Tellgen CorpRegistration acceptance for Alzheimer's diagnostic kits is a positive step but not yet approved, with uncertainty.

Six medical device registration applications submitted by Tellgen and its holding subsidiary Maishibio have been accepted by the Shanghai Medical Products Administration. Among them, the four products submitted by Tellgen are detection kits based on chemiluminescence immunoassay, including kits for measuring beta-amyloid 1-40, beta-amyloid 1-42, phosphorylated Tau181 protein, and phosphorylated Tau217 protein, intended for the auxiliary diagnosis of Alzheimer's disease. The two products submitted by subsidiary Maishibio are measurement kits based on liquid chromatography-tandem mass spectrometry, including a six-class steroid hormone measurement kit and a fat-soluble vitamin measurement kit. The company stated that these products align with its strategic layout and are conducive to expanding its product matrix in non-oncology testing areas, but they are currently in the registration acceptance stage and still need to go through technical review, administrative approval, and other steps. Obtaining the registration certificate is subject to uncertainty and will not affect recent performance.
Tellgen CorpRegistration acceptance for Alzheimer's diagnostic kits is a positive step but not yet approved, with uncertainty.
Subsidiary's kits accepted for registration, but approval and commercial impact uncertain.