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长春高新:吸附无细胞百白破b型流感嗜血杆菌联合疫苗获临床试验批准
Core Viewpoint - Changchun High-tech announced that Changchun Baike Biotechnology Co., Ltd. received the clinical trial approval notice from the National Medical Products Administration for its combined vaccine against whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b, indicating progress in vaccine development and potential market impact [1] Group 1 - The combined vaccine aims to reduce the number of doses required and improve vaccination rates, which is a significant advantage in public health [1] - The vaccine is currently in the clinical trial phase, highlighting ongoing research and development efforts in the biotechnology sector [1]
长春高新(000661) - 关于子公司吸附无细胞百白破b型流感嗜血杆菌联合疫苗临床试验申请获得批准的公告
2025-10-09 11:45
证券代码:000661 证券简称:长春高新 公告编号:2025-133 长春高新技术产业(集团)股份有限公司 关于子公司吸附无细胞百白破 b 型流感嗜血杆菌联合疫苗 受理号:CXSL2500582 通知书编号:2025LP02637 药品名称:吸附无细胞百白破 b 型流感嗜血杆菌联合疫苗 结论:建议批准开展用于预防百日咳、白喉、破伤风和 b 型流感嗜血杆菌引起 的侵袭性感染(包括脑膜炎、肺炎、败血症、蜂窝组织炎、关节炎、会厌炎等)的 临床试验。 批准日期:2025 年 10 月 9 日 二、吸附无细胞百白破 b 型流感嗜血杆菌联合疫苗的简介 联合疫苗具有"一剂多防"的优势,可减少接种次数、降低接种成本,提升疫 苗接种覆盖率。因其符合公共卫生需求和免疫接种的发展趋势,正成为国内疫苗发 展的重要方向。 本次百克生物获批临床的吸附无细胞百白破 b 型流感嗜血杆菌联合疫苗(以下 简称"百白破-Hib 联合疫苗")是一种可以同时预防百日咳、白喉、破伤风以及 b 型流感嗜血杆菌的疫苗。接种对象为 2 月龄及以上婴幼儿,接种后可刺激机体产生 免疫应答,用于预防百日咳、白喉、破伤风和 b 型流感嗜血杆菌引起的侵袭性感染。 临 ...
长春高新:子公司百克生物吸附无细胞百白破b型流感嗜血杆菌联合疫苗临床试验申请获得批准
Xin Lang Cai Jing· 2025-10-09 11:40
Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of an adsorbed acellular combined vaccine for whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b [1] Group 1 - The approved vaccine aims to prevent infections caused by whooping cough, diphtheria, tetanus, and Haemophilus influenzae type b [1] - Currently, there are no approved adsorbed acellular combined vaccines from domestic manufacturers in the market [1]
长春高新:子公司百克生物获批吸附无细胞百白破b型流感嗜血杆菌联合疫苗临床试验
Xin Lang Cai Jing· 2025-10-09 11:33
Core Viewpoint - Changchun High-tech announced that its subsidiary, Baike Biological, has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its acellular combined vaccine for whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b [1] Group 1: Product Development - The vaccine is intended to prevent whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b [1] - Baike Biological's acellular combined vaccine (three-component) and lyophilized Haemophilus influenzae type b conjugate vaccine (Hib vaccine) are the foundation and core of the combined vaccine [1] Group 2: Business Impact - The approval will help enhance the company's combined vaccine research and development pipeline and optimize its product structure [1] - This development is expected to create new growth points for the company's performance [1] - However, there is uncertainty regarding the subsequent clinical trial process, and it will not have a significant impact on the company's recent performance [1]
长春高新(000661) - 关于回购股份进展情况的公告
2025-10-09 11:33
证券代码:000661 证券简称:长春高新 公告编号:2025-132 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.cnin fo.com.cn)上分别披露的《关于公司回购股份方案暨取得金融机构股票回购专 项贷款的公告》(公告编号 ...
