Core Viewpoint - Changchun High-tech has received approval for clinical trials of its drug, Cabergoline Tablets, aimed at treating hyperprolactinemia and pituitary prolactin adenomas, marking a significant step in addressing unmet clinical needs in this area [1][2] Group 1: Product Development - Cabergoline Tablets are a dopamine receptor agonist with effective activity on dopamine D2 receptors, classified as a chemical drug of category 3, intended for the treatment of hyperprolactinemia and pituitary prolactin adenomas [1] - The drug has been approved for clinical trials in China, which will facilitate its clinical development and address unmet clinical needs for patients [2] - The original product of Cabergoline has been approved in over 80 countries since 1992, making it a first-line treatment for hyperprolactinemia and pituitary prolactin adenomas [2] Group 2: Market Context - Hyperprolactinemia is a common endocrine disorder, particularly among young women, with an annual incidence rate of 23.9 per 100,000 for women aged 25 to 34 [1] - The condition is prevalent in 10% to 25% of patients with secondary amenorrhea and 70% to 80% of patients with amenorrhea and galactorrhea, with 20% to 30% of hyperprolactinemia patients having pituitary tumors, primarily prolactinomas [1] Group 3: Company Strategy and Other Developments - Changchun High-tech is involved in various pharmaceutical sectors, including gene engineering, biological vaccines, antibody drugs, high-end chemical drugs, and modern traditional Chinese medicine [2] - The company has also received approvals for other products, including GenSci098 for thyroid eye disease and GenSci122 for advanced solid tumors, indicating a robust pipeline of clinical trials [3] - Additionally, the company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international presence and financing capabilities [4]

Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical, received approval from the National Medical Products Administration for the clinical trial of its drug, Cabergoline Tablets, which is intended for the treatment of hyperprolactinemia and pituitary prolactin adenoma [1] Company Summary - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, has been granted a clinical trial approval for Cabergoline Tablets, a dopamine receptor agonist [1] - The drug is classified as a Class 3 chemical drug and is aimed at treating conditions related to elevated prolactin levels [1] Industry Summary - The approval of Cabergoline Tablets indicates a positive development in the pharmaceutical industry, particularly in the area of treatments for hormonal disorders [1] - The drug's mechanism of action involves effective agonistic activity on the dopamine D2 receptor, which is crucial for its therapeutic application [1]

长春高新（SZ 000661，收盘价：104.44元）8月11日晚间发布公告称，近日，长春高新技术产业（集 团）股份有限公司控股子公司——长春金赛药业有限责任公司收到国家药品监督管理局核准签发的《药 物临床试验批准通知书》，金赛药业卡麦角林片的境内生产药品注册临床试验申请获得批准。 2024年1至12月份，长春高新的营业收入构成为：制药业占比94.07%，房地产占比5.61%，服务业占比 0.32%。 （文章来源：每日经济新闻） ...