报告摘要 市场表现： 2025 年2 月25 日，医药板块涨跌幅+0.84%，跑赢沪深300 指数0.24pct，涨跌幅居申万31 个子行业第14 名。各医药子行业中，其他生物制品(+2.39%)、医院（+2.04%)、医疗耗材(+1.58%)表现居前，线下药 店（+0.32%）、体外诊断(+0.33%)、医疗研发外包（+0.34%)表现居后。个股方面，日涨幅榜前3 位分 别为长春高新(+10.00%)、爱迪特（+9.03%)、常山药业(+8.87%)；跌幅榜前3 位为前沿生物（-4.09%)、 百利天恒（-3.62%）、硕世生物(-2.97%)。 行业要闻： 公司要闻： 赛诺医疗（688108）：公司发布2025 年业绩快报，公司2025 年实现营业收入5.25 亿元，同比增长 14.53%，归母净利润为0.47 亿元，同比增长3057.05%，扣非后归母净利润为0.34 亿元，同比增长 293.82%。 联影医疗（688271）：公司发布2025 年业绩快报，公司2025 年实现营业收入138.21 亿元，同比增长 34.18%，归母净利润为18.88 亿元，同比增长49.60%，扣非后归母净利润为17. ...

近日，汇宇制药发布公告称，收到美国食品药品监督管理局（简称"美国 FDA"）的通知，公司向美国 FDA 申报的依托泊苷注射液、氟尿嘧啶注射液的新药申请（NDA）均已获得批准，意味着公司可以生 产并通过海外合作方在美国市场销售前述产品。 （汇宇制药公告） 公告提到，获得FDA批准后，将有助于公司拓展美国市场的销售，强化产品供应链，并丰富产品梯队， 为国际市场的可持续发展奠定基础。虽然公司已开始上市销售的前期准备，但由于产品的非唯一性及同 类产品的竞争，未来收入存在较大不确定性。 ...

Policy Developments - Shandong Province held a meeting on February 25, 2026, to address corruption and misconduct in the healthcare sector, emphasizing the need for a coordinated effort to safeguard medical insurance funds and promote orderly development in healthcare [1] Drug and Device Approvals - Kanghong Pharmaceutical received approval from the National Medical Products Administration for clinical trials of KHN707 tablets for insomnia, a class 1 innovative drug [2] - Fosun Pharma's subsidiary received approval for clinical trials of Rumaine® (generic name: Luwomeitini tablets) for advanced non-small cell lung cancer, with global sales of MEK1/2 inhibitors projected to reach approximately $2.068 billion in 2024 [3] - China Pharmaceutical announced that its subsidiary received a drug registration certificate for injectable fosfomycin, aimed at treating acute bacterial skin and soft tissue infections [4] - Huyou Pharmaceutical received FDA approval for its new drug applications for Etoposide injection and Fluorouracil injection, enabling sales in the U.S. market [5] - Kangfang Biotech's application for the monoclonal antibody AK120 was accepted for review by the National Medical Products Administration [6] Industry Developments - Junshi Bioscience and Deqi Pharmaceuticals entered a strategic collaboration to explore the combined treatment potential of JS207 and ATG-037 for cancer patients in mainland China [8] - Illumina announced an 18-month innovation upgrade roadmap for the NovaSeq X sequencer, enhancing its capabilities and productivity [9] Capital Market Activities - Sainuo Medical announced a share repurchase plan with a total amount between 15 million and 30 million yuan, aimed at employee stock ownership plans or equity incentives [10] Financial Data - United Imaging reported a net profit of 1.888 billion yuan for 2025, a year-on-year increase of 49.60%, driven by new product launches and growth in overseas business [11] - Xiansheng Pharmaceutical projected a revenue of approximately 7.7 billion to 7.8 billion yuan for the 2025 fiscal year, with a net profit increase of 80.1% to 93.9% [12] - Sainuo Medical reported a net profit of 47.29 million yuan for 2025, a significant increase of 3,057.05% year-on-year, attributed to revenue growth and cost management [13]

汇宇制药表示，公司研发的依托泊苷注射液、氟尿嘧啶注射液获得美国FDA批准，标志着具备了在美国 市场销售产品的资格，有利于公司拓展美国市场的销售、强化产品供应链、丰富产品梯队，为国际市场 的可持续发展进一步夯实了基础。 北京商报讯（记者 丁宁）2月25日晚间，汇宇制药（688553）发布公告称，公司于近日收到美国食品药 品监督管理局（以下简称"美国FDA"）的通知，公司向美国FDA申报的依托泊苷注射液、氟尿嘧啶注射 液的新药申请均已获得批准，意味着公司可以生产并通过海外合作方在美国市场销售前述产品。 ...

