医药生物行业专题研究 "小而美"药辅行业迎来产业升级 2026 年 02 月 24 日 【投资要点】 【配置建议】 建议关注医药辅料优势企业山河药辅等；植物胶囊优势企业山东赫达 等。 【风险提示】 挖掘价值 投资成长 强于大市（维持） 东方财富证券研究所 证券分析师：何玮 证书编号：S1160517110001 相对指数表现 -10% -2% 6% 14% 22% 30% 2025/2 2025/8 2026/2 医药生物 沪深300 相关研究 《ADC 商业化进程提速，本土创新药企多 路径布局产能》 2026.02.09 《《药品管理法实施条例》全面修订，推动 医药产业创新与监管升级》 政策落地执行不达预期； 药用辅料国产替代延迟； 新型高端辅料推进不达预期； 消费降级保健品增长不达预期； 2026.02.03 《医药零售高质量发展政策发布，行业有 望加速整合利好龙头》 2026.01.27 《J.P. Morgan 健康大会召开，中国创新药 企扬帆出海》 2026.01.20 《聚焦脑机接口与小核酸药物，JPM 盛会 前奏下医疗布局新浪潮》 2026.01.14 行 业 研 究 / 医 药 生 物 / 证 ...

另一方面， 缺乏专业操作人才 ，无法精准检测微量杂质、优化工艺参数。 转机来自 淮安市科研仪器设备共享服务平台 。通过平台牵线搭桥，东南纳米与江苏食品药品 职业技术学院达成深度合作，构建"仪器共享+技术协同"攻关模式，共享高校的电感耦合等离 子体质谱仪、Water s高效液相色谱仪，破解了检测与人才的双重瓶颈。 特别提示 微信机制调整，点击顶部"仪器信息网" → 右上方"…" → 设为 ★ 星标，否则很可能无法看到我 们的推送。 "曾因缺少高端检测设备，我们的合成磷脂国产化研发卡了壳，是市科研仪器设备共享服务平 台帮我们解了燃眉之急。"日前，江苏东南纳米材料有限公司执行董事詹熙感慨。通过平台实 现仪器共享与校企协同，企业不仅降低了研发成本，更加速了进口替代进程。 深耕药用辅料领域近10年，东南纳米是国内少数能生产合成磷脂类药用辅料的高新技术企业。 在 攻 克 脂 质 体 辅 料 进 口 替 代 难 题 时 ， 其 核 心 技 术 曾 获 2018 年 江 苏 省 科 学 技 术 奖 一 等 奖 。 然 而，此前企业在推进生产工艺优化时陷入两难： 一方面， 暂不需要购置电感耦合等离子体质谱仪等高端设备 ； "2 ...

安徽山河药用辅料股份有限公司于2025年12月4日至12月5日接受了美国FDA的现场检查，检查范围包括 质量管理、生产管理、设施与设备管理、实验室质量控制、物料和包装标签管理六大体系。公司已收到 美国FDA出具的现场检查报告（EIR），确认检查结束并顺利通过。此次为公司首次通过美国FDA现场 检查，表明其质量管理体系符合国际标准，有利于拓展美国及其他国际市场，同时对国内药用辅料替代 进口业务产生积极影响。公司提示投资者注意海外业务可能受到市场环境、关税、汇率等因素影响的风 险。 当日关注点 交易信息汇总资金流向 2月4日主力资金净流入1290.58万元；游资资金净流入1183.64万元；散户资金净流出2474.22万元。 公司公告汇总关于通过美国FDA现场检查公告 截至2026年2月4日收盘，山河药辅(300452)报收于15.77元，上涨2.8%，换手率8.84%，成交量17.55万 手，成交额2.75亿元。 以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 来自交易信息汇总：2月4日主力资金净流入1290.58万元，游资资金同步净 ...

