证券代码：688513 证券简称：苑东生物 公告编号：2026-002 成都苑东生物制药股份有限公司 关于自愿披露 EP-0226 片 I 期临床试验完成首例受试 者给药的公告 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。 成都苑东生物制药股份有限公司（以下简称"公司"）与中国科学院上海药物 研究所、中科中山药物创新研究院共同研发的 1 类化学创新药 EP-0226 片正在开 展用于治疗神经病理性疼痛的 I 期临床试验，于近日完成首例受试者给药。现将 相关情况公告如下： 一、 EP-0226 片的基本情况 EP-0226 片拟用于治疗神经病理性疼痛，是一种新型的钙离子通道（Cav2.2） 调节剂，其作用机制是通过与钙离子通道α2δ亚基结合，减少神经元钙离子内流， 从而减少谷氨酸盐、去甲肾上腺素等兴奋性神经递质的释放，进而有效控制神经 病理性疼痛。 特此公告。 成都苑东生物制药股份有限公司 本品作为新一代的钙离子通道调节剂，与中枢神经系统组织中的α2δ亚基有 高度亲和力。临床前研究表明，EP-0226 片在靶点选择性、体内 ...

Core Viewpoint - Yuan Dong Bio's wholly-owned subsidiary, Shuo De Pharmaceutical, has received approval from the National Medical Products Administration for the drug registration certificate of Chloral Hydrate Syrup, specifically designed for children [1] Group 1: Product Details - Chloral Hydrate Syrup is intended for sedation and hypnosis in children prior to examinations and procedures [1] - The syrup offers advantages such as no need for dilution, precise dosage control, and a child-friendly taste [1] Group 2: Company Impact - The approval of this drug enriches the company's product pipeline in the anesthesia and analgesia sector [1] - The product has not yet been commercialized, so it will not have a significant impact on the company's recent performance [1]

Group 1 - Huibo Yuntong plans to acquire 65.47% of Baode Computer System shares through a share issuance and has received acceptance from the Shenzhen Stock Exchange for its application [1] - Mingyang Smart Energy intends to purchase 100% of Dehua Chip's equity through a combination of share issuance and cash payment, with stock resuming trading on January 23, 2026 [2] - Sanhua Intelligent Control's controlling shareholder and board members plan to reduce their holdings by up to 0.2425% of the company's shares [3] Group 2 - Wuchan Jinlun's shareholder plans to reduce holdings by up to 3% of the company's total shares [4] - Chengdu Road and Bridge expects a net loss of 65 million to 97.5 million yuan for 2025, compared to a loss of 92.17 million yuan in the previous year [5] - Guoxin Technology anticipates a net loss of 238 million yuan for 2025, an increase in loss of 56.97 million yuan compared to the previous year [6] Group 3 - Taiankang's subsidiary received approval for a clinical trial of CKBA ointment for treating vitiligo in children aged 2-12 [7] - Boyun New Materials' shareholder plans to reduce holdings by up to 1% of the company's total shares [8] - *ST Shengwu has terminated its major asset restructuring plan and expects a net profit of 28.5 million to 32.5 million yuan for 2025, compared to a loss of 19.84 million yuan in the previous year [9] Group 4 - Junchen Technology's shareholder plans to reduce holdings by up to 2.94% of the company's shares [10] - Haiguang Information's shareholder plans to reduce holdings by up to 0.5% of the company's shares [11] - ST Juewei expects a net loss of 160 million to 220 million yuan for 2025, compared to a profit of 227 million yuan in the previous year [12] Group 5 - Nanjing Bank reported total assets exceeding 3 trillion yuan by the end of 2025, with a revenue of 55.54 billion yuan, up 10.48% year-on-year [13] - Haitan Ruisheng's shareholders plan to reduce holdings by up to 5% of the company's shares [14] - Zhaoyi Innovation expects a net profit of approximately 1.61 billion yuan for 2025, a year-on-year increase of about 46% [15] Group 6 - Xiangrikui is discussing a repayment arrangement for a deposit of 40 million yuan with Shanghai Xipu Technology [16] - Yinglian Co. signed a strategic agreement with LG Chem to develop new polymer materials for lithium battery applications [17] - Yingfang Micro expects a net loss of 69 million to 97 million yuan for 2025, compared to a loss of 61.97 million yuan in the previous year [18] Group 7 - Heshun Electric's shareholders plan to reduce holdings by up to 3.5% of the company's shares [20] - Guanghua Technology expects a net profit of 85 million to 120 million yuan for 2025, reversing a loss of 205 million yuan in the previous year [21] - Ruichuang Weina anticipates a net profit of approximately 1.1 billion yuan for 2025, a year-on-year increase of about 93% [22] Group 8 - Huatu Mountain Ding's shareholder plans to reduce holdings by up to 3% of the company's shares [23] - Yinfeng Storage's subsidiary won two procurement projects with a total value of approximately 1.23 billion yuan [24] - Hengyi Petrochemical plans to repurchase shares worth 500 million to 1 billion yuan for employee stock ownership plans [25] Group 9 - Mengcao Ecology's controlling shareholder plans to reduce holdings by up to 3% of the company's shares [26] - Tefa Service's shareholder plans to reduce holdings by up to 3% of the company's shares [27] - Green Alliance Technology's shareholders plan to reduce holdings by up to 4% of the company's shares [28] Group 10 - Yunyi Electric plans to repurchase shares worth 100 million to 150 million yuan for employee stock ownership plans [29] - Dongpeng Beverage plans to invest 1.1 billion yuan in a new production base in Chengdu [30] - Zhongyuan Co. expects a net profit of 139 million to 158 million yuan for 2025, a year-on-year increase of 80% to 105% [31] Group 11 - Qiangyi Co. expects a net profit of 368 million to 399 million yuan for 2025, a year-on-year increase of 57.87% to 71.17% [32] - Guochuang High-tech anticipates a net profit of 16 million to 24 million yuan for 2025, reversing a loss of 49.1 million yuan in the previous year [33] - Yuandong Bio received a drug registration certificate for a pediatric medication [34] Group 12 - Liya Technology expects a net profit of 300 million to 380 million yuan for 2025, reversing a loss of 889 million yuan in the previous year [35] - Dongfeng Co. anticipates a net loss of 390 million to 480 million yuan for 2025, compared to a profit of 29.16 million yuan in the previous year [36] - Huaming Equipment reported a 15.29% year-on-year increase in net profit for 2025 [37] Group 13 - Botong Integrated expects a net profit of 17.19 million to 25.78 million yuan for 2025, reversing a loss from the previous year [38] - Qingsong Co. anticipates a net profit of 130 million to 165 million yuan for 2025, a year-on-year increase of 137.73% to 201.74% [39] - Ruihua Tai's shareholder plans to reduce holdings by up to 3% of the company's shares [41]

