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康恩贝:吸入用复方异丙托溴铵溶液获药品注册证书
Zheng Quan Shi Bao Wang· 2025-09-08 08:36
Group 1 - The core point of the article is that Kang En Bei has received approval from the National Medical Products Administration for its inhalation solution containing compound ipratropium bromide, which is intended for patients requiring multiple bronchodilators for the treatment of reversible bronchospasm related to obstructive airway diseases [1] - The product is expected to address a market demand, with projected sales in the domestic retail and medical terminal market amounting to 240 million yuan in 2024 [1]
康恩贝(600572) - 关于子公司吸入用复方异丙托溴铵溶液获得药品注册证书的公告
2025-09-08 08:30
证券简称:康恩贝 证券代码:600572 编号:2025-046 浙江康恩贝制药股份有限公司 关于子公司吸入用复方异丙托溴铵溶液 获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其 内容的真实性、准确性和完整性承担法律责任。 近日,浙江康恩贝制药股份有限公司(以下简称"公司")全资子公司浙江金华康恩 贝生物制药有限公司(以下简称"金华康恩贝")收到国家药品监督管理局(以下简称" 国家药监局")核准签发的吸入用复方异丙托溴铵溶液《药品注册证书》,现将相关情况公 告如下: 上市许可持有人:金华康恩贝 批准文号:国药准字 H20255282 证书编号:2025S02669 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品 注册的有关要求,批准注册,发给药品注册证书。 二、药品其他相关情况 吸入用复方异丙托溴铵溶液由勃林格殷格翰药业有限公司开发,于 1994 年 12 月在法 国首次获批上市,并于 1996 年和 1998 年分别在美国、德国上市。2006 年 10 月,商品名 为 Combivent®(可必特)的吸入用复方异丙托溴 ...
康恩贝:子公司吸入用复方异丙托溴铵溶液获得药品注册证书
Xin Lang Cai Jing· 2025-09-08 08:29
康恩贝9月8日公告,公司全资子公司浙江金华康恩贝生物制药有限公司获得国家药品监督管理局核准签 发的吸入用复方异丙托溴铵溶液《药品注册证书》。公司将积极安排该品种的生产上市,预计将对公司 业绩产生积极影响。但因受国家政策、市场环境等因素影响,未来产品销售及收入存在不确定性。 ...
康恩贝(600572.SH):子公司吸入用复方异丙托溴铵溶液获得药品注册证书
Ge Long Hui A P P· 2025-09-08 08:24
格隆汇9月8日丨康恩贝(600572.SH)公布,公司全资子公司浙江金华康恩贝生物制药有限公司(称"金华 康恩贝")收到国家药品监督管理局核准签发的吸入用复方异丙托溴铵溶液《药品注册证书》。该药品 适用需要多种支气管扩张剂联合应用的患者,用于治疗气道阻塞性疾病有关的可逆性支气管痉挛。 ...
康恩贝(600572.SH)子公司吸入用复方异丙托溴铵溶液获得药品注册证书
智通财经网· 2025-09-08 08:20
Core Viewpoint - 康恩贝's subsidiary, Zhejiang Jinhua Kang En Bei Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the inhalation solution of compound ipratropium bromide [1] Group 1: Company Developments - 康恩贝's subsidiary, Jinhua Kang En Bei, has been granted a drug registration certificate for the inhalation solution of compound ipratropium bromide [1] - The inhalation solution was developed by Boehringer Ingelheim and was first approved in France in December 1994 [1] - The product was subsequently approved in the United States and Germany in 1996 and 1998, respectively, and was approved for sale in China in October 2006 under the brand name Combivent® [1] Group 2: Product Information - The inhalation solution is intended for patients requiring the combined use of multiple bronchodilators [1] - It is used for the treatment of reversible bronchospasm associated with obstructive airway diseases [1]
康恩贝:子公司吸入用复方异丙托溴铵溶液获药品注册证书
Xin Lang Cai Jing· 2025-09-08 08:18
康恩贝公告,全资子公司金华康恩贝生物制药有限公司收到国家药品监督管理局核准签发的吸入用复方 异丙托溴铵溶液《药品注册证书》。该药品适用于治疗气道阻塞性疾病有关的可逆性支气管痉挛,由勃 林格殷格翰药业有限公司开发,1994年首次在法国获批上市。金华康恩贝于2024年1月提交注册申请并 获得受理,目前已投入研发费用约790万元。2024年,国内相应终端市场销售金额达2.4亿元。 ...