Core Viewpoint - The company, Anhui Shanhe Pharmaceutical Excipients Co., Ltd., successfully passed its first on-site inspection by the U.S. FDA, indicating that its quality management system meets international standards, which is expected to facilitate the expansion into U.S. and other international markets [1]. Group 1: Stock Performance - As of February 4, 2026, the stock price of Shanhe Pharmaceutical Excipients closed at 15.77 yuan, reflecting a 2.8% increase from the previous trading day [1]. - The stock opened at 15.35 yuan, reached a high of 16.01 yuan, and a low of 15.28 yuan, with a trading volume of 2.75 billion yuan and a turnover rate of 8.84% [1]. Group 2: FDA Inspection - The company underwent an on-site inspection by the U.S. FDA from December 4 to December 5, 2025, covering six major systems: quality management, production management, facility and equipment management, laboratory quality control, material and packaging label management [1]. - The company received the FDA's Establishment Inspection Report (EIR), confirming that the inspection was completed successfully [1]. Group 3: Market Implications - The successful FDA inspection is expected to positively impact the company's domestic pharmaceutical excipients business by reducing reliance on imports [1]. - The company cautions investors about potential risks to overseas business due to market conditions, tariffs, and exchange rates [1].

Core Viewpoint - Hualan Co., Ltd. has signed a share transfer agreement to acquire a 35% stake in Ningbo Guangfeng Capsule Co., Ltd. for 8.4647 million yuan, with plans to increase its ownership to between 51% and 70% by 2028 [1] Group 1: Company Acquisition - Hualan Co., Ltd. will purchase a 35% stake in Ningbo Guangfeng Capsule Co., Ltd. from Ningbo Spokan Biotechnology Co., Ltd. for 8.4647 million yuan [1] - After the transaction, Hualan will have the right to further acquire an additional 16% to 35% of Guangfeng Capsule's shares between 2026 and 2028 [1] - The acquisition aims to achieve controlling interest in Guangfeng Capsule, which specializes in the manufacturing and sales of hollow capsules, a pharmaceutical excipient [1]

Core Viewpoint - After 13 months of international trade disputes, Chinese hard capsule manufacturers have received a favorable ruling from the U.S. Department of Commerce, significantly reducing anti-dumping and countervailing duties, which enhances their competitiveness in the U.S. market [1][4]. Group 1: Impact of Ruling on Shandong Heda - Shandong Heda's anti-dumping tax rate has dropped from 172.24% to 18.71%, a reduction of 153.53 percentage points, while the countervailing duty is set at 6.90% [1][6]. - The substantial decrease in tax rates not only restores the company's export competitiveness but also allows for the refund of previously paid high-rate deposits, positively impacting cash flow [1][10]. - Following the announcement, Shandong Heda's stock price surged, indicating market optimism regarding the ruling's implications [1][10]. Group 2: Background of the Investigation - The investigation began on November 13, 2024, when the U.S. Department of Commerce initiated anti-dumping and countervailing duty investigations on hard capsules from China, Brazil, India, and Vietnam [4][5]. - At the initial ruling stage, Shandong Heda faced a punitive tax rate of 172.24%, which raised concerns about its market viability in the U.S. [5][6]. - The U.S. market is crucial for Shandong Heda, with exports to the U.S. accounting for 62.38% of its total revenue from hard capsules [3][4]. Group 3: Future Strategies - Despite the favorable ruling, uncertainties remain as the U.S. International Trade Commission will announce its final determination on industry damage in February 2026, which could affect the enforcement of the anti-dumping duties [3][11]. - Shandong Heda has prioritized establishing a manufacturing facility in the U.S. as a strategic move to mitigate tariff risks and enhance its market presence [3][11]. - The company is also expanding its global footprint beyond the U.S., targeting markets in Germany, France, Italy, Canada, Brazil, India, and Japan, and has signed an exclusive agency agreement with IMCD to penetrate emerging markets [12].

Core Points - The company reported a revenue of 697 million yuan for the first three quarters of 2025, representing a year-on-year growth of 8.09% [1] - The net profit attributable to shareholders for the same period was 133 million yuan, with a year-on-year increase of 8.28% [1] - In the third quarter alone, the company achieved a revenue of 226 million yuan, marking a year-on-year growth of 16.06% [1] - The net profit for the third quarter was approximately 39.53 million yuan, showing a significant year-on-year increase of 46.99% [1]

