长春高新: 关于子公司卡麦角林片临床试验申请获得批准的公告

Group 1 - The core point of the announcement is that Changchun High-tech Industry (Group) Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial application of its subsidiary Changchun Jinsai Pharmaceutical Co., Ltd.'s drug, Cabergoline Tablets, for domestic production [1] - Cabergoline Tablets are developed as a dopamine receptor agonist, specifically targeting dopamine D2 receptors, and are classified as a chemical drug of category 3, intended for the treatment of hyperprolactinemia and pituitary prolactin adenoma [1][2] - The approval of the clinical trial application is expected to facilitate the clinical development of the product and address unmet clinical needs for patients, as there are currently no similar products available in the domestic market [2] Group 2 - Hyperprolactinemia is a clinical condition characterized by elevated serum prolactin levels, with a reported annual incidence of 23.9 per 100,000 women aged 25-34, and it is a common endocrine disorder among young women [2] - The first-line treatment for hyperprolactinemia and pituitary prolactin adenoma is dopamine receptor agonists, with Cabergoline being a highly selective D2 receptor agonist that offers stronger inhibition of prolactin compared to its predecessor, Bromocriptine, while having fewer side effects and a longer duration of action [2] - The original product of Cabergoline has been approved in over 80 countries since 1992 and is recommended as a first-line treatment for hyperprolactinemia and pituitary prolactin adenoma [2]