证券代码：000756 证券简称：新华制药 公告编号：2025-27 山东新华制药股份有限公司 关于阿司匹林肠溶片新增规格及通过仿制药一致性评价的公告 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。 近日，山东新华制药股份有限公司（"新华制药"或"本公司"）收到国家药品监督管理局核准签 发的阿司匹林肠溶片（100mg）（"本品"）的《药品补充申请批准通知书》，本品通过仿制药质量和疗效 一致性评价（"仿制药一致性评价"）。现将相关情况公告如下： 一、基本情况 药品名称：阿司匹林肠溶片 剂型：片剂 规格：100mg 药品批准文号：国药准字H20258068 通知书编号：2025B01839 二、其他相关信息 2024年3月，新华制药向国家药品监督管理局药品审评中心（CDE）递交阿司匹林肠溶片增加规格 合并一致性评价注册申报资料并获受理，2025年4月获得《药品补充申请批准通知书》，审评结论为： 经审查，同意批准本品增加100mg规格的补充申请，核发药品批准文号，本品通过仿制药质量和疗效一 1 药品分类：处方药 注册分类：化学药品 申请人：山东新华制药股份有限公司 ...

证券代码：000756 证券简称：新华制药 公告编号：2025-25 山东新华制药股份有限公司 三、审议通过关于召开 2024 年度周年股东大会的议案（股东大会通知将另行公告）。 9 名董事赞成本议案，0 票反对，0 票弃权。 备查文件 一、审议通过本公司 2025 年第一季度报告（见同日发布于《证券时报》及巨潮资讯网 （http://www.cninfo.com.cn）公告）； 9 名董事赞成本议案，0 票反对，0 票弃权。 二 、 审 议 通 过 了 2024 年 环 境 、 社 会 及 管 治 报 告 （ 见 同 日 发 布 于 巨 潮 资 讯 网 （http://www.cninfo.com.cn）公告）。 9 名董事赞成本议案，0 票反对，0 票弃权。 第十一届董事会第七次会议决议公告 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。 山东新华制药股份有限公司（"本公司"）第十一届董事会第七次会议通知于二零二五年四 月十四日以电邮方式发出，会议于二零二五年四月二十八日在山东省淄博市高新区鲁泰大道 1 号公司会议室召开，应到会董事 9 名，实际参会董事 ...

Financial Performance - The company's operating revenue for Q1 2025 was ¥2,429,825,335.81, a decrease of 1.81% compared to ¥2,474,697,457.66 in the same period last year[5] - Net profit attributable to shareholders was ¥112,095,257.24, down 20.99% from ¥141,879,437.62 year-on-year[5] - Basic and diluted earnings per share were both ¥0.15, representing a decline of 28.57% from ¥0.21 in the same period last year[5] - Total comprehensive income for the current period was 104,998,682.16, down from 146,079,426.17 in the previous period, a decrease of about 28.2%[20] - Net profit for the current period was 115,643,803.12, down from 145,264,098.40 in the previous period, representing a decrease of approximately 20.4%[19] Cash Flow and Operating Activities - The net cash flow from operating activities decreased by 77.87%, amounting to ¥8,425,190.10 compared to ¥38,063,364.43 in the previous year[5] - Cash flow from operating activities generated a net amount of 8,425,190.10, significantly lower than 38,063,364.43 in the previous period[21] - The decline in net cash flow from operating activities was attributed to an increase in the proportion of bank acceptance bill collections and a decrease in inventory changes compared to the previous year[8] Assets and Liabilities - Total assets at the end of the reporting period were ¥9,269,855,861.11, an increase of 2.77% from ¥9,019,601,567.53 at the end of the previous year[5] - The total current assets increased to ¥3,999,396,150.59 from ¥3,726,840,162.91, reflecting a growth of about 7.3%[16] - Accounts receivable rose significantly to ¥1,200,307,190.06, up from ¥868,204,001.79, indicating an increase of approximately 38.2%[16] - The total liabilities increased to ¥3,879,907,761.23 from ¥3,802,101,150.19, marking a rise of about 2.0%[17] - The non-current liabilities decreased to ¥645,097,935.77 from ¥1,006,487,037.80, a reduction of approximately 35.9%[17] Shareholder Equity - Shareholders' equity attributable to the parent company increased by 3.28% to ¥5,155,519,978.65 from ¥4,991,588,524.78[5] - The total equity attributable to shareholders increased to ¥5,155,519,978.65 from ¥4,991,588,524.78, indicating a growth of approximately 3.3%[17] Expenses - Research and development expenses for the current period were 109,788,595.18, compared to 141,905,763.44 in the previous period, showing a reduction of approximately 22.6%[19] - The company reported a decrease in sales expenses from 291,064,033.27 in the previous period to 99,952,491.15 in the current period, a reduction of about 65.6%[19] - The company's total operating costs decreased from 2,328,929,009.30 to 2,299,988,387.70, a reduction of approximately 1.2%[19] Other Income and Changes - The company reported non-operating income of ¥7,067,182.83, primarily from government subsidies and asset disposal gains[7] - The company approved changes to accounting policies that are not expected to have a significant impact on the financial statements[13] - The company experienced an investment loss of 760,243.82 in the current period, compared to a gain of 1,188,728.16 in the previous period[19]

