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科笛-B(02487):CU-30101(局部外用利多卡因丁卡因乳膏剂)中国III期临床试验结果获第30次CSD年会接受以电子壁报形式展示
智通财经网· 2025-06-26 23:53
智通财经APP讯,科笛-B(02487)发布公告,该集团用于表皮麻醉手术的CU-30101(局部外用利多卡因丁 卡因乳膏剂)的中国III期临床试验(「该III期临床试验」)结果获中华医学会第30次皮肤性病学术年会 (「CSD年会」)接受以电子壁报形式展示。这是本集团的研究成果连续两届入选CSD年会,代表了本集 团在皮肤科领域的行业影响力及前沿水準。 基于该III期临床试验的结果,本集团已向国家药品监督管理局提交CU-30101的药品上市许可,并于 2024年7月获受理。 该III期临床试验为一项多中心、随机、双盲、阳性药对照、配对设计的临床试验,以评估CU-30101用 于表皮麻醉手术局部镇痛的安全性及疗效。该III期临床试验以参比制剂Pliaglis®利多卡因丁卡因乳膏 (「Pliaglis®」)作为对照,主要疗效终点为点阵激光术后即刻疼痛视觉模拟评分(「VAS」),并同时对不 良事件和局部皮肤耐受性进行了评估。 临床试验结果显示,在疗效方面,两侧面部VAS差值(CU-30101侧-Pliaglis®侧)均在预设的等效区间範围 内,显示CU-30101与Pliaglis®镇痛疗效相当,达到主要终点。此外,受 ...
创新药新秀泰恩康大动作,拟斥1.5亿元—2亿元启动第二期员工持股计划
Zheng Quan Shi Bao Wang· 2025-06-23 00:43
Core Viewpoint - The announcement of the second employee stock ownership plan by TianKang aims to enhance long-term incentive mechanisms, improve employee cohesion and corporate competitiveness, and deeply bind the interests of the company, shareholders, and employees [1] Summary by Relevant Sections Employee Stock Ownership Plan - The scale of the employee stock ownership plan is set between RMB 150 million and RMB 200 million, with an average purchase price based on the closing price of RMB 33.77 per share on June 20, 2025, leading to a minimum of approximately 4.44 million shares and a maximum of about 5.92 million shares, accounting for no more than 1.39% of the total share capital as of the announcement date [1] - The holding period for the stock is strictly regulated, with a minimum of 12 months required [1] Market Confidence and Stock Performance - Industry insiders highlight three key points regarding TianKang's equity incentive: the stock will be sourced through secondary market purchases, the buy-in scale is significant, and the plan reflects strong confidence in future development [2] - TianKang's stock price has surged by 130% this year, ranking fourth among innovative drug concept stocks [2] Innovation and Clinical Development - The collective rise of innovative drug leaders reflects a systematic re-evaluation of the long-term value of R&D investments, driven by expectations of industry upgrades rather than solely academic data disclosures [3] - TianKang's innovative drug CKBA for vitiligo has completed 100% subject enrollment in its Phase II clinical trial, with plans to explore additional indications in the next 3-5 years [3] Growth Areas - The company is focusing on several growth areas, including gastrointestinal drugs, sexual health, and ophthalmology [4] - In the gastrointestinal sector, TianKang aims to expedite the registration process for its product and target over RMB 1 billion in sales within 3-5 years [4] - The sexual health segment features leading products with significant market presence, and a new product is expected to enhance the company's portfolio [4] - In ophthalmology, the company is progressing with clinical trials for a product aimed at treating presbyopia, which could become the first of its kind in China [4] Overall Outlook - TianKang's employee stock ownership plan reflects the company's strong confidence in future growth, driven by innovation and clinical needs, while building high-value competitive barriers in core areas [5] - As key projects move towards commercialization, the company is expected to generate new performance growth points and enter a new growth cycle [5]
“10秒,我症状还没说,处方药就开好了”
Zhong Guo Xin Wen Wang· 2025-06-15 15:31
中国新闻网消息,伴随互联网医疗蓬勃发展,线上购药因便捷高效已成为不少患者的新选择。然而,部分 电商平台处方药销售乱象频发,严重威胁消费者用药安全。 中国新闻网《民生调查局》记者调查发现,在多家电商平台网售处方药过程中,患者无须上传病历、处方 等资料,"医生"在缺乏实质性医疗评估的情况下"秒开"处方,甚至存在"先药后方"现象。此外,部分在线 诊疗平台的处方药销售页面还存在违规展示、超适应症宣传和销售未获批药品的情况。 01 乱象一: 处方审核形同虚设 "先药后方"成潜规则 实测:10s,从问诊到开处方 "秒开"处方、"先药后方"……近日,记者登录多家电商平台,提交购药申请,实测了线上买药的全过程。 记者发现购买处方药的流程异常简便,消费者无须上传病历、处方等资料,在线医生"对药下症"秒回复、 缺乏实质性的医疗评估。 记者在某平台下单处方药玛巴洛沙韦后,平台提示"请选择线下已确诊疾病"。记者仅在"疾病栏"选择了"流 行性感冒",并确认"已确诊此疾病并使用过该药,且无过敏史、无相关禁忌症和不良反应"。很快,记者的 购药订单通过了验证。 提交清单后,系统跳转至问诊板块。系统显示一位汉中百寿健康互联网医院"医生"已接诊 ...
