Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the registration application of melatonin granules, indicating progress in the development of a product aimed at addressing sleep difficulties in children with neurodevelopmental disorders [2]. Company Summary - Jinsai Pharmaceutical's melatonin granules are developed for the pediatric neuropsychiatric field and are classified as a Class 4 chemical drug [2]. - The product works by activating the MT1 and MT2 receptors in the suprachiasmatic nucleus, demonstrating sleep-inducing effects [2]. - The completion of the bioequivalence study comparing the test formulation with the reference formulation has been reported, and a generic drug application (ANDA) has been submitted [2]. Industry Summary - The approval of melatonin granules is expected to enhance the options available for treating sleep difficulties in children, thereby better meeting clinical needs [2].
长春高新:子公司褪黑素颗粒上市申请获得受理