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长春高新: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
Di Yi Cai Jing· 2025-10-09 12:07
长春高新公告,公司子公司长春百克生物科技股份公司收到国家药品监督管理局对其吸附无细胞百白破 b型流感嗜血杆菌联合疫苗下发的《药物临床试验批准通知书》。百克生物本次获批的百白破-Hib联合 疫苗中的Hib疫苗为冻干剂型,与液体剂型的百白破疫苗(三组分)联合使用,相比分别使用百白破疫 苗和Hib疫苗,减少了注射次数,从而提高婴幼儿接种的依从性。 ...
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
南财智讯10月9日电,长春高新公告,长春百克生物科技股份公司收到国家药品监督管理局对其吸附无 细胞百白破b型流感嗜血杆菌联合疫苗下发的《药物临床试验批准通知书》,批准其开展用于预防百日 咳、白喉、破伤风和b型流感嗜血杆菌引起的侵袭性感染的临床试验。该联合疫苗具有减少接种次数、 提高接种率的优势,目前正处于临床试验阶段。 ...
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
【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】智 通财经10月9日电,长春高新(000661.SZ)公告称,公司子公司百克生物收到国家药品监督管理局批准的 《药物临床试验批准通知书》,同意开展吸附无细胞百白破b型流感嗜血杆菌联合疫苗的临床试验。该 疫苗可预防百日咳、白喉、破伤风和b型流感嗜血杆菌引起的侵袭性感染。目前国内厂家暂无吸附无细 胞百白破(组分)联合疫苗的产品获批上市。 转自:智通财经 ...
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
长春高新公告,子公司百克生物近日收到国家药品监督管理局对其吸附无细胞百白破b型流感嗜血杆菌 联合疫苗下发的《药物临床试验批准通知书》。该疫苗用于预防百日咳、白喉、破伤风和b型流感嗜血 杆菌引起的侵袭性感染。百克生物的吸附无细胞百白破疫苗(三组分)和冻干b型流感嗜血杆菌结合疫 苗(Hib疫苗)是百白破-Hib联合疫苗的基础和核心。此次获批将有助于完善公司联合疫苗研发管线, 优化产品结构,为公司业绩创造新的增长点。但后续临床试验的开展存在不确定性,对公司近期业绩不 会产生重大影响。 ...
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
证券之星消息,10月9日,生物经济(970038)指数报收于2386.01点,涨0.61%,成交285.28亿元,换手 率1.76%。当日该指数成份股中,上涨的有32家,深科技以10.01%的涨幅领涨,下跌的有18家,信立泰 以3.96%的跌幅领跌。 生物经济(970038)指数十大成份股详情如下: | 证券代码 | PARTIC A - 1 MACE I VERSE - 1 股票简称 | 权重 | 最新价 | 涨跌幅 | 总市值(亿元) | | | --- | --- | --- | --- | --- | --- | --- | | sz300760 | 迈瑞医疗 | 13.81% | 248.24 | 1.04% | | 3009.76 | | sz000661 | 长春高新 | 5.41% | 129.25 | -0.58% | | 527.26 | | sz300759 | 康龙化成 | 4.66% | 35.30 | -1.26% | | 627.70 | | sz002252 | 十肖史上 | 4.52% | 6.78 | 1.35% | | 450.06 | | sz300347 | 泰格医药 ...
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
景气延续,继续推荐创新药械产业链 [Table_Industry] 医药 ——国泰海通医药 2025 年 10 月月报 | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | | 郑琴(分析师) | 021-23219808 | zhengqin@gtht.com | S0880525040108 | | 谈嘉程(分析师) | 021-38038429 | tanjiacheng@gtht.com | S0880523070004 | 本报告导读: 相关赛道高景气延续,继续推荐创新药械及产业链。 投资要点: [Table_Invest] 评级: 增持 [Table_Report] 相关报告 医药《集采优化,持续看好创新药械产业链》 2025.09.21 医药《继续看好创新药械产业链》2025.09.14 医药《设备更新政策持续落地,医疗设备景气度 延续》2025.09.11 医药《景气延续,持续推荐创新药械产 ...
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]