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Shanghai Newsummit Biopharma Co.Ltd
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Core Competitive Advantages
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Newsummit CRO Service Network


1. Core competitive advantages

Since its inception, Newsummit has been focusing on exploration and development of CRO business, innovatively developing the GRDP management system and establishing a high-quality, professional management team and operations. Gradually, Newsummit has integrated a large number of platforms, customers, hospitals, research institutions, etc. as BD channels and R&D resources. Currently, Newsummit is in a position to offer a full chain of CRO service capabilities that cover all the major stages of drug development.

(1) Advantages of all-encompassing services

Due to the complexity of CRO services along the drug development process, as well as the massive technical differences that exist between each part of the R&D, significant gaps between preclinical studies and clinical studies, most of the domestic CRO companies only focus on specific fields of CRO services in drug discovery process, resulting in deficiencies when it comes to proposing a comprehensive drug development services. Conversely, Newsummit has been deeply involved in CRO services for many years, and thus can currently provide technical services covering all the major stages of drug R&D, including pharmaceutical research, preclinical pharmacology and toxicology research studies, writing and compilation of application materials, clinical trials application; clinical phase I, II, III studies, clinical data analysis, clinical research summary, registration certificate application, post-market evaluation.

Since its establishment, Newsummit has made full use of the advantages brought by synergies among various stages of CRO services in a holistic manner, and contracted numerous projects of novel drug R & D, thus achieving excellent economic returns.

(2) Advantages of management system

Newsummit has been operating in the CRO industry for many years. In order to enhance service efficiency, Newsummit has notably improved the possibility of success on drug R&D, via the development of the innovative GRDP service management system. GRDP was generated based on the "Good Laboratory Quality Management Practices" (GLP), "Drug Clinical Research Practice" (GCP) and "Good Manufacturing Practices" (GMP) promulgated by the Chinese goverment, and runs through the whole process of drug development, covering pharmaceutical research, pharmacology/pharmacokinetic/safety assessment (non-clinical studies), phase I-IV clinical research, industrialization, IND/NDA application. At the same time, complex drug R&D activities are split into relatively simple and combined modules, within which work has been standardized and staff have been trained to be professional. As a result, said complicated modules are converted into streamlined operations covering the whole CRO business. The system consists of more than 4,000 files, including: management system, SOPs, records and accounting, guidelines and other types of documents. It has been subject to national copyright registration and has been granted a trademark registration certificate.

Capitalizing on the enhanced efficiency of its proprietary GRDP management system, Newsummit has undergone rapid development.

(3) Advantages of Platforms and Resources

Newsummit has been committed to building the "Government – Manufacturing – Clinical – Research " innovative business model, which means to associate four previously separated resources: Government (biotech/science clusters with government background), Manufacturing (healthcare and pharmaceutical companies), Clinical (hospitals) and Research (research institutions), which, when combined together, synergistically promote the development of the bio-pharmaceutical industry.

Currently, NSB established several research platforms such as Shanghai Zhangjiang Bio-Pharmaceutical International Cooperation Incubator Platform, Wuhan Optical Valley National Technology Enterprise Incubator, Taizhou China Medical City National Drug Innovation Medicine Development Industry Base with ZJ Innopark (Shanghai), Biolake (Wuhan), China Medical City (Taizhou) – all national-level biomedical industry bases.

High-level, high-impact biotechnology cluster platforms provide powerful support for speeding up the development of Newsummit.

In terms of industry resources, NSB has established long-term cooperation relationships whith a number of well-known healthcare corporations (both domestic and overseas), including Honeywell, Roche Diagnostics, Beckman Coulter, Di’an Diagnostics, Neusoft A&T, AnkeBio etc.

In terms of clinical resources, NSB has established cooperation programs with famous clinical institutions (both domestic and overseas) to develop clinical trials for innovative products, including: Zhongshan Hospital of Fudan University, Huashan Hospital of Fudan University, Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Chinese PLA General Hospital (301), Guangdong General Hospital, Xijing Hospital, Institute Gustave Roussy (IGR), Charité University Pathology Research Center.

In the fields of research institutes, NSB has also established the cooperation relationships with animal research institutes of Chinese Academy of Sciences, Beijing University, Fudan University, Shanghai Jiaotong University, China Pharmaceutical University, Medical Research Council Technology (MRCT), Nottingham University etc.

Combining the power of policy, manufacturing, clinical and research, as well as relying on excellent resource integration capabilities, NSB has established influential service platforms in Shanghai, Wuhan and Taizhou and has achieved excellent economic benefits.

(4) Brand advantages

Newsummit has been engaged in new drug research and development outsourcing services for 15 years years and obtained a series of research service achievements. Since its establishment, Shanghai Newsummit and its subsidiary companies have provided services for more than 550 CRO projects and more than 230 clients at home and abroad, and completed the clinical approval reports for more than 40 projects. Besides, in response to the country's call for the development of innovative drugs, Newsummit has achieved a wealth of results in the fields of innovative drug CRO services. By now, Newsummit has become one of the industry leaders in the field of innovative product CRO services and has overall serviced more than 450 innovative products.

In addition, Newsummit either presided over or participated in a number of major scientific research projects at national, provincial and ministerial level, including 10th/11th/12th Five-Year Plans. Shanghai Newsummit is the implementation arm of the “Scientific Action Plans for the Prevention and Treatment of Major Diseases” of the Development Center for Medical Science and Technology, National Health and Family Planning Commission (formerly Ministry of Health). Now the brand ”Newsummit” has gained a great influence within the industry.

2. Position in Industry

Newsummit developed rapidly and has become a group company with a well-performing management system, strong technical teams and rich platform resources. Over the past 10 years, Newsummit has provided effective CRO service for more than 230 healthcare companies including multinational pharmaceutical companies, small- and medium-sized pharmaceutical and biotech companies, various research institutes etc. Newsummit has become one of the industry leaders in the fields of innovative product CRO services, building up a good reputation in the pharmaceutical and biotech industry and constantly growing its market influence.

 

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