Beijing Leadingpharm Medicine Technology Development—Shimadzu China Innovation Center New Milestone of Strategic Cooperation

The strategic cooperation and launching ceremony between Beijing Leadingpharm Medicine Technology Development(hereinafter referred to as "New Leading") and Shimadzu China (hereinafter referred to as "Shimadzu") Innovation Center was grandly held at the headquarters of New Leading on August 13.The Chairman of New Leading Xinhua Tao, President Shijing Gao, Executive Vice President Kun Liu, Vice President Yunfan Yao, The Center Director of Shimadzu China Innovation Center Lei Cao, and Deputy Center Director Xiaodong Li, members of the research team and many special guests from research institutes and enterprises witnessed this important moment.
 

In this strategic cooperation, the two parties will establish a joint research group "Using Multidimensional Mass Spectrometry to Develop Antibiotic Polymer Impurity Detection Methods". This research group, led by Dr. Xiaodong Li, deputy director of Shimadzu China Innovation Center, and Dr. Ying Dong, general manager of the New Leading Analytical and Testing Division, will conduct in-depth research on the detection of antibiotic polymer impurities, build multidimensional tandem mass spectrometry, and jointly tackle antibiotics. Research methods of polymer impurities and establish related databases.
 

（The picture shows Research team members: Jing Dong, Ying Dong, Guolan Wang, Lichun Zhou, Changqin Hu, Xiaodong Li, Zhenhe Chen, Yunfan Yao, Weidong Hu, Hui Wang from left to right）

The conference was firstly addressed by Mr. Xinhua Tao, Chairman of New Leading. Mr. Tao said that New Leading has nearly 20 years of antibiotic research and development experience and impurity research team. Shimadzu has internationally leading analysis and testing equipment and application technology engineers. The choice not only reflects the new leading R&D height, but also gives full play to Shimadzu's equipment advantages. Since the establishment of the cooperation between New Leading and Shimadzu in August 2019, the teams of both parties have been constantly running in and have achieved fruitful research and development results, and have accumulated experience in the development of several antibiotic polymer impurity detection methods. This signing ceremony is not only a new beginning, but also a test of the results of previous cooperation. I hope that through the joint efforts of both Shimadzu and the New leading, as well as the experts and business representatives present, we will push the cause of consistency evaluation to a new height.

Subsequently, Lei Cao, the director of the Innovation Center, said that in recent years, the consistency evaluation of generic drugs has been carried out in an orderly manner throughout the country. Since the cooperation between the New Leading and the Shimadzu in 2019, they have successively completed a number of cephalosporin antibiotic polymer impurities detection programs, and the results have been recognized by the national drug review department as supplementary materials for drug declaration. In order to better improve the scope of application of relevant methods and solve the problems encountered in the application process of enterprises, New Leading and Shimadzu established a joint research team. It is hoped that the two parties can work together to develop a set of experts and enterprises. Impurity analysis solutions and databases that comply with the drug declaration process will provide a solid guarantee for the smooth development of pharmaceutical companies and drug CROs in the future.

At the launching ceremony, the research team expert Mr. Changqin Hu gave a keynote speech titled "Current Status and Prospects of Antibiotic Polymer Research and Development". Mr.Hu introduced the development and research history of antibiotics in the past 100 years firstly , and explained in depth the mechanism of cephalosporin antibiotics causing allergic reactions, the polymerization characteristics of cephalosporins and the polymer structure, and the polymer impurities of β-lactam antibiotics The formation and development of the control strategy were analyzed in detail, and the guests present benefited a lot.
 

(The  picture shows Dr. Xiaodong Li introducing Shimadzu’s leading technology and equipment and showing the existing results.)

(The picture shows Dr. Ying Dong introducing the new leading analysis and testing division and showing the existing results)

In this strategic cooperation, many colleagues from pharmaceutical companies are invited to join the polymer method development research group. Through multi-party cooperation, expand the scope of research, jointly establish an antibiotic impurity analysis database, solve research and development technical difficulties, and upgrade the pharmacopoeial standards of antibiotics. To promote the high-quality and efficient completion of the consistency evaluation of antibiotic varieties and the listing of imitations by pharmaceutical companies, so that the people's medication can be safe, effective and accessible! Guests from various companies expressed that today’s ceremony is particularly exciting. At present, the cooperation between New Leading and Shimadzu has achieved initial results. I sincerely wish both parties can achieve more innovative results in the future and be more determined to cooperate with New Leading.

