Yahuilong (688575) announced on the evening of May 10 that recently, the company's glycocholic acid assay kit (chemiluminescence method) and anti-desmosogrein 1 antibody assay kit (chemiluminescence method) have obtained the medical device registration certificate issued by Guangdong Drug Administration and obtained the domestic market access qualification.

According to the announcement, serum glycocholic acid is one of the main components of bile acid, with a molecular weight of 465.6. It is formed by the combination of glycine and bile acid, and mainly exists in the form of protein binding in serum. Glycholic acid is mainly synthesized by liver cells, and the serum glycocholic acid in normal adults is stable at a low level no matter fasting or postprandial. When the liver cells are damaged or cholestasis, the liver's reabsorption of glycocholic acid will be abnormal, which will cause the metabolism and circulation of glycocholic acid to be disturbed, resulting in the increase of the content of glycocholic acid in the blood. The content of serum glycocholic acid is closely related to the injury of liver cells and the severity of bile acid metabolism disorder. Glycocholic acid is an important diagnostic indicator for hepatobiliary diseases. In acute hepatitis, chronic hepatitis, liver cirrhosis, cholelithiasis, jaundice, bile duct, gallbladder excretion dysfunction, obstructive liver disease, intestinal-liver circulation disorders and other diseases in patients with the level will be significantly increased. Glycholic acid can be used as an important index to evaluate intrahepatic cholestasis of pregnancy (ICP). ICP is an idiopathy of pregnancy, which is more common in the second and third trimester of pregnancy. It is characterized by skin pruritus and jaundice, accompanied by varying degrees of elevated serum total bile acid, elevated serum transaminase and bilirubin, abnormal liver function, etc. The serum CG level of ICP patients was significantly higher than that of normal pregnant women, even up to 10-100 times, and the rate of amniotic fluid contamination, preterm birth rate, intrauterine fetal distress and cesarean section increased with the increase of CG.

Desmoglein 1(Dsg1) is a desmosomere-forming protein, which belongs to the cadherin family and is involved in the regulation of cell-to-cell adhesion and cell shape. Pemphigus is a stratified squamous epithelial autoimmune disease mediated by IgG. There are three main subtypes: pemphigus vulgaris (PV), pemphigus foliaceus (PF) and paraneoplastic pemphigus (PNP). Anti-Dsg1 antibody, an autoantibody found in the serum of patients with PF and PV, has been identified as the cause of PF and can serve as a serological marker of PF. PF is an autoimmune blistering disease characterized by scattered superficial blisters that later evolve into crusting erosions. Almost all PF patients have anti-Dsg1 antibodies, while anti-Dsg1 antibodies are mostly absent in healthy individuals. At present, Yahuilong has obtained 4 projects for the detection of autoimmune bullous skin diseases, covering the main three disease subtypes, and can provide perfect solutions for autoimmune bullous skin diseases in clinic. The combined detection of the four items can effectively reduce the risk of missed diagnosis and misdiagnosis, and can help the clinic to accurately classify the disease, so as to formulate a reasonable personalized treatment plan.

Yahuilong said that up to now, the company has successively obtained 159 domestic "medical device registration certificates" for chemiluminescence reagents (a total of 223 domestic registration certificates for luminescent reagents). The acquisition of the "Medical Device Registration Certificate" is conducive to further enriching the company's fully automatic chemical luminescence product line, and perfecting the testing package in the field of autoimmune diseases and hepatobiliary diseases of Yahui Long. Up to now, the company has obtained 55 chemical luminescence from the test reagent domestic "medical device registration certificate."