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润都股份(002923) - 润都股份投资者关系管理信息
2024-11-29 11:23
Production Capacity and Utilization - The company's original production capacity utilization in Zhuhai has reached a high level [2] - A new oral solid dosage production facility with an annual capacity of 6 billion tablets/capsules has been completed and put into operation, meeting EU GMP standards [2] - The subsidiary in Jingmen has a designed annual capacity of 4,000 tons, currently in the ramp-up phase with significant improvement compared to 2023 [2] - Approximately 70% of the raw materials for the company's regular formulation products are sourced internally [3] R&D and Innovation - The company's Class 1 innovative drug, Higenamine Hydrochloride Injection and its API, has completed on-site verification by the National Medical Products Administration [4] - The company continues to explore synthetic biology and frontier technologies for future innovation [4] - CMO and CDMO businesses have shown steady growth, covering intermediates, APIs, tablets, capsules, and small-volume injections [4] Market Expansion and Strategy - The company is actively expanding into the third terminal market and retail channels, including online pharmaceutical e-commerce platforms [4] - Established direct supply relationships with top 100 pharmacy chains and built its own sales team and agent network [4] - Open to strategic M&A opportunities that align with the company's development needs [3] Financial and Operational Performance - The company maintains a reasonable debt structure with a lower debt ratio compared to industry peers [4] - Debt was primarily used for the Jingmen production base and Zhuhai's new solid dosage facility construction [4] - Accounts receivable changes are consistent with business scale, influenced by national centralized procurement policies [4] Medical Technology Development - Myocardial Perfusion Imaging (MPI) technology has relatively low penetration in China due to equipment availability and medical practices [3] - MPI technology is expected to grow with national support for precision medicine and gradual adoption in more hospitals [3]
润都股份:厄贝沙坦片增加75mg规格获批
Core Viewpoint - The company, Rundu Co., Ltd. (002923), has received approval from the National Medical Products Administration for a supplementary application regarding the drug Irbesartan, which includes the addition of a new 75mg specification and the issuance of a drug approval number [1] Group 1 - The approved supplementary application allows for the new specification of Irbesartan tablets to be packaged in high-density polyethylene bottles for oral solid medication [1] - The changes include updated quality standards and production processes, which will be effective for 18 months [1] - The product's instructions and packaging labels will be revised accordingly, while other aspects will follow the original approved content [1]
润都股份:关于厄贝沙坦片获得药品补充申请批准通知书的公告
2024-11-13 08:55
珠海润都制药股份有限公司(以下简称"公司"或"本公司")近日收到国 家药品监督管理局签发的《药品补充申请批准通知书》。现将有关情况公告如下: 一、药品基本情况 1、药品基本信息 药品名称:厄贝沙坦片 (以下简称"本品") 剂型:片剂 申请内容:药学研究信息:增加75mg规格,新增规格产品使用口服固体药用 高密度聚乙烯瓶装。 证券代码:002923 证券简称:润都股份 公告编号:2024-052 珠海润都制药股份有限公司 关于厄贝沙坦片获得药品补充申请批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 2、药品的其他相关情况 厄贝沙坦片适用于治疗原发性高血压。合并高血压的2型糖尿病肾病的治疗。 公司厄贝沙坦片(规格:0.15g)于2022年10月以注册分类:化学药品4类获得 国家药品监督管理局下发的《药品注册证书》,该药品的获批上市标志着此产品 视同通过仿制药质量与疗效一致性评价。 2023年8月,公司向国家药品监督管理局药品审评中心递交了厄贝沙坦片(规 格:75mg)的药品补充申请,申请增加本品规格并获得受理;2024年11月,公司 收到国家药品 ...
