证券研究报告：医药生物 | 公司点评报告 发布时间：2025-12-11 股票投资评级 资料来源：聚源，中邮证券研究所 公司基本情况 | 最新收盘价（元） | 17.80 | | --- | --- | | 总股本/流通股本（亿股）37.08 | / 27.89 | | 总市值/流通市值（亿元）660 | / 496 | | 52 周内最高/最低价 | 21.97 / 17.47 | | 资产负债率(%) | 62.1% | | 市盈率 | 14.47 | | 第一大股东 | HKSCC NOMINEES | | LIMITED | | 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 分析师:龙永茂 SAC 登记编号:S1340523110002 Email:longyongmao@cnpsec.com 上海医药(601607) 减值影响利润，看好创新业务驱动成长 l 商业板块稳健增长，Q3 减值影响利润 公司发布 2025 年三季报：2025Q1-3 公司实现营业收入 2150.72 亿元（+2.60%），其中医药工业实现销售收 ...

Investment Rating - The investment rating for the company is "Recommended" (maintained) with a current stock price of 17.94 yuan [1]. Core Views - The company's revenue for Q1-Q3 2025 reached 215.07 billion yuan, a year-on-year increase of 2.60%, while the net profit attributable to shareholders was 5.15 billion yuan, up 26.96%. This increase was primarily due to a one-time special gain from changing the accounting treatment of a joint venture to a subsidiary [3]. - Excluding one-time special gains, the net profit attributable to shareholders was 3.98 billion yuan, reflecting a year-on-year decrease of 1.85% [3]. - The innovative drug business continues to advance, with 57 new drug applications accepted for clinical trials, including 45 innovative drug pipelines [6]. - The pharmaceutical commercial segment showed steady growth, with innovative drug sales reaching 40.7 billion yuan, a year-on-year increase of over 25%, and import agency business sales of 27.6 billion yuan, up over 14% [6]. - The company adjusted its profit forecast for 2025-2027, expecting net profits of 5.195 billion yuan, 5.689 billion yuan, and 5.966 billion yuan, respectively [6]. Summary by Sections Financial Performance - Revenue for 2023 is projected at 260.30 billion yuan, with a year-on-year growth of 12.2%. For 2024, revenue is expected to be 275.25 billion yuan, growing by 5.7%, and for 2025, it is estimated at 291.77 billion yuan, with a growth of 6.0% [5]. - Net profit for 2023 is projected at 3.77 billion yuan, with a significant decline of 32.9%. However, it is expected to recover to 4.55 billion yuan in 2024, representing a growth of 20.8% [5]. - The gross margin is expected to be 12.0% in 2023, decreasing to 11.1% in 2024, and stabilizing at 11.5% from 2025 to 2027 [5]. Cash Flow and Balance Sheet - Operating cash flow for 2024 is projected at 5.11 billion yuan, increasing significantly to 10.70 billion yuan in 2025 [8]. - Total assets are expected to grow from 221.21 billion yuan in 2024 to 241.84 billion yuan by 2027 [7]. - The company’s debt ratio is projected to decrease from 62.1% in 2024 to 58.2% in 2027, indicating improved financial stability [7]. Market Position and Future Outlook - The innovative drug pipeline is expected to contribute significantly to future growth, with ongoing clinical trials for various new drugs [6]. - The company is well-positioned to maintain a steady growth trajectory in the pharmaceutical sector, supported by its commercial operations and innovative drug developments [6].

Core Viewpoint - Shanghai Pharmaceuticals has demonstrated resilience in its financial performance, achieving a net profit increase driven by accounting changes, while also focusing on innovative drug development and expanding its market presence in traditional Chinese medicine [3][4][11]. Financial Performance - For the first nine months of 2025, the company reported a total revenue of CNY 215.07 billion, a year-on-year increase of 2.60% [3]. - The net profit attributable to shareholders reached CNY 5.15 billion, reflecting a significant year-on-year growth of 26.96%, primarily due to a one-time special gain from accounting changes [3]. - Excluding one-time items, the adjusted net profit was CNY 3.98 billion, showing a slight decline of 1.85% year-on-year [3][4]. - The operating cash flow for the period was CNY 2.35 billion, indicating sustained high-quality development [4]. Business Highlights - The company ranked among the top ten in the "2024 Annual Top 100 Pharmaceutical Enterprises in China" and improved its MSCI ESG rating to AA [3]. - Research and development investments totaled CNY 1.73 billion, accounting for 9.52% of pharmaceutical industrial sales revenue [4]. - The company has 57 new drug candidates in clinical trials, including 45 innovative drugs [4]. Drug Development - The BCD-085 project, an innovative monoclonal antibody targeting IL-17, has submitted a new drug application for ankylosing spondylitis [5]. - The company is advancing the clinical trials for its traditional Chinese medicine, Shenqi Shiru Wan, aimed at treating cervical spondylotic myelopathy [5]. - The B019 project, a CAR-T cell therapy targeting CD19 and CD22, is in the I phase of clinical trials for acute lymphoblastic leukemia and lymphoma [6]. Traditional Chinese Medicine Development - The company is enhancing its core competitiveness through the secondary development of major traditional Chinese medicine products [7]. - Significant progress has been made in clinical trials for products like Weifuchun and Daning Pian, with expert consensus published for their clinical applications [8][9]. International Expansion - The company has successfully exported its products, including Zhenqi Pian and Daning Pian, to Canada, marking a significant step in the internationalization of traditional Chinese medicine [10]. Social Responsibility - Shanghai Pharmaceuticals is committed to rare disease treatment, establishing a collaborative ecosystem to enhance the accessibility of rare disease medications [11]. - The company has 51 products in the rare disease treatment pipeline, covering 67 rare disease conditions [11]. Commercial Growth - The pharmaceutical commercial business continues to show resilience, with innovative drug sales reaching CNY 40.7 billion, a growth of over 25% [12][13]. - The import agency business achieved sales of CNY 27.6 billion, growing by over 14% [14]. - The medical device health business reported sales of CNY 33.99 billion, with a growth of over 4% [14].

