Core Viewpoint - Yuan Dong Biotech (688513.SH) has received a drug registration certificate for Elamomide tablets, indicating a significant regulatory approval for the company’s product aimed at treating active rheumatoid arthritis [1] Group 1: Company Information - The drug Elamomide, developed by the company's wholly-owned subsidiary Chengdu Shuo De Pharmaceutical Co., Ltd., has been approved by the National Medical Products Administration (NMPA) [1] - Elamomide tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1]

Core Viewpoint - Yuan Dong Biotech (688513) announced the approval of its subsidiary Chengdu Shuo De Pharmaceutical Co., Ltd. for the drug registration certificate of Elamomab tablets by the National Medical Products Administration [1] Company Summary - The active ingredient of Elamomab tablets is Elamomab, which is indicated for the treatment of active rheumatoid arthritis [1] - Elamomab tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024) [1]

Group 1 - The core point of the article is that Chengdu Yuandong Biopharmaceutical Co., Ltd. has received a drug registration certificate from the National Medical Products Administration for its product "Elamomab Tablets" [1] Group 2 - Chengdu Yuandong Biopharmaceutical's wholly-owned subsidiary, Chengdu Shuo De Pharmaceutical Co., Ltd., is responsible for the newly approved product [1]

Core Viewpoint - Yuan Dong Biotech (688513.SH) has received approval from the National Medical Products Administration for its drug, Elamomab Tablets, which is indicated for active rheumatoid arthritis and is classified as a Category B drug in the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog [1] Group 1 - The company’s wholly-owned subsidiary, Chengdu Shuo De Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Elamomab Tablets [1] - Elamomab, the active ingredient in the tablets, is specifically aimed at treating active rheumatoid arthritis [1] - The drug is included in the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog as a Category B product [1]

证券代码：688513 证券简称：苑东生物 公告编号：2025-075 关于自愿披露艾拉莫德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"）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：艾拉莫德片 剂型：片剂 规格：25mg 注册分类：化学药品 4 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 成都苑东生物制药股份有限公司 米内网重点省市公立医院数据显示，艾拉莫德片2024年销售金额约38,211万 元，同比增长12.90%。 生产企业：成都硕德药业有限公司 药品注册标准编号：YBH25802025 受理号：CYHS2402863 证书编号：2025S03153 药品批准文号：国药准字 H20255709 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 ...

Core Insights - The company announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., received the drug registration certificate for Elamomab tablets from the National Medical Products Administration [1] - Elamomab tablets are indicated for the treatment of active rheumatoid arthritis and are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The projected sales amount for Elamomab tablets in key public hospitals in major provinces and cities for 2024 is approximately 382 million yuan, representing a year-on-year growth of 12.90% [1] - The approval of this drug is considered equivalent to passing the consistency evaluation, and it is not expected to have a significant impact on the company's recent performance [1]

每经AI快讯，10月17日，据科兴制药公众号消息，今年，公司与成都苑东生物制药股份有限公司（简 称：苑东生物）签署了战略合作协议。近日，双方就苑东生物阿帕他胺片仿制药达成印尼、埃及、沙 特、哥伦比亚等十余个国家的海外商业化独家授权，进一步深化双方合作，推动这款前列腺癌治疗领域 的重磅药物在东南亚、中东、拉美等潜力市场落地。 ...

Company Overview - Yuandong Biopharmaceutical Co., Ltd. is located in Chengdu, Sichuan Province, established on June 1, 2009, and listed on September 2, 2020. The company specializes in the research, production, and sales of chemical raw materials and chemical drug formulations [1] - The main revenue composition includes: 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] Stock Performance - On October 15, Yuandong's stock rose by 5.12%, reaching a price of 54.03 CNY per share, with a trading volume of 42.6 million CNY and a turnover rate of 0.46%. The total market capitalization is 9.538 billion CNY [1] Fund Holdings - The Guotou Ruijin Fund has a significant holding in Yuandong Biopharmaceutical, with the Guotou Ruijin Healthcare Mixed A Fund (000523) holding 98,300 shares, accounting for 2.96% of the fund's net value, making it the seventh-largest holding. The estimated floating profit today is approximately 258,600 CNY [2] - The Guotou Ruijin Healthcare Mixed A Fund was established on February 25, 2014, with a latest scale of 121 million CNY. Year-to-date returns are 31.89%, ranking 2270 out of 8161 in its category; the one-year return is 25.9%, ranking 2959 out of 8015; and since inception, the return is 150.74% [2]

Core Viewpoint - Chengdu Yuandong Biopharmaceutical Co., Ltd. has recognized Mr. Zhao Liwen as a core technical personnel to enhance the company's innovation capabilities and accelerate the implementation of its innovation transformation strategy [1][3]. Summary by Sections New Core Technical Personnel - Mr. Zhao Liwen, born in November 1973, holds a doctoral degree from the Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences, and has over 15 years of experience in pharmaceutical R&D management [1][2]. - He has previously held significant positions at Nanjing Shenghe Pharmaceutical Co., Ltd. and is currently the CEO of Shanghai Chaoyang Pharmaceutical Co., Ltd. [1][2]. Impact on the Company - The decision to recognize Mr. Zhao as a core technical personnel is based on his professional background, work experience, research achievements, and potential contributions to the company's R&D projects and business development [3]. - The company plans to maintain a high proportion of R&D investment and improve its technical innovation mechanisms, while also enhancing the development of its R&D team by attracting more talented researchers and managers [3].

证券代码：688513 证券简称：苑东生物 公告编号：2025- 074 成都苑东生物制药股份有限公司 关于新增认定核心技术人员的公告 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。 | 本次变动后 | | --- | 本次变动后 关正品、陈艳、金明志、乔智涛、李竹石、赵立文 成都苑东生物制药股份有限公司（以下简称 "公司"或"苑东生物"） 为进一 步提升公司创新能力和技术水平，加快公司创新转型战略的实施步伐，于 2025 年 10 月 13 日召开第四届董事会第九次会议审议通过了《关于新增认定核心技 术人员的议案》，新增认定赵立文先生为公司核心技术人员。具体情况公告如下： 一、新增认定核心技术人员简历 赵立文先生，男，1973 年 11 月出生，中国国籍，无境外永久居留权，中科 院广州生物医药与健康研究院博士研究生学历，具有 15 年以上的医药研发全流 程管理经验。2011 年 7 月至 2021 年 12 月期间，历任南京圣和药业股份有限公 司项目经理、研发中心副主任和副总经理兼研究院院长等职，2022 年 1 月至今 ...