment of the septum of cardiac muscle cells, and improves the arrangement of sarcomere. As a result, Dr. Zhou proposed to the international community that this protein molecule may become a brand-new drug that directly affects cardiomyocytes and treats heart failure.
On April 20th, 2000, Zensun (Shanghai) Sci. & Tech. Co., Ltd. was established at Zhangjiang High-tech Park, and started preclinical studies of two “First-in-Class” new drugs, which included rh-Neuregulin-1,Neucardin®. They were the first drugs to have international intellectual property rights protection in China. The company name “Zensun” means “Healing of Life” in Chinese.

Zensun began its lab on Bibo Road, Zhangjiang High-tech Park. Here Zensun finished preclinical research for the earliest “First-in-Class” product NRG-1 and rhErbB3-f in China.

HF rat model induced by LAD-ligation. Left: 24 hours after 7 days IV infusion of Neucardin, cardiac function of all dosing groups was found to be improved. Right: survival rate was observed to be improved after either IV or SC infusion at an optimal dose for different periods of time.

In April 2003, Zensun completed the rh-Neuregulin-1 preclinical study. It was a rigorous and scientific preclinical study of multiple pathological animal models of heart failure caused by ischemic, dilated, rapid pacing and viral infections. rh-Neuregulin-1 initially demonstrated that it repairs damaged myocardial cell structures caused by ischemia, hypoxia, and viral infections, enhances cardiac function, improves cardiac hemodynamics, but also prolongs the lives of animals with heart failure. This finding was later published in “The American Journal of Cardiology”, the most authoritative independent medical journal in regards to the cardiovascular field.

In 2005, Zensun raised about 100 million RMB from Morningside to fund clinical trials overseas. Two locations were established for this purpose, Zensun Australia in 2005 and Zensun USA in 2006.

Zensun USA offices are located at 12760 High Bluff Dr., Ste360. Many world famous biotech companies gather in San Diego.

Zensun’s headquarters and research center are located in Zhangjiang High-tech Park, over thirteen thousand square meters to perform cytology, molecular biology and pharmacology.

From 2006 to 2007, Zensun purchased Shanghai Dongxin Biotechnology Co., Ltd. for it’s factory, equipment and land in the central area of Zhangjiang. It is now Zensun’s headquarter and research center.

In March 2009, Zensun China completed the phase II clinical study (ZS-01-206) of rh-Neuregulin-1. Trial was designed as a placebo parallel control study based on randomized, double-blind, multicenter, and standard therapy, which uses advanced and sophisticated nuclear magnetic resonance imaging (MRI) to measure and assess cardiac function in subjects such as left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV). The results showed that rh-Neuregulin-1 can significantly improve LVEF of heart failure patient, improve cardiac function, and can effectively reduce LVESV and LVEDV, and reverse ventricular remodeling. Academician Gao Runlin, the clinical program PI for the National Center for Cardiovascular Diseases/ Chinese Academy of Medical Sciences Fuwai Hospital, and the drug inventor, Dr. Zhou Mingdong led and published this new and important research result in the heart failure treatment in the JACC in 2010. It immediately attracted international attention for ​​heart failure treatment. The results of this study are also highly consistent with the results of Phase II clinical studies of HREC06/035 and ZS-01-210 that were subsequently completed in Australia and the United States.

Phase II clinical trial has demonstrated that Neucardin can increase the LVEF of HF patients significantly (left), and also improves cardiac function and continuously reverses ventricular remodeling.

In April 2009, Zensun China completed Neucardin® phase II clinical trial ZS-01-207, which showed that patients’ NT-proBNP was significantly reduced by Neucardin®, which improved long-term prognosis. The following clinical trial, ZS-01-304, produced data supporting this finding.

In July 2009, based on data generated from Chinese and Australia clinical trials, FDA permitted Zensun USA to start phase II clinical trials in the U.S..

Immunogenicity methodology of NRG-1 and animal prausnitz-kstner reactions were done at a former lab of Zensun USA located at 6408 Cornerstone ct, Ste B.

Zensun’s headquarter in Shanghai.
In 2010, Zensun received funding from Zhangjiang Sci.& Tech investment co. LTD and Pudong Sci.& Tech investment co. LTD for approximately 206 million RMB. Additionally, between 2013 to 2015, Zensun received funding from Shanghai Zhiyou Investment Management co. LTD for 155 million RMB.
In 2009, Zensun started the study of energy metabolism related disease, including functional constipation and Alzheimer's disease, which produced key pharmacodynamics data in 2016 and will start clinical studies after IND application.

Zensun’s research center in Shanghai, Zhangjiang.

Zensun obtained FDA permission to perform phase III clinical trial of NRG-1.

At the end of 2013, Zensun USA. completed the Neucardin™ phase II clinical trial (ZS-01-210) in the U.S.. The result showed that Neucardin®, improved patients’ LVEF, athletic ability (6MWD), quality of life(QoL)and significantly reduced mortality and hospital readmission rates. At the Phase II END Meeting with FDA in Maryland, Zensun obtained approval to begin phase III clinical trial of Neucardin® in the U.S.
In November 2015, Zensun became a joint-stock company and was officially renamed Shanghai Zensun Science and Technology Co., Ltd. In May 2017, Zensun was listed in NEEQ and became a public company.

Zensun announces its initial public offering at NEEQ(National Equities Exchange and Quotations) hall . Dr. Mingdong Zhou, President of Zensun, addressed the audience.

ZS-01-305 interim analysis unblinded conference. Dr. Mingdong Zhou, President of Zensun, showed inspiring result of ZS-01-305.

In June 2017, Neucardin® phase III clinical trial (ZS-01-305) was unblinded in interim analysis and the data showed that Neucardin® could significantly reduce target patients’ (NT-proBNP<1600 fmol/mL) annual mortality by 58.8%. The result was highly consistent with former ZS-01-209 clinical trial.
On December 1st 2017, clinical trial of Neucardin® (ZS-01-306) launched in Bejing keeping its lead institution as Fuwai hospital, Chinese academy of medical sciences.

ZS-01-306 launch meeting. Professor Runlin Gao (PI of Neucardin®s Phase II& III Clinical Trial) presents the history of Neucardin®s clinical trial.

In January 2018, Zensun successfully raised approximately ¥504 million (US$76 million). The State Development & Investment Corporation (SDIC) Venture Capital Management, a state-owned investment fund, led the financing round. Xingfeng State Development Capital, Yijing Capital, China Venture Capital and other well-known investment companies also participated in this round of fund raising.

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