9连板天普股份明起停牌核查;永安药业董事长陈勇解除留置丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-03 14:19
Key Points - Tianpu Co., Ltd. announced a suspension of trading for stock verification due to multiple instances of abnormal trading fluctuations from August 22 to September 3, with a reminder for investors about market risks [1] - China Shipbuilding Industry Corporation announced a share exchange ratio of 1:0.1339 for the merger with China Shipbuilding, with the stock ceasing to be listed from September 5, 2025 [2] - Chengdu Huamei reported that its 40G high-precision RF ADC chip is still in the trial production stage and has not achieved mass sales, indicating market demand uncertainty [2] - Taihe Technology's sulfide solid electrolyte project is currently in the trial production phase and has not generated sales revenue [3] - Robotech signed a contract worth approximately €946.50 million for fully automated silicon photonic packaging equipment, expected to positively impact the company's future performance [4] - Wento Holdings reported that its cinema and gaming businesses are still in the recovery phase post-restructuring, with potential uncertainties in future operations [5] - Xibu Muye's fresh milk production increased by 4.8% month-on-month in August [6] - China Shipbuilding announced the implementation of a share exchange merger with China Heavy Industry [6] - Gansu Energy plans to invest CNY 40.89 billion in a wind-solar integrated project [6] - Xinhua Medical's endoscope cleaning workstation received a Class II medical device registration certificate [6]
康恩贝:关于苓桂术甘汤颗粒获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-09-03 14:10
证券日报网讯 9月3日晚间,康恩贝发布公告称,近日,公司收到国家药品监督管理局核准签发的苓桂 术甘汤颗粒《药品注册证书》。 (文章来源:证券日报) ...
康恩贝苓桂术甘汤颗粒获得药品注册证书
Bei Jing Shang Bao· 2025-09-03 10:25
北京商报讯(记者王寅浩实习记者宋雨盈)9月3日,康恩贝(600572)发布公告称,公司近日收到国家药 品监督管理局核准签发的苓桂术甘汤颗粒《药品注册证书》。公告显示,苓桂术甘汤颗粒具有温阳化 饮、健脾利湿功效,主治中阳不足之痰饮。 ...
9月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-03 10:18
Group 1 - Shengtun Mining plans to repurchase shares worth between 500 million and 600 million yuan, with a maximum repurchase price of 11.82 yuan per share, aimed at employee stock ownership plans or equity incentives [1] - Kangnbei received a drug registration certificate for Linggui Shugan Granules, which is derived from traditional Chinese medicine and is used for treating phlegm and dampness due to Yang deficiency [2] - Zhangjiang Hi-Tech intends to publicly transfer 100% equity and related debts of Shanghai Jixin Rui Construction Technology Co., Ltd. with a total price not less than 151 million yuan [3] Group 2 - Shankai Intelligent won a bid for a metering device procurement project worth 13.318 million yuan from Hohhot Water Supply Company [4] - Hason Co. plans to jointly establish a supply chain company with a registered capital of 10 million yuan, in which Hason will hold a 10% stake [5] - Pudong Construction's subsidiaries won multiple major projects with a total amount of 1.271 billion yuan [6] Group 3 - Jinling Pharmaceutical received approval for the Phase III clinical trial of Olaratogrel tablets, which are used for treating moderate to severe pain associated with endometriosis [8] - Menohua's subsidiary obtained a drug registration certificate for Mosapride Citrate Tablets, aimed at improving gastrointestinal symptoms [10] - Shapuaisi's major shareholder plans to reduce holdings by up to 2% of the company's shares due to personal financial needs [11] Group 4 - Changyuan Power reported an August electricity generation of 3.771 billion kWh, a year-on-year decrease of 6.03% [15][16] - Xibu Livestock's August fresh milk production increased by 4.8% month-on-month but decreased by 7.27% year-on-year [19] - Yong'an Pharmaceutical's actual controller and chairman had their detention lifted, allowing them to resume normal duties [20] Group 5 - Jinkai Intelligent's director resigned due to work adjustments [22] - Xinhua Medical received a Class II medical device registration for an endoscope cleaning workstation [23] - Haishi Science and Technology's innovative drug HSK47388 received approval for a new indication clinical trial [25] Group 6 - Baotai Co. plans to participate in a land use rights auction in Baoji City with a starting price of 57.34 million yuan [26] - Minfeng Special Paper received a government subsidy totaling 11.2 million yuan [27] - Jiuchang Bio obtained a medical device registration for a heparin-binding protein assay kit [29] Group 7 - Jingao Technology plans to repurchase shares worth between 200 million and 400 million yuan, with a maximum price of 17.36 yuan per share [31] - Youxunda won a bid for a metering equipment project from China Southern Power Grid worth approximately 161 million yuan [32] - Qianli Technology reported an August vehicle sales increase of 168.55% year-on-year [32] Group 8 - Guangzhou Port expects an August container throughput increase of 1.2% year-on-year [32] - Kexing Pharmaceutical's GB08 injection completed the first subject enrollment for Phase II clinical trials [33] - Wu Ming Pharmaceutical plans to transfer 98.9% of its subsidiary's shares to a newly established wholly-owned subsidiary [34] Group 9 - Shanghai Electric's acquisition of K-Electric Limited shares has not yet completed the transfer [35] - Fulai New Materials plans to raise no more than 710 million yuan through a private placement [36] - Huaren Health's drug registration application for a new type of potassium ion competitive acid blocker has been accepted [37]