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]

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。 ...

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [7] Core Views - The company is expected to achieve revenue growth driven by new product launches, international expansion, and innovation in drug development. The anesthetic pipeline continues to evolve, with several high-barrier products approved for market entry, which is anticipated to enhance the company's competitive edge in the anesthetic and analgesic sectors [10][12] Summary by Relevant Sections Growth Capability - In 2024, the company's chemical preparations generated revenue of 1.077 billion yuan, a year-over-year increase of 22.25%. Chemical raw materials achieved revenue of 121 million yuan, up 28.65%. CMO/CDMO services saw revenue of 65 million yuan, a significant increase of 111.59%. The company has undertaken 23 CMO/CDMO projects, indicating strong growth potential from new product launches and international business expansion [2] - The company plans to launch at least 10 generic drug products and submit at least 10 new product applications in 2025, which is expected to contribute to revenue growth in the coming years [2] Internationalization of Formulations - The company received FDA approval for its Nicardipine Hydrochloride Injection in September 2024, marking its first shipment to the U.S. market. The company is gradually expanding its international product offerings, with several ANDA applications submitted for various products [3] Competitive Position in Anesthesia - As of 2024, the company has launched 16 products in the anesthetic and analgesic fields, with over 20 in development. The market share for key products is strong, with the company's Nalmefene Hydrochloride Injection holding a 61.73% market share. Newly approved high-barrier products are expected to drive revenue growth [4] - The company is advancing its high-end generic drugs, improved new drugs, and innovative drugs in the anesthetic and analgesic sectors, which will help establish its brand and enhance core competitiveness [4] Innovation and R&D Acceleration - The company is accelerating its transition from generic to innovative drug development, with R&D expenditures exceeding 20% of revenue in 2024. Investment in innovative drugs accounts for nearly 30% of R&D spending, indicating a strong commitment to innovation [5] Financial Performance - In 2024, the company achieved revenue of 1.35 billion yuan, a year-over-year increase of 20.82%, with a net profit of 238 million yuan, up 5.15%. The net profit margin after excluding stock incentive expenses showed a stable growth trend [10][12] - The overall gross margin for 2024 was 74.93%, a decrease of 5.08 percentage points, primarily due to declines in the gross margins of technical services, CMO/CDMO, and raw materials [11] Earnings Forecast and Valuation - The company is projected to achieve EPS of 1.56, 1.83, and 2.19 yuan per share for 2025, 2026, and 2027, respectively. The current closing price corresponds to a PE ratio of 22 times for 2025 [12]

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 国产创新药闪耀 ASCO 国际舞台 2025 年 05 月 25 日 增持（维持） [Table_Tag] [Table_Summary] 投资要点 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -18% -15% -12% -9% -6% -3% 0% 3% 6% 9% 12% 15% 2024/5/27 2024/9/24 2025/1/22 2025/5/22 医药生物 沪深300 相关研究 《三抗药物研发进入快车道，建议关 注泽璟制药、三生制药等》 2025-05-18 | 1. 本周及年初至今各医药股收益情况 4 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 2. 中国创新药闪耀 ASCO 会议，口头报告数量再创新高 7 | | | | | | | | | 2.1. 2025 ASCO 摘要披露，众多国产抗体和 ADC 类分子亮相口头报告 7 | | | | | | | | | 后线治疗不断迎 ...

