证券研究报告 | 医药生物 | 2025年9月6日 www.hczq.com 华创医药投资观点&研究专题周周谈·第142期 恩华药业CNS创新管线梳理 联系人:朱珂琛 | 华创医药团队： | | | --- | --- | | 首席分析师 郑辰 | 执业编号: S0360520110002 邮箱: zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号: S0360520120002 邮箱: liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号：S0360520110004 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号：S0360524070007 邮箱：zhukechen@hcyjs.com | 本报告由华创证券有限责任公司编制 报告仅供华创证券有限责任公司的客户使用，本公司 ...

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 AI 制药产业兑现，重点推荐晶泰控股等 2025 年 08 月 24 日 增持（维持） [Table_Tag] [Table_Summary] 投资要点 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 2024/8/26 2024/12/24 2025/4/23 2025/8/21 医药生物 沪深300 相关研究 《WCLC 展示创新药积极成果，产生 新 BD 预期》 2025-08-17 《港股创新药：创新突破奠定高增长， 出海拓疆重塑新估值 》 2025-08-17 东吴证券研究所 1 / 29 请务必阅读正文之后的免责声明部分 ◼ 本周、年初至今 A 股医药指数涨幅分别为 2.2%、26.3%，相对沪深 300 的 超额收益分别为 2.68%、-15.07%；本周、年初至今恒生生物科技指数涨跌 幅分别为 3.1%、101.6%，相对于恒生科技指数跑赢 1.81%、74.2%；本周 A 股医疗器械（+4%）、中药（ ...

Core Viewpoint - The company Enhua Pharmaceutical (002262.SZ) has made progress in the registration application for its raw material drug NH600001, which was accepted on July 29, 2025 [2] Group 1: Company Updates - The NDA (New Drug Application) for NH600001 has been submitted and is currently under review [2] - All subjects have completed the clinical trial for NH600001 emulsion injection, and data analysis is ongoing [2] - The company plans to submit the market registration application after completing the clinical summary report [2]

Core Points - Enhua Pharmaceutical (002262) announced on August 4 that the registration application for the raw material drug NH600001 was accepted on July 29, 2025 [1] - The clinical trial for NH600001 emulsion injection has completed participant recruitment, and data analysis is currently underway [1] - A summary report of the clinical trial will be submitted for the registration application upon completion [1]

Core Viewpoint - The company reported a strong performance in the first half of 2025, with significant revenue and profit growth, driven by robust sales of core products and rapid growth in new products [1][2]. Financial Performance - In the first half of 2025, the company achieved operating revenue of 3.01 billion yuan, a year-on-year increase of 8.93% [1] - The net profit attributable to shareholders was 700 million yuan, reflecting a year-on-year growth of 11.38% [1] - Basic earnings per share (EPS) reached 0.69 yuan, up 11.29% year-on-year [1] Product Performance - Anesthesia products generated revenue of 1.63 billion yuan, accounting for 54.29% of total revenue, with a year-on-year growth of 7.32% [1] - Mental health products achieved revenue of 621 million yuan, representing 20.63% of total revenue, with a year-on-year increase of 4.29% [1] - Neurology products saw revenue of 166 million yuan, making up 5.51% of total revenue, with a remarkable year-on-year growth of 107.33% [1] R&D Investment - The company invested 395 million yuan in R&D in the first half of 2025, a year-on-year increase of 23.97%, representing 13.12% of total revenue [2] - There are currently 17 innovative drug projects in the pipeline, indicating a rich new drug pipeline [2] - The company has completed one Phase III clinical study and two Phase II studies, with additional studies ongoing [2] Profit Forecast - Projected operating revenues for 2025-2027 are 6.40 billion, 7.26 billion, and 8.24 billion yuan, with year-on-year growth rates of 12.39%, 13.34%, and 13.51% respectively [2] - Expected net profits for the same period are 1.29 billion, 1.48 billion, and 1.69 billion yuan, with growth rates of 13.19%, 14.03%, and 14.56% respectively [2] - EPS forecasts for 2025-2027 are 1.27, 1.45, and 1.66 yuan, with corresponding PE ratios of 17, 15, and 13 times [2]

