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：吡仑帕奈片 证券代码：688513 证券简称：苑东生物 公告编号：2025-062 成都苑东生物制药股份有限公司 关于自愿披露吡仑帕奈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。 剂型：片剂 规格：4mg、2mg 注册分类：化学药品 4 类 药品有效期：12 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：YBH21462025 受理号：CYHS2401346、CYHS2401347 证书编号：2025S02701、2025S02702 药品批准文号：国药准字 H20255313、国药准字 H20255314 审批结论： 特此公告。 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、 ...

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吡仑帕奈片药品注册证书。吡仑帕奈片主 要用于成人和4岁及以上儿童癫痫部分性发作患者的治疗。该药品为公司按化学药品4类注册申报，获批 后视同通过一致性评价。目前，该药品尚未实现销售，公司已与万邦医药签署合作协议，万邦医药负责 销售和推广，公司负责生产和供应并享有销售利润的部分分红权益。 ...

智通财经APP讯，苑东生物(688513.SH)发布公告，公司于近日收到国家药品监督管理局(简称"国家药监 局")核准签发的吡仑帕奈片《药品注册证书》。 吡仑帕奈片主要活性成份为吡仑帕奈，属于国家《麻醉药品和精神药品管理条例》规定的第二类精神药 品，适应症为用于成人和4岁及以上儿童癫痫部分性发作患者(伴有或不伴有继发全面性发作)的治疗。 ...

Company Overview - Yuan Dong Bio-pharmaceutical 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 September 4, Yuan Dong Bio's stock fell by 5.42%, trading at 59.80 yuan per share, with a transaction volume of 86.87 million yuan and a turnover rate of 0.79%. The total market capitalization is 10.557 billion yuan [1] Fund Holdings - Tai Ping Fund has one fund heavily invested in Yuan Dong Bio. The Tai Ping Medical Innovation Mixed Fund A (021027) held 11,500 shares in the second quarter, accounting for 3.27% of the fund's net value, ranking as the tenth largest holding. The estimated floating loss today is approximately 39,400 yuan [2] - The Tai Ping Medical Innovation Mixed Fund A (021027) was established on June 4, 2024, with a latest scale of 13.9827 million yuan. Year-to-date returns are 63.38%, ranking 349 out of 8,180 in its category; one-year returns are 58.77%, ranking 1,728 out of 7,978; and since inception returns are 57.25% [2]

Group 1 - The core viewpoint of the news is that Yuan Dong Bio has seen a significant increase in its stock price, with a rise of 5.08% to 66.20 CNY per share, and a total market capitalization of 11.686 billion CNY [1] - Yuan Dong Bio, established on June 1, 2009, specializes in the research, production, and sales of chemical raw materials and chemical drug formulations, with its main revenue sources being 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] - The company has a trading volume of 1.13 million CNY and a turnover rate of 1.00% as of the report date [1] Group 2 - The Hongde Medical Innovation Mixed Fund A (012481) holds a significant position in Yuan Dong Bio, with 27,000 shares, accounting for 7.84% of the fund's net value, making it the third-largest holding [2] - The fund has achieved a year-to-date return of 64.56% and a one-year return of 83.28%, ranking 294 out of 8180 and 684 out of 7967 respectively in its category [2] - The fund was established on February 22, 2023, with a current scale of 10.4748 million CNY [2]

Group 1 - In the first half of the year, A-share listed companies reported a total net profit attributable to shareholders of 2.99 trillion yuan, a year-on-year increase of 2.45%, with nearly 77% of stocks achieving profitability and about 46% showing positive net profit growth [2] - The agricultural, forestry, animal husbandry, fishery, steel, building materials, computer, and non-ferrous metals sectors experienced rapid performance growth, while the real estate sector showed significant losses [2] - BYD's new energy vehicle sales in August reached 373,600 units, slightly up from 373,100 units in the same month last year, with cumulative sales from January to August totaling 2.864 million units, representing a year-on-year growth of 23% [10] Group 2 - New energy vehicle manufacturers such as Leap Motor, Xpeng Motors, and NIO reported record monthly delivery numbers, while Li Auto experienced a decline in monthly deliveries for three consecutive months due to product transitions and adjustments in its sales and service system [5] - Longi Green Energy has invested in a storage company, Suzhou Jingkong Energy Technology Co., Ltd., and is in discussions to acquire another storage company [7] - Chengdu Huamei announced the release of a 4-channel 12-bit 40G high-precision RF direct sampling ADC chip and has received intention orders [9] Group 3 - Heng Rui Pharmaceutical announced that its innovative drug, Zemeituosita Tablets, has received conditional approval for market launch [8] - Yuan Dong Bio announced that its sodium nafamostat oral disintegrating tablets have obtained a drug registration certificate, making it the first domestic generic drug approved for market [11] - Guizhou Moutai announced that its controlling shareholder, Moutai Group, increased its stake by purchasing 67,821 shares, accounting for 0.0054% of the company's total share capital [12] Group 4 - Yonghui Supermarket announced an adjustment to its plan for issuing A-shares to specific targets, with the total fundraising amount adjusted to no more than 3.114 billion yuan [13] - Su Da Weige announced plans to acquire up to 51% of Changzhou Weipu's equity for no more than 510 million yuan [16] - The company Zongtai Auto announced that its subsidiary's assets are under compulsory execution, and it will not be able to resume production this year [15]

