The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has recognized the Biotime BIOT-YG-I Fluorescence Immunoassay Analyzer and the fully-automated HLC-100 High-Performance Liquid Chromatography Analyzer for their safety and qualification to detect glycosylated hemoglobin HbA1c on Big-News Day. As far as glycosylated hemoglobin detection is concerned, the IFCC is the most widely used laboratory standard. As a provider of diabetes screening, diagnosis, blood glucose control and efficacy observation tests, Biotime is dedicated to providing clinicians and patients with accurate and effective test results.

Adlai Nortye Ltd. (“Adlai Nortye”) and Xiamen Biotime Biotechnology Co., Ltd. (“Biotime”) Announce Technical and Commercial Partnership on PD-L1 Inhibitors, Anti-hTNFR2 Antibody Products and Many Other Products Adlai Nortye Biopharma Co., Ltd. a global clinical-stage biopharmaceutical company focused on innovative oncology drugs, with R&D and global clinical operation centers in both China and the United States, has expanded its technical and commercial partnership with Xiamen Biotime Biotechnology Co., Ltd. a Hi-Tech enterprise that specialized in R&D, production, and sales of POCT in vitro diagnostic devices and reagents, and offer the industry’s most comprehensive in vitro diagnostics solutions to more than 60 countries and regions. The agreement aims to boost the development, production and commercialization of the PD-L1 inhibitors AN4005, anti-hTNFR2 antibody products and other products in Greater China and other regions of the world. Under the deal, the total amount of investment has reached several hundreds of millions of yuan which includes the down payment, the milestone payment that triggered by the milestone events and the royalties. The AN4005 Adlai Nortye developed is a drug candidates that made the fastest progress in clinical trials. It shows strong anti-tumour efficacy, good multibinding, high safety and meets clinical and commercial needs，in addition to that, it also shows great potential and might pioneer oral small-molecule inhibitor of PD-L1. AN3025 is a new humanized IgG1anti-hTNFR2 antibody which is in the early part of development of preclinical trial, it’s expected to enhance antitumor immune response which may help to achieved better tumour control and improve treatment. “Indigenous innovation is the core to Biotime, we just create a new business of innovative medicine, increase the research and development funding, take part in the innovative network and try to be a high-quality developer, innovative engineer to the industry.” said Yu Jianping, Executive Secretary of Biotime. “Adlai Nortye is a leading brand of innovative medicine, so this cooperation would be a win-win prospect.” “We are glad to come to an agreement with Biotime who has well-grounded research and technical capabilities, they continue to pursue innovation-driven development and highly value product research. Partnership is expected to begin the process profit-oriented, development of AN4005, AN3025 and other products across the globe. We are confident these products would benefit all the patient in the world and the cooperation would only accelerate the actions we are going to take.” said He Nanhai, Ph.D., Head of Adlai Nortye’s global R&D. About Biotime Established in April 2008, Xiamen Biotime is a Hi-tech enterprise that specialized in R&D, production, and sales of POCT in vitro diagnostic devices and reagents. Biotime has successfully settled the mature medical marketing channels during the past year...

