CCHT(SZ:000661) Cai Jing Wang·2025-08-11 13:43Core Viewpoint - Changchun Gaoxin announced the approval of clinical trial application for its subsidiary, Jinsai Pharmaceutical's Cabergoline tablets, by the National Medical Products Administration, marking a significant step in the development of a treatment for hyperprolactinemia and prolactin-secreting adenomas [1][2]. Group 1: Company Information - Jinsai Pharmaceutical, a subsidiary of Changchun Gaoxin, received the clinical trial approval for Cabergoline tablets, which are classified as chemical drug category 3 [1]. - Cabergoline is a dopamine receptor agonist with effective activity on dopamine D2 receptors, aimed at treating hyperprolactinemia and prolactin-secreting adenomas [1][2]. Group 2: Industry Context - Hyperprolactinemia is a clinical condition characterized by elevated serum prolactin levels, with a notable incidence rate of 23.9 per 100,000 women aged 25-34 [1]. - The first-line treatment for hyperprolactinemia and prolactin-secreting adenomas is dopamine receptor agonists, with Cabergoline being a highly selective D2 receptor agonist that offers stronger inhibition of prolactin with fewer side effects compared to bromocriptine [2]. - Since its global approval in over 80 countries since 1992, Cabergoline has been recommended as a first-line treatment for hyperprolactinemia and prolactin-secreting adenomas, and currently, there are no similar products available in the domestic market [2].