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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]
长春高新(000661) - 关于子公司卡麦角林片临床试验申请获得批准的公告
2025-08-11 09:30
证券代码:000661 证券简称:长春高新 公告编号:2025-070 长春高新技术产业(集团)股份有限公司 关于子公司卡麦角林片临床试验申请获得批准的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚 假记载、误导性陈述或重大遗漏。 近日,长春高新技术产业(集团)股份有限公司(以下简称"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,现将有关情况公告如下: 一、药品的基本情况 产品名称:卡麦角林片 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。 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 况引起。流行病学显示:高催乳素血症年轻女性常见的下丘脑-垂体轴内分泌紊 乱,25~34 岁妇女的年发病率为 23.9/10 ...
龙头药企,一指尽揽!国内首只“药ETF联接基金”8·8首发
Xin Lang Ji Jin· 2025-08-08 00:07
Core Viewpoint - The launch of China's first pharmaceutical ETF fund aims to provide investors with exposure to leading companies in the chemical, biological, and traditional Chinese medicine sectors, capitalizing on the growth potential driven by innovation and demographic trends [1][5]. Industry Overview - The pharmaceutical industry is characterized by its essential nature, driven by a large population, aging demographics, and increasing GDP per capita, which supports long-term growth [5]. - By 2024, the proportion of the population aged 65 and above in China is expected to reach 15.6%, indicating a shift into a moderately aging society, which will further expand the pharmaceutical market [5]. Innovation and Growth - Innovative drugs are seen as a key driver for the pharmaceutical industry's growth, with the potential to unlock new value and re-evaluate medical asset worth [5]. - Domestic innovative drugs are anticipated to experience significant growth in 2024, supported by various internal and external factors, potentially leading to a "Davis Double Play" scenario [5]. - The integration of AI in drug development is expected to accelerate the research and development of new medications [5]. ETF Fund Details - The newly launched ETF fund (A class: 024985 / C class: 024986) will exclusively track the CSI Pharmaceutical Index, which includes leading companies in the chemical, biological, and traditional Chinese medicine sectors [1][19]. - The fund aims to provide a balanced investment approach, combining high-growth innovative drugs with more stable traditional Chinese medicine to mitigate volatility [1][19]. Performance Metrics - The pharmaceutical index has shown a significantly smaller decline compared to similar indices over the past five years, with positive returns over the last three years [14]. - The index's long-term annualized volatility and maximum drawdown are notably lower than those of comparable indices, indicating a more stable investment profile [14]. Key Constituents - The top ten constituents of the pharmaceutical index include major companies such as Heng Rui Medicine (14.91% weight), Pian Zai Ye (5.83%), and Yunnan Baiyao (4.81%), reflecting a diverse representation across the pharmaceutical sectors [13].
长春高新:长效生长激素持续领跑全球 10年15万例临床验证安全壁垒
Zheng Quan Shi Bao· 2025-08-06 14:49
Core Insights - Multiple long-acting growth hormones are nearing market approval, breaking the trend of only one product being launched in the past decade, which enhances the diversity of growth hormone options [1] - The safety, efficacy, and quality of new drugs, along with sufficient clinical feedback, are critical for competition in the market [1] Group 1: Product Development and Innovation - Long-term growth hormone technology involves modifying or protecting the hormone to extend its retention time in the body, addressing issues of short-acting formulations [2] - The core subsidiary of Changchun High-tech, Jinsai Pharmaceutical, has focused on developing domestic long-acting formulations after successfully launching short-acting growth hormones [2] - Jinsai Pharmaceutical has optimized the PEG modification process, achieving a half-life extension to 32 hours, allowing for weekly dosing and improved efficacy over short-acting formulations [2][3] Group 2: Quality and Safety Assurance - Ensuring efficacy and safety is paramount for long-acting growth hormones, with individual differences in pediatric patients necessitating long-term monitoring [4] - Jinsai Pharmaceutical has achieved a PEG purity of 100%, significantly higher than the typical 95% standard from suppliers, ensuring product quality and safety [6] - The company has invested heavily in developing a comprehensive production process to maintain high purity levels, overcoming challenges in production quality control [5][6] Group 3: Market Position and Future Strategy - Jinsai Pharmaceutical's long-acting growth hormone, Jinsai Zeng, is currently the only product approved for multiple indications, including GHD, ISS, and TS, setting it apart from competitors [7] - The company aims to expand its international presence and enhance patient care in the pediatric health sector, focusing on continuous improvement in drug formulation [7][8] - The establishment of a positive feedback loop between clinical breakthroughs and patient confidence is essential for driving further innovation in the growth hormone sector [8]
长春高新股价小幅下跌 公司拟赴港IPO引关注
Jin Rong Jie· 2025-08-04 19:21
