On July 22, 2015, the China Food and Drug Administration (国家食品药品监督管理总局) carried out the “most rigorous” self-examination and verification in history on 1,622 drug to be approved for production. The shocking verification result data exposed the potential quality risk of the drug currently and commercially available on the Chinese market, and strengthened the determination of the state to re-evaluate the quality of drug.
On March 5, 2016, the General Office of the State Council (国务院办公厅) issued the Opinions on Conducting the Consistency Evaluation of Quality and Efficacy of Generic drug, and the consistency evaluation of generic drug was upgraded to a national strategy.
Subsequently, the China Food and Drug Administration (CFDA) issued the notice on implementing relevant matters concerning the Opinions on Conducting Consistency Evaluations of the Quality and Efficacy of Generic drug by the General Office of the State Council (Guo Ban Fa  No. 8), wherein the following requirements are proposed:
The consistency evaluation of all oral solid preparations of chemical generics approved for sale and included in the National Essential drug List (2012 edition) by October 1, 2007 should be completed by the end of 2018 as a rule, and after the first one passed the consistency evaluation, the applications for the consistency evaluation of the same variety from other drug manufacturers will no longer be accepted three years later.
For generic drug approved for sale after 2010, other drug manufacturers should complete the consistency evaluation of the same variety within three years after the first one in any given variety passes the consistency evaluation.
In accordance with the above requirements, the consistency evaluation of 289 varieties must be completed in 2018, involving 17,636 domestic approval numbers; 121,000 generic drug have been approved for sale since 2010. In addition to the strategic abandonment of enterprises, it is estimated that 60,000 drug approval numbers (calculated by 50% of the total number of approvals) in China require consistency evaluations. According to the average research investment of 8 million yuan for each variety, the new market scale of consistency evaluation in the future will reach 500 billion yuan.
According to the data of Center for Drug Evaluation (CDE), in 2016, less than 60 units in China have performed the consistency evaluation (BE/I phase project) and were willing to continue to accept the BE/I phase research. Approximately 80 units have undertaken the testing, and less than 20 units can undertake the testing according to the new requirements (mainly concentrated in Shanghai and Beijing). Before the establishment of Duxact, there is no unit that can undertake the testing in Hunan Province (as well as Hubei, Jiangxi, Yunnan, Guangxi and Guizhou). According to the data analysis in 2015, China can complete less than 400 projects every year. Even at the completion rate of 1,000 projects annually, only one-sixth of the target tasks will be completed in 2018. It will take at least 60 years to complete 60,000 projects. While for the United States, Japan and the United Kingdom, it only takes 10 to 15 years (the completion is very close to our forecast of 2015.). Thus, it is urgently necessary to increase the number of institutions and increase the production capacity of individual research institutions.
In Hunan, there are 516 approval numbers in the National Essential drug List and 930 approval numbers off the National Essential drug List for which consistency evaluations must be conducted. Prior to 2016, there was no high-level biological analysis and testing platform in Hunan, and the overall research progress was far below the national average.
"The idle tout the strong pass as a wall of iron. With firm strides we are crossing its summit!
At the critical moment when the national R&D power is seriously insufficient, Duxact has emerged.The establishment of the company not only fills the gap in this field in Hunan Province, but also provides support for the future development of the biomedical industry in Hunan.
Changsha Duxact Biotech Co., Ltd. (abbreviated as Duxact) was registered and established in January 2016. The company has an outstanding, highly respected team of talents (particularly internal experts). The company focuses on the following aspects: evaluation of consistent quality and efficacy of generic drug (one-stop), study of phase-I clinical trials of innovative drug, the detection and R&D of biomarkers, and the genomic study and quality analysis of traditional Chinese medicine. The company has invested more than 60 million yuan in the construction (110 million yuan for filing investment), with an operating area of approximately 4,800 square meters and more than 289 employees .
The company, by centering on the industrial chain by which to establish and maintain the business chain, takes the construction of bioanalysis platform as the core and entry point while capitalizing on the consistency evaluation policy of generic drug to ensure rapid growth.
Based on the comprehensive layout of participant recruitment (Changsha Linkmeds Technology Co., Ltd.), subject management, research-data management and statistical analysis (Changsha Cententech Technology Co., Ltd. and Changsha Phamark Data Technology Co., Ltd.), biological sample analysis and information management (Changsha Tonoinfo Technology Co., Ltd.), all the related companies are developing quickly. In fact, six original achievements that are sure to break through the international monopoly and lead the industry will soon be introduced.
Currently, Duxact has become a testing platform with "the largest scale, the most advanced hardware, the most standardized management and the strongest analytical ability in the region." It ranks sixteenth among the top 20 enterprises with the most investment potential in Hunan in the Hurun Rich List this year, with capitalization growing from 18.8 million yuan to an estimated value of more than 600 million yuan.
The laboratory is designed and constructed according to the concept of GLP, has established the Bioanalysis Laboratory conforming to CFDA GLP, ISO 17025 and CMA system accreditation standards, and has a perfect quality assurance system.
The laboratory has six Waters TQ-D/TQ-S liquid chromatography-mass spectrometers, two AB Sciex 6500+ liquid chromatography-mass spectrometers, one Agilent ICP-MS, two Waters ultra-high performance liquid chromatographs, one Waters convergence mass spectrometer, one Agilent gas chromatography-mass spectrometer, 16 ultra-low-temperature refrigerators (-86℃, Thermofisher and Haier), 13 refrigerators (5℃ and -20℃), and other instruments and equipment.
