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Keep improving Xinbo safety review

Shandong Xinbo is a scientific research service-oriented enterprise that integrates pharmacological research, toxicology research, drug analysis and testing services, animal pathology testing, and medical device evaluation services. It is a high-tech enterprise, Shandong Province Enterprise Technology Center, and Shandong Province Gazelle Enterprise.

Shandong Xinbo has established Jinan Laboratory and Linyi Laboratory. Currently, it has built nearly 20000 square meters of pharmacology and toxicology research laboratories that meet international standards, equipped with more than 1000 advanced instruments and equipment at home and abroad. Among them, the toxicology research laboratory can conduct 9 studies including single dose toxicity tests, repeated dose toxicity tests, safety pharmacology tests, reproductive toxicity tests, genetic toxicity tests, local toxicity tests, immunogenicity tests, toxicokinetics tests, and carcinogenicity tests according to the GLP standards of NMPA and FDA.
The company is committed to providing high-quality commissioned research services for new drug and medical research and development institutions. Since its establishment in 2010, it has provided over 12000 services to more than 590 pharmaceutical companies, new drug research institutions, and research institutes both domestically and internationally. We have completed preclinical evaluation services for nearly 450 innovative drugs in accordance with domestic and foreign regulatory requirements, including small molecule drugs, biomacromolecule drugs, new preventive and therapeutic vaccines, and traditional Chinese medicine/natural medicine evaluation work. We have helped research and development units obtain more than 100 clinical approvals for new drugs, especially in the evaluation of rapidly developing therapeutic vaccines, cell and gene therapy drugs in recent years, and have accumulated rich experience. Completed the evaluation of nearly 4600 varieties of generic drugs.

In addition, the company continuously innovates its practices and breaks through barriers, improving and exploring difficult areas such as administration technology for young animals, continuous intravenous administration technology, and tracheal administration technology, and maturely applying them to safety evaluation. The company also pays attention to the demand for innovative development in the global pharmaceutical industry, focusing on the key link of innovative drug research and development. With the accumulated experience in serving the domestic and international pharmaceutical industry, it provides comprehensive preclinical research and development services for new drugs in the global pharmaceutical industry.

  • 15+year
    New drug evaluation experience
  • 590+family
    Serving customers
  • 450+Item
    Preclinical evaluation experience of innovative drugs
  • 4600+Item
    Preclinical evaluation experience of generic drugs
Deadline:2025-06-30

History

2010
2010
Company site
2012
2012
Obtain GLP certification approval
2015
2015
GLP review, add carcinogenic test approval
2018
2018
GLP review
2021
2021
GLP review
2022
2022
Establishment of Medical Device Evaluation Research Center
Facility expansion
2024
2024
Site selection and establishment of Jinan laboratory
May 2024 GLP review
2025
2025
Jinan laboratory obtains GLP certification approval

Vision

Innovate and break through, keep improving, and build a well-known CRO enterprise that is first-class in China and in line with international standards

Mission

Service innovation drug research, benefit human health

Values

Quality first, integrity first, rigorous and standardized, precise service

Honors

Partners(Only some cooperative enterprises are displayed)

Yichang Humanwell Pharmaceutical Co., Ltd

Yichang Humanwell Pharmaceutical Co., Ltd

Tianjin Hankang Pharmaceutical Biotechnology Co., Ltd

Tianjin Hankang Pharmaceutical Biotechnology Co., Ltd

Changchun Baike Biotechnology Co., Ltd

Changchun Baike Biotechnology Co., Ltd

Changchun Biological Products Research Institute Co., Ltd

Changchun Biological Products Research Institute Co., Ltd

Shiyao Group

Shiyao Group

Qilu Pharmaceutical Co., Ltd

Qilu Pharmaceutical Co., Ltd

Beijing Xiantong International Pharmaceutical Technology Co., Ltd

Beijing Xiantong International Pharmaceutical Technology Co., Ltd

PLA Academy of Military Science

PLA Academy of Military Science

Shandong University

Shandong University

Kelun Pharmaceutical

Kelun Pharmaceutical

Shandong Luoxin Pharmaceutical Group Co., Ltd

Shandong Luoxin Pharmaceutical Group Co., Ltd

Sinopharm

Sinopharm

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