证券代码：688176 证券简称：亚虹医药 公告编号：2025-046 江苏亚虹医药科技股份有限公司 自愿披露关于 APL-2401 临床试验申请获得国家药品 监督管理局批准的公告 一、药品基本情况 药物名称：ASN-8639 片 申请事项：临床试验申请 申请人：江苏亚虹医药科技股份有限公司 1 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"）收到国家药品 监督管理局（NMPA）签发的《药物临床试验批准通知书》，公司 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 申请获得批准。APL-2401 为全球同步研发的 1 类创新药，其国际多中心临床试 验设计及申报资料符合国际临床试验技术标准体系要求，成功纳入国家药监局于 2025 年 9 月 12 日发布的《关于优化创新药临床试验审评审批有关事项的公告 （2025 年第 86 号）》规定的"30 日通道"，并以仅 22 个工作日获得批准， ...

Core Viewpoint - The company Aihong Pharmaceutical (688176.SH) has received approval from the National Medical Products Administration (NMPA) for its clinical trial application of APL-2401 (ASN-8639 tablets) in patients with advanced solid tumors driven by FGFR2/3 [1] Group 1 - APL-2401 is a first-class innovative drug developed globally in parallel [1] - The clinical trial design and submission materials meet international clinical trial technical standards [1] - The project was approved under the "30-day channel" established by the NMPA's announcement on optimizing the review and approval of innovative drug clinical trials, and it received approval in just 22 working days [1]

Core Viewpoint - Aihong Pharmaceutical (688176) has received approval from the National Medical Products Administration for its clinical trial application of APL-2401, a first-class innovative drug targeting FGFR2/3-driven advanced solid tumors, marking a significant milestone in its development process [1] Group 1 - The clinical trial for APL-2401 (also known as ASN-8639 tablets) is approved to be conducted on patients with advanced solid tumors driven by FGFR2/3 [1] - APL-2401 is a globally developed innovative drug that meets international clinical trial technical standards [1] - The approval was granted within 22 working days, making it one of the first projects to receive approval under the new policy announced on September 12, 2025, which includes a "30-day channel" for innovative drug clinical trial reviews [1]

Core Viewpoint - The company, Yahui Pharmaceutical (688176.SH), has received approval from the National Medical Products Administration (NMPA) for its clinical trial application of APL-2401, a novel drug targeting FGFR2/3 in patients with advanced solid tumors, marking a significant milestone in its development process [1] Group 1: Clinical Trial Approval - The NMPA issued a "Drug Clinical Trial Approval Notification" for APL-2401, allowing the company to conduct Phase I clinical trials in patients with FGFR2/3-driven advanced solid tumors [1] - APL-2401 is classified as a first-class innovative drug and has been designed in accordance with international clinical trial technical standards [1] - The approval was granted in just 22 working days, making it one of the first projects to receive approval under the new policy announced by the NMPA on September 12, 2025, which aims to optimize the review and approval process for innovative drugs [1] Group 2: Drug Profile and Potential - APL-2401 is a highly selective small molecule inhibitor targeting fibroblast growth factor receptors 2 and 3 (FGFR2/3) [1] - The drug is expected to provide a new treatment option for patients with advanced solid tumors, including urothelial carcinoma, cholangiocarcinoma, endometrial cancer, gastric cancer, breast cancer, ovarian cancer, non-small cell lung cancer, and other specific solid tumors [1]

Group 1 - Dongfang Electric announced that three executives plan to reduce their holdings by a total of no more than 30,000 shares due to personal financial needs [1] - Yahu Pharmaceutical's APL-1401 clinical trial data was presented at the 19th European Colorectal Congress, indicating progress in treating moderate to severe ulcerative colitis [1] - Guizhou Bai Ling's actual controller is under investigation by the China Securities Regulatory Commission for insider trading and information disclosure violations [3] Group 2 - Bairen Medical's ePTFE pericardial membrane product has been approved for registration, ending the reliance on imports for this product in the domestic market [4] - Qianxin received approval for a total of 2 billion yuan in technology innovation bonds, with plans to issue medium-term notes and short-term financing bonds [6] - Tengjing Technology's shareholder plans to reduce holdings by no more than 1.96% of the company's shares [7] Group 3 - Yuntianhua's subsidiary is required to pay 386 million yuan in overdue taxes and penalties, which will impact the company's net profit for 2025 [8] - Jianyou Pharmaceutical's propofol emulsion injection has received FDA approval in the United States [9] - Suzhou Gaoxin successfully acquired land use rights for a residential project for 360 million yuan [9] Group 4 - Chalco International's subsidiary won a bid for a 3.03 billion yuan electrolytic aluminum project [11] - Tai Long Pharmaceutical's stock will continue to be suspended due to potential changes in control as the major shareholder is planning a share transfer [12] - Qianli Technology reported a 63.44% year-on-year increase in automobile sales for November, although new energy vehicle sales decreased by 43.98% [13] Group 5 - Fosun Pharma's innovative drug FXS0887 has received approval for a Phase I clinical trial for advanced malignant solid tumors [14] - Guoen Co. has obtained approval for a project to produce 20,000 square meters of aviation-grade acrylic glass, with a total investment of 560 million yuan [15] - Guofa Co.'s chairman resigned due to personal reasons [17] Group 6 - Shanghai Construction won a bid for a state-owned construction land use right for 264 million yuan [18] - Weixin Kang's subsidiary received approval for a clinical trial of lidocaine cream for local anesthesia [20] - Sanxing Medical's subsidiary is a candidate for a 152 million yuan transformer procurement project for the State Grid [20] Group 7 - People's Daily announced the resignation of its president due to work changes, while retaining other leadership roles [21] - Beibu Gulf Port reported a 0.29% year-on-year increase in cargo throughput for November [22] - Chongqing Construction won three engineering projects with a total value of approximately 2.773 billion yuan [23] Group 8 - Xingyu Co. is planning to issue H-shares and list on the Hong Kong Stock Exchange [24] - Huajian Group signed a design contract worth 160 million yuan for a comprehensive project [25] - Wankai New Materials plans to invest 350 million yuan in a technical transformation project for producing 100,000 tons of adipic acid [26] Group 9 - Kaipuyun received a government subsidy of 18 million yuan, which is 87.43% of its net profit for the last audited fiscal year [28] - Ningbo Port expects a 10.8% year-on-year increase in container throughput for November [30] - An Cai High-Tech plans to invest 498 million yuan to upgrade its photovoltaic glass production line [32] Group 10 - Shunhao Co. stated that its existing business has not generated synergies with the rail business, which faces various risks [34] - Yihualu plans to publicly transfer 35% of its stake in Liaoyun Company [35] - ST Wanfang's shareholder plans to reduce holdings by no more than 3% of the company's shares [36] Group 11 - Youyou Food's shareholder plans to reduce holdings by no more than 110,000 shares [38] - Hengtong Optic-Electric's incentive fund has spent 49.98 million yuan to purchase company shares [41] - Zoli Pharmaceutical plans to issue convertible bonds to raise no more than 1.556 billion yuan for various projects [42]

