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百利天恒将延迟H股全球发售及上市;北大医药董事长已被批准逮捕 | 健讯Daily
Healthcare Policy - National Healthcare Security Administration held a series of discussions on the adjustment of the disease-based payment grouping scheme 3.0, involving over 70 representatives from medical institutions and industry associations [1] Drug and Medical Device Approvals - Shijiazhuang Pharmaceutical Group's application for the listing of Pertuzumab injection has been accepted by the National Medical Products Administration, targeting HER2-positive breast cancer [1] - Huason Pharmaceutical received a registration certificate for its special medical purpose formula food, Ganyimei®, designed for patients over 10 years old with strict fat restrictions and digestive absorption disorders [2] - United Imaging Healthcare's subsidiary obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system, enhancing its product range across various market segments [3] - Yiling Pharmaceutical's application for the listing of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, has been approved [4] - Zhifei Biological's clinical trial application for a freeze-dried varicella inactivated vaccine has been accepted by the National Medical Products Administration [10] - Changchun High-tech's subsidiary received approval for a clinical trial of an acellular pertussis-diphtheria-tetanus combined vaccine for adolescents and adults [11] Capital Market Activities - Peking University Pharmaceutical announced the release of 34,615,386 shares from pledge, representing 51.52% of the pledged shares and 5.81% of the total share capital [5] - Kelun Pharmaceutical received approval for a registration of 4 billion yuan in ultra-short-term financing bonds, with a validity period of 2 years [6][7] - Baili Tianheng decided to delay its global offering and listing of H-shares due to current market conditions [8] - Aipeng Medical announced a plan for a shareholder to reduce holdings by up to 1% of total shares, citing personal funding needs [12] - Hendi Pharmaceutical's shareholders plan to collectively reduce their holdings by up to 2.33% of total shares for personal financial planning [13] Financial Adjustments - Baihua Pharmaceutical plans to use 1.91 billion yuan from its capital reserve to cover losses, primarily due to goodwill impairment from a previous major asset restructuring [14]
长春高新:关于子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准的公告
证券日报网讯 11月12日晚间,长春高新发布公告称,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")收到国家药品监督 管理局对其吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知 书》。 (编辑 楚丽君) ...
11月12日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-12 10:24
Group 1 - Longjian Co., Ltd. won a bid for a highway maintenance project in Heilongjiang with a contract value of 483 million yuan, accounting for 2.64% of the company's expected revenue for 2024 [1] - Transsion Holdings plans to issue H-shares and list on the main board of the Hong Kong Stock Exchange [1] - Good Home's controlling shareholder intends to reduce its stake by up to 2.7%, equivalent to no more than 39.4468 million shares [1][2] Group 2 - Xinhua Insurance reported a cumulative premium income of 181.973 billion yuan from January to October, representing a year-on-year growth of 17% [2][4] - Zhejiang Jiaokao is part of a consortium that plans to bid for a new urbanization project with an estimated total investment of 11.103 billion yuan [4] Group 3 - Changchun High-tech received approval for clinical trials of a vaccine for adolescents and adults [6] - XinNuoWei's application for the listing of Pertuzumab injection has been accepted, targeting HER2-positive breast cancer [8] - Dash Smart won a bid for an intelligent project at the new Huanggang Port inspection building, valued at 55.056 million yuan, which is 1.74% of its expected revenue for 2024 [8] Group 4 - Electronic City is involved in a lawsuit for debt recovery, with the amount in dispute estimated at 777 million yuan [9] - Haibo Technology signed a strategic cooperation agreement with CATL for a cumulative procurement of no less than 200 GWh of electricity from 