格隆汇8月1日｜东吴证券研报指出，恩华药业半年报业绩稳健增长，创新药梯队蓄势待发。分行业来 看，公司医药工业营收25.83亿元（+9.52%），商业医药营收3.94亿元（+9.80%）；分产品来看，麻醉 类营收16.34亿元（+7.32%），精神类营收6.21亿元（+4.29%），神经类营收1.66亿元（+107.33%）， 原料药营收0.90亿元（-6.17%），商业医药营收3.94亿元（+9.80%）。公司经营稳健，各项费用管控有 效；同时实施创仿并重的策略，积极对创新药物的研发，2025H1研发费用同比增长11.36%，公司目前 17个在研创新药项目，其中NH600001乳状注射液完成III期临床项目研究，预计2026年获批上市； NHL35700完成Ⅱ期临床研究，预计25年III期临床，此外开展仿制药项目48个。考虑到公司精麻领域的 领导地位，维持"买入"评级。 ...

Core Viewpoint - The company reported a strong performance in the first half of 2025, with revenue and net profit showing positive growth compared to the previous year [1][2]. Financial Performance - In H1 2025, the company achieved revenue of 3.01 billion yuan (+8.93%) and a net profit attributable to shareholders of 700 million yuan (+11.38%) [1]. - For Q2 2025, revenue was 1.50 billion yuan (+6.64%) with a net profit of 400 million yuan (+9.94%) [1]. Segment Performance - The pharmaceutical industry revenue reached 2.58 billion yuan (+9.52%), while commercial pharmaceutical revenue was 394 million yuan (+9.80%) [2]. - Anesthesia revenue was 1.63 billion yuan (+7.32%), CNS revenue was 166 million yuan (+107.33%), and raw material drug revenue was 90 million yuan (-6.17%) [2]. R&D and Innovation - The company has a robust pipeline with 17 innovative drug projects in development, including NH600001, which is expected to be approved in 2026 [2]. - R&D expenses increased by 11.36% in H1 2025, indicating a commitment to innovation [2]. Strategic Focus - The company is enhancing market access for new anesthesia products, with significant growth expected for the newly approved drug, fumaric acid oseltamivir [3]. - The CNS product line is being refined, with promising growth anticipated for the new drug, Antitan [3]. - The company is expanding its pipeline and commercial layout through the launch of new products and a rich innovation reserve [3]. Profit Forecast - The adjusted net profit forecasts for 2025-2026 are 1.32 billion yuan and 1.52 billion yuan, respectively, with an expected net profit of 1.76 billion yuan in 2027 [3].

Core Insights - The company reported a continuous growth in operating performance for the first half of 2025, achieving a revenue of 3.01 billion yuan, an increase of 8.93% year-on-year, and a net profit attributable to shareholders of 700 million yuan, up 11.38% from the previous year [2] - The company specializes in the research and production of central nervous system drugs, with 60 approved new drug formulations and a market share leading in 29 products nationwide [2] Financial Performance - Revenue for the first half of 2025 reached 3.01 billion yuan, reflecting an 8.93% increase compared to the same period last year [2] - Net profit attributable to shareholders was 700 million yuan, marking an 11.38% year-on-year growth [2] - The net profit after deducting non-recurring gains and losses was 699 million yuan, which is a 10.33% increase from the previous year [2] Research and Development - The company has over 70 ongoing research projects, with a research expenditure of approximately 395 million yuan, representing a 23.97% increase year-on-year [2] - There are currently 17 innovative drug projects under development, including 1 project in Phase III clinical trials and 2 projects in Phase II clinical trials [3] - The company has signed a Pre-A round preferred stock purchase agreement with San Sheng Pharmaceutical, gaining priority negotiation rights for certain in-development drugs [3] Collaborations and Partnerships - The company has entered into a commercial cooperation agreement with Chengdu Yuandong Biopharmaceutical Co., Ltd. for the market development of its Oxycodone tablets [3] - The NHL35700 drug, introduced from Denmark, has completed Phase II clinical trials and is set to enter Phase III trials [3] - The Protollin project, developed in collaboration with Harvard Medical School and Tianjing Biotech, has successfully completed Phase I clinical trials in the U.S. and is moving to Phase II trials [3]