Group 1: Financial Performance Highlights - Lante Optics achieved a revenue of 1.536 billion yuan in 2025, a year-on-year increase of 48.52%, with a net profit of 388 million yuan, up 76.09% [1] - United Imaging reported a revenue of 13.82 billion yuan for 2025, reflecting a 34.18% year-on-year growth, and a net profit of 1.888 billion yuan, up 49.60% [2] - Hengxuan Technology's revenue reached 3.525 billion yuan, an 8.02% increase, with a net profit of 588 million yuan, up 27.75% [3] - Nanya New Materials reported a significant net profit increase of 378.65%, reaching 241 million yuan, with revenue of 5.228 billion yuan, up 55.52% [4] - Yancoal Australia, a subsidiary of Yancoal Energy, reported a revenue of 5.949 billion AUD and a net profit of 4.4 billion AUD for 2025 [5] - Hanlan Co. reported a revenue of 10.467 billion yuan, a 13.04% increase, but a net profit decline of 9.59% to 592 million yuan [10][11] - Transsion Holdings experienced a revenue decline of 4.50% to 65.623 billion yuan, with a net profit drop of 53.43% to 2.584 billion yuan [14] - Huachuang Technology achieved a revenue of 628 million yuan, a 2.78% increase, with a net profit of 42.678 million yuan, up 89.45% [21] - Aiko Optoelectronics reported a revenue of 440.311 million yuan, a 77.36% increase, with a net profit of 64.0919 million yuan, up 307.63% [34] - Chip Microelectronics achieved a revenue of 1.408 billion yuan, a 47.61% increase, with a net profit of 290 million yuan, up 80.42% [35] - Shenkong Co. reported a revenue of 443 million yuan, a 46.26% increase, with a net profit of 101 million yuan, up 146.54% [36] - Qinda Environmental reported a revenue of 2.042 billion yuan, a 55.42% increase, with a net profit of 181 million yuan, up 94.62% [39] Group 2: Corporate Developments - Huilong New Materials announced that its actual controller is planning a significant matter that may lead to a change in company control, resulting in a stock suspension [6] - Fangzheng Securities disclosed that its shareholder China Cinda did not reduce its shareholding as planned during the designated period [7] - Lingyi Technology plans to invest 20 million yuan in a partnership with several investment firms [8] - Longbai Group's subsidiary has partially resumed production after a safety incident [9] - Fuda Co. plans to reduce its repurchased shares by up to 1% through centralized bidding [13] - Fuxing Pharmaceutical's subsidiary received approval for clinical trials of a new drug for lung cancer [15] - Beixin Road and Bridge won a bid for a highway reconstruction project worth 751 million yuan [16] - Songsheng Co. established a joint venture with a registered capital of 30 million yuan, focusing on digital energy products [17] - Moxinlin reported a revenue of 577 million yuan, a 20.98% increase, with a net profit of 55.8745 million yuan, up 22.69% [18] - Zhuhai Beer reported a revenue of 5.878 billion yuan, a 2.56% increase, with a net profit of 903 million yuan, up 11.42% [24] - Honghua Digital reported a revenue of 2.308 billion yuan, a 28.90% increase, with a net profit of 529 million yuan, up 27.63% [25] - Xinfeng Pharmaceutical received FDA approval for two injectable drugs [26] - Jiazhe New Energy's project for green hydrogen production received regulatory approval [27] - Chip Microelectronics reported a revenue of 5.24 billion yuan, a 29.48% increase, with a net profit of 302 million yuan, up 36.1% [28] - Debang Co. completed the cash settlement process for its delisting [29] - Xingfu Electronics reported a revenue of 1.475 billion yuan, a 29.72% increase, with a net profit of 208 million yuan, up 30.37% [30] - Longda Food announced the resignation of its general manager due to work adjustments [31] - Bohai Chemical reported that some fundraising projects have commenced production [32] - Shengke Communication reported a net loss of 150 million yuan for 2025 [33] - Jin Cheng Pharmaceutical's subsidiaries received drug registration certificates for two products [37] - Jinpu Titanium Industry announced the resumption of production at its subsidiary [38] - Zhigao Electric's subsidiary won a bid for a project worth 182 million yuan [40]

