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The Technology Forum on Biological Drug Research and Development Hotspot under the New Situation Has

In recent years, the domestic biological drugs have developed rapidly and the market has shown a strong growth trend. The research on biological drugs has become a hot field in the pharmaceutical industry. Driven by technological progress and demand growth, biological drug research and development ushered in a golden period of development. In order to further promote the development of the domestic biomedicine industry and promote the internationalization of the domestic biomedicine industry, sponsored by the clinical research committee of Shanghai pharmaceutical association and supported by Shanghai Xihua detection technology service co., LTD., the Technology Forum on Biological Drug Research and Development Hotspot under the New Situation  was held in Shanghai on August 22, 2019.


Professor Jing Zhang from Shanghai pharmaceutical association and Dr. Xiaohang Shen from Shanghai Xihua made speeches at the meeting. Compared with small-molecule drugs, the large molecules of biological drugs are characterized by large molecular weight, complex structure and immunogenicity. What kind of situation is China facing in the field of biological medicine? How to deal with the current situation? How to seize the opportunity and meet the challenge? Domestic and international experts from various fields of biomedical research and development provided participants with new perspectives from different aspects.


Prof. Jingying Jia and Prof. Guoying Cao from Shanghai pharmaceutical association chaired the forum. First of all, Dr. Qinwei Zhou from Innoventbio introduced the opportunities and challenges faced by China's biopharmaceutical research and development in detail. Among the top 10 best-selling drugs in the world, 80% are biological drugs, which shows that the development prospect of biological drugs is unlimited. China started late in the field of biological drugs, and the proportion of research is small. It is the consistent direction of the pharmaceutical industry in China to realize the localization of biological drugs and to promote the integration of drug research and development with international standards. In the process of this endeavor, drug testing is indispensable, and gene testing is one of the most powerful factors in the development of biological drugs. Dr. Hua Cheng from Sinotech Genomics shared his own cases and experience in promoting the development of biological drugs through gene testing, which provides a new vision for future research and development and testing.


In the global biological drug development momentum, the relevant laws and regulations at home and abroad have experienced what kind of development history? What are the differences between domestic and foreign laws and regulations? Dr. Jinsong Xing of Xihua explained the challenges of Nab testing and the choice of the platform. At the same time, he called on the insiders to follow the most stringent international regulations in the future research and development and testing work, in order to cope with the continuous development and progress of the industry.


Doctor Haijing Yang from Huashan Hospital of Fudan University summarized the current situation of the development of biological agents and their clinical applications. Due to the particularity of biological agents, the safety of biological agents should not be ignored. She elaborated on how to carry out risk management and control in the phase I clinical trial of biological agents from the aspects of scheme design, environmental personnel, drug samples and subjects, and shared her team's experience in risk management and control with examples.


Professor Jingkai Gu, drug metabolism research center of Jilin University and modern drug metabolism research institute of Beijing, described the current situation and challenges of bio-macromolecular drugs spectrum analysis, and provided a new idea in the detection of macromolecule drug by combining ion mobility with mass spectrometry.


Dr. Jie Liu of Fusunkite and Dr. Jinjing Che of the academy of military medical sciences shared the application of CAR-T cell therapy and biomarkers in clinical research and bioanalysis strategies respectively, expecting the scientific findings in these clinical trials to be translated into clinical applications as soon as possible to benefit more patients.


In the global biological drug development momentum, the relevant laws and regulations at home and abroad have experienced what kind of development history? What are the differences between domestic and foreign laws and regulations? Dr. Jinsong Xing of Xihua explained the challenges of Nab testing and the choice of the platform. At the same time, he called on the insiders to follow the most stringent international regulations in the future research and development and testing work, in order to cope with the continuous development and progress of the industry.


Doctor Haijing Yang from Huashan Hospital of Fudan University summarized the current situation of the development of biological agents and their clinical applications. Due to the particularity of biological agents, the safety of biological agents should not be ignored. She elaborated on how to carry out risk management and control in the phase I clinical trial of biological agents from the aspects of scheme design, environmental personnel, drug samples and subjects, and shared her team's experience in risk management and control with examples.


Professor Jingkai Gu, drug metabolism research center of Jilin University and modern drug metabolism research institute of Beijing, described the current situation and challenges of bio-macromolecular drugs spectrum analysis, and provided a new idea in the detection of macromolecule drug by combining ion mobility with mass spectrometry.


Dr. Jie Liu of Fusunkite and Dr. Jinjing Che of the academy of military medical sciences shared the application of CAR-T cell therapy and biomarkers in clinical research and bioanalysis strategies respectively, expecting the scientific findings in these clinical trials to be translated into clinical applications as soon as possible to benefit more patients.