证券代码：688176 证券简称：亚虹医药 公告编号：2026-001 二、该药品研发及其他相关情况 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： 近日，江苏亚虹医药科技股份有限公司（以下简称"公司"）自主研发的 APL-2401 在 FGFR2/3 驱动的晚期实体瘤患者中开展的 I 期临床试验（以下简称 "该研究"）完成首例受试者入组。现就相关情况公告如下： 一、药品基本情况 APL-2401 是公司自主研发的高选择性成纤维生长因子受体 2/3（FGFR2/3） 双靶点小分子抑制剂，有望为晚期实体瘤（例如：尿路上皮癌、胆管癌、子宫内 膜癌、胃癌、乳腺癌、卵巢癌、非小细胞肺癌和其他特定实体瘤）患者提供一种 新的治疗选择。 公司通过 TAIDD 平台进行靶点多构象模拟，并以其选择性机制作为苗头化 合物发现和设计为核心，从而优化出最终的临床前候选化合物 APL-2401。 APL-2401 是一款通过非共价结合模式与靶点相结合的高选择性的 FGFR2/3 小分 子抑制剂。相比现阶段 FGFR2 或 FGFR3 ...

格隆汇1月8日丨亚虹医药(688176.SH)公布，公司自主研发的APL-2401在FGFR2/3驱动的晚期实体瘤患 者中开展的I期临床试验（简称"该研究"）完成首例受试者入组。APL-2401是公司自主研发的高选择性 成纤维生长因子受体2/3（FGFR2/3）双靶点小分子抑制剂，有望为晚期实体瘤（例如：尿路上皮癌、 胆管癌、子宫内膜癌、胃癌、乳腺癌、卵巢癌、非小细胞肺癌和其他特定实体瘤）患者提供一种新的治 疗选择。 ...

亚虹医药公告，近日，公司自主研发的APL-2401在FGFR2/3驱动的晚期实体瘤患者中开展的I期临床试 验完成首例受试者入组。APL-2401是公司自主研发的高选择性成纤维生长因子受体2/3（FGFR2/3）双 靶点小分子抑制剂，有望为晚期实体瘤患者提供新的治疗选择。 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of December 28, 2025 [1] Core Insights - The report highlights the intensive policy support for brain-computer interface (BCI) technology development, particularly in the medical field, with several policies already implemented [2] - It emphasizes the significant market opportunity in radiation therapy equipment, particularly the ZAP-X system, which is expected to capture a substantial share of the growing market for non-invasive tumor radiation treatment [3] - The introduction of pathology fee reforms is seen as a breakthrough for the commercialization of AI applications in pathology, allowing for better integration of AI-assisted diagnostics into the pricing structure [5] - The report discusses the trend of Chinese innovative drugs entering international markets, which is expected to reduce domestic competition and provide new valuation anchors for these companies [6] - It also notes the promising developments in oral autoimmune drugs and small nucleic acid drugs, with several companies making significant progress in clinical trials [7][9] Summary by Sections 1. Policy Support for BCI Technology - In July 2025, a joint opinion was issued by multiple government departments to promote BCI industry innovation, with medical health being a core application area [2] - The National Medical Products Administration (NMPA) has prioritized the approval of implantable BCI medical devices, with expected registration certificates to be issued by Q1 2026 [2] 2. Radiation Therapy Equipment Market - The ZAP-X system is designed for precise radiation therapy for brain tumors, with a significant patient population in China, estimated at 1.5 million new cases of brain metastases annually [3] - The non-invasive tumor radiation treatment market is projected to grow from RMB 27.2 billion in 2018 to RMB 59.4 billion by 2024, with a compound annual growth rate (CAGR) of 13.9% [3] 3. AI in Pathology - The NMPA's new guidelines for pathology services include AI-assisted diagnostics as an expansion item, which will help streamline the commercialization of AI technologies in pathology [5] 4. Innovative Drug Exports - The report notes that partnerships between Chinese companies and international firms are increasing, providing funding and reducing competition in the domestic market [6] - The innovative drug index has risen by 38.11% since the beginning of 2025, outperforming the CSI 300 index [6] 5. Oral Autoimmune Drugs - Takeda's new oral TYK2 inhibitor has shown positive results in clinical trials for psoriasis, indicating a potential breakthrough in treatment options [7] - Several domestic companies are also advancing in the development of oral autoimmune drugs targeting various conditions [7] 6. Small Nucleic Acid Drugs - Yuyuan Pharmaceutical's YKYY032 injection has received clinical approval from both the FDA and NMPA, with multiple companies in China advancing in the small nucleic acid drug space [9] - The report highlights the reliability of domestic technology platforms as they progress through clinical trials [9] 7. Stock Recommendations - The report recommends specific companies based on the identified opportunities, including Meihua Medical for BCI technology, Baiyang Pharmaceutical for ZAP-X, and Yuyuan Pharmaceutical for small nucleic acid drugs [11]