What is NGAL? The full name of NGAL is human lipocalin 2 (Ln2) or siderocalin. It belongs to the lipocalin family and is the earliest proposed marker of acute kidney injury (AKI).   What is the clinical significance of NGAL? 1. NGAL is a marker of acute kidney injury (AKI) When AKI occurs, NGAL rises rapidly in a very short period of time, and the most obvious is 2h. Serum creatinine (sCr), urinary enzymes, etc. often increase significantly after 24 to 72 hours. At this time, the glomerular filtration rate (GFR) has decreased significantly, and NGAL can change before GFR decreases, so it is suitable for early diagnosis of AKI. At the same time, the increase in NGAL concentration is closely related to the duration of AKI, the severity of kidney injury (RIFLE classification), and the treatment effect and prognosis. 2、Can predict the progression of chronic kidney disease (CKD), especially diabetic nephropathy Studies have found that NGAL may be involved in the occurrence and development of diabetes as an inflammatory factor. In diabetic nephropathy, renal tubule damage may be earlier than glomerulus. As a marker of early renal tubular damage, NGAL can reflect renal function damage in diabetic patients (especially type 2 diabetes) before urinary microalbumin (mALB). 3、NGAL also has a certain relationship with tumors Data from different laboratories indicate that the concentration level of NGAL is related to a variety of tumors. It promotes cell proliferation by uptake of iron ions and helps tumor cell growth and infiltration. It is related to tumor cachexia and has become an independent predictor of poor prognosis for patients with cachexia. Compared with traditional projects, what are the advantages of NGAL? When AKI occurs, NGAL rises rapidly in a very short time. The following figure shows the time of increase in the concentration of various markers after the occurrence of AKI: Therefore, testing NGAL can buy more time for AKI patients and grasp the best time for treatment. What are the clinical applications of NGAL? Due to the excellent predictive and diagnostic value of NGAL in AKI, the detection of NGAL can be increased in clinical situations that easily cause AKI. · Routine monitoring after major surgery · Monitoring of ICU patients · Triage of conditions in the emergency department · Early diagnosis of AKI caused by infection and sepsis · Contrast nephropathy (CIN) monitoring after interventional therapy...... NGAL is also an evaluation index of chronic kidney disease, so it can also be used to predict the progression of chronic kidney disease and early detection of kidney damage in patients with diabetic nephropathy. The neutrophil gelatinase-associated lipocalin assay kit provided by Biotime uses fluorescence immunochromatography, which is easy to operate and results in 10 minutes. Product Name：NGAL Rapid Quantitative Test Link: https://www.xiamenbiotime.com/ngal-rapid-quantitative-test_p60.html

Recently, Xiamen Biotime Biotechnology Co., Ltd Monkeypox Virus (MPV) nucleic acid IVD kit (fluorescent PCR method) was certified by the UK MHRA. On July 23, the World Health Organization declared the monkeypox epidemic a "Public Health Emergency of International Concern", which is the highest level of alert issued by the World Health Organization for a global public health emergency, and also means that the current COVID-19 pandemic and the monkeypox epidemic are at this alert level at the same time. Xiamen Biotime Biotechnology Co., Ltd Monkeypox virus nucleic acid test kit adopts rapid PCR amplification mode, and the test kit can obtain the detection result in 40 minutes; it has high specificity and sensitivity, and can detect low concentrations of virus in the sample. There is no cross-reaction between monkeypox virus detection and smallpox virus, vaccinia virus, vaccinia virus, etc. At present, Xiamen Biotime Biotechnology has stockpiled diagnostic technologies such as immunofluorescence, chemiluminescence, molecular diagnosis, electrochemistry, and colloidal gold, contributing "Biotime power" to global public health prevention and control.

This is the official announcement of the National Day of the People's Republic of China. All our customers have been informed that due to the National Day holiday we will be closed on Friday 1st October and will resume normal business on Wednesday 8th October. We salute the founding of our country and the heroic warriors who gave their lives for this country. National Day holiday: October 1 to October 7, 2021 Reopen date: October 8, 2021 During this time, please feel free to call the office if you have any questions about your business. Congratulations and thanks to everyone who has contributed to the success of our business. Xiamen Biotechnology Co., Ltd. 30th September, 2021

Qualitative VS Quantitative Test , which one is better ? Here’s a quick rundown on what is the difference between the two types of diagnostic test and when would be most appropriate to use them respectively： Qualitative Test Qualitative test relies on the collection of non-numerical insights such as opinions. Like a non-quantitative hCG pregnancy test can check whether the hCG hormone is present in the blood thus to suggest whether a woman is pregnant while it is not 100% accurate since it does not measure the exact amount of hCG in the blood . From what's been observed during COVID 19, antibody or Antigen test kits are the most convenient and cost-effective test kits that is adaptable to a wide range of uses. Quantitative test Quantitative test is designed to gather data points in measurable, numerical form. With this kind of test method, an hCG pregnancy test checks human chorionic gonadotropin levels in the blood or urine. This measurement means that an HCG test can test whether a woman is pregnant by telling you the amount of hCG present in the blood or urine. Back to the HCG test kit, β-HCG level during a woman’s pregnancy under different conditions can range from 5 to 200,000 mIU/ml. Below is the specification of Biotime’s β-Hcg product. At the early stage of the prevention and control of COVID 19, the National Health Commission issued the "COVID-19 Diagnosis and Treatment Protocol (Trial Version 7)" on March 3, 2020 which suggested adding the Serological test in the clinical performance.  IgG antibody titer in recovery period was 4 times higher than in acute period. Nevertheless, quantitative test is often regarded as a more superier test approach. But still, qualitative test shines in its own way. It is a simple, less fussy, more straight forward choice for someone who is only looking to get a “yes or no” answer from the test results. In a word, no matter which one you prefer, we at Biotime are able to provide you with both choices and deliver answers in more settings, for more conditions.

