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泰恩康CKBA乳膏申报儿童白癜风临床试验取得受理通知书
Bei Jing Shang Bao· 2025-11-20 12:08
Core Viewpoint - The announcement by TianKang regarding the approval of a Phase II clinical trial for CKBA cream in treating non-segmental vitiligo in children aged 2-12 is a significant development, potentially positioning CKBA as the first targeted therapy for this condition in children, addressing a gap in treatment options [2]. Group 1 - TianKang's subsidiary, Jiangsu BoChuangYuan Biopharmaceutical Technology Co., Ltd., received a notice from the National Medical Products Administration approving the application for a Phase II clinical study [2]. - The clinical trial will assess the safety, efficacy, and pharmacokinetic characteristics of CKBA cream combined with narrowband ultraviolet B in children with non-segmental vitiligo [2]. - Following the approval, the company plans to expedite the Phase II clinical trial for pediatric vitiligo, indicating a strong commitment to advancing this innovative treatment [2].
11月20日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-20 10:15
Group 1 - EVE Energy signed a procurement framework agreement with its affiliate, Smoore International, for continuous procurement of battery cells starting from January 1, 2026 [1] - Zhaoyi Information plans to issue H-shares and list on the Hong Kong Stock Exchange [1] - Fuke Environmental announced a change in its stock abbreviation to "Fuke Technology" effective November 26 [1] Group 2 - Dajia Weikang's shareholder and director terminated a share reduction plan ahead of schedule, having reduced 1% of total shares [2] - Aohong Electronics received approval from the China Securities Regulatory Commission for the issuance of convertible bonds [2] - Yingfeng Environment's controlling shareholder plans to issue exchangeable bonds not exceeding 1 billion yuan [2] Group 3 - Longshen Rongfa's subsidiary obtained a renewed drug production license covering various pharmaceutical products [4] - Xinhua News' subsidiary invested 15 million yuan in a fund with a total commitment of 221 million yuan [5] - Guang'an Aizhong appointed two new deputy general managers [6] Group 4 - Fosun Pharma's subsidiary's drug for gastric cancer treatment was included in the breakthrough therapy program by the National Medical Products Administration [7] - Nanjiao Foods reported a significant decline in October net profit due to rising raw material costs [8] - Nanfeng Co. won two nuclear power project bids totaling 928.7 million yuan [10] Group 5 - Puluo Pharmaceutical received a drug registration certificate for its Cefdinir capsules [11] - Liming Co.'s subsidiary received environmental approval for a new pesticide raw material project [12] - Longhua New Materials' expansion project for polyether polyols has commenced trial production [13] Group 6 - Pumen Technology's products received IVDR CE certification from TÜV Rheinland [15] - China Chemical reported new contracts worth 312.67 billion yuan from January to October [18] - China Nuclear Construction achieved new contracts totaling 123.84 billion yuan as of October [19] Group 7 - Changshu Bank's executives plan to purchase at least 550,000 shares of the bank [20] - Shandong Steel's subsidiary is applying for bankruptcy liquidation to focus on core business [21] - Huakang Clean is expected to win a bid for a purification system project worth 176 million yuan [23] Group 8 - Huawu Co. plans to internally transfer subsidiary equity [24] - Tianen Kang's subsidiary received clinical trial acceptance for a new drug [26] - Tianyi Medical's subsidiary obtained a medical device registration certificate for a blood dialysis product [27] Group 9 - Xuelang Environment is facing a pre-restructuring application from creditors [27] - Chitianhua's subsidiary resumed production after passing safety inspections [28] - Huaping Co.'s director plans to reduce 0.03% of company shares [30] Group 10 - Xizhuang Co. plans to establish a wholly-owned subsidiary in Singapore [31] - Ruisheng Intelligent's subsidiary won a 60.23 million yuan ICT project bid [32] - Junyi Digital plans to invest 120 million yuan in Guanghong Precision [33] Group 11 - Fuguang Co.'s controlling shareholder plans to increase holdings between 80 million to 150 million yuan [34] - Ganyue Express reported a 13.68% increase in logistics revenue in October [39] - Jiangsu Sop terminated its 2025 private placement plan [41] Group 12 - Langke Intelligent's shareholders plan to reduce a total of 1.68% of company shares [42] - Yuantong Express reported an 8.97% increase in express product revenue in October [45] - Jinbei Automotive plans to invest 158 million yuan to acquire 52% of Zhongtuo Technology [46]
泰恩康控股子公司CKBA乳膏申报儿童白癜风临床试验获受理
Zhi Tong Cai Jing· 2025-11-20 08:23
泰恩康(301263)(301263.SZ)公告,公司控股子公司江苏博创园生物医药科技有限公司(简称"博创园") 于近日收到国家药品监督管理局签发的受理通知书,同意受理博创园提交的CKBA乳膏联合窄谱中波紫 外线(简称"NB-UVB")在2-12岁(含2岁)儿童非节段型白癜风受试者中的安全耐受性、疗效和药代动力学 特征的多中心、随机、双盲、安慰剂对照II期临床研究申请。 ...
