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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]
泰恩康(301263.SZ):公司现有业务板块2026年收入将会有明显增长,2027年和2028年预计将有爆发性的增长
Ge Long Hui· 2026-01-30 01:20
Core Viewpoint - The company, 泰恩康 (301263.SZ), is experiencing stable revenue from existing products while anticipating significant growth from upcoming core products expected to be approved or submitted for approval in the near future [1] Existing Products - The company’s current products, including the dual-purpose health medication "爱廷玖", ophthalmic drug "沃丽汀", and traditional Chinese medicine, are maintaining stable revenue [1] Upcoming Product Approvals - Multiple core products are expected to be approved or submitted for approval: - "爱廷列" Finasteride and Tadalafil compound capsule (first domestic generic) is expected to be approved by December 2025 - Lidocaine and Prilocaine aerosol (first domestic generic) has completed clinical trials, with registration expected to be accepted by the drug regulatory authority soon - Compound Sodium Sulfate tablets (first domestic generic) are anticipated to be approved in the first half of 2026 - "和胃整肠丸" (exclusive domestic) localization production registration is expected to be approved in the first half of 2026 - Pilocarpine eye drops for presbyopia (first domestic generic) are expected to be approved in the second half of 2026 [1] Revenue Growth Projections - With the approval and launch of the aforementioned core products, the company expects a significant increase in revenue from existing business segments in 2026, with explosive growth anticipated in 2027 and 2028 [1]