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康泰生物:三价流感病毒裂解疫苗获药物临床试验批准
Xin Lang Cai Jing· 2025-08-18 08:12
Core Viewpoint - The company has received approval from the National Medical Products Administration for a trivalent influenza virus split vaccine developed in collaboration with Lanzhou Bailing Biotechnology Co., which is intended for individuals aged 3 and above [1] Group 1: Vaccine Development - The trivalent influenza vaccine is designed to stimulate the immune system to produce antibodies against influenza viruses, thereby preventing influenza caused by vaccine-related strains [1] - The company plans to initiate clinical trials for the vaccine as soon as possible [1] Group 2: Strategic Implications - Successful development of the vaccine will enhance the company's product portfolio, strengthening its core competitiveness and market position [1]
康泰生物(300601) - 三价流感病毒裂解疫苗(MDCK细胞)药物临床试验批准通知书2025LP02063
2025-08-18 08:02
CXSL2500428 2025LP02063 深圳康泰生物制品股份有限公司;兰州百灵生物技术有限公司: 根据《中华人民共和国药品管理法》、《中华人民共和国疫苗管理法》及有关规定,经审查,2025年05月28日受理的三价 流感病毒裂解疫苗(MDCK细胞)符合药品注册的有关要求,同意在3岁及以上人群中开展预防疫苗相关型别流感病毒引起 的流行性感冒的临床试验。 申请人提交的临床试验方案名称: 1.评价三价流感病毒裂解疫苗(MDCK细胞)在3周岁及以上人群中接种的安全性和初步免疫原性的随机、盲法、阳性对照 Ⅰ期临床试验(版本号:0.1,版本日期:2025年05月08日) 2.评价三价流感病毒裂解疫苗(MDCK细胞)在3周岁及以上人群中接种的免疫原性和安全性的随机、盲法、阳性对照Ⅲ期 临床试验(版本号:0.1,版本日期:2025年05月08日) 关注以下内容: (一)临床试验开展前,完成以下工作。 1.本品3批成品及各型别原液(各3批)经中检院检定合格后方可开展临床试验。 2.请完善半成品配制工艺研究,严格按照固定的配制点进行配制。临床试验样品应采用完善后的工艺配制,且相关制品安 全性风险不得高于毒理批。后续商业化批 ...
康泰生物(300601) - 关于三价流感病毒裂解疫苗(MDCK细胞)获得药物临床试验批准通知书的公告
2025-08-18 08:02
债券代码:123119 债券简称:康泰转 2 证券代码:300601 证券简称:康泰生物 公告编号:2025-061 深圳康泰生物制品股份有限公司 关于三价流感病毒裂解疫苗(MDCK 细胞) 获得药物临床试验批准通知书的公告 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。 深圳康泰生物制品股份有限公司(以下简称"公司")和兰州百灵生物技术 有限公司研发的三价流感病毒裂解疫苗(MDCK细胞)近日获得国家药品监督管理 局出具的《药物临床试验批准通知书》,根据《中华人民共和国药品管理法》《中 华人民共和国疫苗管理法》及有关规定,经审查,本品符合药品注册的有关要求, 同意本品进行临床试验。现将相关情况公告如下: 公司将根据药物临床试验批准通知书的要求,尽快开展相关临床试验工作。 该文件有效期为获得批准之日起 3 年,3 年内未有受试者签署知情同意书的,通 知书自行失效。 本次获得药物临床试验批准通知书的三价流感病毒裂解疫苗(MDCK 细胞) 适用于 3 周岁及以上人群,可刺激机体产生抗流感病毒的免疫力,用于预防疫苗 相关型别的流感病毒引起的流行性感冒。流行性感冒(也称 ...
生物制品板块8月14日跌1.1%,康泰生物领跌,主力资金净流出8.83亿元
证券之星消息,8月14日生物制品板块较上一交易日下跌1.1%,康泰生物领跌。当日上证指数报收于 3666.44,下跌0.46%。深证成指报收于11451.43,下跌0.87%。生物制品板块个股涨跌见下表: | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 688331 | 荣昌生物 | 73.78 | 8.20% | 18.87万 | | 13.90 Z | | 688520 | 神州细胞 | 68.45 | 5.21% | 17.34万 | | 11.98亿 | | 603590 | 康辰药业 | 57.61 | 4.20% | 0 9.00万 | | 5.24亿 | | 002773 | 康弘药业 | 46.13 | 3.69% | 10.20万 | | 4.67亿 | | 616889 | 欧林生物 | 24.30 | 1.17% | 14.58万 | | 3.52亿 | | 688488 | 艾迪药业 | 16.80 | 0.90% | 20.46万 | | 3.45亿 | ...
