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长春高新(000661) - 关于子公司GenSci134注射液临床试验申请获得批准的公告
2025-06-13 11:46
证券代码:000661 证券简称:长春高新 公告编号:2025-060 长春高新技术产业(集团)股份有限公司 关于子公司 GenSci134 注射液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")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 GenSci134 注射液的 境内生产药品注册临床试验申请获得批准,现将相关情况公告如下: 一、药品的基本情况 产品名称: GenSci134 注射液 申请事项:境内生产药品注册临床试验 生长激素缺乏症是由垂体发育异常、颅脑损伤、遗传基因突变、下丘脑功能 障碍、慢性系统性疾病等因素引起的生长发育及代谢障碍,可在一生中各个阶段 发生。成人生长激素缺乏常合并多种并发症,带来诸多危害。基于治疗现状, AGHD 患者需要长期甚至终身替代治疗,存在未被满足的临床需求。 综上所述,GenSci134 注射液具有潜在治疗 AGHD 的成药性,本次临床试验 申请的获 ...
长春高新(000661) - 关于醋酸甲地孕酮口服混悬液(美适亚)药物临床试验申请获得批准的公告
2025-06-13 11:46
产品名称:醋酸甲地孕酮口服混悬液 商品名称:美适亚® 证券代码:000661 证券简称:长春高新 公告编号:2025-061 长春高新技术产业(集团)股份有限公司 关于醋酸甲地孕酮口服混悬液(美适亚® ) 药物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")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》,授权经销合作产品醋酸 甲地孕酮口服混悬液(美适亚®)的境外生产药品注册临床试验申请获得批准, 现将本次获批相关情况公告如下: 一、药品的基本情况 申请事项:境外生产药品注册临床试验申请 受理号:JXHL2500056 申请人:保盛药业股份有限公司(中国台湾) 境内责任人/注册代理机构:长春金赛药业有限责任公司 审批结论:同意本品开展临床试验 适应症:预防化疗引起的恶心呕吐 二、药品的其它情况 化疗所致的恶心、呕吐(CINV)是抗肿瘤治疗的常见不良反应之一,70% 以上的抗肿瘤患者会出现不同程度的恶心 ...
维昇药业的独立性与生长激素困局
3 6 Ke· 2025-06-12 23:15
Core Viewpoint - The innovative drug company Weisheng Pharmaceutical has faced significant market challenges post-IPO, with a 30% drop in stock price and a market capitalization loss exceeding 2 billion HKD, despite a booming market for new listings in Hong Kong [1][14]. Company Overview - Weisheng Pharmaceutical, known as the "first growth and development stock" in Hong Kong, has struggled to attract investor interest, reflected in its poor stock performance [1]. - The company reported a cumulative loss of 1.3 billion HKD over five years, with zero revenue generated in the past four years, which is unusual in the relatively tolerant Hong Kong market [3][14]. Financial Performance - The company has a cash balance of only 200 million HKD as of the end of 2024, raising concerns about its financial sustainability if it fails to achieve timely product approvals [5]. - Weisheng's IPO valuation was nearly 20% lower than its 2021 Series B financing valuation, indicating a lack of confidence from investors [1][14]. Product Pipeline - The flagship product, Longpei Growth Hormone, has completed Phase III clinical trials and is expected to receive market approval in 2025 [2]. - The company has two additional products in development, but it has yet to commercialize any products since its establishment over six years ago [3][14]. Market Competition - Longpei Growth Hormone faces stiff competition from established players like Changchun High-tech, which has dominated the market for over a decade with its product JinSaiZeng [11][13]. - The competitive landscape includes several other companies with products at various stages of clinical trials, which could further dilute Weisheng's market share upon its product launch [11][13]. Operational Independence - Weisheng Pharmaceutical's operational independence is questioned, as it appears to function more as a local agent for Danish biopharmaceutical giant Ascendis Pharma, with over 70% of shares held by Ascendis and Vivo Capital [7][9]. - The company relies heavily on external partners for production and technology transfer, raising concerns about its ability to independently develop and manufacture pharmaceutical products [9][10]. Future Challenges - Even with a successful product launch, Weisheng Pharmaceutical will face ongoing operational challenges, including potential price pressures from centralized procurement policies that could significantly impact profit margins [13][14]. - The market's skepticism regarding Weisheng's future profitability is evident, as reflected in its low market valuation despite the potential for its flagship product [14].