Group 1 - The core point of the article is that Yuandong Biologics has received approval from the National Medical Products Administration for the drug registration certificate of its product, Sodium Naphthylacetate Oral Disintegrating Tablets [2] Group 2 - The drug is named Sodium Naphthylacetate Oral Disintegrating Tablets, indicating a new addition to the company's product portfolio [2] - The announcement was made on the evening of September 1, highlighting the company's ongoing efforts in drug development and regulatory compliance [2]

Group 1: BYD Performance - BYD's August sales of new energy vehicles reached 373,600 units, nearly unchanged from 373,100 units in the same month last year [1] - Cumulative sales from January to August totaled 2.864 million units, representing a year-on-year growth of 23% [1] - BYD plans to export a total of 80,813 new energy vehicles by August 2025 [1] Group 2: Kweichow Moutai Shareholding - Kweichow Moutai's controlling shareholder, Moutai Group, increased its stake by 67,821 shares on September 1, 2025, accounting for 0.0054% of the total share capital [2] - The increase amounted to 100 million yuan and is part of a larger plan to buy back between 3 billion and 3.3 billion yuan worth of shares from September 1, 2025, to February 28, 2026 [2] Group 3: Chengdu Huamei Chip Development - Chengdu Huamei announced the successful launch of a 4-channel, 12-bit, 40G high-speed, high-precision RF direct sampling ADC chip [3] - The chip improves upon existing multi-channel high-speed ADCs, achieving international leading standards and filling a gap in similar products [3] - The company has received intention orders after sending samples to several clients [3] Group 4: Industrial Fulian Share Buyback - Industrial Fulian has repurchased a total of 7.6974 million shares, representing 0.04% of its total share capital, as of August 31, 2025 [6] - The highest repurchase price was 19.84 yuan per share, while the lowest was 18.40 yuan per share, with a total expenditure of 147 million yuan [6] Group 5: Innovative Drug Approval by Hengrui Medicine - Hengrui Medicine received conditional approval from the National Medical Products Administration for its innovative drug, SHR2554 tablets, aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma [7] - This drug is noted as China's first independently developed EZH2 inhibitor [7] Group 6: Yonghui Supermarket Fundraising Adjustment - Yonghui Supermarket announced adjustments to its plan for issuing A-shares to specific investors, reducing the total fundraising amount from a maximum of 3.992 billion yuan to 3.114 billion yuan [8] - The adjustments primarily affect the funding amounts for store upgrades and working capital or bank loan repayments [8] Group 7: Automotive Sales Performance - SAIC Motor's vehicle sales in August reached 363,400 units, reflecting a year-on-year increase of 41.04% [9] - Great Wall Motors reported August sales of 115,600 units, marking a year-on-year growth of 22.33% [12] - Dong'an Power's engine sales in August increased by 3.44% year-on-year [12]

Core Viewpoint - Yuan Dong Bio (688513.SH) has received the drug registration certificate for its hydrochloride nafurolafine orally disintegrating tablets from the National Medical Products Administration, indicating compliance with drug registration requirements and marking a significant milestone for the company [1] Group 1 - The active ingredient of the hydrochloride nafurolafine orally disintegrating tablets is hydrochloride nafurolafine, classified as a second-class psychoactive drug under national regulations [1] - The indication for the drug is to improve itching in patients undergoing hemodialysis, specifically for cases where existing treatments are ineffective [1] - The drug was registered under the category of chemical drugs type 4, and its approval is considered equivalent to passing the consistency evaluation [1] Group 2 - The approval of this drug is not expected to have a significant impact on the company's recent performance [1]

证券代码：688513 证券简称：苑东生物 公告编号：2025-060 成都苑东生物制药股份有限公司 关于自愿披露盐酸纳呋拉啡口崩片获得 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：盐酸纳呋拉啡口崩片 剂型：片剂 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：YBH20352025 受理号：CYHS2401764 证书编号：2025S02608 药品批准文号：国药准字 H20255225 规格：2.5 μg 注册分类：化学药品 4 类 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 1 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范要求 ...