Group 1 - The stock price of Changchun High-tech is reported at 104.78 yuan, down 0.86% from the previous trading day, with a trading volume of 7.74 billion yuan [1] - The company operates in the biopharmaceutical industry, focusing on the production and sales of biopharmaceuticals and traditional Chinese medicine, with a product line that includes growth hormones and vaccines [1] - Changchun High-tech announced its plan to pursue an IPO in Hong Kong in July, becoming one of 17 A-share companies to announce such plans that month [1] Group 2 - Recent clinical trials for a copy-type Tian Tan smallpox vaccine carrier HIV vaccine by the Chinese Center for Disease Control and Prevention may have a positive impact on the biopharmaceutical vaccine industry [1] - The net inflow of main funds into Changchun High-tech on the day was 471.66 million yuan, with a cumulative net inflow of 1.85 billion yuan over the past five days [1]
年内月度新高! 长春高新等17家A股公司首次披露拟赴港IPO
Mei Ri Jing Ji Xin Wen· 2025-08-04 14:12
Group 1 - In July, the number of companies applying for listing on the Hong Kong Stock Exchange decreased significantly, with only 21 companies submitting applications, marking the lowest monthly figure since April 2025 [1][2] - Meanwhile, 17 A-share listed companies announced plans for an IPO in Hong Kong, setting a new monthly high for the year, indicating a continued acceleration of A-share companies seeking to list in Hong Kong [2] - The A-share IPO market saw 9 companies go public in July, with all but one passing the review, and the new stocks listed experienced significant gains, with the highest increase reaching 479.12% [4][5] Group 2 - The China Securities Regulatory Commission (CSRC) issued only 3 approvals for companies seeking to list abroad in July, a sharp decline from 20 in June [2] - The number of companies terminating their IPO applications in July was 6, a decrease from 10 in June, indicating a potential stabilization in the IPO process [6] - The A-share market had only one company accepted for IPO review in July, which is the first under the fifth set of listing standards for the Sci-Tech Innovation Board [7]
长春高新技术产业(集团)股份有限公司 关于回购股份进展情况的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-01 23:11
Core Viewpoint - The company has approved a share repurchase plan to utilize its own funds and special loans from financial institutions for the purpose of incentivizing its core team and employee stock ownership plans. Group 1: Share Repurchase Plan - The company plans to repurchase shares with a total fund amount not less than RMB 300 million and not exceeding RMB 500 million, with a maximum repurchase price of RMB 160.00 per share [1] - The repurchase will be conducted through centralized bidding for the company's A-shares that have been issued domestically [1] - The specific number of shares repurchased will be determined at the end of the repurchase period [1] Group 2: Progress of Share Repurchase - As of July 31, 2025, the company has repurchased a total of 3,894,517 shares, accounting for 0.95% of the total share capital [2] - The highest transaction price during the repurchase was RMB 112.25 per share, while the lowest was RMB 84.00 per share, with a total transaction amount of approximately RMB 400 million [2] Group 3: Compliance and Regulations - The share repurchase complies with relevant laws and regulations, including the requirements set forth by the Shenzhen Stock Exchange [3] - The company has not repurchased shares during periods that could significantly impact the stock price or during other restricted periods as defined by regulatory authorities [3] - The company will continue to implement the repurchase plan based on market conditions and will fulfill its information disclosure obligations in accordance with relevant laws and regulations [3]
长春高新股价微涨0.16% 公司累计回购389万股耗资4亿元
Jin Rong Jie· 2025-08-01 16:52
Core Viewpoint - Changchun High-tech's stock price has shown a slight increase, reflecting positive market sentiment and ongoing strategic initiatives in the biopharmaceutical sector [1][2]. Group 1: Stock Performance - The latest stock price of Changchun High-tech is 105.69 yuan, with a 0.16% increase from the previous trading day [1]. - The stock reached a high of 109.65 yuan and a low of 104.67 yuan during the trading session, with a total trading volume of 8.32 billion yuan [1]. Group 2: Business Overview - Changchun High-tech's main business includes biopharmaceuticals and traditional Chinese medicine production and sales [1]. - Key products include recombinant human growth hormone and recombinant human follicle-stimulating hormone, positioning the company as a significant player in the pediatric growth and development treatment market [1]. Group 3: Corporate Actions - As of July 31, Changchun High-tech has repurchased 3.89 million shares, accounting for 0.95% of the total share capital, with a total repurchase amount of 400 million yuan [1]. - The company's subsidiary, Jinsai Pharmaceutical, is making strides in the treatment of pediatric neurodevelopmental disorders [1]. Group 4: Capital Flow - Data indicates that on the day of reporting, the net inflow of main funds into Changchun High-tech was 14.21 million yuan, with a cumulative net inflow of 3.34 million yuan over the past five days [2].
长春高新:累计回购公司股份3894517股
Zheng Quan Ri Bao· 2025-08-01 14:09
证券日报网讯 8月1日晚间,长春高新发布公告称,截至2025年7月31日,公司累计通过回购专用证券账 户,以集中竞价交易方式累计回购公司股份3,894,517股,占本公司总股本的0.95%。 (文章来源:证券日报) ...