Core Viewpoint - Yahui Pharmaceutical is accelerating the review and approval process for its drug APL-1702 after receiving technical review completion from the National Medical Products Administration's Center for Drug Evaluation (CDE) [1] Group 1 - The CDE has completed the technical review of APL-1702 [1] - The company aims to expedite the listing approval process for APL-1702 [1]

Core Viewpoint - Yahui Pharmaceutical has shown significant trading activity with a notable increase in stock price and fluctuations in financing and margin trading, indicating investor interest and potential volatility in the stock. Group 1: Stock Performance - On January 22, Yahui Pharmaceutical's stock rose by 2.01%, with a trading volume of 316 million yuan [1] - The financing buy-in amount on the same day was 28.60 million yuan, while the financing repayment was 37.93 million yuan, resulting in a net financing buy of -9.33 million yuan [1] - As of January 22, the total financing and margin trading balance for Yahui Pharmaceutical was 238 million yuan, accounting for 3.98% of its market capitalization [1] Group 2: Financing and Margin Trading - The financing balance of Yahui Pharmaceutical is at a high level, exceeding the 80th percentile of the past year [1] - On January 22, the company had a margin repayment of 1,956 shares with no shares sold, resulting in a margin balance of 374,000 yuan, which is above the 90th percentile of the past year [1] Group 3: Company Overview - Yahui Pharmaceutical, established on March 16, 2010, is located in the Pudong New Area of Shanghai and was listed on January 7, 2022 [1] - The company's main business involves the research, production, and sales of innovative drugs, with 96.34% of its revenue coming from anti-tumor products [1] Group 4: Financial Performance - As of September 30, 2025, Yahui Pharmaceutical reported 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 -249 million yuan, showing an increase of 8.08% year-on-year [2] - The number of shareholders decreased to 25,200, while the average circulating shares per person increased by 16.41% to 17,294 shares [2] Group 5: Institutional Holdings - As of September 30, 2025, the seventh largest circulating shareholder of Yahui Pharmaceutical is Penghua Medical Technology Stock A, holding 6.14 million shares, which is a decrease of 401,700 shares from the previous period [2]

Core Viewpoint - Jiangsu Yahui Pharmaceutical Technology Co., Ltd. has received approval for the Phase I clinical trial of its product APL-2401 in Australia, which targets FGFR2/3-driven advanced solid tumors, marking a significant step in its international clinical research efforts [2][3]. Group 1: Drug Information - The drug APL-2401, also known as ASN-8639 tablets, is a highly selective small molecule inhibitor targeting FGFR2/3, aimed at providing new treatment options for patients with advanced solid tumors such as urothelial carcinoma, cholangiocarcinoma, endometrial cancer, gastric cancer, breast cancer, ovarian cancer, non-small cell lung cancer, and other specific solid tumors [3][4]. - APL-2401 demonstrates superior dual kinase inhibition activity compared to existing FGFR2 or FGFR3 selective inhibitors, showing enhanced tumor cell killing and modulation of the tumor microenvironment while significantly reducing side effects associated with FGFR1 and FGFR4 [4]. Group 2: Clinical Trial Approval - The clinical trial application for APL-2401 has already been approved by the National Medical Products Administration (NMPA) in China, and the company is actively advancing the product's international multi-center clinical research [2][5]. - The approval process for the clinical trial in Australia was expedited, with the application being processed in just 22 working days, making it one of the first projects to receive approval under the new policy aimed at optimizing the review and approval of innovative drugs [5]. Group 3: Market Impact - The recent approval for the Phase I clinical trial in Australia is not expected to have a significant impact on the company's short-term performance, as drug development is characterized by long cycles, multiple approval stages, and substantial investment [2][6].