Core Viewpoint - The company Erkang Pharmaceutical (300267) showcases its strengths and development potential in the pharmaceutical excipients industry during the 2025 Hunan Listed Companies Collective Reception Day and Semi-Annual Performance Briefing held on September 19. Group 1: Company Strengths - The company offers a diverse range of products, with 127 pharmaceutical excipient varieties, accounting for 32.87% of the 387 varieties listed in the 2025 edition of the Chinese Pharmacopoeia, covering nearly all commonly used pharmaceutical excipients [1] - Established supply relationships with over 3,000 domestic downstream customers, indicating high product and customer stickiness [1] - Possesses three significant research platforms: the "National Pharmaceutical Excipients Engineering Technology Research Center," the "National Recognized Enterprise Technology Center," and the "Key Laboratory of Pharmaceutical Excipients Engineering Technology of the National Medical Products Administration" [1] - Actively participates in the formulation and revision of standards for pharmaceutical excipients in the Chinese Pharmacopoeia and contributes to the compilation of the "Infrared Spectrum Collection of Pharmaceutical Excipients" [1] - Awarded the qualification of "Variety Guardian" for 12 types of pharmaceutical excipients by the National Pharmacopoeia Committee [1] - Achievements in quality improvement research for injectable pharmaceutical excipients, with the project "Key Technology Development and Industrialization of Injectable Pharmaceutical Excipients" winning the second prize in Hunan Province's Science and Technology Progress Award [1] - The company's starch capsules and other varieties have been included in the list of key varieties in the biopharmaceutical industry chain published by the Hunan Provincial Department of Industry and Information Technology (second batch) [1]

Core Viewpoint - The passing of Yin Zhenglong, the controlling shareholder and chairman of Anhui Shanhe Pharmaceutical Auxiliary Co., Ltd., is a significant event for the company, which may lead to changes in leadership but is not expected to disrupt its operations [1][3]. Group 1: Company Leadership - Yin Zhenglong passed away on August 26, 2025, at the age of 60, and had been the chairman and general manager since the company's inception [3][5]. - He held 63,057,454 shares, representing 26.90% of the total shares, making him the controlling shareholder [3]. - The company announced that the board's functionality will remain intact, and the management team will continue its operations without interruption [3]. Group 2: Company Operations - Following Yin Zhenglong's death, the company will conduct a board election to fill the chairman position, with current director and general manager Song Daocai temporarily assuming the role [3][5]. - The company reported a revenue of 471 million yuan for the first half of 2025, a year-on-year increase of 4.65%, while the net profit attributable to shareholders was approximately 93 million yuan, a decrease of 2.61% [8]. - Basic earnings per share were reported at 0.40 yuan, down 2.44% year-on-year [8]. Group 3: Company Background - Anhui Shanhe Pharmaceutical Auxiliary Co., Ltd. was established in April 2001 and specializes in the production, research, and sales of new pharmaceutical excipients, holding a leading position in the domestic market [8]. - The company was listed on the Shenzhen Stock Exchange's Growth Enterprise Market in May 2015 [8]. Group 4: Recent Developments - The company's official website has been changed to a black-and-white page, indicating a period of mourning [6]. - Yin Zhenglong had recently chaired a shareholders' meeting on August 18 and a board meeting on the morning of August 26, just hours before his passing [5].

Core Viewpoint - The chairman and actual controller of Shanhe Pharmaceutical Excipients, Yin Zhenglong, passed away at the age of 60, leading to a significant impact on the company's stock price and governance structure [1][3]. Company Overview - Shanhe Pharmaceutical Excipients is engaged in the research, production, and sales of pharmaceutical excipients, with main products including fillers, adhesives, disintegrants, lubricants, and coating materials for oral solid dosage forms and injectable pharmaceutical excipients [2]. Impact of Chairman's Death - Following the announcement of the chairman's death, the company's stock price fell over 4%, closing at 13.64 yuan per share [3]. - The company’s official website has been changed to black and white as a sign of mourning [3]. - Yin Zhenglong was the founder and had served as chairman and general manager since the company's inception, playing a crucial role in its growth and listing on the Shenzhen Stock Exchange [3]. - He held 63,057,454 shares, representing 26.90% of the total shares, making him the controlling shareholder [3]. Governance Transition - The company announced that it will promptly complete the election of a new chairman according to relevant laws and regulations [3]. - In the interim, the current director and general manager, Song Daocai, will assume the responsibilities of chairman and legal representative until a new chairman is elected [3].