Quantitative analysis of clinical biological samples of generic and innovative drugs
Release time:
2023-09-22 11:05
Source:
The pharmaceutical industry is related to national life, health and safety, and is highly valued worldwide. With the vigorous development of the global biomedical industry, the wave of innovation is one after another, and the scale of investment in pharmaceutical research and development is growing. CRO(Contract Research Organization, or contract research organization) industry market penetration is increasing, the industry development speed is obvious.
Shanghai Xihua Testing Technology Services Co., Ltd. was established in 2015. It is a pharmaceutical R & D outsourcing service provider with bioanalysis and drug analysis as its core business. On July 26, the audit status of the company's proposed listing on the Shenzhen Stock Exchange's Growth Enterprise Market has been changed to inquiry. The funds raised by the IPO will be invested in the company's Xihua Life Science Division and industrialization base project to further expand the existing research and development capacity and enhance the strength of research and development services.
Deep cultivation of CRO business results
After decades of development, industry companies have completed the transformation from simple technical support to comprehensive drug research and development services by providing professional pharmaceutical research and outsourcing services to help pharmaceutical companies realize various technical services and management support for new drug research and development. CRO has become an indispensable part of the pharmaceutical industry.
Since its establishment, Xihua Testing has been engaged in CRO industry services. Its main business is divided into two major sectors: life science and CMC(Chemical,Manufacturing and Control, mainly referring to production process, impurity research, quality research, stability research, etc.), it covers bioanalytical services, data management and statistical analysis services and clinical prepharmacokinetic (DMPK) services, as well as drug analysis, process development and optimization of APIs and formulations.
Bioanalysis, as an important part of the evaluation of drug effects in the process of drug research, will determine the results of pharmacokinetics research, and the bioanalysis business of Xihua Detection can provide services such as methodological development and validation of large and small molecules, gene therapy drugs and biomarkers, and clinical sample testing and analysis, able to comply with the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), China National Drug Administration (NMPA) and the International Council for Harmonization of Technical Requirements for Medicines for Human Use (ICH) and other relevant technical guidelines and to meet the requirements of Good Practice for Drug Non-clinical Research (GLP) and Good Practice for Drug Clinical Trials (GCP) regulations.
As an enterprise engaged in pharmaceutical research and development, Xihua Testing has a number of leading technology platforms, the chemical drug biological analysis platform, biological drug biological analysis platform, pharmaceutical analysis platform, preparation process research and development platform and API process research and development platform serving CMC business can provide high-quality and high-efficiency pre-clinical DMPK, clinical stage biological analysis, data management and statistical analysis, and the whole process and integrated services of pharmaceutical research for global pharmaceutical enterprises.
As of December 31, 2022, Xihua Testing has completed the analysis of clinical samples of more than 100 bio-innovative drugs and bio-similar drugs, more than 160 chemical innovative drugs and more than 800 generic drugs, and has established nearly 1000 bioanalysis methods, of which more than 380 have independent intellectual property rights. Of the completed bioanalytical programs, 74 drugs have been approved for marketing.
At the same time, Xihua Testing actively deploys cutting-edge technologies and has a first-mover advantage in the field of gene therapy-as of the end of December 2022, a total of 16 applications for new clinical trials (IND) of adeno-associated virus (AAV) gene drugs in China have been approved, and the enterprise has undertaken the clinical bioanalysis business of 5 gene drugs.