Liver fibrosis is an inevitable step in the progression of chronic hepatitis toward cirrhosis and hepatocellular carcinoma, and it also represents the final therapeutic window for halting disease deterioration. However, the pathophysiological process of liver fibrosis is highly complex, involving multiple organs and systems, and currently there is no ideal pharmacological agent available in clinical practice for treating liver fibrosis. Consequently, the development of anti-fibrotic drugs holds broad market potential and significant clinical importance. Recently, the “Signing Ceremony for the Development of a Novel Class 1.1 Anti-Fibrotic Drug” was held at Zhengzhou University, where Shijiazhuang Sihua Pharmaceutical Co., Ltd. and Zhengzhou University joined forces to leverage their complementary resources, harness natural medicines to tackle the challenging problem of liver fibrosis, expedite the translation of innovative natural-product-based drugs into clinical applications, and accelerate their market launch.
Institution-Enterprise Complementarity
Stimulating the Vitality of New Natural Drug Launches
Liver fibrosis is a pathophysiological process characterized by the abnormal proliferation of hepatic connective tissue induced by various etiological factors. Any form of liver injury involves a fibrotic response during the repair and healing process; if the injurious stimulus persists over the long term, the fibrotic process will continue unabated, eventually progressing to cirrhosis, which can culminate in liver failure and even hepatocellular carcinoma. Globally, a large number of patients suffer from liver fibrosis, yet no effective therapeutic agent exists to reverse this condition.
For more than a decade, Professor Dai Guifu of Zhengzhou University and his team have devoted themselves to overcoming technical challenges and have ultimately succeeded in developing a novel therapeutic approach—the innovative drug ADN-9. This drug is derived from andrographolide, a natural medicinal compound, and was obtained through systematic molecular optimization and targeted indication screening, resulting in a drug molecule that demonstrates particularly outstanding efficacy in the treatment of hepatic fibrosis. Administered orally, ADN-9 exhibits high efficacy, low toxicity, and multi-target synergistic action, thereby fully demonstrating the therapeutic advantages of natural medicines in addressing complex diseases.
Professor Dai Guifu boasts outstanding research capabilities and has been recognized as the leader of the Henan Province Innovative Science and Technology Team for “Research and Development of Anti-Infective and Anti-Tumor Drugs” as well as an expert on the National Key R&D Program for Major New Drug Creation during the 13th Five-Year Plan period. To date, the ADN-9 project has secured more than 20 domestic and international invention patents. Relevant data also indicate that the candidate drug ADN-9 exhibits unique biological activity and favorable drug-like properties, thereby supporting its further research and development under Category 1.1 of the Chemical Drug Registration Classification.
Mechanism Innovation
Entering a New Normal and New Pace of Development
“Leveraging our robust financial strength, extensive experience in pharmaceutical R&D, and Zhengzhou University’s cutting-edge innovation capabilities, the innovative anti-liver-fibrosis drug research project is poised to successfully complete clinical trials at an early stage and be promptly launched onto the market, thereby alleviating the suffering of countless patients with liver diseases,” said Su Xuejun, General Manager of Shijiazhuang Sihua Pharmaceutical Co., Ltd.
As a well-known domestic pharmaceutical enterprise, Shisi Pharmaceutical boasts seven decades of specialized pharmaceutical expertise and a strong brand legacy. The company is primarily engaged in the research, development, manufacturing, and marketing of a broad portfolio of pharmaceutical products, with intravenous infusions as its core offering. For many consecutive years, Shisi Pharmaceutical has been ranked among the Top 100 Chinese Pharmaceutical Manufacturers and the Top 10 Outstanding Export-Oriented Brands in China’s Chemical Pharmaceutical Industry.
As a national high-tech enterprise, Shisi Pharmaceutical actively monitors and participates in major national research initiatives in innovative drug development and related fields. To this end, the company has successively established high-end R&D and innovation platforms, including a National Engineering Laboratory, a Postdoctoral Research Station, and an Academician Workstation, while also forging forward-looking, practical, and close collaborations with research institutions and academic universities. These efforts have continuously enhanced the company’s R&D and innovation capabilities. In 2017, Shisi Pharmaceutical was granted 16 patents, including 11 invention patents, and filed 10 patent applications, of which 6 were for inventions. (Zhang Xiaodong, Health News)