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 ...

Core Insights - The report maintains a positive outlook on the pharmaceutical and biotechnology sector, with a focus on raw material prices as of July 2025 [1][3] Hormonal Drug Price Situation - In July 2025, prices for hormonal drugs such as progesterone, medroxyprogesterone acetate, saponin, dexamethasone sodium phosphate, hydrocortisone, and acetate hydrocortisone remained stable month-on-month. Year-on-year, progesterone prices remained unchanged, while medroxyprogesterone acetate, saponin, dexamethasone sodium phosphate, hydrocortisone, acetate hydrocortisone, and saponin saw declines of 1.85%, 3.23%, 84.22%, 14.04%, 12.15%, and 5.66% respectively [6][10] Antibiotic Intermediate Price Situation - In July 2025, prices for antibiotic intermediates such as 4-AA remained stable month-on-month, while 7-ADCA, 7-ACA, 6-APA, and penicillin industrial salt saw decreases of 1.92%, 2.08%, 8.33%, and 7.89% respectively. Year-on-year, 7-ADCA, 7-ACA, 6-APA, 4-AA, and penicillin industrial salt prices fell by 1.92%, 4.08%, 45.00%, 13.92%, and 41.67% respectively [10][11] β-Lactam Antibiotic Price Situation - In July 2025, prices for β-lactam antibiotics such as cephalexin, ampicillin, cefotaxime sodium, and cefaclor remained stable month-on-month. However, ceftriaxone sodium, cefixime, and amoxicillin saw declines of 1.55%, 1.37%, and 11.36% respectively. Year-on-year, cephalexin, ampicillin, ceftriaxone sodium, cefotaxime sodium, cefixime, and amoxicillin prices decreased by 1.82%, 2.22%, 9.29%, 3.40%, 12.20%, and 35.00% respectively, while cefaclor saw an increase of 6.12% [15][17] Cardiovascular Drug Price Situation - In July 2025, prices for cardiovascular raw materials such as valsartan, irbesartan, telmisartan, lisinopril, enalapril maleate, and atorvastatin calcium remained stable month-on-month. Year-on-year, valsartan prices decreased by 1.54%, while the other drugs remained unchanged [19][20]

Group 1 - The company has made strategic acquisitions of Chang Le Pharmaceutical and Long Yi Pharmaceutical to enhance overall competitiveness through synergy, optimization of layout, complementary production lines, and cost advantages [1] - The acquisition of Long Yi Pharmaceutical aims to expand the CSO business and improve the pharmaceutical distribution sector, leveraging its market foundation and sales network in the Sichuan-Chongqing region to quickly increase local market share [1] - Post-acquisition, the company is focusing on improving efficiency through coordinated R&D project management and resource allocation, optimizing product layout to reduce costs, and integrating sales networks for resource sharing [1] Group 2 - The company is concentrating on innovative drugs, high-end formulations, and large-volume generic drugs, with a R&D team led by over ten PhDs and a planned R&D investment of approximately 277 million yuan in 2024 [1] - The company is innovating in sales by building a compliance system internally and enhancing market expansion externally [1] - The company is enhancing quality stability through intelligent transformation in production, with its new facility set to pass FDA inspections again in August 2024 [1] Group 3 - The company's core new drug LH-1801 (SGLT2 inhibitor) is in Phase III clinical trials, with 615 patients enrolled by January 2025, and the follow-up is expected to conclude in January 2026 [2] - LH-1801 shows significant synergistic effects for diabetic patients with hypertension, potentially opening a market worth 2 billion yuan upon approval in 2026 [2] - The prevalence of hypertension among adults in China is 31.6%, with the market for antihypertensive drugs dominated by sartans, which had sales of 2.2 billion yuan and 2 billion yuan for Irbesartan and Valsartan respectively in 2023 [2] Group 4 - The company recognizes the strategic value of centralized procurement policies for the pharmaceutical industry and has established a dynamic policy research mechanism to enhance its ability to respond to market changes [3] - The company aims to transform policy challenges into new opportunities for corporate transformation and upgrading through product structure optimization, accelerated innovation, and deepened cooperation with hospitals [3]

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].

Core Insights - The rapid development of the domestic pharmaceutical industry has significantly advanced the raw material drug sector, particularly in the "sartan" antihypertensive drug market [1][2] Group 1: Market Overview - The global consumption of sartan raw materials from 2016 to 2022 reached 34,282.2 tons, with valsartan being the most consumed at 9,925.53 tons [2][3] - The highest growth rate in consumption was observed for aliskiren ester, with a compound annual growth rate (CAGR) of 227.76% [4][5] - The top three consumed sartan raw materials in China from 2016 to 2022 were irbesartan, valsartan, and aliskiren ester, with total consumption of 298.96 tons, 172.73 tons, and 37.19 tons respectively [10][21] Group 2: Sales Performance - The global sales of sartan formulations in 2022 reached $23.115 billion, with a CAGR of 12.19% from 2018 to 2022 [8][20] - The leading active ingredient in global sartan formulation sales in 2022 was sacubitril/valsartan, generating $6.941 billion, significantly surpassing other sartan drugs [6][7] - In China, the sales of sartan formulations from 2016 to 2022 totaled 240.37 billion yuan for valsartan, 134.41 billion yuan for irbesartan, and 79.20 billion yuan for losartan [21][22] Group 3: Competitive Landscape - Major companies in the sartan raw material export market include Huahai Pharmaceutical, Tianyu Pharmaceutical, and Shanghai Pharmaceuticals, with Huahai leading in export volume [14][15] - The domestic market for angiotensin II receptor antagonists (sartans) accounted for 26.17% of the total antihypertensive drug market in 2022, indicating a strong market presence [17][20] - The competitive landscape is influenced by the approval of domestic generic drugs and centralized procurement policies, which are expected to drive growth in the sartan raw material and formulation markets [8][20] Group 4: Future Outlook - The report predicts continued growth in the sartan raw material and formulation markets, driven by increasing demand and favorable policy environments [1][24] - Aliskiren ester, a domestically developed angiotensin receptor antagonist, is expected to see significant growth, especially as its compound patent expires in July 2026 [24]