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the supplementary application of Mecobalamin tablets, allowing the transfer of the marketing authorization holder [1] Company Summary - The transaction does not require approval from the company's board of directors or shareholders, as it does not constitute a related party transaction or a major asset restructuring as defined by relevant regulations [1] - Mecobalamin tablets are indicated for peripheral neuropathy and are listed as a Class B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog [1] Industry Summary - In 2023, the sales revenue of Mecobalamin tablets in Chinese public medical institutions is approximately RMB 1.431 billion [1]

Financial Performance - The financial summary indicates that the company achieved a revenue of RMB 1.2 billion, representing a year-over-year growth of 15%[11] - The net profit for the reporting period was RMB 300 million, which is an increase of 20% compared to the previous year[12] - Operating income for 2024 reached RMB 8,466,309,803.08, an increase of 4.51% compared to RMB 8,100,844,707.33 in 2023[15] - Net profits attributable to shareholders of the listed company decreased by 5.33% to RMB 470,023,746.08 from RMB 496,512,201.25 in 2023[15] - Net cash flow from operating activities increased by 38.58% to RMB 367,610,448.95 compared to RMB 265,278,895.87 in 2023[15] - Total assets grew by 8.85% to RMB 9,019,601,567.53 from RMB 8,286,166,330.90 at the end of 2023[15] - Total liabilities increased by 8.31% to RMB 3,802,101,150.19 from RMB 3,510,413,044.14 at the end of 2023[15] - Basic earnings per share for 2024 was RMB 0.69, a decrease of 6.76% from RMB 0.74 in 2023[15] - The ratio of weighted average return on net assets decreased by 1.62 percentage points to 9.79% from 11.41% in 2023[15] - Net profits attributable to shareholders after deduction of non-recurring profit or loss was RMB 448,006,721.77, down 2.93% from RMB 461,535,415.37 in 2023[15] - Minority interest income increased by 73.96% to RMB 16,690,827.80 from RMB 9,594,823.76 in 2023[15] Revenue Guidance and Growth Projections - The company has set a revenue guidance of RMB 1.5 billion for the next fiscal year, projecting a growth rate of 25%[14] - User data shows that the active user base grew to 5 million, reflecting a 25% increase from the last fiscal year[13] - New product launches contributed to 30% of total revenue, highlighting the success of recent innovations[11] - Market expansion efforts have led to a 10% increase in market share in the domestic market[13] Research and Development - The company is investing RMB 200 million in R&D for new technologies aimed at enhancing product efficacy[12] - The company is exploring potential acquisitions to enhance its product portfolio and market presence[14] - Strategic initiatives include partnerships with local distributors to improve supply chain efficiency[11] Shareholder Information - The top shareholder, Hualu Holdings Group Co. Ltd., holds 30.02% of the total share capital, amounting to 204,864,092 shares[31] - The number of registered shareholders increased from 76,496 to 78,450 between December 31, 2024, and February 28, 2025[32] - The company issued 7,724,800 new A-shares due to the exercise of stock options, which were registered and listed for circulation on January 15, 2024[27] - The total number of unconditional tradable shares as of December 31, 2024, was 643,774,361, slightly up from 636,006,160 the previous year, indicating an increase of approximately 1.21%[26] - The shareholding of domestic legal person shares remained stable at 37,091,988, accounting for 5.44% of the total share capital[31] - The number of shares held by the second-largest shareholder, HKSCC (Nominees) Limited, is 193,314,147, representing 28.33% of the total share capital[31] - There were no pledges or freezes on the shares held by the top ten shareholders[37] Corporate Governance - The Company has established effective internal controls in all material aspects according to the Basic Standards for Corporate Internal Control, achieving its internal control objectives without any significant deficiencies[166] - The Company has complied with all code provisions set out in the Corporate Governance Code for the year