10月9日生物经济(970038)指数涨0.61%,成份股深科技(000021)领涨
Sou Hu Cai Jing· 2025-10-09 11:29
Core Points - The Bioeconomy Index (970038) closed at 2386.01 points, up 0.61%, with a trading volume of 28.528 billion yuan and a turnover rate of 1.76% [1] - Among the index constituents, 32 stocks rose while 18 fell, with Deep Technology leading the gainers at 10.01% and Xinlitai leading the decliners at 3.96% [1] Index Constituents Summary - Major constituents of the Bioeconomy Index include: - Mindray Medical (13.81% weight) at 248.24 yuan, up 1.04% [1] - Changchun High-tech (5.41% weight) at 129.25 yuan, down 0.58% [1] - Kanglong Chemical (4.66% weight) at 35.30 yuan, down 1.26% [1] - Deep Technology (4.08% weight) at 30.66 yuan, up 10.01% [1] Capital Flow Analysis - The Bioeconomy Index constituents experienced a net outflow of 224 million yuan from main funds, while retail investors saw a net inflow of 207 million yuan [3] - Notable capital flows include: - Deep Technology with a main fund net inflow of 28.4 million yuan [3] - Mindray Medical with a main fund net inflow of 80.8494 million yuan [3] - Other companies like Boteng Co. and Zhifei Biological also showed varying net inflows and outflows [3]
生长激素风光不再的长春高新计划港股二次上市
Xin Lang Cai Jing· 2025-10-09 09:02
Core Viewpoint - Changchun High-tech aims to enhance its international presence and innovation capabilities by issuing H-shares for listing on the Hong Kong Stock Exchange, with funds primarily allocated for R&D, clinical trials, and international market expansion [1][3]. Fundraising Purpose - The funds raised will be used for two main directions: advancing the innovation pipeline, including clinical trials and regulatory affairs, and establishing a commercial team overseas for global collaboration and market expansion [1][3]. Financial Performance - Since 2022, Changchun High-tech's stock price has experienced significant fluctuations due to rumors surrounding the centralized procurement of growth hormones, culminating in a decline in both revenue and net profit for the first time in nearly two decades in 2024 [3]. Innovation Pipeline - The company has over 40 projects in clinical stages or IND applications, including 11 Class I innovative biological agents and 4 Class I innovative chemical drugs, focusing on endocrine and metabolic diseases, women's health, immune and respiratory systems, and oncology [3][4]. Key Products - GenSci134, a long-acting growth hormone, is currently undergoing Phase I clinical trials for adult growth hormone deficiency and has received IND approval for pediatric growth hormone deficiency and idiopathic short stature [4][5]. - GenSci074, an NK3R antagonist for treating vasomotor symptoms in menopausal women, is in Phase II clinical trials, with competition from other drugs in the same category [7][8]. Oncology Pipeline - The company is developing several innovative drugs targeting prostate, breast, and ovarian cancers, including GenSci139, GenSci140, and GenSci143, which are expected to enter Phase I clinical trials by Q4 2025 [10][11]. - GenSci139 targets low-expressing HER2 tumors and faces a competitive landscape with existing ADC therapies [11][12]. - GenSci140 aims to expand patient coverage for FRα-positive cancers and is the only FRα dual-target ADC in development in China [13][14]. - GenSci143 targets both B7-H3 and PSMA antigens, potentially offering broader patient coverage but is still in early development stages [15]. Other Therapeutic Areas - GenSci098 is a TSHR antagonist for treating thyroid-associated ophthalmopathy, indicating the company's diversification into immune and respiratory diseases [16].
国泰海通医药2025年10月月报:景气延续,继续推荐创新药械产业链-20251009
Investment Rating - The report maintains an "Overweight" rating for the industry [3] Core Viewpoints - The report continues to recommend innovative pharmaceuticals and medical devices along the industry chain [2][7] - The performance of the pharmaceutical sector in September 2025 was weaker than the broader market, with the SW Pharmaceutical Biotech index declining by 1.7% compared to a 0.6% increase in the Shanghai Composite Index [16][22] - The report highlights that the medical service sub-sector performed relatively well, increasing by 1.8%, while medical devices and chemical preparations saw slight declines [22] Summary by Sections - **Investment Recommendations**: The report includes a list of A-share stocks with an "Overweight" rating, including Heng Rui Pharmaceutical, Kelun Pharmaceutical, East China Pharmaceutical, Changchun High-tech, Enhua Pharmaceutical, WuXi AppTec, Tigermed, Lepu Medical, United Imaging Healthcare, and Huatai Medical [7][9] - **Performance Analysis**: The report notes that the monthly portfolio of Guotai Junan Pharmaceuticals outperformed the pharmaceutical index in September 2025, with an average increase of 1.1% compared to a 0.7% increase in the overall pharmaceutical index [12][13] - **Market Comparison**: The report indicates that the pharmaceutical sector's premium level relative to all A-shares is currently at a normal level, with a relative premium rate of 77.5% as of the end of September 2025 [26][28]
港股IPO周报:长春高新等多家A股公司集中递表 西普尼挂牌首周暴涨逾4倍
Xin Lang Cai Jing· 2025-10-05 07:52
