宁波美诺华药业股份有限公司2025 年半年度报告 公司代码：603538 公司简称：美诺华 转债代码：113618 转债简称：美诺转债 宁波美诺华药业股份有限公司 宁波美诺华药业股份有限公司2025 年半年度报告 重要提示 一、 本公司董事会、监事会及董事、监事、高级管理人员保证半年度报告内容的真实性、准确 性、完整性，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。 二、 公司全体董事出席董事会会议。 三、 本半年度报告未经审计。 四、 公司负责人姚成志、主管会计工作负责人应高峰及会计机构负责人（会计主管人员）应高 峰声明：保证半年度报告中财务报告的真实、准确、完整。 五、 董事会决议通过的本报告期利润分配预案或公积金转增股本预案 无 六、 前瞻性陈述的风险声明 √适用 □不适用 本报告中所涉及的未来计划、发展战略等前瞻性描述不构成公司对投资者的承诺，敬请投资 者注意投资风险。 七、 是否存在被控股股东及其他关联方非经营性占用资金情况 否 八、 是否存在违反规定决策程序对外提供担保的情况 否 九、 是否存在半数以上董事无法保证公司所披露半年度报告的真实性、准确性和完整性 否 十、 重大风险 ...

Financial Performance - The company's net profit for the first half of 2025 is projected to be between 100 million and 135 million CNY, representing an increase of 237.95% to 356.24% compared to the same period last year [2] - The net profit after deducting non-recurring gains and losses is expected to decline by 1.9 million to 3.5 million CNY, a decrease of 70.96% to 84.23% year-on-year [2][3] - The fair value changes of financial assets resulted in a significant gain of approximately 110 million CNY in the first half of the year [3] Product Development and Innovation - Key innovative drugs in development include DT678, MBT-1608, PHP1003, PHP0101, long-acting recombinant human follicle-stimulating hormone injection, and GLP-1-Fc fusion protein [4] - The long-acting recombinant human follicle-stimulating hormone injection and GLP-1-Fc fusion protein have completed clinical trials and are about to be submitted for market approval [4] - The company has a unique anti-platelet aggregation drug developed in collaboration with a U.S. university, which is currently in Phase II clinical trials [4][5] New Product Launches - The nitroglycerin spray, as a unique dosage form in China, has significant market potential, especially for emergency use in angina and myocardial infarction [6] - The company plans to enhance marketing strategies for the nitroglycerin spray through academic conferences and collaborations with various sales channels [6] Shareholder Returns - Since its listing in 2004, the company has consistently paid cash dividends, with total dividends exceeding 2.1 billion CNY, which is more than ten times the initial fundraising amount [7] E-commerce and Sales Channels - The company has established a flagship store on JD.com, with a growing range of products available for sale [9] - The proportion of oral formulations has been increasing, prompting the company to explore new marketing models, including e-commerce [9] Investment Activities - The company holds a 55.69% stake in Beijing New Mile Health Industry Group through a partnership, which is expected to yield good returns in the future [10]

Group 1 - The company successfully passed the FDA cGMP inspection at its Badu factory from March 17 to March 21, 2025, indicating compliance with quality management systems and production environment standards required by the FDA [1][4] - The inspection covered six major systems: quality system, materials, production, packaging and labeling, facilities, and laboratory controls [1] - The FDA issued an Establishment Inspection Report (EIR) confirming that the company met the necessary requirements, which supports the company's efforts to expand into international markets [1] Group 2 - The inspection results were classified as NAI (No Action Indicated), which is a favorable outcome for the company [4] - The products involved in the inspection include active pharmaceutical ingredients such as Ipratropium, Abiraterone Acetate, and Pregabalin [4] - The successful inspection is expected to have a positive impact on the company's ability to enter and grow in global regulated markets [1]