2026 to 2028 [10] Group 5 - Renfu Pharmaceutical's HW231019 tablets have entered the second phase of clinical trials for postoperative pain relief [11] - Tonghua Dongbao received a drug registration certificate for Aspart Insulin injection from the Dominican Republic [11] Group 6 - Shaanxi Construction reported winning major projects worth a total of 1.016 billion yuan in October [12] - Fuzhou Environmental Protection plans to change its stock name to "Fuzhou Technology" [12] Group 7 - Panlong Pharmaceutical's gel patch for knee osteoarthritis has received approval for clinical trials [15] - Zhongyida's application for a specific stock issuance has been terminated by the Shanghai Stock Exchange [16] Group 8 - Zhizhong Home's controlling shareholder reduced its holdings of convertible bonds by 905,000 units, accounting for 13.51% of the total issued [19] - Haibo Co., Ltd. plans to establish a subsidiary with an investment of 1 billion yuan for high-end component projects [21] Group 9 - Caina Co. plans to use 57 million yuan of idle funds to purchase structured deposits [23] - Zhendong Pharmaceutical's new drug for acute ischemic stroke has entered the IIa phase of clinical trials [25] Group 10 - Weiman Sealing's overseas subsidiary plans to lease a factory in Saudi Arabia for 5 years at a total rent of approximately 54.039 million yuan [26] - Yiling Pharmaceutical's application for Memantine Hydrochloride has been approved for market entry [28] Group 11 - Dongfang Zhizao plans to acquire 70% of Saifu Machinery for 27.4887 million yuan [30] - JianKai Technology's actual controller intends to transfer 3% of the company's shares through inquiry [31] Group 12 - Rejing Bio plans to repurchase shares worth between 100 million and 200 million yuan [32] - Bangji Technology has decided to terminate a major asset restructuring project due to failure to reach an agreement [34] Group 13 - Huadong Pharmaceutical's application for the marketing license of a new drug has been accepted [36] - Zhonggu Logistics' shareholder plans to reduce its stake by up to 3% [38] Group 14 - Bohui Innovation's subsidiary received approval for a clinical trial of a vaccine for invasive infections [40] - Shannon Chip's shareholder pledged 0.27% of the company's shares for financing [42] Group 15 - Shanghai Petrochemical appointed a new general manager [44] - Jiaojian Co. plans to reduce the holdings of some directors and executives by up to 0.35% [46] Group 16 - Weiting Electric plans to raise no more than 300 million yuan through a private placement [47] - Zhongjin Irradiation plans to invest approximately 200 million yuan in an electronic accelerator manufacturing project [49] Group 17 - Tongxing Technology signed a framework agreement to invest 3.2 billion yuan in a sodium battery project [50] - Hongri Da plans to establish a subsidiary focused on semiconductor packaging [51] Group 18 - Shanghai Kaibao's new drug for acute ischemic stroke has received approval for clinical trials [53] - Yitong Century announced a change in its control structure, becoming a company without a controlling shareholder [55]
长春高新:子公司百克生物吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Ge Long Hui A P P· 2025-11-12 09:13
格隆汇11月12日|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对其吸 附无细胞百(二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知书》。该疫苗是一种可 以同时预防青少年及成人百日咳、白喉、破伤风的疫苗,接种对象为10周岁及以上人群。若该疫苗顺利 完成临床试验并获批上市,将进一步完善公司疫苗研发管线,丰富公司联合疫苗产品矩阵,有助于公司 优化产品结构和主营业务的全面发展。 ...
长春高新(000661.SZ):子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Ge Long Hui A P P· 2025-11-12 09:13
本次百克生物获批临床的吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)(以下简称"青少 年及成人百白破疫苗")是一种可以同时预防青少年及成人百日咳、白喉、破伤风的疫苗。接种对象为 10周岁及以上人群,接种后可刺激机体产生免疫应答,用于预防百日咳、白喉、破伤风引起的侵袭性感 染。 格隆汇11月12日丨长春高新(000661.SZ)公布,公司子公司百克生物收到国家药监局对其吸附无细胞百 (二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知书》。 近年来,国内外青少年和成人的百日咳发病率呈现上升趋势,针对这一现象,国外开始应用青少年及成 人接种的百白破疫苗,预防控制该传染病的发生,并普遍推荐青少年和成人每10年接种一次。我国目前 的百日咳、白喉、破伤风的免疫规划主要在婴幼儿阶段,尚未批准用于青少年及成人的百白破疫苗。 若本次获批的青少年及成人百白破疫苗顺利完成临床试验,并获批上市,将进一步完善公司疫苗研发管 线,丰富公司联合疫苗产品矩阵,有助于公司优化产品结构和主营业务的全面发展,为公众提供更为高 质量的疫苗接种选择,为公司业绩创造新的增长点。 目前我国使用的国产百白破疫苗仍为共纯化工艺,而发达国家 ...