泰恩康(301263.SZ)控股子公司CKBA乳膏申报儿童白癜风临床试验获受理
智通财经网· 2025-11-20 08:20
Core Viewpoint - The company, Tianenkang (301263.SZ), announced that its subsidiary, Jiangsu Bochuangyuan Biopharmaceutical Technology Co., Ltd. (referred to as "Bochuangyuan"), has received a notice of acceptance from the National Medical Products Administration, allowing the submission of a clinical research application for CKBA cream combined with narrowband ultraviolet B (NB-UVB) for the treatment of non-segmental vitiligo in children aged 2 to 12 years [1] Group 1 - The acceptance notice pertains to a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study [1] - The study will evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of CKBA cream in the specified age group [1]
泰恩康:CKBA乳膏申报儿童白癜风临床试验取得受理通知书
Xin Lang Cai Jing· 2025-11-20 08:15
Core Viewpoint - The announcement indicates that Jiangsu Bochuangyuan Biopharmaceutical Technology Co., Ltd., a subsidiary of Tiancong, has received an acceptance notice from the National Medical Products Administration for a Phase II clinical study application regarding CKBA cream for treating non-segmental vitiligo in children aged 2 to 12 years [1] Group 1 - The clinical study will assess the safety, tolerability, efficacy, and pharmacokinetic characteristics of CKBA cream [1] - The study design is a multicenter, randomized, double-blind, placebo-controlled trial [1]
泰恩康(301263.SZ):控股子公司CKBA乳膏申报儿童白癜风临床试验取得受理通知书
Ge Long Hui A P P· 2025-11-20 08:15
Core Viewpoint - The company, Taiankang (301263.SZ), has received a notice from the National Medical Products Administration, indicating the acceptance of its application for a Phase II clinical study of CKBA cream for treating non-segmental vitiligo in children aged 2 to 12 years [1] Group 1 - The application pertains to a multi-center, randomized, double-blind, placebo-controlled clinical study [1] - The study will evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of CKBA cream in the specified age group [1]
泰恩康(301263) - 关于控股子公司CKBA乳膏申报儿童白癜风临床试验取得受理通知书的公告
2025-11-20 08:08
证券代码:301263 证券简称:泰恩康 公告编号:2025-076 广东泰恩康医药股份有限公司 关于控股子公司 CKBA 乳膏申报儿童白癜风 临床试验取得受理通知书的公告 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")控股子公司江苏博创 园生物医药科技有限公司(以下简称"博创园")于近日收到国家药品监督管 理局(以下简称"国家药监局")签发的受理通知书,同意受理博创园提交的 CKBA 乳膏联合窄谱中波紫外线(以下简称"NB-UVB")在 2-12 岁(含 2 岁) 儿童非节段型白癜风受试者中的安全耐受性、疗效和药代动力学特征的多中心、 随机、双盲、安慰剂对照 II 期临床研究申请。现将相关情况公告如下: 结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审查, 决定予以受理。 二、后续流程 CKBA(抑制CD8+ T细胞向Tc1及Tc17分化,下调IFN-γ和IL-17的表达)与 NB-UVB的联合治疗,核心优势在于:CKBA改善皮肤区域免疫环境,阻止"白 斑"扩增;NB-UVB直接激活黑素干细胞,使其分 ...
