Core Viewpoint - Aihong Pharmaceutical has submitted a medical device registration application for its product APLD-2304 to the EU Notified Body, which has been accepted, pending further review and approval for market launch [1][2] Group 1: Product Development and Market Potential - APLD-2304 is the world's first portable disposable blue light cystoscope developed for bladder cancer diagnosis and monitoring, addressing the limitations of traditional white light cystoscopy [1] - The product aims to improve bladder cancer detection rates and reduce recurrence rates, leveraging blue light imaging technology to identify small lesions and carcinoma in situ [1] - The European market has a high incidence of bladder cancer, with over 130,000 new cases annually, creating significant clinical demand for effective monitoring solutions [1] Group 2: Regulatory and Approval Process - The acceptance of the registration application does not have a significant impact on the company's recent performance, as the product still requires further evaluation and approval [2] - Medical devices are characterized by high technology, high risk, and high added value, with lengthy development and approval cycles influenced by various factors [2] Group 3: Recent Clinical Trial Approvals - Aihong Pharmaceutical received approval from the National Medical Products Administration for the clinical trial of APL-2401 in patients with advanced solid tumors driven by FGFR2/3, marking a significant milestone in the company's research efforts [3] - APL-2401 is a globally developed innovative drug that successfully entered the "30-day channel" for clinical trial approval, receiving approval in just 22 working days [3] Group 4: Financial Performance and Strategic Focus - The company reported revenue of approximately 216 million yuan for the first three quarters of 2025, representing a year-on-year growth of 55.74% [3] - Aihong Pharmaceutical is focused on the urogenital oncology and women's health sectors, developing a competitive product pipeline to address unmet clinical needs [4] - The company is actively advancing its research and development of several products, including APL-1702, APL-1202/APL-1501, APL-2302, APLD-2304, APL-1401, and APL2301 [4]

Core Viewpoint - The company, Yahuang Pharmaceutical (688176.SH), has submitted a medical device registration application for its product APLD-2304 to the EU Notified Body (BSI Group The Netherlands B.V.), which has been accepted, pending further review and approval for market launch [1] Group 1 - APLD-2304 is the world's first portable single-use blue light bladder endoscope developed for the diagnosis and follow-up monitoring of bladder cancer [1]

证券代码：688176 证券简称：亚虹医药 公告编号：2025-047 江苏亚虹医药科技股份有限公司 自愿披露关于 APLD-2304 申报欧洲医疗器械注册获接 收的公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 江苏亚虹医药科技股份有限公司（以下简称"公司"）产品 APLD-2304 于近 日向欧盟公告机构（BSI Group The Netherlands B.V.）提交了医疗器械注册申请 材料，并获得欧盟公告机构接收，后续尚需通过欧盟公告机构的审评、审批后方 可上市销售。本次 APLD-2304 医疗器械注册申请递交获接收事项，对公司近期 业绩不会产生重大影响。由于产品的研发周期长、审批环节多、研发投入大，容 易受到一些不确定性因素的影响，敬请广大投资者谨慎决策，注意防范投资风险。 现将相关情况公告如下： 一、产品基本情况 产品名称：APLD-2304 申请事项：欧盟 CE 医疗器械注册申请 申请人：上海亚虹医药科技有限公司 APLD-2304 是公司针对膀胱癌诊断及随访监测的使用场景和需求，研 ...

证券代码：688176 证券简称：亚虹医药 公告编号：2025-048 邮 箱：securities@asieris.cn 联系地址：上海市浦东新区东育路 221 弄前滩世贸中心（三期）B 栋 19F 1 江苏亚虹医药科技股份有限公司 关于公司董事会秘书正式履职的公告 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、准确性和完整性依法承担法律责任。 江苏亚虹医药科技股份有限公司（以下简称"公司"）于 2025 年 10 月 29 日召开第二届董事会第十九次会议，审议通过了《关于聘任高级管理人员的议案》， 董事会同意聘任陈宝华先生担任公司董事会秘书，由于陈宝华先生尚未取得上海 证券交易所颁发的科创板董事会秘书任职培训证明，暂由其作为财务负责人代行 董事会秘书职责，对陈宝华先生董事会秘书职务的聘任将于其取得相关证明后正 式生效。具体内容详见公司于 2025 年 10 月 30 日在上海证券交易所网站 （www.sse.com.cn）披露的《江苏亚虹医药科技股份有限公司关于选举第二届董 事会职工董事及聘任高级管理人员的公告》（公告编号：2025-040）。 近日 ...

Core Viewpoint - The company, Yahui Pharmaceutical (688176.SH), has submitted a medical device registration application for its product APLD-2304 to the EU Notified Body (BSI Group The Netherlands B.V.), which has been accepted. The product aims to enhance bladder cancer diagnosis and monitoring, but this submission will not have a significant impact on the company's recent performance [1]. Group 1 - APLD-2304 is the world's first portable single-use blue light cystoscope developed for bladder cancer diagnosis and follow-up monitoring [1]. - The product addresses the limitations of traditional white light cystoscopy, which often overlooks early-stage bladder cancer due to its flat growth or small margins, leading to low detection rates and high recurrence rates [1]. - The combination of APLD-2304 with blue light imaging agents forms a diagnostic solution that improves bladder cancer detection rates and reduces recurrence rates, while its design enhances convenience for doctors and comfort for patients, minimizing the risk of cross-infection [1].

