证券代码：002923 证券简称：润都股份 公告编号：2025-027 | 认证申请号 | | | 认证有效期至 | | | | | --- | --- | --- | --- | --- | --- | --- | | 1448856/24-8 | 2027 | 年 | 05 | 月 | 26 | 日 | | 0241560/23-3、1576191/24-9 和 1449272/24-0 | 2027 | 年 | 06 | 月 | 09 | 日 | 关于通过巴西国家卫生监督局 GMP 认证的公告 本公司及全体董事会成员保证公告内容真实、准确和完整，并对公告中的 虚假记载、误导性陈述或者重大遗漏承担责任。 珠海润都制药股份有限公司（以下简称"公司"）于 2025 年 03 月 17 日至 2025 年 03 月 21 日接受了巴西国家卫生监督局（以下简称"巴西 ANVISA"）官 方的现场 GMP（药品生产质量管理规范）认证，认证范围为化学原料药：坎地沙 坦酯、沙库巴曲缬沙坦钠、替米沙坦、缬沙坦。 近日，公司收到巴西 ANVISA 签发的两张 GMP 认证证书，具体如下： 巴西 ANVISA 现场检查结论为 ...

Core Viewpoint - The company has successfully obtained GMP certification from Brazil's National Health Surveillance Agency (ANVISA) for four chemical raw materials, indicating compliance with international quality standards [1] Group 1: Certification Details - The GMP certification was conducted from March 17 to March 21, 2025, covering the following products: Candesartan Cilexetil, Sacubitril/Valsartan, Telmisartan, and Valsartan [1] - The certification is valid until May 26, 2027, and June 9, 2027, respectively, for the two certificates issued by ANVISA [1] - The on-site inspection by ANVISA concluded that the company’s facilities met the required standards, resulting in a qualified status for the four raw material products [1]

Core Viewpoint - The company successfully passed the FDA's cGMP inspection, which is a significant achievement that enhances its competitiveness and supports its expansion into the U.S. raw material drug market [1][2]. Group 1: FDA Inspection Details - The company underwent an FDA cGMP inspection from February 12 to February 17, 2025, focusing on the production of nine active pharmaceutical ingredients [1]. - The inspection covered various systems including quality, production, equipment, laboratory control, and material management [1]. - The company received the Establishment Inspection Report (EIR) confirming the successful completion of the inspection [1]. Group 2: Implications for the Company - Passing the FDA inspection establishes a solid foundation for the company's further expansion into the U.S. raw material drug market [2]. - This achievement is expected to inject momentum into the company's ongoing international market expansion efforts [2]. - The successful inspection is anticipated to enhance the company's overall competitiveness and promote future development [2].

证券代码：002923 证券简称：润都股份 公告编号：2025-026 珠海润都制药股份有限公司（以下简称"公司"）于 2025 年 02 月 12 日至 02 月 17 日接受了来自美国食品药品监督管理局（以下简称"FDA"）的 cGMP（现 行药品生产质量管理规范）现场检查。此次检查主要涉及坎地沙坦酯、奥美沙坦 酯、缬沙坦、厄贝沙坦、缬沙坦钠、沙库巴曲钠、沙库巴曲缬沙坦钠、伏立康唑、 硫酸羟氯喹 9 个原料药产品的生产制造，检查范围涵盖了质量体系、生产体系、 设备设施体系、实验室控制体系、物料管理体系等。 近日，公司收到 FDA 出具的现场检查报告（EIR，Establishment Inspection Report），FEI（工厂注册号）为 3009954717。根据该核查报告，确认此次检查 已经结束，公司已顺利通过本次美国 FDA 现场检查。 本次通过美国 FDA 的现场检查，表明公司在 GMP（药品生产质量管理规范） 方面保持着较高水平，为公司进一步开拓美国原料药市场奠定了坚实基础，为公 司持续拓展国际市场注入动力，对提升公司综合竞争力及推动未来发展具有促进 作用。 珠海润都制药股份有限公司 关于 ...