5月30日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-30 10:21
华培动力:收到新能源车企项目定点意向书 5月30日晚,华培动力(603121)发布公告称,公司近日收到国内一家新能源车企的项目定点意向书, 定点产品为热管理系统PTC水加热器,项目生命周期为5年,预计2026年开始量产,生命周期内销售金 额约900万元。 资料显示,华培动力成立于2006年6月,主营业务是涡轮增压器、传感器等关键零部件的研发、生产及 销售。 所属行业:汽车–汽车零部件–底盘与发动机系统 安图生物:产品取得医疗器械注册证 5月30日晚,安图生物(603658)发布公告称,公司及全资子公司安图实验仪器(郑州)有限公司于近 日收到国家药品监督管理局、河南省药品监督管理局颁发的医疗器械注册证。包括"巨细胞病毒IgM抗 体检测试剂盒"等产品。 资料显示,安图生物成立于1999年9月,主营业务是体外诊断试剂及仪器的研发、制造、整合及服务。 所属行业:医药生物–医疗器械–体外诊断 映翰通:调整回购股份价格上限至65.04元/股 5月30日晚,映翰通(688575)发布公告称,公司拟将回购价格上限调整为65.04元/股。此次调整旨在 保障回购方案顺利实施,除价格调整外,回购方案其他内容不变。公司已累计回购股份 ...
毛里塔尼亚:2024年国家基本医疗器械名录(法语)
WHO· 2025-05-25 04:25
Investment Rating - The report does not explicitly provide an investment rating for the healthcare industry or specific companies within it. Core Insights - The Universal Health Coverage (UHC) aims to provide equitable and sustainable access to essential health products at affordable prices across all levels of the healthcare system [4]. - The World Health Organization (WHO) has established a Model List of Essential Medicines, which serves as a guideline for countries to adopt or adapt according to local priorities [4]. - Mauritania has revised its National List of Essential Medicines (LNME) multiple times, with the latest revision in March 2021, which will be effective from 2024 to 2026 [5][6]. - The new LNME includes essential medicines for both adults and children, introduces a list of essential medical consumables, identifies 40 tracer products, and incorporates the WHO's AWaRe classification of antibiotics to combat antimicrobial resistance [7]. Summary by Sections Section I: Overview of Essential Medicines - Essential medicines must meet the majority of the population's health needs, be effective, of proven quality, easy to use, available at all times, have minimal side effects, and be financially accessible [12]. Section II: National List of Essential Medicines - The LNME is organized into 31 therapeutic classes, with medicines listed alphabetically by their International Nonproprietary Name (INN) [13]. - The list includes various columns detailing therapeutic class, INN, pharmaceutical form, dosage, and the AWaRe classification for antibiotics [13][16]. Section III: Implementation and Monitoring - A roadmap has been developed outlining key guidelines, activities, and performance indicators for the implementation of the LNME [8]. - The adoption of the LNME involved participation from prescribers, dispensers, managers, and civil society, ensuring a comprehensive approach to healthcare delivery [7]. Section IV: Regulatory Framework - The application of the LNME is mandatory for certain healthcare levels and serves as a guideline for others, with revisions occurring every two years [22][23].
九典制药:利多卡因凝胶贴膏获药品注册证书
news flash· 2025-05-21 09:16
Core Viewpoint - The company has received a drug registration certificate from the National Medical Products Administration for Lidocaine Gel Patch, indicating a significant regulatory approval for a new product aimed at treating postherpetic neuralgia [1] Group 1: Product Details - The drug is named Lidocaine Gel Patch, classified as a Class 3 chemical drug [1] - The formulation is a patch with dimensions of 14cm x 10cm, containing 14g of gel and 700mg of Lidocaine per patch [1] - The product is specifically indicated for alleviating pain associated with postherpetic neuralgia and is suitable for use on intact skin [1]
出通后单日股价大涨20%,肉毒素成科笛-B(02487)的“灵丹妙药”?