Group 1 - The core viewpoint of the news is that Yahuang Pharmaceutical has shown significant trading activity and financial performance, with a notable increase in revenue and a high level of financing and margin trading [1][2]. Group 2 - As of December 24, Yahuang Pharmaceutical's stock price decreased by 0.27%, with a trading volume of 60.89 million yuan [1]. - The financing buy-in amount on December 24 was 8.21 million yuan, while the financing repayment was 6.93 million yuan, resulting in a net financing buy of 1.28 million yuan [1]. - The total margin trading balance for Yahuang Pharmaceutical reached 211 million yuan, accounting for 4.40% of its market capitalization, indicating a high level of financing activity [1]. - The company has a high margin balance, with the margin balance exceeding the 70th percentile of the past year [1]. - On the same day, Yahuang Pharmaceutical repaid 2,200 shares in margin trading and sold 400 shares, with the selling amount calculated at 4,404 yuan [1]. - The margin balance of 30,020 yuan is above the 90th percentile of the past year, indicating a high level of short selling [1]. Group 3 - As of September 30, the number of shareholders for Yahuang Pharmaceutical was 25,200, a decrease of 1.06% from the previous period [2]. - The average number of circulating shares per shareholder increased by 16.41% to 17,294 shares [2]. - For the period from January to September 2025, Yahuang Pharmaceutical achieved a revenue of 216 million yuan, representing a year-on-year growth of 55.74% [2]. - The net profit attributable to the parent company was -24.9 million yuan, showing a year-on-year increase of 8.08% [2]. - Among the top ten circulating shareholders, Penghua Medical Technology Stock A ranked seventh, holding 6.14 million shares, a decrease of 401,700 shares compared to the previous period [2].

12月23日，亚虹医药跌1.52%，成交额8891.79万元。两融数据显示，当日亚虹医药获融资买入额790.28 万元，融资偿还945.64万元，融资净买入-155.36万元。截至12月23日，亚虹医药融资融券余额合计2.10 亿元。 融资方面，亚虹医药当日融资买入790.28万元。当前融资余额2.10亿元，占流通市值的4.36%，融资余 额超过近一年70%分位水平，处于较高位。 机构持仓方面，截止2025年9月30日，亚虹医药十大流通股东中，鹏华医药科技股票A（001230）位居 第七大流通股东，持股614.24万股，相比上期减少40.17万股。 责任编辑：小浪快报 资料显示，江苏亚虹医药科技股份有限公司位于上海市浦东新区东育路221弄前滩世贸中心(三期)B栋 19F，成立日期2010年3月16日，上市日期2022年1月7日，公司主营业务涉及创新药物的研发、生产和 销售。主营业务收入构成为：抗肿瘤类产品96.34%，其他3.66%。 截至9月30日，亚虹医药股东户数2.52万，较上期减少1.06%；人均流通股17294股，较上期增加 16.41%。2025年1月-9月，亚虹医药实现营业收入2.16亿元，同比 ...

