Keep improving Xinbo safety review

Shandong Xinbo is a scientific research service enterprise integrating pharmacodynamic research, toxicological research, drug analysis and testing services, animal pathology testing, and medical device evaluation services. It is a high-tech enterprise and a Shandong Provincial Enterprise Technology Center.

Shandong Xinbo has established Jinan Laboratory and Linyi Laboratory. Currently, it has built nearly 20,000 square meters of pharmacology and toxicology research laboratories that meet international standards, equipped with over 800 advanced instruments and equipment from both domestic and international sources. The toxicology research laboratory is capable of conducting single-dose toxicity tests, repeated-dose toxicity tests, safety pharmacology tests, reproductive toxicity tests, genetic toxicity tests, local toxicity tests, immunogenicity tests, and toxicokinetic tests in accordance with the GLP standards of NMPA and FDA.

The company is dedicated to providing high-quality commissioned research services for new drug and medical research institutions. Since its establishment in 2010, it has provided over 12,000 services to more than 620 pharmaceutical companies, new drug research institutions, and research institutes both domestically and internationally. It has completed nearly 550 preclinical evaluation services for innovative drugs in accordance with domestic and international regulatory requirements, including small molecule drugs, biological macromolecule drugs, new preventive and therapeutic vaccines, and traditional Chinese medicine/natural medicine evaluations. It has assisted research and development units in obtaining over 100 clinical approvals for new drugs, and has accumulated rich experience in the evaluation of therapeutic vaccines, cell and gene therapy drugs, which have developed rapidly in recent years. It has also completed the evaluation of nearly 4,800 generic drug varieties.

In addition, the company continuously innovates and practices, breaks through barriers, and has made improvements and explorations in areas such as challenging administration techniques for young animals, continuous intravenous administration techniques, and tracheal administration techniques. These advancements have been maturely applied to safety evaluations. The company also pays attention to the needs of innovative development in the global pharmaceutical industry, focuses on the key links of innovative drug research and development, and leverages the experience accumulated from serving the domestic and international pharmaceutical industry to provide comprehensive preclinical research and development services for new drugs to the global pharmaceutical industry.

  • 16+year
    New drug evaluation experience
  • 630+family
    Serving customers
  • 550+Item
    Preclinical evaluation experience of innovative drugs
  • 4800+Item
    Preclinical evaluation experience of generic drugs
Deadline:2026-04-30

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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