Summary of Key Points Core Viewpoint The article provides an overview of the recent activities in the Hong Kong stock market, highlighting the number of companies that have submitted listing applications, those that have passed the hearing process, and new stocks that have been listed. Group 1: Companies Submitting Listing Applications - A total of 30 companies submitted listing applications to the Hong Kong Stock Exchange during the week from September 29 to October 5 [1] - Notable companies include: - Yantai Lannacheng Biotechnology Co., Ltd., a clinical-stage biotech company focused on radiopharmaceuticals for cancer treatment, reported revenues of approximately 1.027 million RMB for 2023 and a loss of about 112 million RMB [2][3] - XGIMI Technology Co., Ltd., the world's largest consumer-grade projector brand by revenue, reported revenues of approximately 4.22 billion RMB for 2022 and a profit of about 501 million RMB [2][3] - WeDoctor Holdings Limited, a leading digital health service provider in China, reported revenues of 1.368 billion RMB for 2022 and a loss of 909 million RMB [4][5] - Puyuan Precision Electronics Co., Ltd., the largest electronic measurement instrument supplier in China, reported revenues of approximately 631 million RMB for 2022 and a profit of about 92.5 million RMB [5][6] - Shenzhen Huanchuang Technology Co., Ltd., a leader in high-precision spatial perception solutions, reported a market share of over 50% in the laser radar products for robotic vacuum cleaners [6] Group 2: Companies Passing Hearing Process - Four companies passed the listing hearing this week: - Jushuitan Group Co., Ltd., the largest e-commerce SaaS ERP provider in China, reported revenues of approximately 523 million RMB for 2022 and a loss of about 507 million RMB [30][31] - Fujian Haixi New Drug Creation Co., Ltd., a commercial-stage pharmaceutical company, reported revenues of approximately 212 million RMB for 2022 and a profit of about 69 million RMB [30][31] - Beijing Tongrentang Medical Investment Co., Ltd., the largest non-public Chinese hospital group by market share, reported revenues of approximately 911 million RMB for 2022 and a loss of about 9.23 million RMB [32] - Beijing Yunji Technology Co., Ltd., a robotics service provider, reported revenues of approximately 161 million RMB for 2022 and a loss of about 365 million RMB [32][33] Group 3: New Stocks Listed - Three new stocks were listed on September 30: - Zijin Gold International, which saw a significant increase in market value, surpassing 350 billion HKD [35] - Xipuni, which had an oversubscription rate of 2505.9 times during its public offering [35] - Botai Che Lian, which also experienced a notable increase in stock price [35]
激素茅冲击A+H上市,市值5年缩水1570亿元
Core Viewpoint - Changchun High-tech is accelerating its plan for a Hong Kong IPO to seek new opportunities amid a significant decline in performance, marking the start of its "A+H" dual-platform listing journey [2][13]. Financial Performance - The company's market value has shrunk by approximately 157 billion RMB over five years, from over 210 billion RMB in May 2021 to 53 billion RMB as of September 30, 2025 [4]. - Revenue projections for 2022 to 2024 are approximately 12.63 billion RMB, 14.57 billion RMB, and 13.47 billion RMB, with net profits of 4.21 billion RMB, 4.78 billion RMB, and 2.71 billion RMB respectively. The first half of 2025 saw a revenue of 6.60 billion RMB and a net profit of 932 million RMB [5]. - Notably, revenue is expected to decline by 7.55% year-on-year in 2024, with net profit dropping by 43.01%. The mid-2025 net profit is projected to decrease by 42.85% year-on-year [5]. Market Challenges - The primary issue facing Changchun High-tech is performance volatility, largely due to over-reliance on growth hormone products [6][7]. - The introduction of centralized procurement policies has led to price reductions for growth hormone products, significantly impacting revenue [7]. - The growth hormone market in China has seen rapid expansion, growing from 4 billion RMB in 2018 to 11.6 billion RMB in 2023, with a compound annual growth rate of 23.9% [7][8]. Competitive Landscape - Changchun High-tech holds a 74% market share in the growth hormone sector, but faces increasing competition, particularly from long-acting growth hormone products, which are gaining market share at over 50% annually [8]. - The company’s vaccine business has also faced setbacks, with a 39.96% decline in revenue year-on-year for the first quarter of 2025 [9]. Strategic Moves - The company is pursuing a Hong Kong listing as a critical step in its internationalization strategy, aiming to enhance its funding for research and development, improve brand influence, and optimize shareholder structure [2][13]. - As of September, around 20 companies are planning to list in Hong Kong, indicating a growing trend among biopharmaceutical firms [12][14]. Future Outlook - The success of the Hong Kong IPO is seen as vital for transitioning from a regional leader to a global biopharmaceutical platform, with immediate benefits in financing and brand empowerment [16]. - However, the long-term value will depend on the company's ability to deliver on its product pipeline and expand into international markets [16].