hang Jie, the inventor (from Jiuzhang Biotech), released the clinical data of CHA for injection at the conference.

The "China Pharmaceutical Innovation and Investment Conference" was held at the Suzhou Jinji Lake International Convention Center on November 14, 2016. Jiuzhang Biotech released the phased clinical research data of the CHA for injection preparation.

119 years ago, British scientists Osbome and Cambell discovered an active substance that could turn sunflower seed protein black. Twelve years later, Corter and others named this active substance CHA (which can appear oily green under specific conditions). Thirty-eight years later, that is, in 1947, half a century after the discovery of CHA, Rudkin and Nelson determined the molecular structure of CHA (with a molecular weight of 354.31). One hundred and three years after the discovery of this substance, Jiuzhang Biotech for the first time carried out systematic research and development of CHA monomer as a therapeutic drug and completed all pre-clinical studies. In 2013, it obtained the clinical approval document issued by the CFDA.

After the year 2000, Jiuzhang Biotech was able to obtain CHA monomer with a purity of over 99% at the kilogram level, and qualitatively and quantitatively analyzed the 0.1% impurities in it. As a raw material drug of CHA, it is characterized by low toxicity, low irritation, and no sensitization.

In terms of drug research, Jiuzhang Biotech respects nature, conforms to objective laws, explores and understands the characteristics of CHA, and masters its biological activity. It has established a close and long-term strategic cooperative relationship with the Institute of Materia Medica of the Chinese Academy of Medical Sciences, forming a high-end platform for the research and development of CHA. Currently, the research on the mechanism of action, pharmacodynamic effect of CHA, and its combined use with drugs for other tumors is going very smoothly in terms of both depth and breadth. In addition, the data shows that CHA has shown excellent curative effects in the treatment of autoimmune diseases (such as erythrodermic psoriasis and systemic lupus erythematosus), and the research and development of drugs in the field of such diseases are also proceeding steadily.

The research on the anti-tumor mechanism shows that CHA is a natural active substance (monomer) with multiple channels and multiple targets, and exerts anti-tumor effects at both the immune and cellular levels. At the immune level, CHA has the characteristics of multiple channels and multiple targets, and can identify and regulate multiple immune checkpoints, such as LAG-3. In addition, CHA can also regulate tumor-associated macrophages, inhibit the proliferation of M2 macrophages, and promote the transformation of M2 macrophages into M1 macrophages. At the cellular level, CHA can induce the differentiation of tumor cells and promote the transformation of tumor cells into a form with a lower degree of malignancy.

Jiuzhang Biotech carried out Phase I clinical trials in Beijing Cancer Hospital, Beijing Shijitan Hospital, and the Cancer Hospital of the Chinese Academy of Medical Sciences respectively, focusing on three research aspects: the exploration of the advantageous tumor spectrum, the exploration of gliomas and the administration route, and the exploration of the pharmacodynamic effect on lung cancer. The current clinical trial research results show that the advantageous tumor spectrum of CHA includes malignant tumors such as lung cancer, glioma, and liver cancer. It has good safety and tolerability among clinical trial subjects, and there are no obvious toxic and side effects in clinical practice. The results of pharmacokinetic studies show that the drug is eliminated relatively quickly in the body, with a half-life (t1/2) of 1.15 hours, and there is no drug accumulation.

Professor Li Wenbin, the main researcher of the glioma clinical trial (Director of the Department of Glioma at Beijing Shijitan Hospital), released the glioma clinical trial data at the conference.

Over the years, Jiuzhang Biotech has applied for 84 international and domestic invention patents and 1 utility model patent around the key treatment fields, related derivatives, core processes, and new dosage forms of CHA, and 20 patents have been authorized. In the future, based on the broad - spectrum anti - tumor property of CHA, we will search for and determine the advantageous tumor spectrum, carry out international and domestic clinical research on different tumor types, and promote immune - related diseases to clinical trials as soon as possible.