The national multi-center phase II/III clinical trial for the treatment of malignant glioma was officially launched;
Jiuzhang Biotech was rated by the Journal of Pharmaceutical Times as “The Tide of Times” in 2019 and had a special report.
13 overseas invention patents of Jiuzhang Biotech were approved;
In January, Research and Development of Chlorogenic Acid for Injection (Phase Ib Clinical Study of Advanced Lung Cancer) obtained the Directional Financial Transfer Payment Project in Sichuan Province;
In March, at “The 2nd China Glioma Congress” in Changsha, Professor LI Wenbin, principle investigator (PI) of glioma, presented the data of phase I clinical trials of malignant glioma and achieved significant repercussions;
In April, our company signed a statistical analysis service contract with Jiaxing Taimei Medical Technology Co., Ltd. for the treatment of grade IV glioblastoma (GBW) phase II/III clinical trials with chlorogenic acid for injection;
In May, Jiuzhang Biotech's team of clinical research and development of chlorogenic acid conducted a special report on phase I clinical research results and phase II clinical design to CDE leaders and relevant assessment experts. Consensus was reached at the meeting: Phase II clinical study 100 cases of injectable chlorogenic acid and 100 cases of positive control drugs (all subjects were grade IV glioma patients who had recurrence after surgery and failed to be treated by international standards) were approved for conditional marketing by making significant differences.
In January, Scientific Reports, a journal of Nature, published an article entitled Chlorogenic Acid Inhibits Glioblastoma Growth through Repolarization Macrophage from M2 to M1 Phenotype, which elaborated and demonstrated the mechanism of chlorogenic acid for injection promoting apoptosis and inhibiting growth of malignant tumors. Great external repercussions have been achieved;
In September, Phase I clinical trials on the safety, tolerance and pharmacokinetics of chlorogenic acid for injection in the treatment of malignant glioma were completed;
In October, at “The 2nd China Medical Investment and Innovation Conference”, Jiuzhang Biotech published the data of Phase I clinical trials on the safety, tolerance and pharmacokinetics of chlorogenic acid for injection in the treatment of advanced malignant glioma, and received a good response;
In November, “Phase II clinical study on the treatment of glioma with chlorogenic acid for injection, class I of the innovative natural small molecule immune drug” was appraised as “a major special project in Sichuan Province” by Sichuan Science and Technology Department;
Phase I/II Clinical Study of Chlorogenic Acid for Injection, the Class I of the New Medicines had been listed by National Health and Family Planning Commission of PRC and Ministry of Science and Technology of the People's Republic of China in the National 13th-five-year plan Science and Technology Major Special Major New Drug Creation Project;
In February, a Phase I clinical study on the safety, tolerability and pharmacokinetics of malignant glioma was conducted at the Beijing Shijitan Hospital, Capital of Capital Medical University;
In July, Phase I clinical trial of chlorogenic acid for injection in the treatment of advanced solid tumors was completed. The results showed that, according to RECIST1.0 standard, the clinical benefit rate was 50.0%, which exceeded the investigators' expectations. Chlorogenic acid for injection is safe, effective and had a wide range of clinical features in the treatment of tumors.
In November, Phase I clinical trial data of malignant glioma were published for the first time in the world at “The First China Congress on Medical Investment and Innovation”;
In December, Nature interviewed ZHANG Jie, inventor of chlorogenic acid drug substance and injection chlorogenic acid of Jiuzhang Biotech, Prof. CHEN Xiaoguang, Institute of Materia Medica, Chinese Academy of Medical Sciences, and Prof. LI Wenbin, Head of Clinical Trials of Glioma, Shijintan Hospital at that time (Beijing Tiantan, Capital Medical University at present). In the same month, a special article entitled New Breakthrough in Antitumor Drug was published in the English edition of Nature published on 22nd December 2016;
Beijing Cancer Hospital Phase I clinical trial of advanced malignant solid tumors was initiated;
Cooperated with the Institute of Pharmaceutical Research, Chinese Academy of Medical Sciences to establish the “Chlorogenic Acid Cooperative Development Project Committee”;
The company's name was changed to “Sichuan Jiuzhang Biological Science and Technology Co., Ltd.”
Obtained CFDA (CHINA FOOD AND DRUG ADMINISTRATION) (Currently National Medica L Products Administration, NMPA) approval of clinical trial of drug substance and clinical trial for injection;
It had been listed as a special project of transformation of scientific and technological achievements by Science and Technology Department of Sichuan Province and High-tech Zone;
Initiate phase I clinical exploration in Chinese Academy of Medical Sciences.
Declaration of clinical trials;
It had been listed as an independent innovation project by Chengdu Science and Technology Bureau;
It had been listed by Chengdu Science and Technology Bureau as a key scientific and technological project of Chengdu City.
It was listed by the Ministry of Industry and Information Technology of People's Republic of China as a major national science and technology achievements transformation project in 2010.
“A class I new drug monomer and its injections for treating lung cancer” was listed as the innovation project of SME's Technology Innovation Fund by Ministry of Science and Technology of the People's Republic of China;
“The Preclinical Study of A class I new drug substance and its injection for treating lung cancer” had been listed as the project of science and technology support program by Science and Technology Department of Sichuan Province;
The company was listed as the key cultivation enterprise in the development plan of biomedical industry in Chengdu and the drug substance and its preparations are listed as the key products.
“The Class I New Drug Monomer and its Injection for Treating Lung Cancer” are listed as the Chengdu High-tech Area Innovation Fund Project;
The project “a Class I new drug--drug substance and monomer lyophilized powder injection” was listed as” the seventh China Scientist Forum's most valuable investment item;
“The Research and Development of a Class I New Drug Monomer and its Injection for Treating Lung Cancer” had been listed as Industrial Technology Research and Development Project by Sichuan Province Development and Reform Commission;
“The Research on Anticancer Mechanism and Further Application Development of Plant Monomer Molecule” had been listed as the key project of technology innovation in Sichuan province in 2007 by Sichuan Province Economic and Information Department.
“Preclinical Study on High Purity Plant Monomer and its Preparation” had been listed as key scientific and technological research projects in Sichuan Province;
“Preclinical Study on High Purity Plant Monomer and its Preparation” had been listed as the key scientific and technological innovation project in high-tech district of Chengdu.
Carry out the preclinical study of chlorogenic acid and chlorogenic acid drug substance for injection as the class I anticancer new drugs worldwide;
The “High-purity Plant Monomer Project” had listed as the national torch project by Ministry of Science and Technology of the People's Republic of China;
“The research on anticancer mechanism and application development of new anti-tumor drug-plant monomer molecule” had been listed in the pilot project of national science and technology innovation by Sichuan Provincial Development and Reform Commission.
The “High-purity Plant Monomer Project” was listed as the torch project by Science and Technology Department of Sichuan Province;
The pilot-scale study of extracting chlorogenic acid monomer from Folium Eucommiae leaves was completed, and the pilot test identification certificate was obtained;
Complete the process and quality research of chlorogenic acid drug substance, which can qualitatively and quantitatively analyze one thousandth or above impurities. It was the first time to realize the transformation of high purity chlorogenic acid into drug substance. It lies a pharmaceutical foundation for further research and development of chlorogenic acid;
The factory was located at No. 10 South Second Road, Science Park, Chengdu High-tech Zone, Sichuan Province.
A laboratory research on the extraction of chlorogenic acid monomer from Folium Eucommiae leaves was completed and the quality of chlorogenic acid monomer was started.
Study on monomer process of chlorogenic acid for medicinal use was started.
Sichuan Jiuzhang Biological Science and Technology Co., Ltd. was established.