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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
Zheng Quan Zhi Xing· 2025-08-11 16:16
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]
长春高新:卡麦角林片临床试验申请获批,拟开发治疗高催乳素血症/垂体催乳素腺瘤
Cai Jing Wang· 2025-08-11 13:43
8月11日,长春高新发布关于子公司卡麦角林片临床试验申请获得批准的公告。披露控股子公司——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。 卡麦角林片是金赛药业开发的一款多巴胺受体激动剂,对多巴胺D2受体具有有效的激动剂活性,注册 分类为化药 3 类,拟开发用于高催乳素血症/垂体催乳素腺瘤的治疗。 (企业公告) 目前治疗高催乳素血症、垂体催乳素腺瘤(无论微腺瘤或大腺瘤),首选多巴胺受体激动剂治疗。卡麦 角林是具有高度选择性的多巴胺D2受体激动剂,是溴隐亭的换代药物,抑制催乳素的作用更强大而不 良反应相对减少,作用时间更长。 卡麦角林原研产品自1992年起在全球80多个国家或地区获批上市,为国内外推荐的高催乳素血症/垂体 催乳素腺瘤一线治疗药物。截至目前,国内尚无同品种产品上市,本次临床试验申请获批可推动后续该 产品临床开发及符合患者的未满足临床需求。 高催乳素血症(hyperprolactinemia,HPRL)是由于各种原因引起外周血清催乳素水平持续高于正常值的 一种临床病理生理状态,由多种生理、药理、病理情况 ...
长春高新子公司卡麦角林片临床试验申请获批
Zheng Quan Shi Bao Wang· 2025-08-11 13:33
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]
长春高新(000661)8月11日主力资金净流出2693.83万元
Sou Hu Cai Jing· 2025-08-11 12:32
Group 1 - The core viewpoint of the news is that Changchun High-tech (000661) has experienced a decline in stock price and financial performance, indicating potential challenges for the company [1][3] - As of August 11, 2025, the stock closed at 104.44 yuan, down 0.49%, with a turnover rate of 1.47% and a trading volume of 58,600 lots, amounting to 609 million yuan [1] - The latest financial results for the first quarter of 2025 show total revenue of 2.997 billion yuan, a year-on-year decrease of 5.66%, and a net profit attributable to shareholders of 473 million yuan, down 44.95% year-on-year [1] Group 2 - The company has a current ratio of 4.323, a quick ratio of 2.956, and a debt-to-asset ratio of 16.20%, indicating a strong liquidity position [1] - Changchun High-tech has made investments in 26 companies and participated in 13 bidding projects, showcasing its active engagement in the market [2] - The company holds 30 trademark registrations and has obtained 6 administrative licenses, reflecting its commitment to intellectual property and regulatory compliance [2]
8月11日晚间公告 | 九鼎投资拟收购人形机器人零部件公司;长春高新卡麦角林片临床试验申请获得批准
Xuan Gu Bao· 2025-08-11 11:59
Mergers and Acquisitions - Jinding Investment plans to acquire 53.29% stake in Nanjing Shenyuan Intelligent Technology for 213 million yuan, entering a key segment of the robotics industry [1] - Huangshanghuang is acquiring 51% stake in Fujian Lixing Food for 495 million yuan, gaining controlling interest in Lixing Food, which will become a subsidiary [1] Shareholding Increase and Transfers - All current directors and executives of Changan Automobile intend to increase their shareholdings [2] - Tianfu Communication's share transfer price is set at 88.55 yuan per share [2] - Shareholders of Changsheng Bearing, Baisheng Investment and Lu Xiaolin, are transferring 2.64% of the company shares at a price of 61.82 yuan per share [2] Daily Operations and External Investments - Changchun Gaoxin's subsidiary has received approval for clinical trial application of Camycin, with no similar products currently on the market in China [3] - Huaxi Biological has completed the registration of the main document for sodium chondroitin sulfate using fermentation methods [4] - Shanghai Yanpu plans to establish a joint venture with related parties focusing on the research, production, and sales of industrial robots [4] - Luxiao Technology is planning to issue H-shares and list on the Hong Kong Stock Exchange [4] - Fosun Pharma has granted global development, production, and commercialization rights for the in-development product XH-S004 to Expedition [4] - Hubei Yihua has launched a project with an annual production capacity of 400,000 tons of phosphate ammonium and 200,000 tons of sulfur-based compound fertilizer [4] - Chengdu Huami has released an ultra-low power consumption RISC-V MCU [4] - Samsung Medical's subsidiary Foxytech Sp.zo.o has signed a smart meter project in Poland, with a total contract value of approximately 185 million yuan [4] - Dongfang Guoxin plans to acquire 33.3529% stake in Shituo Cloud for 133 million yuan [4] - Zhiguang Electric's subsidiary has signed a sales contract for energy storage system equipment worth 204 million yuan [4] Performance Changes - Bofei Electric reported a net profit of 8.5871 million yuan