Group 1 - The company has received the drug registration certificate for Oxazepam Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1][2] - Oxazepam Tablets are classified as a Class 3 chemical drug with a specification of 15mg and a shelf life of 18 months [1][2] - The drug is primarily used for short-term relief of anxiety, tension, and agitation, and can also assist in treating anxiety with depression and acute alcohol withdrawal symptoms [2] Group 2 - The product was originally developed by Wyeth and later acquired by Pfizer, with the first launch in Sweden in 1966 under the brand name Sobril [2] - In 2024, the sales amount for Oxazepam Tablets in key public hospitals in China exceeded 500 million yuan, with the product's sales amounting to approximately 10.044 million yuan, reflecting a year-on-year growth of 9.58% [2] - The company has signed a cooperation agreement with Jiangsu Enhua and Xin Medical Marketing Co., Ltd., where the company will be responsible for production and supply, while Jiangsu Enhua will handle exclusive commercialization in mainland China [3]

成都苑东生物制药股份有限公司 差异化分红事项的 法律意见书 Merits Ir 植德律师事务 北京植德律师事务所 关于 植德(证)字[2025]0014 号 二〇二五年五月 北京市东城区东直门南大街 1 号来福士中心办公楼 12 层 邮编: 100007 12th Floor, Raffles City Beijing Office Tower, No.1 Dongzhimen South Street, Dongcheng District, Beijing 100007 P.R.C 电话(Tel):010-56500900 传真(Fax):010-56500999 www.meritsandtree.com 北京植德律师事务所 关于成都苑东生物制药股份有限公司 差异化分红事项的 法律意见书 植德(证)字[2025]0014 号 致:成都苑东生物制药股份有限公司 北京植德律师事务所（以下简称"本所"）接受成都苑东生物制药股份有限 公司(以下简称"苑东生物"或"公司"）的委托,依据《中华人民共和国公司 法》(以下简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证 券法》"）、《上市公司股份回购规则 ...

证券代码：688513 证券简称：苑东生物 公告编号：2025-031 成都苑东生物制药股份有限公司 关于自愿披露奥沙西泮片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"）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：奥沙西泮片 剂型：片剂 规格：15mg 注册分类：化学药品 3 类 药品有效期：18 个月 上市许可持有人：成都苑东生物制药股份有限公司 生产企业：成都苑东生物制药股份有限公司 药品注册标准编号：YBH08782025 受理号：CYHS2400144 证书编号：2025S01571 药品批准文号：国药准字 H20254336 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 书、标签及生产工艺照所附执行。本品应当进行上市前的药品生产质量管理规 根据米内网数据显示， ...

证券代码：688513 证券简称：苑东生物 公告编号：2025-030 成都苑东生物制药股份有限公司 2024年年度权益分派实施公告 本公司董事会及全体董事保证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： 每股现金红利0.43元 相关日期 | 股权登记日 | | 除权（息）日 | 现金红利发放日 | | --- | --- | --- | --- | | 2025/6/10 | 2025/6/11 | | 2025/6/11 | 一、 通过分配方案的股东大会届次和日期 本次利润分配方案经公司2025 年 5 月 16 日的2024年年度股东大会审议通过。 二、 分配方案 截至股权登记日下午上海证券交易所收市后，在中国证券登记结算有限责任 公司上海分公司（以下简称"中国结算上海分公司"）登记在册的本公司全体股东（成 都苑东生物制药股份有限公司回购专用证券账户除外）。 根据《中华人民共和国公司法》、《中华人民共和国证券法》、《上海证券交易 所上市公司自律监管指引第 7 号--回购股份》等相关规定，上市公司回购专用账户 中的股份，不享有股 ...

Core Viewpoint - Company has received approval from the National Medical Products Administration for the drug Ozazepam Tablets, which is classified as a Class 3 chemical drug and has a shelf life of 18 months [1] Company Summary - The drug Ozazepam Tablets, with a dosage of 15mg, is primarily used for short-term relief of anxiety, tension, and agitation [1] - The drug is categorized as a second-class psychoactive substance under national regulations [1] - Company has signed a cooperation agreement with Jiangsu Enhua and Xin Medical Marketing Co., Ltd. to accelerate market expansion and clinical application of Ozazepam Tablets [1] Industry Summary - According to data from Minai Network, the sales amount of anti-anxiety chemical drugs in key public hospitals in China is expected to exceed 500 million yuan in 2024 [1] - The projected sales amount for Ozazepam Tablets in 2024 is approximately 100 million yuan, representing a year-on-year growth of 9.58%, ranking second among anti-anxiety drug products [1]