Group 1 - The core viewpoint of the news is that Mingyu Asset Management has conducted research on a listed company, Rundu Co., focusing on the development and commercialization of a new drug, and the company's operational performance [1] - Rundu Co. is advancing the registration application for its innovative drug, a hydrochloride injection of dehydroevodiamine, which has shown good safety in Phase III clinical trials [1] - The company plans to promote the drug through its own marketing team and collaborative promotion, while exploring more innovative results in the field of synthetic biology [1] Group 2 - Rundu Co.'s production value has significantly increased, with improved synergy between its two major bases in Zhuhai and Jingmen, and a substantial rise in nicotine sales compared to the same period last year [1] - However, the increase in nicotine sales has not yet had a significant impact on the company's overall performance [1]

Group 1: Product Development and Regulatory Status - The registration application for the innovative drug, Sodium Deoxycorticosterone Injection, is progressing smoothly, with the company having submitted the necessary documentation to the National Medical Products Administration (NMPA) [1] - The company completed supplementary research work in April 2025, following a notification from the NMPA regarding additional data requirements [1] Group 2: Market Potential and Commercialization - Sodium Deoxycorticosterone is a partial agonist of adrenal β receptors, used for myocardial perfusion imaging (MPI) to assist in diagnosing and evaluating myocardial ischemia [3] - In the U.S., approximately 4.57 million MPI tests were conducted in 2023, representing 22.3% of the 20.5 million coronary heart disease patients [3] - The company plans to actively promote the product through its marketing team and is open to collaborations with experienced partners for commercialization [4] Group 3: Clinical Safety and Efficacy - The Phase IIIb clinical trial for Sodium Deoxycorticosterone Injection, led by Peking Union Medical College Hospital, showed good safety with mild adverse reactions that resolved quickly after discontinuation [5] Group 4: Future Plans and Market Expansion - The company has not yet considered international commercialization rights for Sodium Deoxycorticosterone Injection [6] - The Jingmen facility has seen significant growth in total output value, with multiple products achieving stable supply, enhancing the company's integrated supply chain advantages [6] - The company aims to increase market coverage and capacity utilization to enhance competitiveness [6]

Group 1: Product Development and Approval - The company has submitted the registration application for the innovative drug, Dexmedetomidine Hydrochloride Injection, to the National Medical Products Administration (NMPA) and has completed on-site inspections by expert groups [1] - The company received a supplementary data notification from the NMPA in December 2024 and completed the required supplementary research by April 2025 [1] - The drug is expected to assist in diagnosing and evaluating myocardial ischemia through non-invasive intravenous administration [1] Group 2: Market Potential and Trends - In the U.S., approximately 4.57 million MPI tests were conducted in 2023, representing 22.3% of the 20.5 million coronary heart disease patients [2] - The penetration rate of MPI technology in China is relatively low compared to the U.S., but the aging population and increasing prevalence of coronary heart disease are expected to boost the market for Dexmedetomidine Hydrochloride Injection [2] - The sales of Olmesartan Medoxomil and Amlodipine Tablets grew by 12.5% in the first three quarters of 2024, reaching 230 million yuan, indicating strong clinical application and potential in hypertension treatment [3] Group 3: Future Product Plans and Financial Goals - The company currently has no products related to Semaglutide in its pipeline [3] - The financial budget for 2025 is outlined in the company's internal report, which does not guarantee profit predictions and is subject to various uncertainties [3][4]

Market Overview - As of June 12, the Shanghai Composite Index closed at 3402.66 points, with a slight increase of 0.34 points, representing a change of 0.01% [1] - The Shenzhen Component Index closed at 10234.33 points, down by 11.69 points, a decrease of 0.11% [1] - The ChiNext Index closed at 2067.15 points, up by 5.29 points, reflecting an increase of 0.26% [1] Trading Activity - A total of 128 A-shares had a turnover rate exceeding 20% on the same day, indicating significant trading activity [1] - Notably, C Haiyang and Zhongke Magnetic had turnover rates exceeding 50%, suggesting a high level of liquidity and interest in these stocks [1] Top Performing Stocks - C Haiyang (603382) had a closing price of 55.97 yuan with a turnover rate of 85.43% and a remarkable increase of 386.70% [1] - Zhongke Magnetic (301141) closed at 68.13 yuan, with a turnover rate of 67.96% and a gain of 3.20% [1] - Yingsite (301622) closed at 97.32 yuan, achieving a turnover rate of 60.53% and a rise of 20.00% [1] - Jiangnan New Materials (603124) closed at 48.20 yuan, with a turnover rate of 57.58% and an increase of 4.83% [1] - Xiongdi Technology (300546) closed at 34.41 yuan, with a turnover rate of 56.64% and a gain of 7.20% [1] Additional Notable Stocks - Kangliyuan (301287) closed at 50.52 yuan, with a turnover rate of 48.58% and a slight decrease of 0.26% [1] - Qingmu Technology (301110) closed at 72.42 yuan, achieving a turnover rate of 46.33% and a rise of 20.00% [1] - Baixinglong (833075) closed at 46.99 yuan, with a turnover rate of 44.54% and an increase of 29.99% [1] - Hengbao Co., Ltd. (002104) closed at 11.82 yuan, with a turnover rate of 44.51% and a gain of 2.34% [1] - Guokang Biochemical (300804) closed at 61.10 yuan, with a turnover rate of 42.76% and a slight increase of 1.08% [1]

