EASTONBIOPHARMACEUTICALS(688513)
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苑东生物EP-0226片I期临床试验完成首例受试者给药
Bei Jing Shang Bao· 2026-01-29 11:21
北京商报讯(记者丁宁)1月29日晚间,苑东生物(688513)发布公告称,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。 公告显示,临床前研究表明,EP-0226片在靶点选择性、体内镇痛活性及药效方面优于已获批同机制的 普瑞巴林,且安全性良好,有望为神经病理性疼痛患者带来安全有效的治疗新选择。 ...
苑东生物(688513.SH):EP-0226 片I期临床试验完成首例受试者给药
Ge Long Hui A P P· 2026-01-29 10:28
格隆汇1月29日丨苑东生物(688513.SH)公布,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。 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。 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、体内镇痛活性及药效方面优于已获批同机制的普瑞巴林,且安全性良 好,有望为神经病理性疼痛患者带来安全有效的治疗新选择。 ...
苑东生物(688513) - 苑东生物: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
2026-01-29 10:15
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 ...
苑东生物: 2 类改良型新药水合氯醛糖浆获批,适用于儿童镇静催眠
Cai Jing Wang· 2026-01-23 07:20
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]
1月23日重要公告一览





Xi Niu Cai Jing· 2026-01-23 02:40
慧博云通:发行股份购买资产相关申请文件获深交所受理 1月23日,慧博云通(301316)发布公告称,公司拟通过发行股份的方式向乐山高新投资发展(集团)有 限公司等57名交易对方购买其合计持有的宝德计算机系统股份有限公司65.47%股份,并拟向公司实控 人余浩发行股份募集配套资金。1月22日,公司发行股份购买资产并募集配套资金申请文件获得深交所 受理。 明阳智能:拟购买德华芯片100%股权 股票复牌 1月23日,明阳智能(601615)发布公告称,公司拟通过发行股份及支付现金的方式向交易对方合计购买 德华芯片100%的股权,并向不超过35名符合中国证监会条件的特定投资者发行股份募集配套资金,标 的公司主要产品为半导体外延片、芯片、电源系统等。公司股票将于2026年1月23日(星期五)开市起 复牌。 三花智控:实控人等拟合计减持不超过0.2425%公司股份 1月23日,三花智控(002050)发布公告称,公司实控人、董事长张亚波、董事王大勇、董事倪晓明、董 事陈雨忠、董事会秘书胡凯程及财务总监俞蓥奎计划合计减持不超过0.2425%公司股份。 物产金轮:股东拟减持不超过3%公司股份 1月23日,物产金轮(00272 ...
9部门发文促进药品零售行业发展;百川发布循证增强医疗大模型
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-23 00:09
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]
苑东生物(688513.SH):2类改良型新药水合氯醛糖浆获得药品注册证书
Ge Long Hui A P P· 2026-01-22 10:30
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 ...
苑东生物(688513) - 苑东生物: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
2026-01-22 10:30
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 ...
苑东生物:2类改良型新药水合氯醛糖浆获得药品注册证书
Ge Long Hui· 2026-01-22 10:19
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]
苑东生物:公司已实现对欧盟成员国出口部分化学原料药产品
Zheng Quan Ri Bao Wang· 2026-01-20 14:10
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]