Core Viewpoint - The company has submitted a medical device registration application for its product APLD-2304 to the EU regulatory body, which has been accepted, but it still requires further review and approval before market launch [1] Group 1: Product Information - APLD-2304 is the first portable single-use blue light bladder endoscope, which, when combined with blue light imaging agents, can improve bladder cancer detection rates and reduce recurrence rates [1] - The annual new cases of bladder cancer in Europe exceed 130,000, indicating a high market potential for the product [1] Group 2: Financial Impact and Risks - The acceptance of the application will not have a significant impact on the company's recent performance [1] - There are uncertainties associated with product development and approval, which investors are advised to consider [1]

Market Performance - The chemical pharmaceutical sector increased by 1.95% on December 19, with XinNuoWei leading the gains [1] - The Shanghai Composite Index closed at 3890.45, up 0.36%, while the Shenzhen Component Index closed at 13140.22, up 0.66% [1] Top Gainers in Chemical Pharmaceutical Sector - XinNuoWei (300765) closed at 34.69, up 11.44%, with a trading volume of 311,700 shares and a transaction value of 1.069 billion [1] - KangYi Pharmaceutical (300086) closed at 11.02, up 11.43%, with a trading volume of 965,500 shares and a transaction value of 1.018 billion [1] - MuNanHai Pharmaceutical (000566) closed at 7.24, up 10.03%, with a trading volume of 1,325,900 shares and a transaction value of 914 million [1] Market Capital Flow - The chemical pharmaceutical sector saw a net inflow of 68.1822 million from institutional investors, while retail investors contributed a net inflow of 31.3 million [2] - The sector experienced a net outflow of 381 million from speculative funds [2] Individual Stock Capital Flow - ST Renfu (600079) had a net inflow of 92.7508 million from institutional investors, while it faced a net outflow of 26.4283 million from speculative funds [3] - GuangShengTang (300436) recorded a net inflow of 49.2520 million from institutional investors, with a net outflow of 17.4322 million from speculative funds [3] - KangZhi Pharmaceutical (300086) had a net inflow of 28.1873 million from institutional investors, while it faced a net outflow of 3.1280 million from retail investors [3]

Core Viewpoint - The A-share market shows positive momentum with the Shanghai Composite Index closing at 3890.45 points, above the half-year line, reflecting a gain of 0.36% and a total trading volume of 1.748742 trillion yuan [1] Group 1: Market Performance - The Shanghai Composite Index closed at 3890.45 points, above the half-year line, with a gain of 0.36% [1] - Total trading volume in the A-share market reached 1.748742 trillion yuan [1] Group 2: Stocks Breaking Half-Year Line - A total of 266 A-shares have surpassed the half-year line, indicating strong market interest [1] - Notable stocks with significant deviation rates include: - GQY Vision (10.23%) - Hongwei Technology (9.84%) - Zhongwang Fabric (8.75%) [1] Group 3: Detailed Stock Data - GQY Vision: Today's price increased by 11.23% with a turnover rate of 13.78%, latest price at 7.23 yuan [1] - Hongwei Technology: Today's price increased by 12.30% with a turnover rate of 17.12%, latest price at 27.49 yuan [1] - Zhongwang Fabric: Today's price increased by 9.98% with a turnover rate of 1.78%, latest price at 25.78 yuan [1]

Group 1 - The Shanghai Composite Index closed at 3887.81 points, above the six-month moving average, with a gain of 0.30% [1] - The total trading volume of A-shares reached 1,390.087 billion yuan [1] - A total of 249 A-shares have surpassed the six-month moving average, with notable stocks including GQY Vision, Hongwei Technology, and Zhongwang Fabric, showing significant deviation rates of 12.05%, 9.88%, and 8.75% respectively [1] Group 2 - GQY Vision (300076) had a daily increase of 13.08% with a turnover rate of 10.52%, and its latest price was 7.35 yuan, showing a deviation rate of 12.05% [1] - Hongwei Technology (688711) increased by 12.34% with a turnover rate of 15.68%, latest price at 27.50 yuan, and a deviation rate of 9.88% [1] - Zhongwang Fabric (605003) rose by 9.98% with a turnover rate of 1.76%, latest price at 25.78 yuan, and a deviation rate of 8.75% [1]

（文章来源：证券时报网） | 600367 | 红星发 | 10.02 | 7.95 | 16.41 | 17.13 | 4.41 | | --- | --- | --- | --- | --- | --- | --- | | | 展 | | | | | | | 002363 | 隆基机 | 5.65 | 3.37 | 8.25 | 8.60 | 4.28 | | | 械 | | | | | | | 603001 | 奥康国 | 7.61 | 1.49 | 8.68 | 9.05 | 4.25 | | | 际 | | | | | | | 000679 | 大连友 | 7.00 | 2.69 | 8.53 | 8.87 | 3.95 | | | 谊 | | | | | | | 601089 | 福元医 | 5.64 | 0.87 | 23.42 | 24.33 | 3.89 | | | 药 | | | | | | | 603596 | 伯特利 | 6.36 | 2.18 | 48.96 | 50.85 | 3.86 | | | 利源股 | | | | | | | 002501 | 份 | 10.14 | 4.6 ...