Group 1 - Huakang Clean announced it is the first candidate for the bid of the Wuhan First Hospital expansion project with a bid amount of 54.88 million yuan and a construction period of 120 days [1] - Hualing Steel's subsidiary plans to invest 449.88 million yuan in a major overhaul project for its coking plant, aiming to address aging issues and restore production capacity over a 19-month construction period [2] - Yinjia Technology expects a net loss of 140 million to 110 million yuan for 2025, compared to a loss of 129 million yuan in the previous year [3] Group 2 - Guochuang High-tech forecasts a net profit of 16 million to 24 million yuan for 2025, recovering from a loss of 58.52 million yuan in the previous year [4] - Shiyi Da anticipates a net profit increase of 31 million to 46 million yuan for 2025, turning around from a loss of 23.41 million yuan last year [5] - Lijun Co. expects a net profit of 48 million to 66 million yuan for 2025, representing a decline of 45.05% to 60.03% compared to the previous year [7] Group 3 - Xindian Pharmaceutical plans to repurchase shares worth 25 million to 50 million yuan for employee stock ownership plans or equity incentives, with a maximum repurchase price of 42 yuan per share [6] - Jingchen Co. has set the initial transfer price for its shares at 82.85 yuan per share, with a total of 13.1 million shares to be transferred to 28 institutional investors [8] - Zejing Pharmaceutical received approval for clinical trials of its innovative cancer immunotherapy drug ZG005 in combination with platinum-based chemotherapy for advanced nasopharyngeal and esophageal squamous cell carcinoma [9] Group 4 - Xingqi Eye Medicine expects a net profit of 662 million to 749 million yuan for 2025, marking a growth of 95.82% to 121.56% compared to the previous year [10] - Liancheng Precision anticipates a net loss of 12 million to 17 million yuan for 2025, reducing its loss from 37.96 million yuan in the previous year [11] - Beidou Star expects a net loss of 230 million to 290 million yuan for 2025, improving from a loss of 350 million yuan last year [13] Group 5 - Qing Shan Paper's affiliate won a bid for a wastewater treatment project worth 51.9 million yuan [15] - Yiling Pharmaceutical forecasts a net profit of 1.2 billion to 1.3 billion yuan for 2025, recovering from a loss of 725 million yuan in the previous year [16] - Huahai Pharmaceutical received a drug registration certificate for its product used in treating depression and obsessive-compulsive disorder [23] Group 6 - Nanjing Panda expects a net profit of 10 million to 15 million yuan for 2025, turning around from a loss of 189 million yuan last year [40] - Rui Sheng Intelligent anticipates a net profit of 33.92 million to 38.40 million yuan for 2025, representing a growth of 112% to 140% compared to the previous year [41] - Jiechang Drive expects a net profit of 395 million to 437 million yuan for 2025, with a growth of 40% to 55% compared to the previous year [43]

Core Viewpoint - Asieris Pharmaceuticals has received approval from Australian authorities to conduct Phase I clinical trials for its product APL-2401, a dual-target small molecule inhibitor for FGFR2/3, which is expected to provide a new treatment option for patients with advanced solid tumors [1] Group 1 - APL-2401, also known as ASN-8639 tablets, has been developed independently by the company [1] - The product has previously received clinical trial approval from the National Medical Products Administration [1] - The approval in Australia is not expected to have a significant impact on the company's recent performance, and there are uncertainties associated with the research and development process [1]

Core Viewpoint - Asieris Pharmaceuticals has received ethical approval for its product APL-2401 to conduct Phase I clinical trials in Australia for patients with advanced solid tumors driven by FGFR2/3 [1] Group 1: Clinical Trial Approval - The company’s subsidiary, Asieris Pharmaceuticals (Aus) Pty Ltd, has obtained ethical approval from the Human Research Ethics Committee in Australia for APL-2401 [1] - The clinical trial has also been registered with the Therapeutic Goods Administration, the Australian drug regulatory authority [1] - APL-2401 has previously received approval from the National Medical Products Administration in China, indicating the company's commitment to advancing international multi-center clinical research [1] Group 2: Product Overview - APL-2401 is a highly selective small molecule inhibitor targeting FGFR2/3, developed to provide new treatment options for patients with advanced solid tumors such as urothelial carcinoma, cholangiocarcinoma, endometrial cancer, gastric cancer, breast cancer, ovarian cancer, non-small cell lung cancer, and other specific solid tumors [1] - The drug was optimized through the TAIDD platform, focusing on its selective mechanism for compound discovery and design [2] - APL-2401 demonstrates superior dual kinase inhibition activity compared to existing FGFR2 or FGFR3 selective inhibitors, with enhanced tumor cell killing and tumor microenvironment modulation effects [2] Group 3: Safety and Efficacy - Preclinical studies indicate that APL-2401 shows excellent efficacy and a wider safety window across various FGFR2/3 gene mutation, amplification, or overexpression models [2] - Compared to pan-FGFR inhibitors, APL-2401 significantly reduces the side effects associated with FGFR1 and FGFR4 [2] - The product exhibits potential best-in-class advantages in terms of activity, selectivity, safety, and druggability within the FGFR2/3 targeted therapy field [2]

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。 证券代码：688176 证券简称：亚虹医药 公告编号：2026-003 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"）子公司 Asieris Pharmaceuticals (Aus) Pty Ltd 收到澳大利亚人类研究伦理委员会签发的关于批准 公司开发的产品 APL-2401（药物名称为 ASN-8639 片）在 FGFR2/3 驱动的晚期 实体瘤患者中开展Ⅰ期临床试验的临床试验伦理许可，并于澳大利亚卫生部所属 的 Therapeutic Goods Administration（即澳大利亚药品管理局）完成临床试验备 案。按照澳大利亚药品注册相关法律法规，公司已获得该产品 I 期临床试验许可。 此前 APL-2401 临床试验申请已获得国家药品监督管理局批准，公司将积极推进 该产品的国际多中心临床研究。 江苏亚虹医药科技股份有限公司 自愿披露关于 APL-2401 在澳大利亚获得开展Ⅰ期临床 试验许可的公告 1 CTN 号：CT-2025-CTN- ...

