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泰恩康(301263) - 关于全资子公司收到米诺地尔搽剂药品注册证书的公告
2026-02-06 08:16
证券代码:301263 证券简称:泰恩康 公告编号:2026-012 受理号:CYHS2400976、CYHS2400977 药品名称:米诺地尔搽剂 申请事项:境内生产药品注册上市许可 许可药品注册分类:化学药品 3 类 广东泰恩康医药股份有限公司 关于全资子公司收到米诺地尔搽剂 药品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假 记载、误导性陈述或者重大遗漏。 广东泰恩康医药股份有限公司(以下简称"公司")全资子公司山东华铂 凯盛生物科技有限公司(以下简称"华铂凯盛")于近日收到国家药品监督管 理局(以下简称"国家药监局")签发的米诺地尔搽剂《药品注册证书》。现 将相关情况公告如下: 一、申请注册药品的基本情况 规格:60ml:1.2g;60ml:3.0g 药品批准文号:国药准字 H20263325、国药准字 H20263326 申请人:山东华铂凯盛生物科技有限公司 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、药品相关情况简介 米诺地尔是目前常用的外用脱发治疗药物,作为地尔类血管扩张药,可使 血 ...
泰恩康:CKBA乳膏治疗玫瑰痤疮已于近期正式开始招募患者入组
Zheng Quan Ri Bao Wang· 2026-02-02 09:10
Core Viewpoint - The company TianKang (301263) has initiated patient recruitment for the CKBA cream treatment for rosacea, addressing a significant unmet clinical need in China where no Class 1 innovative drugs have been approved for this indication [1] Group 1: Clinical Trials and Approvals - The CKBA cream for rosacea is currently in the patient recruitment phase for clinical trials [1] - The company plans to apply for breakthrough therapy designation if clinical trial results meet expectations, given the lack of approved innovative treatments for rosacea in China [1] - The Phase II clinical trial application for CKBA cream combined with narrowband ultraviolet B (NB-UVB) for treating non-segmental vitiligo in children aged 2-12 has been approved by NMPA, with plans to submit a clinical trial application to the FDA this year [1] Group 2: Information Disclosure - The company will fulfill its information disclosure obligations in accordance with regulations regarding any progress related to submissions to the FDA and BD [1]
泰恩康(301263) - 关于控股股东、实际控制人部分股份质押的公告
2026-02-02 08:12
| | 是否为控 | | 占其所 | 占公司 | 是否为 | 是否 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 股股东或 | 本次质押 | 持股份 | 总股本 | 限售股 | 为补 | 质押 | 质押到 | | 质押 | | 名称 | 第一大股 | 数量(股) | 比例 | 比例 | (如是, | 充质 | 起始日 | 期日 | 质权人 | 用途 | | | 东及其一 | | | | 注明限 | | | | | | | | 致行动人 | | (%) | (%) | 售类型) | 押 | | | | | | | | | | | | | | 办理解 | 华能贵 | 个人 | | 郑汉杰 | 是 | | | | 否 | 否 | | 除质押 | 诚信托 | 资金 | | | | 3,500,000 | 3.96 | 0.82 | | | 2026-1-30 | 登记手 | 有限公 | | | | | | | | | | | | | 需要 | | | | | | | | | | 续之日 | 司 ...
泰恩康:ckba乳膏治疗玫瑰痤疮已于近期正式开始招募患者入组
Mei Ri Jing Ji Xin Wen· 2026-02-02 01:29
Core Viewpoint - The company is advancing its clinical trials for CKBA cream, targeting both rosacea and vitiligo, with significant unmet clinical needs in the domestic market [1][3]. Group 1: Clinical Trials and Approvals - The CKBA cream for treating rosacea has recently begun patient recruitment for clinical trials, with plans to apply for breakthrough therapy designation if results meet expectations [1]. - The company has received NMPA approval for a Phase II clinical trial of CKBA cream combined with narrowband UVB therapy for treating non-segmental vitiligo in children aged 2-12, with plans to submit a clinical trial application to the FDA this year [1]. Group 2: Future Plans and Regulatory Considerations - If the clinical trial results for rosacea are favorable, the company will consider applying for breakthrough therapy designation and subsequent market approval [1]. - The company is also exploring the possibility of obtaining orphan drug designation for the treatment of vitiligo in children aged 2-12 [3].
000821,突然火了!48家机构调研!公司称对太空光伏进行技术储备
证券时报· 2026-02-01 04:20
Core Insights - The article highlights the recent institutional investor research activities involving 113 listed companies, with notable stock performance from companies like Kewen Technology and Hason Co., which saw increases exceeding 30% [3]. Group 1: Shanghai Bank - Shanghai Bank received the highest number of institutional investor visits last week, with 75 institutions participating, focusing on the bank's credit deployment plans for the new year [5]. - The bank's management indicated an improvement in the quantity and quality of its "New Year Red" credit projects, particularly in retail credit, emphasizing housing and automotive sectors [5]. - The bank anticipates a slight decline in net interest margin due to expected decreases in both loan and deposit pricing, influenced by market competition and the ongoing repricing of existing assets [5]. Group 2: Tainkang - Tainkang was visited by 57 institutional investors, with a focus on its upcoming product approvals and commercialization strategies [7]. - The company announced significant revenue targets for 2026-2028, aiming for 1 billion, 1.5 billion, and 2 billion respectively, with profit targets of 300 million, 500 million, and 800 million [7][8]. - Tainkang plans to leverage existing products and new approvals to achieve substantial revenue growth, particularly with its unique formulations expected to dominate the market [8]. Group 3: Bee Assistant - Bee Assistant also received 57 institutional visits, with a focus on its developments in AI applications and commercial aerospace [8]. - The company is positioning itself in the aviation internet sector, aiming to enhance communication services and follow advancements in low-orbit satellite technology [8]. Group 4: ST Jingji - ST Jingji engaged with 48 institutional investors, reporting significant breakthroughs in the North American market as a core equipment supplier for photovoltaic components [10]. - The company is preparing for advancements in space photovoltaic technology, having made technical reserves in response to emerging opportunities in this field [10][11]. - ST Jingji emphasizes the importance of lightweight and flexible solar technology for space applications, aligning its R&D efforts with these requirements [11].
