Workflow
Asieris(688176)
icon
Search documents
亚虹医药:APL-2401临床试验申请获得国家药品监督管理局批准
Ge Long Hui· 2025-12-17 07:47
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]
12月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-03 10:19
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]
亚虹医药在ECC发布APL-1401Ⅰb期临床试验相关数据
Zhi Tong Cai Jing· 2025-12-03 09:51
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]
亚虹医药(688176.SH)在ECC发布APL-1401Ⅰb期临床试验相关数据
智通财经网· 2025-12-03 09:51
APL-1401是公司通过自主研究并发现其全新作用机制用于治疗自身免疫疾病的口服创新药物。APL- 1401是一种强效、选择性的多巴胺β-羟化酶(DBH)抑制剂,通过抑制DBH,从而阻断了多巴胺(DA)合成 去甲肾上腺素(NE)唯一的催化酶,导致DA升高、NE降低,使肠道免疫稳态恢复正常。 智通财经APP讯,亚虹医药(688176.SH)发布公告,近日,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期临床试验结果入选第19届欧洲结直肠大会(ECC),并以壁报形式发布该研究的临 床数据。 ...
亚虹医药(688176) - 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-1401Ⅰb期临床试验相关数据的公告
2025-12-03 09:30
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, ...
亚虹医药:APL-1401Ⅰb期临床试验数据在ECC发布
Xin Lang Cai Jing· 2025-12-03 09:29
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]
亚虹医药:在欧洲结直肠大会发布APL-1401 Ⅰb期临床试验数据
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]
亚虹医药跌2.26% 2022上市即巅峰募25亿中信证券保荐
Zhong Guo Jing Ji Wang· 2025-12-01 09:33
Group 1 - The core point of the article highlights that Yahui Pharmaceutical (688176.SH) is currently trading at 9.95 yuan, reflecting a decline of 2.26% and is in a state of share price decline since its IPO [1] - Yahui Pharmaceutical was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on January 7, 2022, with an issuance of 110 million shares at a price of 22.98 yuan per share, underwritten by CITIC Securities [1] - The stock price fell below the IPO price on the first trading day, reaching a maximum price of 20.00 yuan, which was the highest price since its listing [1] Group 2 - The total funds raised from the initial public offering (IPO) amounted to 2.528 billion yuan, with a net amount of 2.381 billion yuan after deducting issuance costs, exceeding the original plan by 311 million yuan [1] - The funds are intended for projects including drug and medical device production, new drug research and development, marketing network construction, and working capital supplementation [1] - The total issuance costs for the IPO were 147 million yuan, with CITIC Securities receiving 130 million yuan in underwriting and sponsorship fees [1] Group 3 - The controlling shareholder and actual controller of Yahui Pharmaceutical is PAN KE, who holds American nationality and serves as the chairman and general manager of the company [1]
亚虹医药(688176) - 江苏亚虹医药科技股份有限公司关于变更签字注册会计师的公告
2025-11-28 09:00
证券代码:688176 证券简称:亚虹医药 公告编号:2025-044 江苏亚虹医药科技股份有限公司 关于变更签字注册会计师的公告 二、本次变更人员的基本信息、诚信记录和独立性情况 1、基本信息 1 王子竹女士,于 2022 年成为注册会计师,2017 年开始从事上市公司审计, 2017 年开始在立信会计师事务所执业,2025 年开始为公司提供审计服务。王子 竹女士近三年从业情况如下: 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")已分别于 2025 年 4 月 18 日召开第二届董事会第十四次会议、2025 年 5 月 23 日召开 2024 年年度股 东大会,审议通过了《关于续聘公司 2025 年度审计机构的议案》,同意续聘立 信会计师事务所(特殊普通合伙)(以下简称"立信会计师事务所")担任公司 2025 年度审计机构,具体内容详见公司分别于 2025 年 4 月 19 日、2025 年 5 月 24 日在上海证券交易所网站(www.sse.com.cn)披露的《江苏 ...
亚虹医药(688176) - 江苏亚虹医药科技股份有限公司关于召开2025年第三季度业绩说明会的公告
2025-11-19 08:00
证券代码:688176 证券简称:亚虹医药 公告编号:2025-043 一、说明会类型 本次投资者说明会以视频结合网络互动的方式召开,公司将针对 2025 年第 三季度的经营成果及财务指标的具体情况与投资者进行互动交流和沟通,在信 息披露允许的范围内就投资者普遍关注的问题进行回答。 1 会议召开时间:2025 年 11 月 27 日(星期四)13:00-14:45 会议召开地点:上海证券交易所上证路演中心 会议召开方式:上证路演中心视频结合网络互动 投资者可于 2025 年 11 月 20 日(星期四)至 11 月 26 日(星期三)16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 securities@asieris.cn 进行提问。公司将在说明会上对投资者普遍关注的问 题进行回答。 江苏亚虹医药科技股份有限公司 关于召开 2025年第三季度业绩说明会的公告 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: (网址:http://roadshow.sseinfo.com/) 江苏亚 ...