Chlorogenic acid for injection is the world's first class I new anti-cancer drug independently developed by Jiuzhang Biotech, and belongs to anti-tumor immune small molecule natural medicines. Jiuzhang Biotech has systematically researched and developed chlorogenic acid since 2000, and has secured the clinical approval documents for chlorogenic acid drug substance and chlorogenic acid for injection in August 2013 (approval numbers: 2013L01855 and 2013L01856). In December 2016, the Phase I/II Clinical Study on Innovative Class I New Drug Chlorogenic Acid for Injection was listed by the National Health and Family Planning Commission and the Ministry of Science and Technology in the national science and technology major new drug discovery projects in 13th Five-year plan, which was also a major science and technology support project in Sichuan Province.
Teams of professor Jiang Jiandong from the Institute of Materia Medica, Chinese Academy of Medical Sciences and Chen Xiaoguang have carried out in-depth systematic studies on the mechanism of action of chlorogenic acid preparations, and have determined that chlorogenic acid is a multi-channel and multi-target natural active substance, which can produce anti-tumor effects through two levels of immune regulation and cell-induced differentiation. In-depth studies on chlorogenic acid preparations have revealed a number of new anti-tumor mechanisms, which had been firstly published in Scientific Reports (a journal under Nature Publishing Group) in 2017.
For this variety, the phase I clinical study on chlorogenic acid for treatment of advanced malignant gliomas has been completed in the Beijing Shijitan Hospital, Capital Medical University, and the phase II/III multicenter clinical study on chlorogenic acid for treatment of advanced malignant gliomas led by the Beijing Tiantan Hospital, Capital Medical University is ongoing, for the seeking of a conditional approval based on the results of phase II/III clinical study, accelerating drug availability; at the same time, the phase Ib multi-center clinical study led by the Cancer Hospital of Chinese Academy of Medical Sciences has also been initiated to further verify the effectiveness in lung cancer by an authoritative hospital, and to expend the use population.
The results of pharmacodynamic and mechanism studies have shown that chlorogenic acid for injection has a broad spectrum of anti-tumor effects. In addition to gliomas and lung cancers for which relevant clinical studies are ongoing, chlorogenic acid for injection can be used for treatment of a variety of cancers, such as prostate cancer, squamous carcinoma of the cervix, lymphoma and colorectal cancer. In addition, in-depth immunomics and proteomics studies have shown that, besides malignant tumors, chlorogenic acid has demonstrated a significant response in the treatment of some autoimmune diseases including erythrodermic psoriasis and systemic lupus erythematosus.
Chlorogenic acid injection developed based on natural products is a kind of innovative drugs independently developed by China and with completely independent intellectual property rights. It will break the long-lasting monopoly in global anti-cancer drug market by foreign pharmaceutical companies. Jiuzhang Biotech will continue to pay attention to the in-depth study on the pharmacological mechanism of chlorogenic acid and its preparations, further explore its development and application potential in the treatment of various diseases, and develop more clinically needed products to better benefit patients.