Core Viewpoint - The article highlights the significant market potential and competitive landscape of Dihydroxypropyl Theophylline Injection, which has shown impressive sales growth and is becoming a target for centralized procurement in China [3][4][10]. Group 1: Product Information - Dihydroxypropyl Theophylline Injection is a smooth muscle relaxant belonging to theophylline class, widely used for treating bronchial asthma, bronchitis, and emphysema [3]. - The original manufacturer of Dihydroxypropyl Theophylline is Japan's Eisai, but the original brand is not available in the domestic market, leading to a dominance of domestic generic drugs [4]. Group 2: Market Performance - In 2023, the sales of Dihydroxypropyl Theophylline Injection in hospitals across China exceeded 250 million yuan, marking a year-on-year growth of 107.2% [4]. - In the first two quarters of 2024, the sales already surpassed 110 million yuan, indicating strong market potential [4]. Group 3: Competitive Landscape - The leading company in the market is Suicheng Pharmaceutical, holding a market share of 19.65% [5]. - A total of 55 companies have successfully passed evaluations and obtained production licenses, while 36 companies are currently under review for production [5]. Group 4: Procurement and Pricing - Dihydroxypropyl Theophylline Injection has been included in centralized procurement initiatives, with the lowest bid price dropping below 1 yuan per unit [10]. - In the 2023 procurement led by Henan, the lowest bid was 0.78 yuan per unit, with other selected prices not exceeding 1 yuan [10]. Group 5: Future Outlook - The ongoing centralized procurement policies and increasing market competition will significantly impact the pricing and market dynamics of Dihydroxypropyl Theophylline Injection [11].

Group 1 - The three major indices experienced fluctuations and declines, while the pharmaceutical and biotechnology sector showed resilience, with significant gains in innovative drugs, brain-computer interfaces, and recombinant proteins [1] - The Science and Technology Innovation Pharmaceutical Index ETF (588700) rose by 0.60%, with a trading volume exceeding 20 million yuan and a turnover rate of over 8%. Notable component stocks included Shouyao Holdings-U, which increased by over 6%, along with Yuan Dong Biological, Oriental Bio, and Haoyuan Pharmaceutical [1] - The Science and Technology Innovation Pharmaceutical Index ETF closely tracks the Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index, which selects 50 large-cap companies in biopharmaceuticals and related fields, reflecting the overall performance of representative biopharmaceutical companies listed on the Science and Technology Innovation Board [1] Group 2 - Guosheng Securities indicated that the domestic CRO industry is nearing a critical turning point, with the potential for layout opportunities arising from policy changes and supply-demand restructuring [2] - The CRO sector has faced operational fluctuations due to external environmental changes, but long-term policy support is expected to drive demand growth once financing issues for innovative drug companies are resolved [2] - The market share of leading CRO companies has expanded to some extent following a period of industry clearing [2] Group 3 - According to Jiao Yin International, multiple significant data on domestic innovative drugs will be presented at the 2025 ASCO conference, highlighting opportunities for innovation and performance resonance [3] - Chinese pharmaceutical companies showcased 71 original research results, with 11 presented in LBA format, indicating a potential surge in interest for the innovative drug sector [3] - The investment attractiveness of the innovative drug sector is notable, with valuations significantly below historical averages and institutional holdings at low levels, supporting the continued implementation of favorable policies [3]

关于自愿披露达可替尼片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。 证券代码：688513 证券简称：苑东生物 公告编号：2025-029 成都苑东生物制药股份有限公司 成都苑东生物制药股份有限公司（以下简称"公司"）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： 登录新浪财经APP 搜索【信披】查看更多考评等级 生产企业：成都苑东生物制药股份有限公司 药品注册标准编号：YBH10652025 受理号：CYHS2300478、CYHS2300479 一、药品基本情况 药品名称：达可替尼片 剂型：片剂 规格：15mg、45mg 注册分类：化学药品4类 药品有效期：18个月 上市许可持有人：成都苑东生物制药股份有限公司 达可替尼片由Pfizer公司开发，最早于2018年9月在美国上市，2019年5月在国内获批上市。达可替尼片 属于《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》乙类品种。国家药监局官网显 示，已有成都倍特药业的国 ...

证券代码：688513 证券简称：苑东生物 公告编号：2025-029 成都苑东生物制药股份有限公司 关于自愿披露达可替尼片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"）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：达可替尼片 剂型：片剂 规格：15mg、45mg 注册分类：化学药品 4 类 药品有效期：18 个月 受理号：CYHS2300478、CYHS2300479 证书编号：2025S01426、2025S01427 药品批准文号：国药准字 H20254222、国药准字 H20254223 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 书、标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规 1 范要求方可生产销售。 二、药品的其他相关情况 达可替尼片活 ...

苑东生物公告，公司近日收到国家药品监督管理局核准签发的《药品注册证书》，药品名称为达可替尼 片，剂型为片剂，规格为15mg、45mg，注册分类为化学药品4类，药品有效期为18个月。达可替尼片 活性成份为达可替尼，适应症为单药用于表皮生长因子受体(EGFR)19号外显子缺失突变或21号外显子 L858R置换突变的局部晚期或转移性非小细胞肺癌(NSCLC)患者的一线治疗。该药品由Pfizer公司开 发，最早于2018年9月在美国上市，2019年5月在国内获批上市，属于《国家基本医疗保险、工伤保险和 生育保险药品目录(2024年)》乙类品种。2024年，达可替尼片销售金额约为1.57亿元。 ...