Group 1 - Huiyu Pharmaceutical's subsidiary received drug registration certificate for Carboxymethyl Sodium Injection, which is used for treating bleeding diseases in various medical fields [1] - Baihe Co., Ltd. announced a plan for a director to reduce holdings by up to 424,000 shares, representing 0.6625% of the total share capital [1] - Kingood Co., Ltd. received a notification from a global leading automaker for a wheel project, expected to start mass production in 2026 with a lifecycle of 10 years [1][2] Group 2 - Wanhua Chemical plans to repurchase shares worth between 300 million and 500 million yuan, with a maximum repurchase price of 99.36 yuan per share [2] - Warner Pharmaceutical's subsidiary received approval for Acetylcysteine raw material drug, primarily used for treating respiratory diseases [3] - ST Mingcheng plans to publicly transfer 45% equity of its subsidiary, aiming to optimize asset structure [4] Group 3 - Qixia Construction announced a plan to reduce up to 31.5 million shares, accounting for 3% of total share capital [5][6] - Zhejiang Rongtai intends to invest 20 million yuan to establish a wholly-owned subsidiary focused on intelligent robotics [7] - Yuandong Biological received drug registration for Chloral Hydrate Enema, used for sedation and seizure control in children [9] Group 4 - Jiemai Technology's subsidiary signed a strategic cooperation agreement with a solid-state battery company to produce high-safety composite conductive materials [10] - Xianju Pharmaceutical received drug registration for Progesterone Soft Capsules, used for treating functional disorders due to luteal deficiency [11] - Lanhua Kecai's subsidiary reported a temporary production halt, with the resumption date yet to be determined [13] Group 5 - Sinopharm Modern's subsidiary received drug registration for Tocilizumab Tablets, used for treating rheumatoid arthritis and other conditions [15] - Shanghai Bank announced the resignation of its vice president due to organizational adjustments [17] - Shanghai Pharmaceutical's Ephedrine Injection passed the consistency evaluation for generic drugs [19] Group 6 - Rundu Co., Ltd. received drug registration for Amlodipine and Olmesartan Tablets, aimed at treating hypertension [21] - Zhong'an Technology announced that 61 million shares held by its controlling shareholder will be auctioned [23] - Shanghai Washba plans to purchase patent assets and establish two subsidiaries focused on hydrogen energy and solid-state battery technologies [25] Group 7 - Nuo Cheng Jianhua's new drug Tafasitamab received approval for treating relapsed/refractory diffuse large B-cell lymphoma [26] - Benli Technology plans to use up to 200 million yuan of idle funds for cash management and financial investments [28] - Taiji Co., Ltd. intends to use 60 million yuan of idle funds to purchase financial products [29] Group 8 - Haishi Co. announced that its innovative drug Anreke Fen Injection received drug registration for treating postoperative pain [32] - Yulong Co. will have its stock delisted on May 27, 2025, following a decision by the Shanghai Stock Exchange [36] - Weifu High-Tech plans to establish a joint venture with Shanghai Baolong Automotive Technology [38] Group 9 - Xichang Electric Power expects a net profit reduction of approximately 5.4 million yuan due to adjustments in the time-of-use electricity pricing mechanism [39] - Alter signed a contract worth 6.8 billion yen for the development and procurement of large truck EV kits [41] - Zhonglian Heavy Industry plans to acquire controlling stakes in its financing leasing subsidiary through public bidding [42] Group 10 - Sanyou Medical's executive plans to reduce holdings by up to 1.44% of the company's shares [43] - Hangyang Co. plans to establish a subsidiary for large modular cryogenic equipment manufacturing with an estimated investment of 557 million yuan [44] - FAW Fuwi received a notification for a dashboard project from a well-known new energy brand, with total sales expected to reach 1.06 billion yuan [45]

证券代码：688513 证券简称：苑东生物 公告编号：2025-028 成都苑东生物制药股份有限公司 生产企业：成都硕德药业有限公司 关于自愿披露水合氯醛灌肠剂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：水合氯醛灌肠剂 剂型：灌肠剂 规格：1.34g:0.5g 注册分类：化学药品 3 类 药品有效期：24 个月 上市许可持有人：成都硕德药业有限公司 药品注册标准编号：YBH09012025 受理号：CYHS2302523 证书编号：2025S01287 药品批准文号：国药准字 H20254101 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。 1 二、药品的其他相 ...

苑东生物公告，全资子公司成都硕德药业有限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》，药品名称为水合氯醛灌肠剂，剂型为灌肠剂，规格为1.34g:0.5g，注册分类为化学药品3类。水 合氯醛灌肠剂主要成分为水合氯醛，适应症为儿童检查、操作前的镇静、催眠及监护条件下抗惊厥。该 药品为国内第2家获批上市且视同通过一致性评价的企业。米内重点省市公立医院数据显示，水合氯醛 2024年Q1-Q3销售额约1481万元，同比增长57.04%，其中水合氯醛灌肠剂销售额为329万元。 ...

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 法律意见书 植德京(会)字20250061 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 Dongcheng District, Beijing 100007 P.R.C 电话(Tel)：010-56500900 传真(Fax)：010-56500999 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 法律意见书 植德京(会)字20250061 号 www.meritsandtree.com 致：成都苑东生物制药股份有限公司（贵公司） 北京植德律师事务所（以下简称"本所"）接受贵公司的委托，指派律师出 席并见证贵公司 2024 年年度股东大会（以下简称"本次会议"）。 本所律师参加本次会议进行见证，并根据《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》"）、 《上市公司股东会规则》（以下简称"《股东会规则》"）、《律师事务所从事 证券法律业务管理办法》（以下简称"《证券法律业务管理办法》"）、《律师 事务所证券法律业务执业规则（试行）》 （以下简 ...