About Us
Wuhan YZY Medical Science and Technology Co., Ltd.
Quality Assurance
Company Introduction
Founded in 2011, with personalized diagnosis and treatment of cardiovascular, tumor as the strategic direction, Wuhan YZY Medical Science and Technology Co., Ltd. (YZY MED) is a high-tech enterprise specializing in the R&D, production and sales of individualized medical diagnostic products. The company has established various technical platforms, including ARMS fluorescence qPCR, multiple fluorescence qPCR, fluorescence in situ hybridization (FISH) and circulating tumor cell detection, etc. Meanwhile, the self-developed products include molecular diagnostic products to guide personalized medicine for cardiovascular and cerebrovascular diseases, companion diagnostic products to guide tumor diagnosis and treatment, FISH products and circulating tumor cell (CTC) autoanalyzer system, all these provide clinical diagnosis basis for precision medicine.
With a R&D center of 2,000㎡and GMP-accredited industrialized workshop of 3,200㎡,YZY MED has successfully developed over 160 genetic diagnostic products and multiple in vitro diagnostic (IVD) devices, among which nearly 20 molecular diagnostic kits have been approved by the NMPA Class III medical device registration and approval, more than 110 products have passed the CE certification.we also have office in hangzhou
Corporate Mission
Enterprise Vision
Core Values
R&D Platform
YZY MED has built a 2000㎡ R&D center, aiming to develop various innovative and personalized medical diagnostic products based on the research results of pharmacogenetics and cancer molecular biomarkers. These products can be used clinically to predict the drugs efficacy and determine the durgs dosage by screening the applicable population, thus to develop personalized treatment plans for patients, reduce patient medical costs with improved efficacy and minimize the adverse drug reactions.The purpose of R&D Center is to vigorously advocate international cutting-edge personalized medicine, achieving a modern personalized treatment model:”The right drug for the right patient”.
Research Cooperation
2012
YZY Personalized Medicine Research Center was successfully established, headed by Honghao Zhou, Academician of Chinese Academy of Engineering
2014
Wuhan Textile University-YZY Joint Research Center for Micro and Nano Medical Science was inaugurated.
2016
The pilot project of”R&D on Digital diagnosis and treatment equipment” was successfully granted, it is a national key research and development program jointly applied by YZY and Shandong Pharmaceutical Research Institute.
2018
“Key Technology Development and Application of Circulating Tumor Cell Enrichment and Identification Project “, jointly completed by YZY and Shandong Institute of Cancer Prevention and Treatment, was awarded the first prize of Shandong Provincial Scientific and Technological Progress Award.
2020
“Establishment and Application Project of Circulating Tumor Cell Capture Technology System”, jointly researched by YZY and Prof. Xiong Bin’s team of Central South Hospital of Wuhan University was awarded the First Prize of Hubei Provincial Scientific and Technological Progress Award in 2020.
Research Cooperation
2012
YZY Personalized Medicine Research Center was successfully established, headed by Honghao Zhou, Academician of Chinese Academy of Engineering
2014
Wuhan Textile University-YZY Joint Research Center for Micro and Nano Medical Science was inaugurated.
2016
The pilot project of”R&D on Digital diagnosis and treatment equipment” was successfully granted, it is a national key research and development program jointly applied by YZY and Shandong Pharmaceutical Research Institute.
2018
“Key Technology Development and Application of Circulating Tumor Cell Enrichment and Identification Project “, jointly completed by YZY and Shandong Institute of Cancer Prevention and Treatment, was awarded the first prize of Shandong Provincial Scientific and Technological Progress Award.
2020
“Establishment and Application Project of Circulating Tumor Cell Capture Technology System”, jointly researched by YZY and Prof. Xiong Bin’s team of Central South Hospital of Wuhan University was awarded the First Prize of Hubei Provincial Scientific and Technological Progress Award in 2020.