for the first half of 2025, a year-on-year increase of 882.67% [9] - Xianggang Technology's net profit for the first half of 2025 reached 78.3161 million yuan, up 432.14% year-on-year [9] - Fengshan Group turned a profit with a net profit of 30.3139 million yuan in the first half of 2025 [9] - Ningbo Fubang's net profit for the first half of 2025 was 9.6797 million yuan, an increase of 194.15% year-on-year [9] - Xiechuang Data reported a net profit of 457 million yuan for the first half of the year, up 27.68% [9] - Gaozheng Mining's net profit for the first half of 2025 was 69.2 million yuan, a year-on-year increase of 25.70% [9] - Wanhua Chemical reported a net profit of 6.123 billion yuan for the first half of the year, a decrease of 25.1% year-on-year [10]
A股公告精选 | 露笑科技(002617.SZ)筹划赴港上市 推进全球化战略布局
智通财经网· 2025-08-11 11:47
今日聚焦 1、露笑科技:筹划发行H股股票并在香港联交所上市 露笑科技(002617.SZ)公告称,公司正在筹划境外发行股份(H股)并在香港联合交易所有限公司上市,以 推进全球化战略布局,打造国际化资本运作平台,提升国际品牌形象和综合竞争力。相关细节尚未确 定,待具体方案确定后,尚需提交公司董事会和股东大会审议,并经中国证券监督管理委员会备案和香 港联交所等监管机构审核。该事项具有较大不确定性,公司将及时履行信息披露义务。 2、山河智能:全资子公司收到保险赔付款 影响净利润金额1.26亿元 山河智能公告,公司全资子公司AVMAX曾与俄罗斯客户签订三份飞机租赁合同。自2022年2月地缘政 治冲突以来,航空业在制裁范围内。AVMAX根据相关政策,多次尝试召回上述租赁在俄罗斯的飞机。 尽管已持续进行交涉与回收操作,仍无法成功收回涉事飞机。近日,AVMAX与飞机保险承保人就赔付 方案达成一致意见,确认AVMAX可从保险承保商获得的保险理赔款为2900万美元,扣除律师费用等后 的保险赔付款净额为2296.51万美元。截至目前,AVMAX已全额收到2296.51万美元保险赔付款,按照8 月8日美元对人民币汇率中间价,折算人 ...
创新药械长牛,把握业绩、技术、需求要素,WCLC划重点
ZHONGTAI SECURITIES· 2025-08-11 11:14
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [2] Core Insights - The industry is entering an accelerated growth phase, driven by innovation in drug and medical device sectors, with a focus on performance, technology, and demand factors [4][11] - The market is experiencing differentiation, with a notable shift towards innovative drugs and medical devices, particularly in the context of AI-driven drug development and brain-computer interface technologies [4][8] - The report highlights the importance of selecting stocks based on robust performance, technological innovation, and potential for clinical research advancements [4][8] Summary by Sections Industry Investment Rating - The report rates the pharmaceutical and biotechnology industry as "Overweight" [2] Key Company Status - The report provides a detailed overview of key companies, including their stock prices, earnings per share (EPS) forecasts, and price-to-earnings (PE) ratios, with several companies rated as "Buy" [2] Market Trends - The report notes that the pharmaceutical sector has outperformed the broader market, with a year-to-date return of 21.28% compared to 4.32% for the CSI 300 index [13] - Recent market dynamics show a divergence within the pharmaceutical sector, with medical devices gaining traction while other segments like biopharmaceuticals and traditional medicine face declines [4][13] Investment Opportunities - The report suggests focusing on companies with stable or reversing performance, particularly in innovative drugs and medical devices, as well as those involved in AI-driven drug discovery [4][8] - Specific companies recommended for attention include WuXi Biologics, Innovent Biologics, and others involved in significant clinical research or technological advancements [4][8] Policy Support and Industry Growth - The report discusses the strong policy support for brain-computer interface technologies, which is expected to accelerate industry growth and innovation [11][9] - By 2027, key technological breakthroughs are anticipated, establishing a robust industry ecosystem with global competitiveness [11][9]
长春高新(000661.SZ)子公司卡麦角林片临床试验申请获得批准
智通财经网· 2025-08-11 10:00
智通财经APP讯,长春高新(000661.SZ)发布公告,近日,公司控股子公司——长春金赛药业有限责任公 司(以下简称"金赛药业")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。 卡麦角林片是金赛药业开发的一款多巴胺受体激动剂,对多巴胺D2受体具有有效的激动剂活性,注册 分类为化药3类,拟开发用于高催乳素血症/垂体催乳素腺瘤的治疗。 ...
长春高新卡麦角林片临床试验申请获得批准
Bei Jing Shang Bao· 2025-08-11 09:48
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:控股子公司获得《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-08-11 09:36
Group 1 - The core revenue composition of Changchun High-tech for the year 2024 is as follows: 94.07% from the pharmaceutical industry, 5.61% from real estate, and 0.32% from the service industry [1] - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its drug, Kamexoline Tablets [3]