自愿披露依托泊苷注射液、氟尿嘧啶注射液 获得美国 FDA 批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 四川汇宇制药股份有限公司（以下简称"公司"）于近日收到美国食品药品 监督管理局（以下简称"美国 FDA"）的通知，公司向美国 FDA 申报的依托泊 苷注射液、氟尿嘧啶注射液的新药申请（NDA）均已获得批准，意味着公司可 以生产并通过海外合作方在美国市场销售前述产品。现将相关情况公告如下： 证券代码：688553 证券简称：汇宇制药 公告编号：2026-010 四川汇宇制药股份有限公司 一、药品基本情况 （一）依托泊苷注射液 公司已开展产品上市销售的前期准备工作，同时受产品的非唯一性、同类产 品竞争以及未来公司业务的推广效果、销售规模等因素影响，未来能否产生较大 收入具有较大不确定性。产品注册批件的取得在短期内对公司经营业绩不构成重 大影响。敬请广大投资者谨慎决策，注意防范投资风险。 二、药品的其他相关情况 依托泊苷注射液是一种拓扑异构酶抑制剂，与其它化疗和/或免疫治疗联合 使用，适用于治疗以下成年患者： 1 ...

公司研发的依托泊苷注射液、氟尿嘧啶注射液获得美国FDA批准，标志着具备了在美国市场销售产品的 资格，有利于公司拓展美国市场的销售、强化产品供应链、丰富产品梯队，为国际市场的可持续发展进 一步夯实了基础。 格隆汇2月25日丨汇宇制药(688553.SH)公布，公司于近日收到美国食品药品监督管理局（以下简称"美 国FDA"）的通知，公司向美国FDA申报的依托泊苷注射液、氟尿嘧啶注射液的新药申请（NDA）均已 获得批准，意味着公司可以生产并通过海外合作方在美国市场销售前述产品。 依托泊苷注射液是一种拓扑异构酶抑制剂，与其它化疗和/或免疫治疗联合使用，适用于治疗以下成年 患者：1.难治性睾丸癌；2.小细胞肺癌。氟尿嘧啶注射液适用于治疗：1.结肠癌和直肠癌；2.乳腺癌；3. 胃腺癌；4.胰腺癌。 ...

每经AI快讯，2月25日，汇宇制药(688553.SH)公告称，公司于近日收到美国FDA的通知，公司向美国 FDA申报的依托泊苷注射液、氟尿嘧啶注射液的新药申请(NDA)均已获得批准。这标志着公司具备了在 美国市场销售产品的资格，有利于公司拓展美国市场的销售、强化产品供应链、丰富产品梯队，为国际 市场的可持续发展进一步夯实了基础。 ...

证券代码：688553 证券简称：汇宇制药 公告编号：2026-009 四川汇宇制药股份有限公司 关于自愿披露通过美国FDA现场检查的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 四川汇宇制药股份有限公司（以下简称"公司"）于2025年10月27日至2025年11月06日接受了来自美国食 品药品监督管理局（以下简称"FDA"）的现行药品生产质量管理规范（cGMP）检查和药品批准前检查 （PAI）。近日，公司收到了FDA签发的现场检查报告（EIR），该报告表明FDA 确认本次检查已结 束，公司通过本次cGMP检查和药品批准前检查（PAI），现就相关情况公告如下： 一、FDA现场检查的相关信息 接受检查企业名称：四川汇宇制药股份有限公司 企业生产地址：四川省内江市市中区汉阳路333号3幢 FDA FEI：301450019 检查结论：VAI（Voluntary Action Indicated，自愿采取整改） 二、本次检查涉及产品情况 ■■ 三、对公司的影响及风险提示 本次检查是公司第三次接受美国FDA现场检查，本次检 ...

《科创板日报》2月24日讯 今日科创板晚报主要内容包括：马斯克设想从月球电磁弹射AI卫星；申联生 物拟2.37亿元收购世之源控股权并开展创新药业务；中微半导发布业绩快报，2025年净利润2.85亿元， 同比增长108.05%。 【热点聚焦】 简讯： 广东省委书记黄坤明：最大限度为技术创新和市场探索"松绑" 让低空经济"飞"起来、自动驾驶"跑"起 来、具身智能"用"起来 广东省委书记黄坤明2月24日在广东省高质量发展大会上表示，要充盈营商环境阳光雨露。两业协同发 展必然伴随新产品、新业态、新模式的持续涌现，迫切需要构建开放、包容、稳定的营商环境，呵护新 生事物成长。要以深化改革强化新赛道新领域制度供给，着力破解"老规矩管新质生产力"的问题，最大 限度为技术创新和市场探索"松绑"，让低空经济"飞"起来、自动驾驶"跑"起来、具身智能"用"起来，确 保既"放得活"又"管得好"。要以扩大开放走在两业协同发展最前沿，深度融入全球产业分工网络，加快 集聚全球制造资源、服务资源，在高水平"引进来"、高质量"走出去"中擦亮"广东制造"、"广东服务"双 品牌。生态好不好、环境行不行，企业满意度是评判标准。全省各级党委政府将一以贯 ...