Innovation Achievements
Gene Detection Reagent
Relying on the core technologies,such as ARMS fluorescent quantitative PCR and multiple fluorescent quantitative PCR, the company has successfully developed 16 molecular diagnostic kits since 2014, and obtained the Class III medical device registration certificate by National Medical Products Administration(NMPA). YZY MED has established a complete solutions in the direction of personalized medication on gene detection for cardiovascular diseases and tumor companion diagnosis. YZY MED has become a leading enterprise, with the detection volume exceeding 1.5 million person/time, ranks the first in domestic market in this subdivision.
CTC Detection Products
Circulating Tumor Cell Separator CTCBIOPSY®-A10 and Slide Scanning Imaging System CTCBIOPSY®-D800 developed by YZY MED have obtained the medical device registration certificates,with over 30,000 cases of clinical data verification.The solid technical accumulationand adequate clinical data enable the company to maintain the leading position in the field of liquid biopsy.
FISH Probes
The fluorescence in situ hybridization (FISH) Probe Kits developed by the company have been successively launched into the market since 2020. It is believed that with excellent quality and perfect service, we will win the trust and support of most customers.
Quality Assurance
YZY MED has been implementing quality management system standards according to GB/T19001-2000 Quality Management System Requirements and YY/T0287-2003 Medical Device Quality Management System for Regulatory Purposes since its establishment.
The company has a GMP standard production workshop and GLP standard advanced laboratory, through ISO13485 quality management system and NMPA in vitro diagnostic reagent production enterprise quality certification assessment. Relying on high-tech talents and mature business model, YZY MED has been creating a brand in Chinese biotechnology industry through high-quality products and professional services.
We promise to organize production in strict accordance with national and industrial standards. Adhering to the tenet of quality first, we insist on scientific management to provide customers with high-quality products.
Development History
2011
In June, selected into the fourth batch of “3551 Optical Valley Talent Program” (Dr. Zhou Pengfei).
In July, officiallyestablished in Biolake,national biologicalindustry base in Wuhan.
In November, won the honor of “Top TenEnterprises with Outstanding Contribution” in Wuhan National BiologicalIndustrial Base.
2012
In April, Academician Honghao Zhou was introduced to establish YZY Personalized Medicine Research Center.
In August, built 1200 square meters of standard production workshop conforming to ISO13485.
In November, obtained Medical Device Production Licence.
In December, obtained Permits for Medical Device Operation.
2013
In April, successfully passed the assessment of quality management system of in vitro diagnostic reagent manufacturer.
In May, won the “Best Management Enterprise Award” on the third anniversary of the construction of Wuhan National Biological Industrial Base.
In June, selected into the sixth batch of “3551 Optical Valley Talent Program” (Dr. Cai Congli).
2014
In January, KRAS and EGFR Gene Mutation Detection Kit obtained Class III medical device registration certificate by NMPA.
In December, established Wuhan Textile University and YZY Joint Research Center for Micro-Nano Mecine.
2015
In March, CYP2C19 Gene Mutation Detection Kit and other 3 products obtained Class Ⅲ Medical Device Registration Certificate by NMPA.
In March, Autoanalyzer system on abnormal cell obtained Class Ⅱ Medical Device Registration Certificate.
In July, awarded the title of “Key Overseas Chinese Entrepreneurial Team” by Overseas Chinese Affairs Office of the State Council .
In October, obtained A round financing of 24 million yuan from Elite Capital.
In November, won the third prize in the “Yellow Crane Cup” High-level Talent Entrepreneurship Project Competition.
2016
In April, awarded Contractor of Gene Detection Demonstration Center by National Development and Reform Commission.
In July, selected into the third batch of Intellectual Property Demonstration Construction Enterprises in Hubei Province.
In July, officially listed on New OTC Market.
In August, ALK and other 3 products obtained the Class III Medical Device Registration Certificate by NMPA.
2017
In March, moved into the new office building of 4,000 square meters.
In July, ALDH2 and other two products obtained Class III Medical Device Registration Certificate by NMPA.
In November, awarded “Enterprise Research and Development Center” in Wuhan.
In December, passed the certification from National Intellectual Property Management System .
In September, selected into the ninth batch of “3551 Optical Valley Talent Program” (Dr. Kan Liu).