润都股份:2024年三季报点评:业绩短期承压,盐酸去甲乌药碱值得期待
Guoyuan Securities· 2024-11-05 09:39
Investment Rating - The report maintains a "Buy" rating for the company [6][14]. Core Views - The company's performance in the first three quarters of 2024 showed a revenue of 877 million yuan, a year-on-year decrease of 7.23%, and a net profit attributable to the parent company of 37 million yuan, down 43.29% year-on-year [2][3]. - The decline in revenue is attributed to the impact of centralized procurement on certain products, while the significant drop in profit is mainly due to the depreciation from the solidification of the Hubei raw material drug base [3]. - The company has effectively controlled its expense ratios, with a sales expense ratio of 22.66%, down 4.44 percentage points year-on-year, and a management expense ratio of 5.81%, down 0.55 percentage points year-on-year [3]. Summary by Sections Financial Performance - For the first three quarters of 2024, the company reported a revenue of 877 million yuan, a decrease of 7.23% year-on-year, and a net profit of 37 million yuan, down 43.29% year-on-year. The earnings per share (EPS) stood at 0.11 yuan [2]. - The company’s sales expense ratio decreased to 22.66%, while the management expense ratio was 5.81%, indicating good control over expenses [3]. Research and Development - The company invested 98 million yuan in R&D, accounting for 11.13% of its revenue, which is an increase of 2.90 percentage points year-on-year. The innovative drug, hydrochloride deoxyephedrine, is highlighted as a key product in the pipeline, with a market potential exceeding 1 billion yuan [4]. Business Development - The company has developed a diversified business model in raw materials, including antihypertensive and proton pump inhibitors. The Hubei Jingmen production base is expected to contribute to revenue growth in the future [5]. - The company has over 20 chemical preparation products in various therapeutic areas, which are anticipated to see sales growth through centralized procurement [5]. Profit Forecast - The company is projected to achieve revenues of 1.305 billion yuan, 1.442 billion yuan, and 1.576 billion yuan for 2024, 2025, and 2026, respectively. The net profit attributable to the parent company is expected to be 59.43 million yuan, 107.67 million yuan, and 142.26 million yuan for the same years [6].
润都股份:硫酸羟氯喹化学原料药上市申请获批
Company Update - RunDu Pharmaceutical (002923) received approval from the National Medical Products Administration (NMPA) for the marketing application of hydroxychloroquine sulfate as a chemical active pharmaceutical ingredient (API) [1] - Hydroxychloroquine sulfate is indicated for the treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and skin diseases caused or exacerbated by sunlight [1] Product Indications - The approved API, hydroxychloroquine sulfate, has therapeutic applications in autoimmune and dermatological conditions [1] - Specific indications include rheumatoid arthritis, juvenile chronic arthritis, lupus erythematosus (both discoid and systemic), and sunlight-induced or exacerbated skin disorders [1]
润都股份:关于硫酸羟氯喹获得化学原料药上市申请批准通知书的公告
2024-11-03 08:22
证券代码:002923 证券简称:润都股份 公告编号:2024-051 珠海润都制药股份有限公司 申请人:珠海润都制药股份有限公司 申请事项:境内生产化学原料药上市申请 受理号:CYHS2360123 登记号:Y20220000403 关于硫酸羟氯喹获得化学原料药上市申请批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 珠海润都制药股份有限公司(以下简称"公司"或"本公司")近日收到国家药 品监督管理局核准签发的硫酸羟氯喹(以下简称:"本品")《化学原料药上市 申请批准通知书》。现将有关情况公告如下: 一、药品基本情况 1、药品基本信息 原料药名称:硫酸羟氯喹 二、对公司的影响及风险提示 本品适用于类风湿关节炎,青少年慢性关节炎,盘状和系统性红斑狼疮以及 由阳光引发或加剧的皮肤疾病。本品获批进一步丰富了公司产品品类,有利于提 升公司的市场竞争力,对公司的未来经营业绩产生积极影响。 本品未来市场销售情况可能受到政策环境、市场变化等多种不确定因素的影 响,存在不确定性。敬请广大投资者谨慎决策,注意投资风险。 特此公告。 珠海润都制药股份有限公司 董 ...