上市药企2023年业绩预喜成主基调
Xin Hua Wang· 2025-08-12 05:47
Core Insights - Over 90 A-share listed pharmaceutical companies have released their 2023 performance forecasts, with a predominant trend of positive expectations, as 64 out of 92 companies anticipate year-on-year net profit growth [1] - The recovery of the market and accelerated overseas sales are significant factors contributing to the performance increase of many pharmaceutical companies in 2023 [1] - The pharmaceutical industry is expected to maintain substantial potential and momentum in the long term, driven by an aging population and improvements in domestic production, investment, and research capabilities [1] Performance Forecasts - 22 pharmaceutical companies forecasted a doubling of net profits for 2023, with notable mentions including Purui Eye Hospital and Kangtai Biological, which expect net profit increases exceeding 500% [2] - Purui Eye Hospital anticipates a net profit of 260 million to 285 million yuan, representing a year-on-year growth of 1163.98% to 1285.51%, driven by a recovery in consumer demand and a surge in patient needs for eye health [2] - Kangtai Biological expects a net profit increase of 815.86%, with a focus on optimizing marketing networks and achieving at least a 16% growth in conventional vaccine sales [2] Sector Performance - Blood product companies, including Weiguang Biological, are also experiencing strong demand, with expected net profit growth of 69% to 111% [3] - Other biological product companies like Baike Biological and Jiukang Biological are also forecasting revenue and net profit increases [4] International Expansion - Many high-quality domestic pharmaceutical companies are now competitive globally, with overseas markets offering significant growth opportunities [5] - Huatai Medical, a cardiac electrophysiology and interventional medical device company, expects a net profit of 510 million to 565 million yuan, with overseas business growth exceeding 90% in the last quarter [6] - Kangtai Biological is actively expanding its overseas market presence, having achieved significant milestones in vaccine cooperation with countries along the Belt and Road Initiative [7] - The collaboration between domestic innovative drug companies and multinational firms is enhancing revenue and reducing losses, as seen with Kelun Pharmaceutical's partnership with Merck [7]
康泰生物实控人前妻完成减持1103.2万股 套现1.92亿元
Zhong Guo Jing Ji Wang· 2025-08-07 07:32
Core Viewpoint - The announcement from Kangtai Biological indicates the completion of a share reduction plan by its controlling shareholder's concerted actor, Yuan Liping, who has reduced her holdings significantly within the specified period [1][2]. Group 1: Share Reduction Details - Yuan Liping completed her share reduction plan by selling 11,031,942 shares from July 23, 2025, to August 6, 2025, at an average price of 17.44 yuan per share, totaling approximately 1.92 billion yuan [1][2]. - The remaining shares of 128,058 will not be further reduced [1]. - The reduction represents 0.99% of the company's total share capital [2]. Group 2: Background Information - Yuan Liping is a concerted actor of the company's controlling shareholder and actual controller, Du Weimin, and is a Canadian citizen [2]. - The company had previously announced a share reduction plan on July 1, 2025, allowing for a maximum reduction of 11,160,000 shares, which is 1.00% of the total share capital [3]. - Kangtai Biological raised 3 billion yuan through a non-public offering of shares in 2020, with the share price set at 110 yuan, which is currently below the market price [3]. Group 3: Fundraising Activities - In 2021, Kangtai Biological issued 20 million convertible bonds with a total fundraising amount of 2 billion yuan, netting approximately 1.99 billion yuan after expenses [4]. - Over the past five years, the company has raised a total of 5 billion yuan [4].