Recently, Xiamen Biotime Biotechnology Co., Ltd. completed the Medical Device Single Audit Program (MDSAP) and obtained the MDSAP certification issued by the international certification body SGS MDSAP Certification Program It is co-sponsored by members of the International Medical Apparatus Regulators Forum (IMDRF) and recognized and joined by regulators in the United States (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC), and Japan (MHLW). A new audit procedure allows medical apparatus manufacturers to undergo only one quality management system audit to meet the standards and regulatory requirements of the above five countries. The audit work is carried out by an audit body authorized by the regulatory agencies of the five countries. As a high-tech enterprise specializing in the research and development, production and sales of in vitro diagnostic reagents and instruments, Xiamen Biotime Biotechnology Co., Ltd. always adheres to the quality policy of 'product-oriented, innovation-oriented, management-oriented, and service-oriented', and strictly controls product quality management. Obtaining the MDSAP certification will further bring advantages and convenience to Xiamen Biotime's products to obtain overseas market access qualifications, and accelerate the pace of the company's global development strategy. In the future, Xiamen Biotime Biotechnology Co., Ltd. will continue to help the global epidemic prevention and control work, be committed to providing high-quality in vitro diagnostic products to more countries and regions around the world, and contribute to the development of the global biomedical industry.

Diabetes mellitus（DM）is a chronic disease caused by deficiency or diminished effectiveness of endogenous insulin. It is characterised by hyperglycaemia, deranged metabolism and sequelae predominantly affecting the vasculature. The most common types include type 1 and type 2 DM. DM represents a major health problem of the 21st century, causing severe long-term damage to the cardiovascular and nervous system as well as eyes and kidneys. The World Health Organization (WHO) estimated 1.6 million deaths each year to be directly caused by diabetes [1]. Most cases (90%) of DM are type 2, which arises from defects in insulin action leading to insulin resistance, often combined with defects in insulin secretion. Circulatory insulin levels therefore may be normal or raised, but it cannot be used effectively. This subtype is predominant in middle-aged overweight patients with a sedentary lifestyle. In 2011 the WHO advocated the use of HbA1c for the diagnosis of type 2 DM and in 2012 UK guidance followed suit [2, 3]. The term HbA1c refers to glycated haemoglobin. It develops when haemoglobin, a protein within red blood cells that carries oxygen throughout your body, joins with glucose in the blood, becoming “glycated”. HbA1c test tells you your average level of blood sugar over the past 2 to 3 months. Most POCT devices for HbA1c use a drop of capillary or venous whole blood. Following application to the test cartridge, the sample is analysed within a few minutes using methods based on either differences in structure or charge of the glycated vs non-glycated haemoglobin. Ion-exchange chromatography: Haemoglobin species (HbA1c and HbA0) are separated based on the difference in isoelectric point, by employing differences in ionic interactions between the haemoglobin in the blood sample and the cation exchange groups on the column resin surface. HPLC is based on ion-exchange chromatography technology, which is a gold standard in detecting HbA1c. Immunoassay: The immunoassay method uses antibodies which bind to the N-terminal glycated tetrapeptide or hexapeptide group of the HbA1c, forming immunocomplexes which can be detected and measured using a turbidimeter or a nephelometer. Affinity chromatography: Affinity chromatography is a separation technique based on structural differences between glycated vs non-glycated haemoglobin which utilises m-aminophenylboronic acid and its specific interactions with the glucose adduct of glycated haemoglobin. Enzymatic assay: Enzymatic quantification of HbA1c is based on cleavage of the beta chain of haemoglobin by specific proteases to liberate peptides, which then further react to produce a measurable signal (4). HbA1c in diagnosis HbA1c can indicate people with prediabetes or diabetes as follows: How often do we need to take a HbA1c test? Everyone with diabetes mellitus should be offered a HbA1c test at least once a year. Some people may have an HbA1c test more often. T...