Core Insights - The company reported a continuous growth in operating performance for the first half of 2025, with revenue reaching 3.01 billion yuan, an increase of 8.93% year-on-year, and a net profit attributable to shareholders of 700 million yuan, up 11.38% year-on-year [1] - The company specializes in the research and production of central nervous system drugs, with 60 approved new drug formulations and a market share leading in 29 products nationwide [1] Financial Performance - Revenue for the first half of 2025 was 3.01 billion yuan, reflecting an 8.93% increase compared to the same period last year [1] - Net profit attributable to shareholders was 700 million yuan, marking an 11.38% year-on-year growth [1] - The net profit after deducting non-recurring gains and losses was 699 million yuan, a 10.33% increase year-on-year [1] Research and Development - The company has over 70 ongoing research projects, with a research expenditure of approximately 395 million yuan, which is a 23.97% increase compared to the previous year [1] - There are currently 17 innovative drug projects under development, including 1 completed Phase III clinical study and 2 completed Phase II studies [2] - The company has signed a Pre-A round preferred stock purchase agreement with San Sheng Pharmaceutical, gaining priority negotiation rights for some of its drug projects [2] Collaborations and Partnerships - The company has entered into a commercial cooperation agreement with Chengdu Yuandong Biopharmaceutical Co., Ltd. for the market development of its oxazepam tablet product [2] - The NHL35700 drug, introduced from Denmark, has completed Phase II clinical research and is about to enter Phase III [2] - The Protollin project, developed in collaboration with Harvard Medical School and Tianjing Biotechnology, has successfully completed Phase I clinical research in the U.S. and is set to enter Phase II [2]

Core Viewpoint - Enhua Pharmaceutical reported continuous growth in its operating performance for the first half of 2025, with revenue reaching 3.01 billion yuan, an increase of 8.93% year-on-year, and a net profit attributable to shareholders of 700 million yuan, up 11.38% year-on-year [1] Financial Performance - The company achieved an operating revenue of 3.01 billion yuan, reflecting an 8.93% increase compared to the same period last year [1] - The net profit attributable to shareholders was 700 million yuan, marking an 11.38% year-on-year growth [1] - The net profit after deducting non-recurring gains and losses was 699 million yuan, which is a 10.33% increase year-on-year [1] R&D Investment - Enhua Pharmaceutical invested approximately 395 million yuan in research and development, representing a 23.97% increase compared to the previous year [2] - The company has over 70 ongoing research projects in the pipeline and holds the largest product line in the central nervous system drug sector in China [2] Innovative Drug Development - The company has 17 innovative drug projects under development, including 1 project in Phase III clinical trials and 2 projects in Phase II clinical trials [3] - Collaborations include partnerships with San Sheng Pharmaceutical and Harvard Medical School for various drug development projects [3] Digital Healthcare Development - Enhua Pharmaceutical has established a digital healthcare platform since 2015, which includes online consultation and health services, with over 70,000 registered doctors and more than 2 million patient visits annually [4] - The company has developed several digital mental health products, including AI-based psychological risk screening systems and virtual reality tools [4] Expansion and Partnerships - The company operates 25 psychological clinics and has signed contracts with over 400 corporate clients, covering nearly 2 million individuals [5] - Enhua Pharmaceutical is actively pursuing overseas listing plans to expand financing channels and support business growth [5]