智通财经网· 2025-05-20 08:26
3月10日,新一期港股通名单调整正式生效,创新药企业"一进六出",科笛-B(02487)便是其中之一。 从往期来看,在被技术性调出港股通投资标的后,短期内个股因流动性以及退通抛压等因素大多会出现显著的股价下跌现象,科笛亦不例外。在正式退通的 6个交易日内,科笛股价累跌20.60%。 但接下来科笛股价并未继续下探,而是在3月20日走出"三连阳"后横盘震荡,直到4月7日,公司股价因恒指大盘剧烈波动出现单日下跌26.88%。而这似乎给 科笛砸出了一个"黄金坑"。 智通财经APP观察到,4月9日,科笛股价触底3.64港元,创下上市以来股价新低,但在随后的1个半月内持续反弹。5月20日,科笛盘中股价最高涨幅达 20%,最高价达到7.62港元,突破退通前的前高股价。也就是说,经过2个多月的股价震荡,科笛股价最终修复了"出通"后全部跌幅。 从港股通变动情况来看,3月10日,科笛的港股通持股比例为10.07%,在接下来2个多月中,无论公司股价涨跌,该持股比例都在持续降低,截至5月19日仅 剩5.32%。不过在4月10日新一轮上涨行情启动时,科笛的港股通持股比例为5.94%,近40天内其变动比例仅为0.62%,较此前明显放缓。 ...
梓橦宫:“创新发展”打开成长新空间
Quan Jing Wang· 2025-05-17 00:06
5月16日,梓橦宫(832566)2024年年度报告业绩说明会在全景路演成功举办。 本次活动通过视频直播形式与投资者进行互动交流,公司方面贴心为投资者直播讲演业绩说明PPT,分别从公司概况、经营情况、财务数据、未来展望等多 个方面全方位、多角度呈现公司经营成果和战略规划,提升了投资者对年报核心内容理解的可及性、便捷性和直观性。 梓橦宫2024年度实现营业收入41567.44万元,净利润8564.39万元,基本每股收益0.59元。 在与投资者互动交流环节,就公司当前在流感药产品布局的有关情况,公司方面直言:公司目前有流感治疗药物磷酸奥司他韦胶囊,感冒类药物有氨咖黄敏 胶囊、酚氨咖敏片等。 针对公司研发管线进展有关情况,公司方面介绍称:目前在研品种有马甲子胶囊,为在研一类新药,主要针对消化道肿瘤,现已启动Ia期临床试验。仿制药 品种富马酸伏诺拉生片已申报药品注册批件。2024年度新立项酒石酸西尼必利片、布洛芬缓释胶囊、地屈孕酮片、盐酸利多卡因无菌凝胶等多个研发项目。 公司表示,将以"创新发展"为中心,加快推进企业研发创新、营销创新、管理创新,为公司"十五五"发展战略的顺利开启打下良好基础。(全景网) 了解更多梓橦 ...
九典制药(300705) - 300705九典制药投资者关系管理信息20250514
2025-05-14 14:56
证券代码:300705 证券简称:九典制药 债券代码:123223 债券简称:九典转 02 湖南九典制药股份有限公司 投资者关系活动记录表 编号:2025-11 | | 特定对象调研 □分析师会议 | | --- | --- | | 投资者关系活动 | □媒体采访 □业绩说明会 | | 类别 | □新闻发布会 □路演活动 | | | □现场参观 其他 | | 参与单位名称及 | 国泰海通证券、光大保德信基金、浦银安盛基金、大成基金 | | 人员姓名 | 、嘉实基金、人保资产、先锋基金机构投资者代表共 9 人 | | 时间 | 2025 年 5 月 14 日下午 2:00-3:30 | | 地点 | 公司会议室 | | 上市公司接待人 员姓名 | 副总经理兼董事会秘书:曾蕾 | | | 首先董事会秘书简要介绍了公司的基本情况,接下来主要采 | | | 用解答投资者提问的方式进行,主要问题回复如下: | | | 1、面对竞品上市,公司接下来的经营规划如何? | | | 回复:公司目前正处于持续健康发展的阶段,未来战略 | | | 规划将聚焦三大关键领域:一是积极拓展销售渠道,重点加 | | 投资者关系活动 ...
泰恩康(301263) - 2025年5月12日投资者关系活动记录表
2025-05-12 09:20
证券代码:301263 证券简称:泰恩康 广东泰恩康医药股份有限公司投资者关系活动记录表 编号:投-003 | 投资者关系活动 | □特定对象调研 □分析师会议 | | --- | --- | | | □媒体采访 √业绩说明会 | | 类别 | □新闻发布会 □路演活动 | | | □现场参观 □其他 | | 参与单位名称及 | 线上参与泰恩康 2024 年度网上业绩说明会的投资者 | | 人员姓名 | | | 时间 | 2025 年 05 月 12 日(星期一)15:00-16:00 | | 地点 | "约调研"小程序 | | 上市公司接待人 | 董事长、总经理:郑汉杰先生 | | | 董事、副总经理兼董事会秘书:李挺先生 | | 员姓名 | 财务总监:周桂惜女士 | | | 独立董事:彭朝辉先生 | | | 保荐代表人:徐振宇先生 | | 投资者关系活动 | 1、问:创新药 白癜风适应症已完成全部受试者入组, CKBA | | | 公司预计该创新药上市后,请问市场前景如何,对公司未来业绩 | | | 增长的贡献程度预计有多大? | | | 年 软膏白癜风 期临 答:投资者您好,2024 10 月,CKBA ...