In December, obtained A+ round financing of 65 million yuan from Beilu Pharmaceutical.
In December, selected as the first batch of supported enterprises for “1,000 Great Enterprises and 10, 000 innovative Talents” Program in Wuhan.
2018
In June, listed as Industrial Enterprises above National Scale.
In September, accredited as New “Little Giant” Technology Enterprise in Wuhan.
In November, selected as Top 20 Fast Growing High-tech companies in Optics Valley in 2018.
In November, passed the reassessment of National High-Tech Enterprise.
2019
In October, selected as “Golden Seed” back-up stock listing enterprise in Wuhan in 2019.
In October, obtained Class II Medical Device Registration Certificate for Slide Scanning Image System(YZY- CTC-D800).
In November, selected as the third batch of Invisible Champion Cultivation Enterprises in the Subdivision Field of Pillar Industries in Hubei Province.
2020
In May, selected as “Golden Seed” back-up stock listing enterprise in Hubei Province from Year 2020 to 2021.
In September, selected as the “Gold Seed” Stock listed Enterprise in East Lake High-tech Development Zone in 2020.
In September, won the first prize of Hubei Science and Technology Progress Award in 2020.
In September, passed the Management System Certification on the Integration of Informatization and Industrialization.
In November, built over 2,200 square meters of new production workshops conforming to ISO13485 standards.
In December, obtained B-round financing of 50 million Yuan from Haitong-Fortis fund and Tongji Modern Medical Fund.
2021
In January, wholly acquired Bioda Diagnostics (Wuhan) Co., LTD.
In March, awarded the second prize of 2020 China Medical Science and Technology Award.
In April, the subsidiary, Youxingtong Co. obtained the Permits for Medical Device Operation.
In June, selected into the TOP 50 Glory List in Wuhan in 2021.
In October, selected as 2021 “Gazelle Enterprise” in East Lake High-tech Development Zone.
In October, selected as the first batch of “New Species” Enterprises (Gazelle Enterprises) on Technological Innovation in Hubei Province.
In November, selected as Golden Seed” back-up stock listing enterprise in Wuhan in 2021.
In November, selected as the “Golden Seed” enterprise in Wuhan East Lake High-tech Development Zone in 2021.
In November, passed the reassessment of National High and New Technology Enterprise.
In December, selected as Specialize and New “Little Giant” Enterprise in Hubei Province.
2022
In March, the hypertension gene detection kit obtained the NMPA Class III Medical Device
Registration Certificate.
In August, the company was selected as the Hubei Province Enterprise Technology Center.
In September, the company was selected as 2022 National Intellectual Property Advantage
Enterprise.
In October, Human Leukocyte B site 5801 gene detection kit obtained the NMPA Class III
Medical Device Registration Certificate.
2023
In March, the hypertension gene detection kit was selected as an outstanding high-tech product by the Wuhan High-tech Industry Association.
In May, Dr. Wei Liang and Dr. Guo Jing were selected as innovative talents and outstanding young talents of the “3551 Optics Valley Talent Plan”.
In November, the CTC detection system was selected for the “Hubei Province
Innovation Product Application Demonstration Recommended Catalog (2023 Edition)”.
In December, the HER2 gene detection kit obtained the NMPA Class III Medical Device Registration Certificate .
Team Introduction
The company adheres to the development strategy of scientific and technological innovation, has the following R&D team leader: Professor Honghao Zhou, Chief Scientific Adviser, academician of Chinese Academy of Engineering(CAE), a pioneer of Chinese pharmacogenetics and pharmacogenomics and an advocate of personalized medicine ; Dr. Pengfei Zhou , Scientific Consultant, founding shareholder, vice chairman and overseas returned scientist; Professor Kan Liu , CTC Technical Consultant, Dean of Electronic and Electrical Engineering School of Wuhan Textile University.
The company has built a high-level scientific research team with professional background in vitro diagnosis industry, the core team consists of over 60 persons, in which Master and PhD account for 90%, many people have working experience in overseas or famous companies in the industry.