IVD China last week: Snibe, Chemclin Diagnostics, Hotgen and Anzhen Hospital, Dian Diagnostics and Ruijin Hospital, AmoyDx and Boehringer Ingelheim

190 products of Snibe received IVDR CE certificate​

On May 27, Snibe announced that their 190 products of have obtained the IVDR certificate issued by TÜV SÜD, including 16 chemiluminescence reagents, 16 chemiluminescence quality control products, 57 biochemical reagents, 41 biochemical quality control products and 60 biochemical calibration products, of which the Hepatitis C Virus antibody test kit (chemiluminescence immunoassay) has obtained the IVDR CE certification of Class D, the highest risk level.

Chemclin Diagnostics' R&D and production headquarters went into operation

​

On May 27, Chemclin Diagnostics' R&D and production headquarter was officially put into production in Suzhou Hi-Tech Zone, and at the same time, it released a new generation of IVD system solutions with the world's leading level, which will further increase the investment in innovation and R&D and continue to plough into the advantageous fields, and add strong kinetic energy for the development of the medical device and health industry of Hi-Tech Zone.

This R&D and production headquarters covers an area of 60 acres, will continue to plough into the layout of fully automated chemiluminescence immunodiagnosis and other advantageous segments, research and development and production of the world's leading clinical immunodiagnostic system and fully automated immunoassay system related products, is expected to go into operation after the annual provision of nearly 300 million copies of the test reagents.

Hotgen and Anzhen Hospital team up for research on the original heart attack antibody drug

​

An innovative drug company incubated by Hotgen Biotech, has obtained the approval and license from FDA for its first innovative drug, SGC001 Clinical Trial Application, and has made a brand-new milestone breakthrough in the development of innovative drugs.

​

SGC001 is a monoclonal antibody drug for emergency treatment of patients with Acute Myocardial Infarction, a myocardial necrosis caused by acute occlusion of coronary arteries, with high morbidity, mortality and disability. AMI is a myocardial necrosis caused by acute occlusion of coronary artery, which has high morbidity, mortality and disability rate, and many serious complications.

​

Ruijin Hospital and Dian Diagnostics collaborate to advance research on rare autoimmune encephalitis in China

​

Recently, the results of a multi-center study on anti-DPPX encephalitis in China, in which Dian Diagnostics participated, were published in the international journal Frontiers in Neuroscience, summarizing information on the clinical manifestations, imaging and pathogenic factors, and therapeutic means of the disease. The results summarize the clinical manifestations, imaging examinations, pathogenic factors, and treatment methods of the disease, and provide new perspectives for the diagnosis and treatment of anti-DPPX encephalitis in the future.

​

AmoyDx and Boehringer Ingelheim collaborate on lung cancer companion diagnostics in China

On May 22, AmoyDx announced a new collaboration with Boehringer Ingelheim to screen and identify patients with non-small cell lung cancer who are most likely to benefit from targeted therapies.

China is one of Boehringer Ingelheim's key markets and innovation plateaus. Boehringer Ingelheim integrates the needs of Chinese patients into its global research and development strategy and is committed to bringing more and better innovative products to Chinese patients at an earlier stage, contributing to the high-quality development of China's healthcare industry, and improving the overall health of people and animals. ​