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Recently, Beijing Shouyan Lab has successfully passed the certification of National Glycohemoglobin Standardization Program (NGSP), and its HbA1c assay has passed the consistency evaluation and the result is qualified.
The test method is based on the working principle of ion exchange high performance liquid chromatography (HPLC), and the testing instrument is Bo Le D-10 Glycosylated Hemoglobin Analyzer. The amount of specimen required for the test is only 5 μL of EDTA-anticoagulated whole blood samples, and the test result will be available in 3 minutes after loading the test machine, and the result meets the CV<2.0%. This international authoritative certification signifies that the quality of Beijing Shouryan Laboratory's HbA1c testing has reached international standards.
NGSP Certificates
In the future, Beijing Shouyan Lab will continue to adhere to the quality policy of “objectivity, science, accuracy and reliability” to provide more high-quality and efficient testing services for diabetes patients around the world, and to contribute more wisdom and strength to the development of the cause of diabetes prevention and treatment.
NGSP
As one of the earliest and most rigorously assessed international accreditation bodies for global consistency of hemoglobin (HbA1c) test results, the NGSP is committed to standardizing hemoglobin testing to ensure that test results are highly comparable and accurate across clinical laboratories. Since its inception in 1996, the NGSP has become one of the highest international accreditation bodies evaluating the standardization of laboratory glycated hemoglobin (HbA1c) testing and is widely recognized by the American Diabetes Association (ADA) and the U.S. Food and Drug Administration (FDA).
Beijing Shouyan Lab
Beijing Shouyan Lab is a central laboratory providing professional and efficient one-stop clinical bioanalytical services, focusing on bioanalysis of vaccines, small molecule drugs and innovative traditional Chinese medicines, etc., with a number of P2 and P2+ laboratories equipped with complete PCR testing facilities. We have built several P2 and P2+ laboratories with complete PCR testing facilities. Beijing Shouyan provides clients with “value-added” testing and R&D strategies, analyzing testing solutions from the perspective of the entire clinical development process, aiming to help clients improve efficiency and reduce costs.
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
Beijing Shouyan Lab is certified by NGSP in the United States.
Provide diverse and better treatment options for patients worldwide.
At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
On October 24-25 2024, Dr. Yuwen, CBO and SVP of SDM Bioservices, was invited to attend the 2024 International Biomedical Industry Innovation Beijing Forum co-sponsored by DIA and Beijing Advanced Medical Equipment Industry Innovation Alliance. The forum brings together representatives of global regulators, leading experts in biomedicine, industry leaders and academics to discuss the latest trends and industry innovations in global drug development.
AMWC China 2024 World Congress on Aesthetics and Anti-Aging was successfully carried out in Chengdu on October 18-20, 2024, with medical and aesthetic experts, scholars, and industry practitioners from all over the world participating and presenting their latest achievements.
On July 24, SDM Bioserices and Australia JP Medical Consulting Pty Ltd (hereinafter referred to as "JP Medical Consulting") announced a strategic cooperation. The cooperation aims to make full use of the clinical resources and professional advantages of the two sides in the field of medicine in China and Australia, promote the internationalization of clinical trials and new drug research and development, and provide one-stop services for Chinese biopharmaceutical enterprises in Australian clinical trials.
August 1, China, Beijing, Liu Xueliang, deputy secretary of the District Party Committee and district governor, led a team to visit key enterprises of Daxing biomedical Industry Base to investigate the development and construction of pharmaceutical research and development service platform enterprises.
On the way to further explore and promote the professional development of medical clinical trials, SDM and Tonghua Dongbao jointly successfully held a nine-month "Diabetes Professional CRA Series course".
On July 11-12, 2024, MedDRA MSSO successfully held the fourth offline face-to-face training of 2024 at the Shenyang office of SDM. As the organizer of this event, SM gathered together with more than 40 experts from various fields such as CRO, pharmaceutical companies and partners, including medical coders, data management and statistics, drug safety/pharmacovigilance, medical writers and other modules.
On July 3, 2024, SDM Bioservices and Shanghai Ruiningkang Bio-Pharmaceutical Technology Development Co., LTD. (" Ruiningkang Bio ") reached a strategic cooperation to work together to help innovative drugs in the quantitative pharmacology, dose exploration level, and promote more innovative drugs with global competitiveness to the market.
On November 21, 2023, Beijing Kangle Guard Biotechnology Co., Ltd. is affiliated with Muhammadiyah University Malang, Indonesia (at) to start the "restructuring nine price 6/11/16/18/31/33/45/52/58) human papilloma virus (HPV) vaccine (e. coli) phase III clinical trials into the group of vaccination. As a CRO focused on vaccine clinical trials, Shanghai SDM undertook the phase III clinical study of the vaccine project in Indonesia, responsible for project management, data management, biostatistical analysis, pharmacovigilance and other important work of the project.
The laboratories operated by SDM in the North and South have their own specialties and technical advantages. Among them, Beijing Shouyan, with several P2 and P2+ laboratories and complete PCR testing facilities, is one of the few testing organizations in China focusing on bioanalysis of vaccines and traditional Chinese medicines; Hangzhou Amador focuses on XDC, macromolecules, and CGT, etc., and provides one-stop bioanalytical services for ADC drugs, which is a technological leader in the industry.
Meiji has advanced its oral paclitaxel softgel capsule, MJC-001, to clinical trial stage. With support from SDM Bioservices, Meiji received FDA clearance for its Investigational New Drug (IND) application, positioning it among the leading developers of oral paclitaxel formulations.
Listen to Dr. Liping Shen: Innovating Vaccine Bioanalysis for Change
KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation.
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