Core Viewpoint - APL-1401, an innovative oral drug developed by the company for the treatment of moderate to severe active ulcerative colitis, has had its phase Ib clinical trial results selected for presentation at the 19th European Colorectal Congress (ECC) [1] Group 1: Clinical Trial Results - The phase Ib clinical trial results of APL-1401 were presented in poster format at the ECC [1] - APL-1401 is designed to treat autoimmune diseases through a novel mechanism of action [1] Group 2: Drug Mechanism - APL-1401 is a potent and selective dopamine β-hydroxylase (DBH) inhibitor [1] - By inhibiting DBH, APL-1401 blocks the only catalytic enzyme for the synthesis of norepinephrine (NE) from dopamine (DA), leading to increased DA and decreased NE, which helps restore intestinal immune homeostasis [1]

Core Viewpoint - Aihong Pharmaceutical (688176.SH) announced that the results of its phase Ib clinical trial for APL-1401, aimed at treating moderate to severe active ulcerative colitis, were selected for presentation at the 19th European Colorectal Congress (ECC) in the form of a poster [1] Group 1 - APL-1401 is an innovative oral drug discovered through the company's independent research, featuring a novel mechanism of action for treating autoimmune diseases [1] - APL-1401 acts as a potent and selective dopamine β-hydroxylase (DBH) inhibitor, which blocks the only catalytic enzyme for the synthesis of norepinephrine (NE) from dopamine (DA) [1] - The inhibition of DBH leads to an increase in DA levels and a decrease in NE levels, thereby restoring intestinal immune homeostasis [1]

证券代码：688176 证券简称：亚虹医药 公告编号：2025-045 江苏亚虹医药科技股份有限公司 自愿披露关于在第 19 届欧洲结直肠大会（ECC）发 布 APL-1401 Ⅰb 期临床试验相关数据的公告 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。 1 肠癌的风险。目前尚无治愈 UC 的方法，现有疗法的有效性和安全性仍存在进一 步提升的空间，存在巨大未被满足的临床需求，亟需新机制的疗法。 重要内容提示： 1、近日，江苏亚虹医药科技股份有限公司（以下简称"公司"）开展的 APL-1401 用于治疗中重度活动性溃疡性结肠炎的 Ⅰb 期临床试验（以下简称"该 研究"）结果入选第 19 届欧洲结直肠大会（European Colorectal Congress，ECC）， 并以壁报形式发布该研究的临床数据。 2、目前上述在研产品尚处于临床试验早期阶段，未来临床试验结果能否支 持药品递交上市申请、能否最终获得上市批准以及何时获批均具有不确定性，产 品获批后能否最终实现预期商业目的也存在一定的不确定性。本次发表临床试验 数据， ...

Core Viewpoint - The company announced that its clinical trial results for APL-1401, aimed at treating moderate to severe active ulcerative colitis, have been selected for presentation at the 19th European Colorectal Congress (ECC) in the form of a poster [1] Group 1 - The clinical trial for APL-1401 is in the Phase Ib stage [1] - The results of the trial have been recognized and will be shared at a significant industry event, indicating potential interest and validation from the medical community [1]

Core Viewpoint - Aihong Pharmaceutical (688176) announced the results of its APL-1401 clinical trial for moderate to severe active ulcerative colitis, which were presented at the 19th European Colorectal Congress [1] Group 1: Clinical Trial Information - APL-1401 is an innovative oral drug developed by the company, targeting autoimmune diseases with a novel mechanism of action [1] - The clinical trial is currently in the early stages, and there is uncertainty regarding whether the results will support a drug submission for market approval and when such approval might occur [1]