Group 1 - The State Council emphasizes the need for all departments to align their actions with the central government's economic work requirements for the upcoming year, enhancing responsibility and urgency in implementing tasks [1] - The Ministry of Commerce highlights the importance of high-quality business development and international trade coordination, aiming to boost domestic and international economic cycles [2] - Researchers at Shanghai Jiao Tong University have achieved a breakthrough in all-optical computing chips, which could significantly enhance computational efficiency for AI and large-scale data processing [3] Group 2 - The National Internet Information Office and the China Securities Regulatory Commission have taken action against 17 accounts spreading rumors and illegal stock recommendations, emphasizing the need for accurate financial information dissemination [4] - Fujian Province has introduced a comprehensive financial support plan for technology innovation, aiming for a 10% annual growth in loans to technology-related industries by 2025-2027 [5] - The world's first commercial supercritical carbon dioxide power generation unit has successfully commenced operations, marking a significant advancement in energy technology [6] Group 3 - Moore Threads has launched a new GPU architecture, "Huagang," which boasts a 50% increase in computing density and a tenfold improvement in energy efficiency [7][8] - The first L3-level autonomous driving license has been issued to Changan Automobile, marking a significant milestone in the development of autonomous driving technology [9] - Nine U.S. pharmaceutical companies have reached agreements with the government to lower drug prices, indicating a shift towards more affordable healthcare solutions [10] Group 4 - The market has shown signs of recovery with a three-day rebound, although caution is advised as the overall trend has not yet confirmed a sustained upward movement [11] - Samsung has unveiled the world's first 2nm smartphone chip, which is expected to enhance performance significantly, indicating advancements in semiconductor technology [12]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The trend of Chinese innovative drugs going overseas is opening up long-term value for companies, with significant collaborations occurring since September 2025. The innovative drug index has decreased by 11.34% from September 1 to December 19, underperforming the CSI 300 index by 12.93 percentage points. However, the index has increased by 38.65% since the beginning of the year, outperforming the CSI 300 index by 20.76 percentage points [2] - The report emphasizes the importance of oral immunomodulatory drugs, highlighting the positive results from Takeda's TYK2 inhibitor, zasocitinib, in treating moderate to severe plaque psoriasis. This drug is expected to provide significant benefits to patients and is part of a broader trend of domestic companies developing oral immunomodulatory drugs [3] - The report notes the progress of domestic small nucleic acid drugs, with YKYY032 receiving clinical approval from both the FDA and NMPA. The report anticipates an increase in clinical approvals for small nucleic acid drugs by 2026, as more companies enter this field [5] - The report tracks the flu season, indicating a peak in flu cases and a corresponding increase in the use of new flu medications, which are expected to see significant sales growth due to improved treatment protocols and online sales [7] - The report highlights a recovery in the financing of domestic innovative drugs, with a total financing amount of $5.51 billion in the first three quarters of 2025, a 67.6% increase year-on-year. The report also notes a significant increase in orders for CXO companies, indicating a positive trend in the industry [8] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.14 percentage points in the last week, ranking 22nd among 31 sectors [20] - Over the past month, the pharmaceutical industry underperformed the CSI 300 index by 2.06 percentage points, ranking 19th [24] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index has decreased by 2.50% over the past month, underperforming the CSI 300 index by 2.06 percentage points [40] - The current PE (TTM) for the pharmaceutical industry index is 37.07, above the five-year historical average of 31.16 [44] 3. Recent Research Achievements - The report includes various deep-dive studies on the pharmaceutical industry, focusing on topics such as the growth of oral drugs and the stability of blood products [48] 4. Recent Industry Policies and News - Recent policies from the National Healthcare Security Administration aim to improve the quality and efficiency of medical insurance fund settlements, which could positively impact the pharmaceutical sector [50] - Significant news includes the approval of new drugs by various companies, indicating ongoing innovation and development within the industry [51][52]

Group 1 - The company has appointed Mr. Chen Baohua as the secretary of the board, pending the acquisition of the necessary training certification from the Shanghai Stock Exchange [1][2] - Mr. Chen has completed the required training and his qualifications have been submitted for record to the Shanghai Stock Exchange [2] - The company emphasizes the accuracy and completeness of the announcement, taking legal responsibility for its content [1] Group 2 - The company has submitted a medical device registration application for APLD-2304 to the EU notification body, which has been accepted [4][5] - APLD-2304 is a portable, single-use blue light bladder endoscope designed for bladder cancer diagnosis and monitoring, addressing a significant clinical need due to high recurrence rates of bladder cancer [6][7] - The product aims to improve detection rates of bladder cancer and reduce recurrence through its innovative design and technology [6][7]

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]