Policy Developments - The Ministry of Commerce and nine other departments issued an opinion to promote the high-quality development of the pharmaceutical retail industry, proposing 18 specific measures focused on improving pharmaceutical services and emergency supply guarantees [1] - The opinion emphasizes the development of smart regulation, including accurate collection and verification of drug traceability codes and uploading to a national medical insurance information platform [1] - A dynamic regulatory model based on risk levels and credit evaluations will be implemented, optimizing inspection frequencies for low-risk enterprises and exploring non-on-site supervision methods like AI video inspections [1] Drug Approval - Yuandong Bio's subsidiary Shod Pharmaceutical received a drug registration certificate for chloral hydrate syrup, aimed at sedation and hypnosis for children, marking the company's first approved Class 2 modified new drug [2] - West Point Pharmaceutical announced the approval of glucosamine sulfate capsules for primary or secondary osteoarthritis, enhancing its product line but facing sales uncertainties due to industry policies and procurement factors [3] Capital Market - OpenEvidence, a medical AI startup, completed a $250 million Series D financing round, achieving a valuation of $12 billion, with total financing nearing $700 million [4] - West Point Pharmaceutical plans to repurchase shares worth between 25 million and 50 million RMB, with a maximum repurchase price of 42.00 RMB per share, representing 0.78% to 1.56% of its total A-share capital [5] Industry Developments - Baichuan Intelligent launched the evidence-enhanced medical model M3 Plus, reducing hallucination rates to 2.6%, the lowest globally, and introduced the "evidence anchoring" technology to link generated medical conclusions to original research [6][7] - Sinovac's inactivated hepatitis A vaccine has secured a two-year exclusive bid in Oman, with over 130 million doses supplied globally, making it one of the most widely used hepatitis A vaccines [8] Public Opinion Alerts - Yiju Medical announced the resignation of non-executive director Dr. Zhou Yi, effective January 22, 2026, to focus on other business commitments [9]

水合氯醛作为临床应用成熟的镇静催眠药物，其安全性与有效性已得到广泛验证，被中华医学会麻醉学 分会、美国急诊医师学院等国内外众多权威学术机构推荐为儿童镇静催眠常用药物或一线用药。国家药 监局官网显示，国内现有3款水合氯醛口服制剂获得批准，为特丰制药的水合氯醛/糖浆组合包装，以及 成都倍特得诺药业、海南鹏康药业的水合氯醛糖浆。 公司全资子公司硕德药业的水合氯醛糖浆是公司首款获得批准的2类改良型新药。该药品的获批，标志 着公司该产品符合药品注册的有关要求，进一步丰富了公司麻醉镇痛领域产品管线，对公司经营发展具 有一定的积极作用。 格隆汇1月22日丨苑东生物(688513.SH)公布，公司全资子公司成都硕德药业有限公司于近日收到国家药 监局核准签发的《药品注册证书》。药品名称：水合氯醛糖浆，药品注册标准编号：YBH26472025。 水合氯醛糖浆活性成份为水合氯醛，是一款针对儿科临床用药痛点设计的专用糖浆剂型，适应症为儿童 检查、操作前的镇静、催眠，属于《国家基本医疗保险、工伤保险和生育保险药品目录（2025年）》乙 类品种。与已上市的水合氯醛/糖浆组合包装相比，本品无需稀释即可直接给药，能精准调控给药剂 量，且专为 ...