康泰生物股价下跌2.17% 控股股东一致行动人完成减持计划
Jin Rong Jie· 2025-08-06 18:56
Core Viewpoint - The stock price of Kangtai Biological fell by 2.17% to 17.56 yuan on August 6, 2025, with a trading volume of 226,069 hands and a transaction amount of 399 million yuan [1] Company Overview - Kangtai Biological specializes in the research, production, and sales of human vaccines, with key products including recombinant hepatitis B vaccine and Haemophilus influenzae type b conjugate vaccine [1] - The company is located in Shenzhen, Guangdong Province, and operates within the biopharmaceutical industry [1] Shareholder Activity - The controlling shareholder's concerted actor, Yuan Liping, reduced her holdings by 11,031,900 shares from July 23 to August 6, 2025, accounting for 0.99% of the total share capital, with an average reduction price of 17.44 yuan per share [1] - After the completion of this reduction plan, Yuan Liping retains 17.07% of the company's shares [1] Financial Performance - In the first quarter of 2025, the company reported operating revenue of 645 million yuan and a net profit attributable to the parent company of 22.43 million yuan [1] Capital Flow - On August 6, 2025, the net outflow of main funds was 79.20 million yuan, with a cumulative net outflow of 120.56 million yuan over the past five days [1]
康泰生物(300601) - 关于控股股东的一致行动人减持计划实施完成的公告
2025-08-06 09:46
债券代码:123119 债券简称:康泰转 2 证券代码:300601 证券简称:康泰生物 公告编号:2025-060 深圳康泰生物制品股份有限公司 关于控股股东的一致行动人减持计划实施完成的公告 公司股东袁莉萍女士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。 公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 深圳康泰生物制品股份有限公司(以下简称"公司")于 2025 年 7 月 1 日披 露了《关于控股股东、实际控制人的一致行动人减持计划预披露的公告》(公告编 号:2025-055),袁莉萍女士计划自公告披露之日起十五个交易日后的三个月内(法 律法规、规范性文件规定不得进行减持的时间除外),以集中竞价或大宗交易方式 减持公司股份不超过 11,160,000 股(即不超过公司总股本比例 1.00%)。本次减 持计划的实施不会影响公司的治理结构和持续经营,不会导致公司控制权发生变化。 公司于今日收到袁莉萍女士出具的《关于股份减持计划实施完成的告知函》, 截至 2025 年 8 月 6 日,袁莉萍女士的减持计划已实施完成,减持计划内剩余的 128,058 股不再减持, ...
康泰生物(300601)8月1日主力资金净流入1626.38万元
Sou Hu Cai Jing· 2025-08-01 10:17
Group 1 - The core viewpoint of the news is that Kangtai Biological has shown a significant increase in revenue but a notable decrease in net profit in its latest quarterly report [1] - As of August 1, 2025, Kangtai Biological's stock closed at 17.59 yuan, with a trading volume of 258,200 hands and a transaction amount of 458 million yuan [1] - The company experienced a net inflow of main funds amounting to 16.26 million yuan, representing 3.55% of the transaction amount, with large orders contributing significantly to this inflow [1] Group 2 - For the first quarter of 2025, Kangtai Biological reported total operating revenue of 645 million yuan, a year-on-year increase of 42.85%, while net profit attributable to shareholders decreased by 58.51% to 22.43 million yuan [1] - The company's non-recurring net profit was 16.91 million yuan, reflecting a year-on-year growth of 17.56% [1] - Financial ratios indicate a current ratio of 2.677, a quick ratio of 2.365, and a debt-to-asset ratio of 32.07% [1] Group 3 - Kangtai Biological, established in 1992 and located in Shenzhen, primarily engages in the pharmaceutical manufacturing industry [2] - The company has made investments in six enterprises and participated in 1,088 bidding projects [2] - Kangtai Biological holds 13 trademark registrations and 57 patents, along with 418 administrative licenses [2]
康泰生物实控人前妻6天再套现0.98亿 8天前套现0.74亿
Zhong Guo Jing Ji Wang· 2025-08-01 03:18
中国经济网北京8月1日讯康泰生物(300601)(300601.SZ)昨日晚间披露《关于控股股东及其一致行动 人权益变动触及1%刻度的公告》。 根据公告,公司于2025年7月1日披露了《关于控股股东、实际控制人的一致行动人减持计划预披露的公 告》,袁莉萍计划自公告披露之日起十五个交易日后的三个月内,以集中竞价或大宗交易方式减持公司 股份不超过11,160,000股(即不超过公司总股本比例1.00%)。截至2025年7月30日累计减持9,832,364股, 占公司总股本的0.88%。 2025年7月25日至2025年7月30日,袁莉萍通过集中竞价交易方式减持股份5,524,460股,致使公司控股股 东、实际控制人及其一致行动人合计持有公司股份由530,121,967股变为524,597,507股,合计持股比例由 47.46%下降至46.97%。根据减持均价17.67元/股计算,套现总金额约97,617,208.2元。 7月25日,康泰生物披露《关于控股股东、实际控制人的一致行动人权益变动触及1%刻度的公告》。公 告显示,截至2025年7月24日,袁莉萍通过集中竞价交易方式减持股份4,307,904股,占公司总股 ...