长春高新:子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Ge Long Hui· 2025-11-12 09:07
格隆汇11月12日丨长春高新(000661.SZ)公布,公司子公司百克生物收到国家药监局对其吸附无细胞百 (二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知书》。 本次百克生物获批临床的吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)(以下简称"青少 年及成人百白破疫苗")是一种可以同时预防青少年及成人百日咳、白喉、破伤风的疫苗。接种对象为 10周岁及以上人群,接种后可刺激机体产生免疫应答,用于预防百日咳、白喉、破伤风引起的侵袭性感 染。 若本次获批的青少年及成人百白破疫苗顺利完成临床试验,并获批上市,将进一步完善公司疫苗研发管 线,丰富公司联合疫苗产品矩阵,有助于公司优化产品结构和主营业务的全面发展,为公众提供更为高 质量的疫苗接种选择,为公司业绩创造新的增长点。 近年来,国内外青少年和成人的百日咳发病率呈现上升趋势,针对这一现象,国外开始应用青少年及成 人接种的百白破疫苗,预防控制该传染病的发生,并普遍推荐青少年和成人每10年接种一次。我国目前 的百日咳、白喉、破伤风的免疫规划主要在婴幼儿阶段,尚未批准用于青少年及成人的百白破疫苗。 目前我国使用的国产百白破疫苗仍为共纯化工艺,而发达国家 ...
长春高新:子公司百克生物吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Xin Lang Cai Jing· 2025-11-12 09:05
【长春高新:子公司百克生物吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请 获得批准】智通财经11月12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 督管理局对其吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知 书》。该疫苗是一种可以同时预防青少年及成人百日咳、白喉、破伤风的疫苗,接种对象为10周岁及以 上人群。若该疫苗顺利完成临床试验并获批上市,将进一步完善公司疫苗研发管线,丰富公司联合疫苗 产品矩阵,有助于公司优化产品结构和主营业务的全面发展。 转自:智通财经 ...
长春高新(000661) - 关于子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准的公告
2025-11-12 09:01
证券代码:000661 证券简称:长春高新 公告编号:2025-144 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(二组分)白破联合疫苗(成人及青少年用) 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 ——长春百克生物科技股份公司(以下简称"百克生物")收到国家药品监督管理 局对其吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)的《药物临床试 验批准通知书》。现将相关情况公告如下: 一、《药物临床试验批准通知书》的主要信息 受理号:CXSL2500724 通知书编号:2025LP02992 药品名称:吸附无细胞百(二组分)白破联合疫苗(成人及青少年用) 结论:建议批准开展预防百日咳、白喉、破伤风的临床试验。 批准日期:2025 年 11 月 11 日 二、吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)的简介 本次百克生物获批临床的吸附无细胞百(二组分)白破联合疫苗(成人及青少 年用)(以下简称"青少年及成人百白破疫苗")是一种可以同时 ...
长春高新:子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验获批
Xin Lang Cai Jing· 2025-11-12 08:59
长春高新11月12日公告,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(二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知书》,建议批准开展预防 百日咳、白喉、破伤风的临床试验。 ...
医药行业周报:本周申万医药生物指数下跌2.4%,关注医保谈判结果-20251109
Investment Rating - The report maintains a positive outlook on the innovative pharmaceutical sector, indicating a preference for companies within this space due to their strong performance and growth potential [3][10]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.4% this week, ranking 29th among 31 sub-industries [4][6]. - The overall valuation of the pharmaceutical sector stands at 30.1 times earnings, placing it 10th among 31 primary industries [6][14]. - The report highlights the successful conclusion of the 2025 National Basic Medical Insurance Drug List negotiations, with 120 companies participating [10]. - The implementation of AI in healthcare is emphasized, with a goal for widespread adoption by 2030 [11]. - Notable performance in the third quarter was observed among weight-loss drug manufacturers, with Eli Lilly reporting a 125% increase in sales for its drug, totaling $24.837 billion [3][17]. Market Performance - The pharmaceutical sector's index fell by 2.4% this week, while the Shanghai Composite Index rose by 1.1% [4][6]. - Among the sub-sectors, chemical preparations saw a decline of 4.4%, while traditional Chinese medicine increased by 0.8% [6][10]. Recent Key Events - The report notes the collaboration between Eli Lilly and NVIDIA to develop a supercomputer for drug discovery [15]. - Manifold Bio's partnership with Roche aims to create new blood-brain barrier drugs, with a total deal value exceeding $2 billion [16]. - Pfizer's acquisition of Metsera for up to $8.625 billion focuses on obesity treatments [17]. Company Performance - The report summarizes the third-quarter performance of major pharmaceutical companies, with Eli Lilly achieving a 54% year-over-year revenue increase [18][19]. - Notable companies include Merck, which reported a 4% increase, and Pfizer, which experienced a 6% decline in revenue [18][19]. Investment Recommendations - The report recommends focusing on innovative drug sectors, medical devices, and AI healthcare applications, highlighting companies such as Hengrui Medicine, Mindray Medical, and WuXi AppTec [3][10].