泰恩康(301263.SZ)全资子公司收到尼莫地平注射液药品注册证书
Xin Lang Cai Jing· 2026-01-30 09:19
Core Viewpoint - The announcement highlights that the company's wholly-owned subsidiary, Shandong Huabo Kaisheng Biotechnology Co., Ltd., has received the drug registration certificate for Nimodipine injection from the National Medical Products Administration of China, indicating a significant regulatory milestone for the company in the pharmaceutical sector [1]. Group 1: Company Developments - The company, Guangdong Tianen Pharmaceutical Co., Ltd., has made progress in its product pipeline by obtaining the registration certificate for Nimodipine injection, which is a critical step for market entry [1]. - The Nimodipine injection is a calcium antagonist that selectively acts on cerebral vascular smooth muscle, promoting relaxation of cerebral arteries and improving blood circulation during recovery from acute cerebrovascular diseases [1]. Group 2: Product Information - Nimodipine injection was developed by BayerVital GmbH and was first approved for market in Germany in 1985 under the brand name Nimotop, with a specification of 50ml:10mg [1]. - The original Nimodipine injection was imported into China in 2004, indicating its established presence in the market prior to the company's recent approval [1].
泰恩康:全资子公司收到尼莫地平注射液药品注册证书
Mei Ri Jing Ji Xin Wen· 2026-01-30 08:25
Core Viewpoint - The company TianKang (301263.SZ) announced that its wholly-owned subsidiary, Shandong Huabo Kaisheng Biotechnology Co., Ltd., has received a drug registration certificate for Nimodipine Injection from the National Medical Products Administration of China [1] Company Summary - The registered product, Nimodipine Injection, is classified as a Class 4 chemical drug with a specification of 50ml: 10mg, and the marketing authorization holder is Shandong Huabo Kaisheng Biotechnology Co., Ltd. [1] - Nimodipine Injection is indicated for its anti-ischemic and anti-vasoconstrictive effects, which can improve blood circulation during the recovery phase of acute cerebrovascular diseases and after subarachnoid hemorrhage [1] Industry Summary - Currently, a total of 44 companies in China have obtained registration approval for this drug, indicating a competitive market landscape [1] - The future sales performance of Nimodipine Injection will be influenced by industry policies and market conditions, which introduces a level of uncertainty [1]
泰恩康(301263) - 关于全资子公司收到尼莫地平注射液药品注册证书的公告
2026-01-30 08:06
证券代码:301263 证券简称:泰恩康 公告编号:2026-010 广东泰恩康医药股份有限公司 广东泰恩康医药股份有限公司(以下简称"公司")全资子公司山东华铂 凯盛生物科技有限公司(以下简称"华铂凯盛")于近日收到国家药品监督管 理局(以下简称"国家药监局")签发的尼莫地平注射液《药品注册证书》。 现将相关情况公告如下: 一、申请注册药品的基本情况 受理号:CYHS2400743 药品名称:尼莫地平注射液 剂型:注射剂 规格:50ml:10mg 注册分类:化学药品 4 类 关于全资子公司收到尼莫地平注射液 药品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假 记载、误导性陈述或者重大遗漏。 四、对公司的影响及风险提示 药品批准文号:国药准字 H20263249 上市许可持有人:山东华铂凯盛生物科技有限公司 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。质量标准、说明 书、标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规 范要求方可生产销售。 二、药品相关情况简介 尼莫地平(Nimodip ...
泰恩康(301263.SZ):公司目前重点聚焦国内2-12岁儿童白癜风适应症的注册上市
Ge Long Hui A P P· 2026-01-30 01:27
Core Viewpoint - The company is focusing on the registration and market launch of treatments for pediatric vitiligo in the domestic market, which has significant potential [1] Group 1: Domestic Market Focus - The company is concentrating on the registration and market launch of treatments for children aged 2-12 with vitiligo [1] - The domestic market for this indication is already substantial [1] Group 2: Global Market Potential - There is a global gap in the treatment of pediatric vitiligo, with no FDA-approved products available [1] - The company acknowledges that expanding into overseas markets will involve time and challenges [1] Group 3: Product Confidence and Future Plans - The company expresses strong confidence in the market prospects of its product due to its unique mechanism of action and good safety profile [1] - Plans are in place to initiate the IND application process with the FDA in the United States this year to explore overseas market opportunities [1]
泰恩康:公司目前重点聚焦国内2-12岁儿童白癜风适应症的注册上市
Ge Long Hui· 2026-01-30 01:21
Core Viewpoint - The company is focusing on the registration and market launch of treatments for pediatric vitiligo in the domestic market, which has significant potential [1] Group 1: Domestic Market Focus - The company is primarily targeting the registration and market launch of treatments for children aged 2-12 with vitiligo [1] - The domestic market for this indication is already substantial, indicating a strong potential for growth [1] Group 2: Global Market Potential - There is a global gap in the treatment of pediatric vitiligo, with no FDA-approved products currently available [1] - The company acknowledges the challenges and time costs associated with expanding into overseas markets [1] Group 3: Product Confidence and Future Plans - The company expresses confidence in the market prospects for its product due to the unique mechanism of action and good safety profile of CKBA [1] - Plans are in place to initiate the IND application process with the FDA in the United States this year, aiming to explore development opportunities in international markets [1]