R&D Process and Team of CHA Project

R&D Process and Team of CHA API

1. Small-scale Process Research of CHA API:

 

From 2000 to 2001, it was independently completed the design of the process route and the research on process parameters by Sichuan Jiuzhang Biotech. Person in charge: Zhang Jie. Main participants: Zhang Liang and Jiang Bo.

 

2. Pilot-scale Process Development Research of CHA API:

 

From 2001 to 2003, it was independently completed by Sichuan Jiuzhang Biotech and obtained the pilot- scale appraisal certificate issued by the National Science and Technology Commission (Certificate No.: Jianzi [2003] No. 006). Person in charge: Zhang Jie. Main participants: Zhang Liang and Jiang Bo.

 

3. Research on the Quality and Stability of CHA API:

 

From 2001 to 2008, Sichuan Jiuzhang Biotech, based on the physical and chemical properties of CHA and the preparation process, took the lead in constructing the quality control index system for the active pharmaceutical ingredient (API). It also entrusted the West China School of Pharmacy, Sichuan University to complete the verification of the analytical methods and the inspection of the quality indicators. Principal responsible person: Zhang Jie. Main participants: Zhang Liang and Li Xinquan. Person in charge of the trustee party: Xu Xiaoping. Main participants: Liao Liyun, Tan Pei, Zhou Sha, Zhang Jie (female), He Wenwen, Tian Xin, Liao Liyun, Luo Fei and Yong Zhiquan. (Contract Name: Research on the Quality Standards of CHA-001 and Its Injection, Contract No.: JZ2004003-JS)

 

4. Research on the Pharmacology of CHA:

 

In 2004, Sichuan Jiuzhang Biotech, based on the physical and chemical properties of CHA, the proposed clinical indications and the mode of administration, determined the general pharmacological research content and experimental scheme of CHA. It also entrusted the West China School of Pharmacy, Sichuan University to complete the verification of the general pharmacological experiments. Principal responsible person: Zhang Jie. Main participant: Zhang Liang. Person in charge of the trustee party: Bao Xu. Main participants: Xiao Yu, Liu Boyang and Zhang Haiying. (Contract Name: Research on the Long-term Toxicity, General Pharmacology, Allergic Reaction, Hemolysis, Local Irritation and Teratogenicity, Carcinogenicity and Mutagenicity Tests of CHA-001 and Its Injection, Contract No.: JZ2003001-JS)

 

5. Research on the Toxicology of CHA:

 

From 2004 to 2005, Sichuan Jiuzhang Biotech, based on the safety characteristics of CHA, the proposed clinical indications, the intended dosage and the mode of administration, took the lead in constructing the safety evaluation system for CHA. It also entrusted the West China School of Pharmacy of Sichuan University to complete the verification of acute toxicity and long- term toxicity tests. Principal responsible person: Zhang Jie. Main participant: Liao Juan. Person in charge of the trustee party: Bao Xu. Main participants: Liu Boyang, Xiao Yu, Zhang Haiying, Zhou Cuiying, Zhong Zhendong and Ai Yingxian. (Contract Name: Research on the Acute Toxicity and Pharmacodynamics of CHA-001 and Its Injection, Contract No.: JZ2003003-JS)

 

In 2005, Sichuan Jiuzhang Biotech, based on the safety characteristics of CHA, the proposed clinical indications, the intended dosage and the mode of administration, determined the research plan for the three types of toxicity (teratogenicity, carcinogenicity, and mutagenicity) of CHA. It also entrusted the West China School of Pharmacy, Sichuan University to complete the verification of reproductive toxicity and mutagenicity tests. Principal responsible person: Zhang Jie. Main participant: Liao Juan. Person in charge of the trustee party: Bao Xu and Hu Yuhua. Main participants: Meng Xianmin, Zhou Sha, Zhao Zhengzhong, Zhang Zunzhen, Li Hong and Ran Yun. (Contract Name: Research on the Long-term Toxicity, General Pharmacology, Allergic Reaction, Hemolysis, Local Irritation and Teratogenicity, Carcinogenicity and Mutagenicity Tests of CHA-001 and Its Injection, Contract No.: JZ2003001-JS)