The key technical personnel have more than ten years' experience in pharmaceutical analysis technology research and development or management.
It has rich clinical resources,has successively established Clinical Research Centers (including phase-I clinical laboratories) with more than 20 hospitals, including Hunan Prevention and Treatment Center for Occupational Diseases, Affiliated Hospital of Xiangnan University, Changsha Central Hospital, the Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province), the Second Nanning People's Hospital (the Third Affiliated Hospital of Guangxi Medical University),Changsha Hospital of Traditional Chinese Medicine (Changsha EighthHospital), Wuhan Mental Health Center / Wuhan Hospital for Psychotherapy, the First People's Hospital of Huaihua, Xianning Central Hospital / Tongji Xianning Hospital of Huazhong University of Science and Technology, Hunan Kangya Hospital,Mengchao Hepatobiliary Hospital of Fujian Medical University.
It as more than 800 clinical trial standard beds and can complete more than 100 bioequivalence (BE) studies on generic drug during the course of a single year.
More than 100 pharmaceutical bioanalysis and detection methods have been developed. With experience and the ability to solve the challenges of various types of pharmaceutical bioanalyses, the passing rate of incurred sample reanalysis (ISR) of projects completed has reached 98%. For two consecutive years, the external quality assessment for pharmacokinetic biological sample detection conducted by the National Center for Clinical Laboratories has been passed with full marks.
The one-stop consistency evaluation for the quality and efficacy of Escitalopram Oxalate Tablets, the first variety of generic drug, has been completed in Hunan. Within less than three months, all work of consistency evaluation of the clinical part has been completed. It creating an almost legendary speed that is difficult to replicate.
1. Subject Intelligent Identification Management System
Through the integrated innovation and national network management mode, the subjects in the clinical trial process are managed accurately, achieving the identification rate of 99.999%. A series of industry pain points--such as subject identity fraud, single-source institutional information and lack of regulatory means by the government--have been completely solved, and the history of subject management in drug clinical trials has been rewritten.
2. Online Participant Recruitment System
This online recruitment platform is developed to solve the problems such as disordered participant recruitment management and irregular data management. It breaks through the traditional mode and realizes nationwide online recruitment and one-stop online and offline services. The platform implements the unification of person and identity card, analyzes the data of subjects through big data, matches qualified subjects for the project, and makes recruitment safe and simple.
3. Clinical Trial Project Management System
This intelligent management and service platform integrates comprehensive management, process control, real-time monitoring and multi-party collaboration to realize standardized, specialized, systematic, process-based management of clinical trials and ensure the quality of clinical trials so as to improves the project management level and operational efficiency.
4. Electronic Data Acquisition System
This clinical electronic data acquisition system based on the latest micro-service idea provides transparent and accurate data management for the whole process of clinical research.
5. Intelligent Biological Sample Bank Management System
This information system supports the multi-center platform, follows normative data-interaction standards, conforms to the computerized system verification system, and adopts barcode recognition and template configuration technologies to conveniently realize the whole life cycle management of biological samples.
6. Bioanalysis Laboratory Information Management System
As the first domestic, self-developed biological analysis laboratory information management system, it breaks through the international monopoly. It can provide information support for biological data analysis and sample management, completely cover the DMPK business process and provide timely, accurate, comprehensive information for management.
Since the implementation of "7.22 CFDA reforms”, 152 BE projects were undertaked and 118 BE tests were completed, wherein the escitalopram oxalate tablet project has passed the evaluation in the fourth batch.
National & Local Joint Engineering Laboratory for Clinical Drug Evaluation Technology;
Hunan Engineering Laboratory for Clinical Drug Evaluation Technology;
Duxact–Waters Joint Lab (the "DMPK" joint laboratory, a world-first);
Third-party Detection Central South Center of Pharmaceuticals, Health-care Products and Cosmetics；
Hunan Key Laboratory for Analysis of Complex Matrix Samples (the only provincial key laboratory built in enterprises in the field of biomedicine in Hunan Province);
One of the first high-tech enterprises in Hunan Province in 201公司简介8;
Duxact-Central South University，Graduate Joint Training Base、Graduate employment base.
"Excellent Unit of Industrial Technology Innovation Alliance," "Enterprise Technology Innovation Demonstration Platform" and "Gazelle Enterprise" of Changsha High-Tech Zone;
Top 20 Enterprises in Hunan in the Hurun Report 2018 China's Top 100 Star Enterprises with the Most Promising Investment Value;
It was selected as one of the first settled institutions on the sharing platform of science and technology service resources for provincial capitals of the urban agglomerations in the middle reaches of the Yangtze River;
Top 14 in the National Final of the 7th China Innovation and Entrepreneurship Competition of Biomedical Industry;
Championship of the Hunan Division in the 7th China Innovation and Entrepreneurship competition;
Standing at the forefront of the times, Duxact people cherish the ideal of establishing an industry that will serve the country and share the country's burden. They adhere to the spirit of innovation and truth-seeking, go with the tide of historical development, and make steady progress toward an international and standardized first-class enterprise. Duxact people are determined to contribute to promoting the economic restructuring and industrial upgrading of China's pharmaceutical industry and to the enhancement of China's international competitiveness in the field of biomedicine.