阿尔茨海默概念下跌0.90%,5股主力资金净流出超3000万元
Group 1 - The Alzheimer's concept sector declined by 0.90%, ranking among the top declines in the concept sector, with notable declines from companies such as Wanbangde, Tonghua Jinma, and Kanghong Pharmaceutical [1][2] - Among the stocks in the Alzheimer's concept sector, 9 stocks experienced price increases, with Beilu Pharmaceutical, Lisheng Pharmaceutical, and Haizheng Pharmaceutical leading the gains at 4.42%, 3.36%, and 1.77% respectively [1][2] - The Alzheimer's concept sector saw a net outflow of 408 million yuan from major funds, with 22 stocks experiencing net outflows, and 5 stocks seeing outflows exceeding 30 million yuan, led by Tonghua Jinma with a net outflow of 126 million yuan [2][3] Group 2 - The top net inflow stocks in the Alzheimer's concept sector included Beilu Pharmaceutical, Luhua Pharmaceutical, and Meinian Health, with net inflows of 23.6 million yuan, 14.7 million yuan, and 14.2 million yuan respectively [2][3] - The stocks with the highest net outflows in the Alzheimer's concept sector included Tonghua Jinma, Changchun Gaoxin, and Dian Diagnostics, with net outflows of 125.8 million yuan, 53.6 million yuan, and 51.5 million yuan respectively [2][3] - The trading activity in the Alzheimer's concept sector showed significant turnover rates, with stocks like Tonghua Jinma and Wanbangde having turnover rates of 4.80% and 15.18% respectively [2][3]
医药行业周报:重估延续,趋势分化-20250609
Huaxin Securities· 2025-06-09 06:13
Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The revaluation of innovative drugs continues, driven by significant transactions and a trend towards differentiation in the market. The value of innovative drugs is increasingly recognized by multinational corporations (MNCs), particularly in the areas of EGFR and PD-1 dual antibodies. The number of pharmaceutical transactions in China increased by 34% year-on-year in Q1 2025, with total transaction value rising by 222% [3] - The upcoming ADA conference presents opportunities for Chinese companies to showcase their research, particularly in the areas of diabetes and weight loss. Notable collaborations and developments in GLP-1 drugs are expected to enhance the market presence of Chinese firms [4] - The gout treatment market shows significant potential, with a projected increase in patients from 170 million in 2020 to 240 million by 2030 in China. New drugs targeting URAT1 are entering critical clinical stages, indicating a strong market opportunity for innovative treatments [5] - Chinese companies are leading breakthroughs in CAR-T technology, with key developments expected in 2025. Recent clinical trials have shown promising results for CAR-T therapies in treating various cancers, indicating a strong future for these innovations [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.25% in the past week, with a weekly increase of 1.13% [17] - Over the past month, the pharmaceutical sector's index rose by 6.48%, surpassing the CSI 300 index by 4.76%, ranking second among all sectors [22] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 34.41, slightly above the five-year historical average of 32.55 [41] 3. Recent Research Achievements - The research team has published several in-depth reports highlighting the growth trends in the blood products industry and the impact of policies on inhalation drug markets [44] 4. Recent Industry Policies and News - Recent policies aim to enhance the pricing and procurement evaluation system in the pharmaceutical sector, promoting a fair and transparent market environment [47] - Notable industry news includes several innovative drugs receiving clinical trial approvals and partnerships between Chinese companies and international firms, indicating a vibrant and evolving market landscape [48][49]
长春高新(000661) - 关于子公司重组带状疱疹疫苗(CHO细胞)临床试验申请获得批准的公告
2025-06-04 10:46
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。 证券代码:000661 证券简称:长春高新 公告编号:2025-059 长春高新技术产业(集团)股份有限公司 关于子公司重组带状疱疹疫苗(CHO 细胞) 带状疱疹是由潜伏在机体内的水痘-带状疱疹病毒(VZV)重新被激活引起的 急性感染性皮肤病,该病毒具有嗜神经性,初次感染后可长期潜伏在脊髓神经后 根或脑神经节的神经元内,在某些诱因的刺激下,潜伏的病毒沿感觉神经移动到 达支配的皮肤,迅速增殖复制使受感染细胞发炎、坏死造成神经痛,并沿着神经 纤维通路到达皮肤表面,出现呈带状分布的红斑及簇集水疱。带状疱疹多发于老 年人和免疫低下人群,常伴剧烈的顽固性带状疱疹后神经痛(PHN),严重影响 患者生活质量。 本次百克生物获批临床的重组带状疱疹疫苗(CHO 细胞)接种对象为 40 岁 及以上成人,接种后可刺激机体产生抗水痘-带状疱疹病毒的免疫力,用于预防 带状疱疹。 1 近日,长春高新技术产业(集团)股份有限公司(以下简称"公司")子公 司——长春百克生物科技股份公司(以下简称"百克生物")收到国家 ...