 

6. Pharmacodynamic Tests of CHA API:

 

From 2004 to 2008, Sichuan Jiuzhang Biotech,  based on the proposed clinical indications, the intended dosage and the mode of administration of CHA, took the lead in constructing the animal pharmacodynamic evaluation system of CHA. It also entrusted the West China School of Pharmacy, Sichuan University to complete the verification of the in-vivo pharmacodynamic experiments. Principal responsible person: Zhang Jie. Main participants: Yang Huarong, Zhang Liang and Liao Juan. Person in charge of the trustee party: Bao Xu. Main participants: Liu Jie, Qiu Guo and Wei Dapeng. (Contract Name: Research on the Acute Toxicity and Pharmacodynamics of CHA-001 and Its Injection, Contract No.: JZ2003003-JS)

 

In 2007, Sichuan Jiuzhang Biotech,  based on the proposed clinical indications, the intended dosage and the mode of administration of CHA, took the lead in constructing the animal in-vitro pharmacodynamic evaluation system of CHA. It also entrusted the West China School of Pharmacy, Sichuan University to complete the verification of the in-vitro pharmacodynamic experiments. Principal responsible person: Zhang Jie. Main participant: Yang Huarong. Person in charge of the trustee party: Xu Xiaoping. Main participants: Wan Yi and Liu Jie. (Contract Name: Supplementary Agreement on the Research Test of In Vivo and In Vitro Antitumor Pharmacodynamics and Mechanism of CHA, Contract No.: JZ2007001-JS)

 

7. Research on the Mechanism of Action of CHA:

 

From 2011 to 2012, Sichuan Jiuzhang Biotech, based on the research results of the pharmacodynamics in vitro and in vivo, took the lead in constructing the research system of the gene targets of CHA. It also entrusted Shanghai Biochip Co., Ltd. to complete the research on gene chips.Principal responsible person: Zhang Jie. Main participant: Yang Huarong. Person in charge of the trustee party: Liu Hongwei. Main participant: Han Junsong. (Contract Name: Contract for the Sale of Gene Chips and Technical Services, Contract No.: JZ2011001-JS)

 

In 2012, Sichuan Jiuzhang Biotech, based on the results of the CHA gene chip research, designed the technical route for the research on the regulation of CHA's cell signaling pathways.  It also entrusted the West China School of Pharmacy of Sichuan University to complete the verification of the CaN - Nfat signaling pathway's function through fluorescent quantitative PCR detection. Principal responsible person: Zhang Jie. Main participant: Yang Huarong. Person in charge of the trustee party: Xu Xiaoping. Main participants: Ren Jie and Kang Qiumei.

 

8. Clinical Approval of CHA API:

 

In 2013, Sichuan Jiuzhang Biotechnology Co., Ltd., the applicant, obtained the clinical trial approval for anti-tumor drugs from the NMPA (formerly CFDA) (Class 1 chemical drug, Approval No. for CHA API: 2013L01856).

 

9. Pharmaceutical Research on the Production Process and Quality Optimization of CHA API:

 

From 2013 to the present, it has been independently completed by Sichuan Jiuzhang Biotech. The purity of chlorogenic acid bulk drug has been increased to 99% or more, and the impurity level has been effectively controlled. Person in charge of the sponsor: Zhang Jie. Main participants: Huang Wang, Zhang Liang, Zhang Fei, Zhang Ya, Yan Yongjiang and Ning Ling.

 

10. Research on the Industrialization Transformation and Application of CHA API:

 

From 2013 to the present, it has been independently completed by Jiuzhang Biotech. Person in charge: Zhang Jie. Main participants: Zhang Liang, Huang Wang, Xu Min, Zhang Fei and Zhang Ya.

 

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