Big News Day！Biotime SARS-CoV-2 Antigen Rapid Qualitative Test has been recognized by SFDA. Saudi Food and Drug Authority (SFDA) is an independent body for the Kingdom of Saudi Arabia that aims to ensure food and drug safety for the nation.  The Saudi Ministry of Health has given it responsibility for the regulation of pharmaceuticals, and it is an influential organization among states within the region. Biotime SARS-CoV-2 Antigen Rapid Qualitative Test based on colloidal gold immunochromatography method and intend to use as the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasal swabs, throat swabs, and sputum from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. SFDA authoritative certification means that SARS-CoV-2 Antigen Rapid Qualitative Test is available for sale in Saudi Arabia. If you are interested in this product, please contact us.

On March 10, Biotime donated 2 million of the SARS-COV-2 Antigen Rapid Qualitative Test Kits to Hong Kong. The increasing numbers of the Covid-19 in Hong Kong have been a big concern for the Chinese Government and its people. The Chinese Government has given full support to Hong Kong in its fight against the Covid-19. All sectors of the society and Hong Kong compatriots are helping each other and assisting Hong Kong in its fight against the Covid-19 in various ways. As a company that has long supported global anti-epidemic efforts through In Vitro Diagnostics, Biotime has actively responded to support Hong Kong in its fight against the COVID-19. We donated 12-million-yuan worth of epidemic prevention materials to Hong Kong. Biotime's Vice President of Operations, Jim Huang, presided over the donation ceremony. Mr. Huang said that as POCT developers, especially during the epidemic, we have a greater responsibility to share the worries and difficulties of our country and compatriots. Biotime COVID-19 antigen tests have played an outstanding role in the UK's epidemic prevention and controlling of the spread of Covid-19. Witnessing the Hong Kong epidemic increasing rapidly, Biotime hoped to play a significant role in Hong Kong's anti-epidemic efforts and assist Hong Kong to win the epidemic prevention and control the spread as soon as possible. ▲vice GM of Operation, Jim Huang Afterward, Biotime contacted Yi Zhiming, a member of the Hong Kong Legislative Council. Mr. Yi expressed his gratitude to the Xiamen Municipal Government and Biotime. He stated that the SARS-COV-2 Antigen Rapid Qualitative Test Kits, once they arrived, Covid-19 test kits will be delivered to the citizens quickly so that a protective wall can be built against the epidemic and protect the health of the Hong Kong citizens. Mr. Yi also mentioned working together will bring Hong Kong back to its former glory ▲ Connect with the senator of Legislative Council of the Hong Kong Special Administrative Region Yi Zhiming. ▲ Dong Zhonghong, Office of the Government of the Hong Kong Special Administrative Region in Fujian. Since Biotime was founded, it has committed itself actively to undertakings such as education, disaster relief, and fulfilling its social responsibility as a company and as well as a form of love to the world. As a result of the epidemic, Biotime has displayed "China's strength" in the prevention and control of epidemics across the globe. ▲ Donor Ceremony

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...

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

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.

Interleukin is a type of cytokine produced by and acting on a variety of cells. Interleukin 6 (Interleukin 6, abbreviated IL-6) is an important member of the cytokine network, and it has been widely used in many clinical fields. PCT has been widely recognized clinically in differential diagnosis of bacterial infection, risk stratification of sepsis and guidance of antibiotic use. IL-6 is an important cytokine expressed in the initial response of the innate immune system to injury and infection, and plays an important role in the early diagnosis of acute infection. IL-6 combined with PCT has complementary advantages, improves detection sensitivity and specificity, and better facilitates the management of the whole course of sepsis. IL-6 is also one of the important monitoring indicators during the diagnosis and treatment of COVID-19. IL-6 is used for early warning of sepsis After the occurrence of inflammation, IL-6 is the first inflammatory marker. IL-6 will be involved in the occurrence and development of many diseases, and its blood level is closely related to inflammation, viral infection and autoimmune diseases, and its changes are earlier than CRP and PCT. Studies have shown that IL-6 increases rapidly after bacterial infection, PCT increases after 2h, and CRP increases rapidly after 6h [1]. So IL-6 can be used for early warning of sepsis. (Kinetic changes of inflammatory markers in vivo after endotoxin stimulation) IL-6 is used to evaluate the prognosis of sepsis Studies have shown that the high IL-6 concentration during the treatment of sepsis indicates the poor prognosis of patients and the higher mortality rate at the later stage of treatment. The expert consensus on the interpretation of the clinical significance of infection-related biomarkers mentioned that IL-6> at 1000 pg/mL suggests a poor prognosis. Therefore, the detection of IL-6 is also of great significance for the prognosis assessment of sepsis. Application of IL-6 in COVID-19 IL-6 is an important pathway that induces cytokine storm. Cytokine storm is a kind of transitional immune response, and the uncontrolled release of inflammatory factors eventually leads to organ damage and even functional failure. From a large number of research data, it is generally believed that cytokine storm is a key factor in the deterioration of COVID-19 patients. Therefore, IL-6 is also an important monitoring indicator in the diagnosis and treatment of COVID-19, which can be used for early warning of severe/critical COVID-19 and can also help guide the clinical selection of appropriate treatment strategies. a) Key laboratory indicators for COVID-19 patient assessment b) IL-6 levels in 99 confirmed COVID-19 patients Figure (a) In a retrospective multicentric study of 150 confirmed COVID-19 cases, IL-6 in the deceased patients was significantly higher than that in other cases [2]. Figure (b) In a study of 99 patients published in the January 29 Lancet, IL-6 was significantly elevated in more th...