Core Viewpoint - Yahui Pharmaceutical has completed the technical review of APL-1702 by the Center for Drug Evaluation (CDE) of the National Medical Products Administration and is accelerating the approval process for its market launch [1] Group 1 - The company aims to obtain market approval for APL-1702 as soon as possible [1] - The company will strictly adhere to the information disclosure obligations as per the Shanghai Stock Exchange's Sci-Tech Innovation Board listing rules and other relevant regulations [1]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of January 19, 2026 [1] Core Insights - 2025 marked a significant year for Chinese innovative drugs going global, with a total transaction amount of $135.655 billion, including $7 billion in upfront payments and 157 deals, setting historical highs. The trend continues into 2026, with notable licensing agreements from companies like Yilian Biotech and Rongchang Biotech, indicating strong global competitiveness for Chinese innovative drugs [2] - Major companies are increasingly investing in the small nucleic acid field, with significant acquisitions and clinical approvals. For instance, China National Pharmaceutical Group acquired Hangzhou Hejiya Biopharmaceutical for 1.2 billion RMB, while international firms like Novartis and GSK are also advancing in this area [3] - The GLP-1 market is expected to grow despite new pricing systems, with ongoing collaborations and new product launches anticipated in 2026. The market for GLP-1 drugs is projected to remain robust due to the large patient population for weight loss and diabetes [4] - The oral autoimmune drug market is gaining attention, with promising results from Takeda's new TYK2 inhibitor for psoriasis. Other domestic companies are also advancing in this space, exploring new targets for oral small molecules [5] - The brain-computer interface sector is poised for industrialization, with companies like Neuralink set to produce devices in 2026. Domestic advancements and regulatory support are enhancing the potential for this technology in medical applications [6] - The ZAP-X radiation therapy device is expected to capture a significant market share in China, with rapid growth projected in non-invasive tumor radiation treatment, driven by increasing clinical recognition and adoption [8] Summary by Sections Industry Trends - The pharmaceutical sector is witnessing a resurgence in interest towards innovative drugs, with a notable increase in the innovative drug index by 8.97% since early January 2026, outperforming the CSI 300 index by 6.77 percentage points [2] Company Recommendations - Recommended companies include: - **Yuekang Pharmaceutical** and **Sunshine Nuohua** in the small nucleic acid space - **Yahong Pharmaceutical** and **Yifang Biotechnology** in the autoimmune sector - **Zhongsheng Pharmaceutical** in the GLP-1 market - **Baiyang Pharmaceutical** for ZAP-X radiation therapy - **Meihao Medical** for brain-computer interface technology [10] Market Opportunities - The non-invasive tumor radiation treatment market is projected to grow from 27.2 billion RMB in 2018 to 59.4 billion RMB by 2024, with a compound annual growth rate of 13.9% [8]

Core Viewpoint - Jiangsu Yahon Pharmaceutical Technology Co., Ltd. plans to utilize part of its temporarily idle raised funds for cash management, aiming to enhance fund efficiency while ensuring the safety of the raised funds and the implementation of investment projects [1][2]. Cash Management Overview - The company intends to use a maximum of RMB 1.2 billion (including the amount) of temporarily idle raised funds for cash management, with a validity period of 12 months from the date of the board's approval [2][8]. - The cash management aims to increase returns for the company and its shareholders while not affecting the normal operation of the fundraising investment projects [2][12]. Investment Details - The investment will focus on high-security, high-liquidity financial products sold by qualified financial institutions, including agreement deposits, time deposits, notice deposits, large certificates of deposit, structured deposits, and income certificates [4][8]. - The company will not use these funds for securities investment purposes [4]. Implementation and Oversight - The board has authorized the chairman to make investment decisions and sign relevant contracts within the approved limits and timeframe, with the finance department responsible for implementation [5][8]. - The company will adhere to strict regulatory requirements and maintain a separation of decision-making, execution, and supervision functions to ensure fund safety [10]. Impact on the Company - The use of temporarily idle raised funds for cash management is expected to improve fund efficiency and provide good investment returns for the company and its shareholders, without affecting daily cash flow needs or the normal operation of fundraising projects [12]. Opinions from Intermediaries - The sponsor, CITIC Securities Co., Ltd., has reviewed the cash management plan and found it compliant with relevant laws and regulations, expressing no objections to the company's decision [12].