润都股份:关于聘任证券事务代表的公告
2024-10-28 10:56
证券代码:002923 证券简称:润都股份 公告编号:2024-050 公司证券事务代表的联系方式如下: 电话:0756-7630378 传真:0756-7630035 电子邮箱:rd@rdpharma.cn 办公地点:广东省珠海市金湾区三灶镇机场北路6号 珠海润都制药股份有限公司 关于聘任证券事务代表的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记 载、误导性陈述或重大遗漏。 珠海润都制药股份有限公司(以下简称"公司")于2024年10月28日召开第五 届董事会第九次会议,审议通过了《关于聘任证券事务代表的议案》。具体情况如 下: 根据《深圳证券交易所股票上市规则(2024 年修订)》《公司章程》等有关规 定,结合公司信息披露管理工作需要,公司拟聘任叶洁云女士为公司证券事务代表 (候选人简历详见附件),任期与公司第五届董事会任期一致,即自本议案经董事 会审议通过之日起至 2026 年 3 月 13 日止。 叶洁云女士已取得了董事会秘书资格证书,具备履行职责所必需的专业知识、 工作经验以及相关素质,其任职资格符合《深圳证券交易所主板股票上市规则(2024 年修订)》《公司章程》等有 ...
润都股份:董事会决议公告
2024-10-28 10:56
证券代码:002923 证券简称:润都股份 公告编号:2024-047 珠海润都制药股份有限公司 第五届董事会第九次会议决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 一、董事会会议召开情况 珠海润都制药股份有限公司(以下简称"公司")第五届董事会第九次会议 于 2024 年 10 月 28 日上午 10:30 以现场结合通讯表决的方式召开,会议通知以 电子邮件的方式于 2024 年 10 月 18 日向各位董事发出。会议应到董事 7 人,实 到董事 7 人(其中 LIAORAN 先生、刘杰先生、TANWEN 先生、王波先生、叶建木先 生以通讯表决的形式出席本次会议)。公司监事、高级管理人员列席了本次会议, 本次会议由公司董事长陈新民先生主持,会议召集及召开程序符合《中华人民共 和国公司法》和《公司章程》的有关规定。 二、董事会会议审议情况 1、审议通过了《2024 年第三季度报告》。 与会董事认为公司 2024 年第三季度报告内容真实、准确、完整地反映了公 司的实际情况,不存在任何虚假记载、误导性陈述或者重大遗漏。 表决结果:7 票同意,0 票反对 ...
润都股份(002923) - 2024 Q3 - 季度财报
2024-10-28 10:56
珠海润都制药股份有限公司 2024 年第三季度报告 证券代码:002923 证券简称:润都股份 公告编号:2024-049 珠海润都制药股份有限公司 2024 年第三季度报告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 重要内容提示: 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整,不存在虚假记载、误导性陈述或重大 遗漏,并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明:保证季度报告中财务信息的真实、准确、完 整。 3.第三季度报告是否经过审计 □是 否 1 珠海润都制药股份有限公司 2024 年第三季度报告 一、主要财务数据 (一) 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 | --- | --- | --- | --- | --- | |------------------------------------------------------|------------------|-------------------------|--------- ...
润都股份:监事会决议公告
2024-10-28 10:56
证券代码:002923 证券简称:润都股份 公告编号:2024-048 珠海润都制药股份有限公司 第五届监事会第八次会议决议公告 三、备查文件 一、监事会会议召开情况 珠海润都制药股份有限公司(以下简称"公司")第五届监事会第八次会议 于 2024 年 10 月 28 日上午 11:30 以现场结合通讯表决的方式召开,会议通知以 电子邮件方式于 2024 年 10 月 18 日向各位监事发出。本次会议由监事会主席华 志军先生召集和主持。会议应出席会议监事 3 名,实际出席会议监事 3 名(其中 华志军先生以通讯表决的形式出席本次会议)。会议召集及召开程序符合有关法 律、行政法规、部门规章、规范性文件和公司章程的规定。 二、监事会会议审议情况 1、审议通过了《2024 年第三季度报告》; 经审核,监事会认为公司 2024 年第三季度报告真实、准确、完整地反映了 公司的实际情况,不存在任何虚假记载、误导性陈述或者重大遗漏。 表决结果:3 票同意,0 票反对,0 票弃权。 《2024 年第三季度报告》(公告编号:2024-049)已于同日披露于《中国证 券报》《证券时报》《证券日报》《上海证券报》和巨潮资讯网(ww ...