 business representatives

Finally, Ms. Shijing Gao, President of New Leading welcomed the arrival of expert leaders and representatives of pharmaceutical companies once again. Mr. Gao expressed her hope that through the new leading CXO platform, the system, professionalism, digitality and openness of services will be improved to meet the industry's demands for technical services and open up the upstream and downstream links of new drug research and development. With the help of Shimadzu's advantages in high-end instrument testing equipment and instrument experts, combined with the advantages in the application of new leading technologies, the two parties have realized a strong alliance, resource sharing, overall coordination, and innovative methods to jointly respond to industry hotspots and difficulties, and optimize and upgrade testing. Instruments promote advanced detection methods and play a leading role in technology.

(The picture shows the president Shijing Gao and the center director Lei Cao signing the formal contract on behalf of the two parties)

We believe that under the cooperation of tacit understanding, mutual trust, mutual promotion and win-win cooperation, the two sides will continue to expand the cooperation space with height, depth and breadth, in order to promote the technological progress of the entire pharmaceutical industry and even the environment, food, chemical industry, etc. And make new and greater contributions to the satisfaction of the masses of high-quality medical consumption!

Experts introduction

	Changqin Hu PhD Tutor Chief expert of chemical drug verification of China Food and Drug Control Institute, former director of antibiotics room and director of microbiological testing room, member of Academic Committee of China Food and Drug Control Institute, executive member of Pharmacopoeia Committee, etc.
	Lichun Zhou Worked in the front line of drug inspection for 32 years Served as Director of the Chemistry Office, Director of the Antibiotics Office, Director and Assistant to the Director of the Beijing Institute of Drug Control, a member of the 9th, 10th, and 11th Pharmacopoeia Committees, and post-marketing drug safety monitoring and re-evaluation in Beijing Expert database experts, review expert database experts of the State Food and Drug Administration and other institutions.
	Guolan Wang Worked in Beijing Drug Inspection Institute for 33 years He has rich professional knowledge and practical experience in drug registration approval, drug quality standard review and research, and is responsible for drafting the quality standards of some antibiotics in the Chinese Pharmacopoeia; Review experts of Beijing Municipal Center for Drug Evaluation, published articles in the "Journal of Pharmaceutical Analysis", 《Chinese Journal of Antibiotics》《Chinese Medical Guidelines》, 《Chinese Drug Standards》and other professional fields of drug testing.
	iaodong Li PhD, Lanzhou Institute of Chemical Physics, Chinese Academy of Sciences Postdoctoral fellow, Tsinghua University He used to work in the instrument analysis room, chemical drug room and reference material technology room of China Food and Drug Control Research Institute. The main research areas are the establishment of drug quality control-related analysis methods and the research and development of national drug reference materials; current deputy director of Shimadzu China Innovation Center, Concurrently serves as the vice chairman of the Beijing Chromatographic Society.
	Ying Dong Master of Chemistry, Lanzhou University PhD, School of Chemistry, University of Sydney, Australia Post-doctorate at Victoria University of Wellington, New Zealand, Served as an overseas expert of doping testing laboratories in the United Kingdom and Brazil, served as the deputy director of the testing laboratory of the Anti-Doping Center of the General Administration of Sport of China, and currently serves as the general manager of the New Leading Analytical Testing Division.
	Jing Dong PhD, Peking University School of Medicine Worked at Shimadzu Corporation, responsible for the application support of LCMS, direct ionization source, imaging mass spectrometry and other products for more than 10 years.
	Zhenhe Chen Ph.D. Co-trained by Complutense University of Madrid and Beijing Institute of Technology Post-doctorate in Environmental Science and Technology, Tsinghua University Worked at Shimadzu Innovation Center and engaged in instrument analysis for more than 10 years.
	Hui Wang Master of Pharmaceutical Engineering, Beijing University of Chemical Technology PhD in Chemistry, Tsinghua University He used to be the leader of the synthesis department of Tianjin WuXi AppTec New Drug Development Co., Ltd., and currently serves as the general manager of the API research division of Beijing New Leading Pharmaceutical Technology Development Co., Ltd., with more than 10 years of research, development and management experience in the field of drug development.
	Weidong Hu PhD, Zhengzhou University, major in medicinal chemistry Worked at Henan Academy of Sciences and engaged in chemical drug impurity research for more than 10 years. Now he is the general manager of the new leading impurity research division.