长春高新(000661) - 关于回购股份进展情况的公告
2025-06-03 09:16
证券代码:000661 证券简称:长春高新 公告编号:2025-058 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 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。 长春高新技术产业(集团)股份有限公司(以下简称"公司")于2024年 11月14日召开了第十一届董事会第六次会议,审议通过了《关于公司回购股份 方案的议案》,同意公司使用自有资金及金融机构股票回购专项贷款资金以集 中竞价交易方式回购部分公司已在境内发行的人民币普通股(A股)股票,全 部用于后续实施公司及子公司核心团队股权激励或员工持股计划。拟用于回购 资金总额不低于人民币3亿元(含)、不超过人民币5亿元(含),回购价格不 超过人民币160.00元/股。具体回购股份数量以回购期限届满时实际回购的股份 数量为准。 上述内容详见公司于2024年11月16日、2024年11月21日在《中国证券报》 《 证 券 时 报 》 《 上 海 证 券 报 》 《 经 济 参 考 报 》 及 巨 潮 资 讯 网 ( http://www.cninfo.com.cn)上分别披露的《关于公司回购股份方 ...
沪深300制药与生物科技指数报7971.61点,前十大权重包含片仔癀等
Jin Rong Jie· 2025-06-03 07:46
Group 1 - The Shanghai Composite Index opened lower but rose throughout the day, with the CSI 300 Pharmaceutical and Biotechnology Index reported at 7971.61 points [1] - The CSI 300 Pharmaceutical and Biotechnology Index has increased by 5.53% in the past month, 7.39% in the past three months, and 7.09% year-to-date [1] - The CSI 300 Index categorizes its 300 sample stocks into 11 primary industries, 35 secondary industries, over 90 tertiary industries, and more than 200 quaternary industries [1] Group 2 - The top ten holdings of the CSI 300 Pharmaceutical and Biotechnology Index are: Heng Rui Medicine (25.29%), WuXi AppTec (16.43%), Pian Zai Huang (6.37%), Yunnan Baiyao (5.21%), Kelun Pharmaceutical (5.11%), East China Pharmaceutical (4.06%), Xinhecheng (3.51%), Changchun High-tech (3.48%), Fosun Pharma (3.34%), and Shanghai Raas (3.27%) [1] - The market segments of the CSI 300 Pharmaceutical and Biotechnology Index show that the Shanghai Stock Exchange accounts for 63.65% and the Shenzhen Stock Exchange accounts for 36.35% [2] - The industry composition of the CSI 300 Pharmaceutical and Biotechnology Index includes: chemical drugs (43.80%), pharmaceutical and biotechnology services (21.66%), traditional Chinese medicine (18.52%), and biological drugs (16.02%) [2] Group 3 - The index samples are adjusted every six months, with adjustments implemented on the next trading day following the second Friday of June and December each year [2] - Weight factors are adjusted along with the periodic sample adjustments, which are generally fixed until the next scheduled adjustment [2] - Temporary adjustments occur when the CSI 300 Index samples are modified, and changes in industry classification due to special events will also lead to corresponding adjustments in the CSI 300 industry index samples [2]
6月十大金股:六月策略和十大金股
Huaxin Securities· 2025-06-02 10:04
Group 1 - The report indicates that in June, overseas focus is on tariff negotiations, debt risks, and interest rate cut expectations, leading to a cautious outlook for US stocks, while domestic economic and policy observations show limited incremental highlights [3][11] - The A-share market is expected to experience range-bound fluctuations, with a continuation of the "barbell strategy" focusing on dividend defense, domestic demand recovery, and technology growth [3][15] - The report highlights the importance of monitoring sectors such as banking, public utilities, transportation, new consumption, innovative pharmaceuticals, agriculture, and technology-driven industries like AI and semiconductors for potential investment opportunities [3][15] Group 2 - The report lists the top ten stocks for June, including companies from various sectors such as electronics, media, automotive, chemicals, pharmaceuticals, food and beverage, and power equipment [4][10] - Specific companies highlighted include Lianchuang Optoelectronics, Juguang Technology, and Changchun Gaoxin, with each showing promising growth potential based on recent performance and market conditions [4][17][27] - The report provides earnings forecasts for these companies, indicating expected revenue growth for Lianchuang Optoelectronics from 32.91 billion to 45.04 billion from 2025 to 2027, and for Juguang Technology from 5.65 billion to 11.01 billion in the same period [21][27]
长春高新技术产业(集团)股份有限公司 关于公司与专业投资机构共同投资进展 暨完成私募投资基金备案登记的公告
Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has announced the establishment of a partnership with professional investment institutions to enhance its investment capabilities and improve capital efficiency [1]. Group 1 - The company held its 11th Board of Directors' fifth meeting on October 24, 2024, where it approved a proposal to jointly invest with professional investment institutions to establish a partnership enterprise [1]. - The company will act as a limited partner alongside CITIC Jin Investment Management Co., Ltd. and Changchun Changfa Private Fund Management Co., Ltd. to establish an investment fund [1]. - The fund has completed the registration process with the Asset Management Association of China and has obtained the Private Investment Fund Registration Certificate [1]. Group 2 - The fund is named Changchun Xinghe Runxin Venture Capital Center (Limited Partnership) [1]. - The fund manager is CITIC Jin Investment Management Co., Ltd., and the custodian is CITIC Bank Co., Ltd. [1]. - The registration date for the fund is May 28, 2025, with the registration code SAXV26 [1].