ended December 31, 2024[169] - The Board of Directors regularly evaluates Senior Officers based on their performance and adherence to resolutions[155] - The Company has established a clear incentive and penalty scheme for Senior Officers to ensure accountability[156] - The Company strictly fulfilled its information disclosure obligations, ensuring the truthfulness and completeness of disclosed information[153] Management and Leadership - The Company has a diverse management team with expertise in engineering, economics, and pharmaceutical fields[88] - The management team has held various positions within the Company, indicating a strong internal promotion culture[84] - The Company emphasizes the importance of experienced leadership with long tenures in key positions[82] - The current term of the Directors, Supervisors, and Senior Officers of the Company is until December 22, 2026[86] Employee Information and Training - As of December 31, 2024, the Group employed 7,296 staff with total wages amounting to RMB 743,487,000[104] - The staff distribution by area of work includes 4,060 production personnel, 946 sales personnel, and 561 research and development personnel[105] - The education level of employees shows that 2,037 hold university degrees or above, while 2,489 have tertiary education[107] - In 2024, the Company completed 79 corporate-level education training programs, training over 4,600 employees[112] Audit and Compliance - Grant Thornton Zhitong Certified Public Accountants LLP issued a standard unqualified audit report for the financial statements as of December 31, 2024, reflecting the company's financial condition accurately[134] - The Audit Committee recommended the reappointment of Grant Thornton Zhitong as the financial auditor for the year 2025[140] - The Company engaged Zhitong to conduct an independent audit on the effectiveness of its internal control[158] Diversity and Inclusion - The Company achieved its goal of having at least one female Director by 31 December 2024, with the current Board comprising eight male members and one female member[200] - Female representation at the workforce level has reached approximately 42.58%, achieving gender diversity across the workforce[200] - The Board adopted a diversity policy to ensure a balance of skills, experience, and perspectives appropriate to the Company's business needs[199]

Financial Performance - The company's operating revenue for Q1 2025 was RMB 2,429,825,335.81, a decrease of 1.81% compared to RMB 2,474,697,457.66 in Q1 2024[6] - Net profit attributable to shareholders for Q1 2025 was RMB 112,095,257.24, down 20.99% from RMB 141,879,437.62 in the same period last year[6] - The net profit after deducting non-recurring gains and losses was RMB 105,028,074.41, reflecting a decline of 23.74% year-on-year[6] - The total comprehensive income for Q1 2025 was RMB 104,998,682.16, down from RMB 146,079,426.17 in the same period last year[10] Cash Flow - The net cash flow from operating activities decreased significantly by 77.87%, amounting to RMB 8,425,190.10 compared to RMB 38,063,364.43 in Q1 2024[6] Earnings and Returns - Basic and diluted earnings per share for Q1 2025 were both RMB 0.15, a decrease of 28.57% from RMB 0.21 in Q1 2024[8] - The weighted average return on equity was 2.21%, down 0.83 percentage points from 3.04% in the previous year[8] Assets and Equity - Total assets as of March 31, 2025, were RMB 9,269,855,861.11, an increase of 2.77% from RMB 9,019,601,567.53 at the end of 2024[8] - Net assets attributable to shareholders increased by 3.28% to RMB 5,155,519,978.65 from RMB 4,991,588,524.78 at the end of 2024[8] Research and Development - Research and development expenses for Q1 2025 were RMB 109,788,595.18, compared to RMB 141,905,763.44 in Q1 2024[9] Accounting Policies - The company has implemented changes to accounting policies as per the Ministry of Finance's issuance of "Interpretation No. 18" effective from December 31, 2024, which addresses accounting treatment for quality assurance not related to individual performance obligations[11] - The changes in accounting policies were approved by the company's board on March 28, 2025, and are not expected to have a significant impact on the group's financial statements[11]