海泰新光:关于向2025年限制性股票激励计划激励对象首次授予限制性股票的公告
Zheng Quan Ri Bao· 2025-11-19 13:10
Core Points - The company, Haitai Xinguang, announced the approval of the first grant of restricted stock under the 2025 restricted stock incentive plan during the ninth meeting of the fourth board of directors held on November 19, 2025 [2] - The grant date is set for November 19, 2025, with a grant price of 25 yuan per share [2] - A total of 800,000 shares of restricted stock will be granted to 15 incentive objects [2]
泰恩康11月17日获融资买入2819.54万元,融资余额9.93亿元
Xin Lang Zheng Quan· 2025-11-18 01:24
Group 1 - The core viewpoint of the news is that 泰恩康 (Tianenkang) experienced a decline in stock price and trading volume, with significant financing activities indicating high investor interest despite recent financial performance challenges [1][2] Group 2 - On November 17, 泰恩康's stock price fell by 2.01%, with a trading volume of 146 million yuan. The financing buy-in amount was 28.2 million yuan, while the financing repayment was 16.5 million yuan, resulting in a net financing buy of 11.7 million yuan. The total financing and securities balance reached 993 million yuan [1] - The financing balance of 泰恩康 accounted for 7.59% of its circulating market value, exceeding the 90th percentile level over the past year, indicating a high level of financing activity [1] - As of September 30, 泰恩康 had 12,000 shareholders, an increase of 9.32% from the previous period, while the average circulating shares per person decreased by 8.53% to 25,381 shares [2] - For the period from January to September 2025, 泰恩康 reported operating revenue of 526 million yuan, a year-on-year decrease of 8.13%, and a net profit attributable to shareholders of 31.4 million yuan, down 73% year-on-year [2] - Since its A-share listing, 泰恩康 has distributed a total of 460 million yuan in dividends, with 377 million yuan distributed over the past three years [2]
社保基金大举建仓!泰恩康布局阿尔茨海默症千亿蓝海,业绩进入高增长期
Core Viewpoint - The company, TianKang, has officially announced the initiation of preclinical research for its innovative drug CKBA targeting Alzheimer's disease (AD), based on significant findings from a research team at Shanghai Jiao Tong University [1][2]. Group 1: Drug Development and Mechanism - CKBA is a first-in-class innovative drug that targets the newly identified MFE-2 pathway, which plays a crucial role in the lipid metabolism and neuroinflammation associated with AD [2][4]. - The drug demonstrates a differentiated advantage by being orally administered and capable of crossing the blood-brain barrier, showing improvements in cognitive function, reduction of neuroinflammation, and decreased Aβ plaque accumulation in AD model mice [4]. Group 2: Market Potential and Financial Outlook - The Alzheimer's drug market in China is projected to grow from approximately 6 billion yuan in 2023 to over 26 billion yuan by 2030, with a compound annual growth rate (CAGR) of 19.2%, while the global market is expected to reach 31.44 billion USD [4]. - The company anticipates submitting its phase I clinical application for CKBA in the second half of 2026, supported by cash flow from its existing generic drug business [4]. Group 3: Broader Product Pipeline and Growth Strategy - In addition to AD, CKBA is part of a broader pipeline that includes treatments for vitiligo and rosacea, with ongoing clinical trials showing promising results [5]. - The company is also expanding its generic and modified drug segments, with several products in the pipeline expected to contribute to revenue growth [5][6]. Group 4: Institutional Support and Market Confidence - The company has gained recognition from institutional investors, with significant increases in holdings from the basic pension insurance fund, indicating confidence in the company's growth potential [7][9]. - Management has shown commitment to the company's long-term success, with no plans for share reduction post-lockup and active participation in shareholding [9].