Market Overview - The Shanghai Composite Index rose by 0.52% on June 11, with 28 out of 33 sectors experiencing gains, led by the non-ferrous metals and agriculture sectors, which increased by 2.21% and 2.02% respectively [1] - The pharmaceutical and biotechnology sector was the biggest loser, declining by 0.41% [1] Capital Flow Analysis - The net inflow of capital in the two markets was 1.506 billion yuan, with 14 sectors seeing net inflows [1] - The non-bank financial sector had the largest net inflow of 4.469 billion yuan, rising by 1.90%, followed by the automotive sector with a net inflow of 2.750 billion yuan and a daily increase of 1.70% [1] Pharmaceutical and Biotechnology Sector - The pharmaceutical and biotechnology sector saw a net outflow of 2.629 billion yuan, with 475 stocks in the sector; 157 stocks rose while 306 fell [2] - The top three stocks with the highest net inflow were Kangyuan Pharmaceutical (2.42 billion yuan), Rundu Co., Ltd. (1.56 billion yuan), and Baiyang Pharmaceutical (840.855 million yuan) [2] - The stocks with the largest net outflows included Hengrui Medicine (1.53 billion yuan), Yong'an Pharmaceutical (1.36 billion yuan), and Kailai Pharmaceutical (1.27 billion yuan) [2] Top Gainers in Pharmaceutical Sector - Kangyuan Pharmaceutical: +9.97%, turnover rate 8.65%, net inflow 241.8664 million yuan [4] - Rundu Co., Ltd.: +9.98%, turnover rate 14.71%, net inflow 155.7670 million yuan [4] - Baiyang Pharmaceutical: +10.33%, turnover rate 8.13%, net inflow 84.0855 million yuan [4] Top Losers in Pharmaceutical Sector - Hengrui Medicine: -0.76%, turnover rate 0.59%, net outflow -153.0498 million yuan [4] - Yong'an Pharmaceutical: -8.87%, turnover rate 24.11%, net outflow -135.7947 million yuan [4] - Kailai Pharmaceutical: -2.35%, turnover rate 1.71%, net outflow -127.0972 million yuan [4]

Group 1: Company Strategy and Development - The company focuses on health sectors, particularly cardiovascular, digestive, analgesic, and anesthetic medications, aiming to enhance its formulation industry and maintain its unique drug formulations and controlled-release technologies [3][6]. - Plans to accelerate the development and market entry of high-barrier generics and innovative drugs while expanding its international business through a global formulation production platform [3][6]. - The company aims to build a high-end active pharmaceutical ingredient (API) and intermediate manufacturing base with a focus on green and intelligent manufacturing technologies [4][6]. Group 2: Financial Performance and Challenges - The company experienced a significant decline in revenue in 2024, primarily due to national procurement policies leading to a substantial drop in sales prices of key formulation products [5][7]. - The decline in revenue was also influenced by competitive pressures in the domestic and international markets affecting the sales prices of major API products [5][7]. - Cumulative cash dividends since the company's listing in 2018 have reached CNY 496 million, reflecting a commitment to shareholder returns [8]. Group 3: Market Expansion and Partnerships - The company has successfully obtained market access qualifications for certain specialty APIs in major markets, including the WHO, the USA, the EU, and Japan, and is actively exploring emerging markets in the Middle East, South Asia, Southeast Asia, and South America [4][6]. - Established long-term stable partnerships with numerous large formulation manufacturers, positioning itself as a leading supplier of antihypertensive APIs globally [4][6]. Group 4: Research and Development Focus - The company continues to focus on both innovative and generic drug development, with recent submissions for new drug applications and multiple product registrations for generics [9]. - Future R&D efforts will concentrate on health-related fields, leveraging core technological advantages in controlled-release formulations and APIs [9].