All the subjects participating in the Phase I clinical trial of CHA for injection were patients with high - grade malignant gliomas who had failed international standard treatments such as surgery, radiotherapy and chemotherapy.

The results of the Phase I clinical trial prove that CHA injection is safe with extremely low toxic and side effects. Its pharmacokinetic pathway is clear and there is no cumulative toxicity. The treatment effect exceeds the researchers' expectations.

For recurrent patients who have failed the classic treatment methods, after using CHA for injection, their median overall survival time is at least 2 to 5 times longer than the globally recognized one.

 On March 17, 2018, at the 2nd China Glioma Conference held in Changsha, Professor Li Wenbin, Director of the Department of Glioma at Shijitan Hospital Affiliated to Capital Medical University, revealed in his report that CHA for injection developed by Sichuan Jiuzhang Biotechnology Co., Ltd. in China has completed the Phase I clinical trial for the treatment of malignant gliomas, and the clinical trial results are positive.

Malignant glioma is the most common intracranial tumor. Among them, high - grade (Grade IV) glioblastoma is the most malignant glioma, with an incidence rate of 3.2/100,000. The median survival time of patients from initial diagnosis to death is 14.6 months, and this data has not been updated in the past 20 years. Almost all patients with high - grade (Grade IV) glioblastoma, even with the most aggressive treatment methods (including surgery, radiotherapy, and chemotherapy), will inevitably experience recurrence later. The median overall survival time of patients with Grade IV glioblastoma after recurrence is about 7.2 - 9.6 months. And the overall survival time of recurrent patients who have failed classic treatment methods such as temozolomide, bevacizumab, or salvage chemotherapy is only 3 - 5 months (Data source: "Science Translational Medicine" on February 28, 2018 (Pellegatta S, et al. Sci Transl Med), "Aiming at Deadly Brain Tumors! The New Target CAR - T Cell Therapy Demonstrates Powerful Therapeutic Advantages").

The clinical team led by Professor Li Wenbin, based on the research on safety, tolerance, and pharmacokinetic characteristics, focused on the treatment effect of CHA for injection on high - grade glioblastoma. All the subjects participating in the Phase I clinical trial of CHA for injection were patients with high - grade malignant gliomas who had failed international standard treatments such as surgery, radiotherapy, and chemotherapy (disease progression). The results of the Phase I clinical trial prove that CHA injection is safe with extremely low toxic and side effects (the adverse reaction is only muscle induration caused by long - term injection), its pharmacokinetic pathway is clear, there is no cumulative toxicity, and the treatment effect exceeds the researchers' expectations.

In the effective dose group, as of March 2, 2018, the median overall survival time of the subjects (calculated from the first - day medication after randomization, that is, the day of the subject's enrollment) was 10.3 months, and the median overall survival time (calculated from the recurrence) was 14.2 months. Since the median overall survival time with 50% of the cases dead has not been reached yet, the currently surviving subjects are still under continuous follow - up. For recurrent patients who have failed the classic treatment methods, after using CHA for injection, their median overall survival time is at least 2 - 5 times longer than the globally recognized one.

In the latest follow - up (February 26, 2018), it was found that among the subjects who continued to take the medicine, there were cases of complete remission (CR, all lesions disappeared) and partial remission (PR, the lesion shrank by more than 50%) in the treatment assessment, which is very exciting. Currently, globally, recurrent high - grade glioma patients who have failed standard treatment will be in an irreversible state of "SD - PD - death" (that is, patients will progress from stable disease SD to progressive disease PD and then to death, and this situation cannot be reversed by any drug at present). There are hardly any cases of CR or PR. In clinical practice, it has also been found that for chemotherapy drugs, such as the PCV (lomustine, procarbazine, and vincristine combination therapy) regimen, even if the tumor volume of a small number of patients can be reduced in the initial stage, their survival time is not extended. In this trial, the appearance of CR and PR in the subjects, and the good living conditions of the subjects with a significant extension of survival time, this therapeutic response far exceeds the researchers' expectations and is a major breakthrough!