Group 1: Company Growth and Innovation Strategies - The company is focusing on establishing innovation platforms with renowned research institutions to enhance high-value new drug development and accelerate results transformation [2][3] - There are over 100 drugs in the research pipeline, including multiple first-class innovative drugs like OAB-14 for Alzheimer's treatment [3][4] - The company aims to deepen internationalization and strengthen its position in the high-value raw material drug market [2][3] Group 2: Financial Performance and Market Position - In 2024, the company achieved a revenue of 8.466 billion yuan, representing a year-on-year growth of 4.51% [6][9] - The company emphasizes cash dividends, with the cash dividend ratio significantly exceeding the stipulated proportion in its articles of association [2][3] - The company's price-to-earnings ratio is lower than most pharmaceutical companies, raising concerns about potential stock buybacks [2][6] Group 3: Cost Control and Efficiency Measures - The company implements comprehensive budget management to control expenses and enhance operational efficiency [3][4] - Measures include optimizing procurement processes and production operations to reduce costs while maintaining quality [3][4] Group 4: Market Challenges and Stock Performance - Despite the approval of multiple new products, the stock price has been declining, influenced by market competition, industry policies, and investor sentiment [5][9] - The company acknowledges the impact of macroeconomic uncertainties and competitive pressures on its market value [9][10] Group 5: Investor Relations and Communication - The company is committed to enhancing communication with investors through regular reports and performance briefings [6][9] - The recent investor relations activities aim to rebuild investor confidence and clarify the company's strategic direction [6][9] Group 6: Industry Outlook - The pharmaceutical industry is expected to grow due to increasing health awareness and an aging population, with innovation driving new drug development [11]

证券代码：000756 证券简称：新华制药 公告编号：2025-23 山东新华制药股份有限公司 关于取得普瑞巴林口服溶液药品注册证书的公告 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。 近日，山东新华制药股份有限公司（以下简称"新华制药"或"本公司"）收到国家药 品监督管理局核准签发的普瑞巴林口服溶液（以下简称"本品"）《药品注册证书》。现将相 关情况公告如下： 受理号：CYHS2302592 一、基本情况 药品批准文号：国药准字H20253926 证书编号：2025S01076 药品名称：普瑞巴林口服溶液 剂型：口服溶液剂 规格：473ml：9.46g 药品分类：处方药 注册分类：化学药品3类 申请人：山东新华制药股份有限公司 申请事项：药品注册（境内生产） 巴林口服溶液是《国家基本医疗保险、工伤保险和生育保险药品目录》（2024年版）乙类品 种，根据有关统计数据显示，2023年中国公立医疗机构普瑞巴林制剂销售额约为人民币6.24 亿元。 三、对上市公司的影响及风险提示 新华制药的普瑞巴林口服溶液于2025年4月取得药品注册证书，该产品的获批上市将进 一步 ...

药品名称：盐酸美金刚口服溶液 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范要求方可生产销售。 二、其他相关信息 2023年9月，新华制药向国家药品监督管理局药品审评中心（CDE）递交盐酸美金刚口服 溶液境内生产药品上市许可注册申报资料并获受理，2025年4月获得《药品注册证书》，审评 结论为批准注册。 证券代码：000756 证券简称：新华制药 公告编号：2025-24 山东新华制药股份有限公司 关于取得盐酸美金刚口服溶液药品注册证书的公告 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。 近日，山东新华制药股份有限公司（以下简称"新华制药"或"本公司"）收到国家药 品监督管理局核准签发的盐酸美金刚口服溶液（以下简称"本品"）《药品注册证书》。现将 相关情况公告如下： 一、基本情况 1 剂型：口服溶液剂 规格：360ml：0.72g 药品分类：处方药 注册分类：化学药品3类 申请人：山东新华制药股份有限 ...