Biological Sample Testing

HQ Bioscience Co., Ltd., a subsidiary of R&G, established in January 2015, is a company focusing on the testing and analysis services of biological samples of large and small molecule drugs and is led by Xiaoyan Chen, a researcher at the Center for Drug Metabolism and Pharmacokinetics Research, Shanghai Institute of Material Medica, Chinese Academy of Sciences. The company is located in Suzhou Industrial Park, Jiangsu Province, and there are about 3000 square meters of laboratory, with more than 20 advanced instruments such as highly sensitive liquid chromatography-tandem mass spectrometry, MSD, flow cytometer and microplate reader.

Nearly 80 professional team members have rich experience in biological sample analysis, pharmacokinetic research and preclinical drug metabolism and pharmacokinetic research of innovative drugs. At present, the company has completed more than 60 preclinical ADME studies of new drugs and has provided more than 300 bioanalytical testings for clinical human trials (phase 1 to 4) of drugs for nearly 200 well-known pharmaceutical enterprises at home and abroad. Passed the inter-laboratory quality assessment of pharmacokinetics conducted by the Ministry of Health with full score for 5 consecutive years.

HQ Bioscience Co., Ltd. has successfully passed the audit by dozens of domestic and foreign customers, and successfully passed the on-site verification by CFDI of NMPA for more than 30 projects, helping customers successfully pass the consistency evaluation of generic drugs for 50+ varieties and obtain the drug registration approval letter or supplementary approval letter, of which 30+ items are exempted from on-site verification. The pass rate of on-site verification is 100%, providing a strong guarantee for the successful marketing of the products.

Services include:

Bioequivalence evaluation and consistency evaluation testing of generic drugs in human body;

Phase 1, 2 and 3 clinical pharmacokinetic studies of innovative drugs;

Non-clinical absorption, distribution, metabolism, excretion and toxicokinetic studies of the drug;

Identification of drugs and metabolites in biological samples;

Pharmacokinetics, immunogenicity and neutralizing antibody detection of macromolecular antibody drugs;

Biomarkers, cytokine assays, etc.