CHA is a natural small - molecule active substance with a molecular weight of 354.31 and is widely present in various plants. It was first discovered in sunflower - like plants by British scientists in 1897, named CHA in 1909, and its structure was confirmed as a polyphenol formed by the condensation of caffeic acid and quinic acid in 1947.

Since 2000, under the leadership of Chairman Zhang Jie, Jiuzhang Biotech has carried out systematic research and development of CHA. In 2002, it achieved industrial extraction, separated the sensitizing plant protein, and completed the transformation from CHA extract to CHA raw material drug. On August 30, 2013, it obtained the clinical trial approval documents for CHA injection and raw material drug (2013L01855, 2013L01856) from the CFDA.

So far, Jiuzhang Biotech has obtained 23 invention patent authorizations related to CHA, 1 utility model patent, and 2 US patents. There are 27 domestic patents and 26 international patents in the substantive examination stage. In December 2016, the "Phase I/II Clinical Research of the First - in - class New Drug CHA for Injection" was included in the major new drug creation project of the 13th Five - Year National Science and Technology Major Project by the National Health and Family Planning Commission and the Ministry of Science and Technology, and it is also a major science and technology support project in Sichuan Province.

Jiuzhang Biotech has established a strategic partnership with the Institute of Materia Medica of the Chinese Academy of Medical Sciences and has conducted in - depth research on the anti - tumor mechanism from multiple levels. The research results show that CHA for injection is a new type of anti - tumor immune small - molecule natural drug, which exerts anti - tumor effects mainly from two aspects: relieving immunosuppression and inducing tumor cell differentiation.

On the one hand, it can target and regulate immune checkpoints, relieve immunosuppression, and promote the proliferation of CD4T lymphocytes. On the other hand, it can induce the differentiation of malignant tumor cells, changing them from a poorly differentiated state with a high degree of malignancy to a well - differentiated state with a low degree of malignancy.

Especially in the pre - clinical and clinical studies of malignant gliomas, it was found that CHA for injection can penetrate the blood - brain barrier, regulate the proportion of immune cells at the lesion site, promote the aggregation of M1 macrophages that help eliminate tumor cells to the lesion, inhibit M2 macrophages that help tumor cell migration and proliferation, and thus inhibit the metastasis and proliferation of gliomas. The relevant basic research results have been published in the journal "Scientific Reports" (Xue N et al. 2017; 7: 39011).

"CHA Inhibits the Growth of Malignant Glioma Cells by Repolarizing M2 Macrophages into M1 Macrophages" elaborates and demonstrates in detail the mechanism by which CHA for injection promotes the apoptosis of malignant tumor cells and inhibits tumor growth. The research results of the drug efficacy and mechanism show that CHA injection has broad - spectrum anti - tumor effects and can be applied to the treatment of various tumors, such as lung cancer, prostate cancer, cervical squamous cell carcinoma, lymphoma, and colorectal cancer.

In view of the broad - spectrum anti - tumor effects of CHA injection, while carrying out the Phase II clinical study for the treatment of recurrent high - grade glioblastoma, Jiuzhang Biotech has launched the Phase Ib/IIa clinical trial research for patients with advanced lung cancer.

The research and development of glioma drugs is a difficult problem in global drug research and development, and there has been no new drug in the past 20 years. Academician Zhao Jizong from Beijing Tiantan Hospital Affiliated to Capital Medical University said in an interview with "China Medical Information Herald": Glioma is a very important part of neurosurgical tumors, accounting for more than half of brain tumors. The current precision research will provide new technologies for the pathogenesis, diagnosis, and treatment of glioma, and play an important role in the treatment of glioma.

The results of the Phase I clinical trial of CHA for injection not only prove its safety but also increase the survival time of glioma recurrence patients by 2 - 3 times. As a research project supported by the national major new drug special project, the Phase I clinical results have received high attention from domestic and foreign experts at the conference as soon as they were announced.

All sectors are looking forward to the results of further clinical trials. If the subsequent trial results further prove its effectiveness, it will be a great gospel for glioma patients around the world. CHA for injection may become a blockbuster innovative drug from China, enhancing China's position in global drug innovation.