规格：10ml:1.0g 注册分类：化学药品 2.2 类 证券代码：688513 证券简称：苑东生物 公告编号：2026-001 成都苑东生物制药股份有限公司 关于自愿披露 2 类改良型新药水合氯醛糖浆获得 药品注册证书的公告 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。 成都苑东生物制药股份有限公司（以下简称"公司"） 全资子公司成都硕德 药业有限公司（以下简称"硕德药业"）于近日收到国家药品监督管理局（以下 简称"国家药监局"）核准签发的《药品注册证书》，现将相关情况公告如下： 一、药品基本情况 药品名称：水合氯醛糖浆 剂型：糖浆剂 药品有效期：12 个月 上市许可持有人：成都硕德药业有限公司 生产企业：成都硕德药业有限公司 药品注册标准编号：YBH26472025 受理号：CXHS2300053 证书编号：2026S00061 药品批准文号：国药准字 H20260003 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本 品符合药品注册的有关要求，批准注册，发给药品注册证书。质量标准、说明 1 米内网 ...

Core Viewpoint - The approval of the drug "Hydrated Chloral Syrup" by the National Medical Products Administration marks a significant advancement for the company in the pediatric clinical medication sector, addressing specific needs for sedation and hypnosis in children [1][2] Group 1: Product Details - The active ingredient of Hydrated Chloral Syrup is hydrated chloral, designed specifically for pediatric use, with indications for sedation and hypnosis before examinations and procedures [1] - This product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - Unlike existing hydrated chloral/syrup combination products, this syrup does not require dilution for administration, allowing for precise dosage control and improved palatability for children [1] Group 2: Market Context - Hydrated chloral is a well-established sedative and hypnotic drug, with its safety and efficacy widely validated and recommended by various authoritative medical institutions [1] - Currently, there are three approved oral formulations of hydrated chloral in China, including those from other pharmaceutical companies [1] Group 3: Company Impact - The approval of Hydrated Chloral Syrup represents the company's first approved Category II modified new drug, enhancing its product pipeline in the anesthesia and analgesia field [2] - This development is expected to have a positive impact on the company's operational growth [2]

Core Viewpoint - The company is committed to implementing an internationalization strategy and has accelerated its expansion into overseas markets [1] Group 1: International Expansion - The company has successfully exported certain chemical raw materials to EU member countries [1] - The sales model for the EU market combines direct sales and distribution [1]

Group 1 - Yuan Dong Bio's stock price fell by 4.07% on January 14, closing at 59.18 CNY per share, with a trading volume of 135 million CNY and a turnover rate of 1.26%, resulting in a total market capitalization of 10.447 billion CNY [1] - The company's stock has experienced a continuous decline over three days, with a cumulative drop of 8.36% during this period [1] - Yuan Dong Bio, established on June 1, 2009, and listed on September 2, 2020, specializes in the research, production, and sales of chemical raw materials and chemical drug formulations, with its main revenue sources being 78.75% from formulation sales, 9.22% from raw material sales, 6.79% from technical services and transfers, 4.01% from CMO/CDMO, and 1.22% from other sources [1] Group 2 - Hongde Fund holds a significant position in Yuan Dong Bio, with its Hongde Medical Innovation Mixed Fund A (012481) maintaining 27,000 shares, unchanged from the previous period, accounting for 8.53% of the fund's net value, making it the second-largest holding [2] - The fund has incurred a floating loss of approximately 67,800 CNY today, with a total floating loss of 145,800 CNY during the three-day decline [2] - The Hongde Medical Innovation Mixed Fund A was established on February 22, 2023, with a latest scale of 14.8031 million CNY, achieving a year-to-date return of 14.04% and a one-year return of 60.26% [2]

Group 1 - The chemical pharmaceutical sector increased by 0.24% on January 8, with Bibete leading the gains [1] - The Shanghai Composite Index closed at 4082.98, down 0.07%, while the Shenzhen Component Index closed at 13959.48, down 0.51% [1] - Notable gainers in the chemical pharmaceutical sector included Bibete, which rose by 20.00% to a closing price of 49.68, and Qijingt, which increased by 10.00% to 28.27 [1] Group 2 - The chemical pharmaceutical sector experienced a net outflow of 191 million yuan from institutional investors, while retail investors saw a net inflow of approximately 84.42 million yuan [2] - The trading volume for Bibete was 140,500 shares, with a transaction value of 682 million yuan, indicating strong market interest [1] - The sector's overall trading activity showed a mix of inflows and outflows, with specific stocks like Hainan Haiyao and Xinyu Pharmaceutical seeing significant institutional interest [3]