登录新浪财经APP 搜索【信披】查看更多考评等级 申请事项：境内生产药品注册临床试验 证券代码：601607 证券简称：上海医药 编号：临2025-076 上海医药集团股份有限公司 关于B019新适应症获得临床试验批准通知书的公告 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、准确性和完整性承担个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"上海医药"或"公司"）下属上海医药集团生物治疗技术有 限公司（以下简称"上药生物治疗"）自主研发的"B019"（以下简称"B019注射液"或"该项目"）收到国家 药品监督管理局（以下简称"国家药监局"）核准签发的《药物临床试验批准通知书》，同意其开展难治 性系统性红斑狼疮（以下简称"新适应症"）的临床试验。现将有关情况公告如下： 一、该项目基本信息 药物名称：靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液 剂型：注射剂 受理号：CXSL2500344 通知书编号：2025LP01884 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年04月29日受理的靶向 CD19和CD2 ...

格隆汇7月29日丨上海医药(601607.SH)公布，下属上海医药集团生物治疗技术有限公司（简称"上药生 物治疗"）自主研发的"B019"（简称"B019注射液"或"该项目"）收到国家药品监督管理局核准签发的 《药物临床试验批准通知书》，同意其开展难治性系统性红斑狼疮的临床试验。 ...

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for clinical trials of its self-developed B019 injection, aimed at treating refractory systemic lupus erythematosus [2]. Company Summary - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [2]. - The drug has previously been approved for clinical trials for two other indications: relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma, with approvals granted in October 2023 and December 2024, respectively [2].

Core Viewpoint - Shanghai Pharmaceuticals (601607) has received approval from the National Medical Products Administration for its self-developed drug "B019" to conduct clinical trials for refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual promoter vector, allowing T-cells to express two independent CARs that can bind to CD19 or CD22 proteins on B lymphocytes without interference [1] Group 2: Clinical Trial Approvals - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma have been approved by the National Medical Products Administration in October 2023 and December 2024, respectively [1]

B019注射液是靶向CD19和CD22的嵌合抗原受体自体T细胞注射液，拟用于治疗难治性系统性红斑狼 疮。B019的嵌合抗原受体结构采用一个双顺反子载体结构，可以在T细胞上表达两个独立的嵌合抗原受 体，在互不影响的情况下分别结合B淋巴细胞表面表达的CD19或CD22蛋白，以发挥治疗作用。B019注 射2液用于治疗复发或难治性急性B淋巴细胞白血病、复发或难治性B细胞非霍奇金淋巴瘤这两个适应症 的临床试验申请已分别于2023年10月、2024年12月获得国家药监局批准。 智通财经APP讯，上海医药(02607)发布公告，该公司下属上海医药集团生物治疗技术有限公司自主研发 的"B019"收到国家药监局核准签发的《药物临床试验批准通知书》，同意其开展难治性系统性红斑狼 疮的临床试验。 ...

格隆汇7月29日丨上海医药(02607.HK)公布，近日，公司下属上海医药集团生物治疗技术有限公司(以下 简称"上药生物治疗")自主研发的"B019"(以下简称"B019注射液"或"该项目")收到国家药品监督管理局(以 下简称"国家药监局")核准签发的《药物临床试验批准通知书》，同意其开展难治性系统性红斑狼疮(以 下简称"新适应症")的临床试验。 该项目由上药生物治疗自主研发，并拥有完全知识产权。截至本公告披露日，在前2个适应症的基础 上，该项目在新适应症已累计投入研发费用约14.90万元人民币。 据悉，B019注射液是靶向CD19和CD22的嵌合抗原受体自体T细胞注射液，拟用于治疗难治性系统性红 斑狼疮。B019的嵌合抗原受体结构采用一个双顺反子载体结构，可以在T细胞上表达两个独立的嵌合抗 原受体，在互不影响的情况下分别结合B淋巴细胞表面表达的CD19或CD22蛋白，以发挥治疗作用。 B019注射液用于治疗复发或难治性急性B淋巴细胞白血病、复发或难治性B细胞非霍奇金淋巴瘤这两个 适应症的临床试验申请已分别于2023年10月、2024年12月获得国家药监局批准。 ...

上海医药(601607.SH)发布公告，近日，公司下属上海医药集团生物治疗技术有限公司(以下简称"上药生 物治疗")自主研发的"B019"(以下简称"B019注射液"或"该项目")收到国家药品监督管理局(以下简称"国 家药监局")核准签发的《药物临床试验批准通知书》，同意其开展难治性系统性红斑狼疮(以下简称"新 适应症")的临床试验。 据悉，B019注射液是靶向CD19和CD22的嵌合抗原受体自体T细胞注射液，拟用于治疗难治性系统性红 斑狼疮。B019的嵌合抗原受体结构采用一个双顺反子载体结构，可以在T细胞上表达两个独立的嵌合抗 原受体，在互不影响的情况下分别结合B淋巴细胞表面表达的CD19或CD22蛋白，以发挥治疗作用。 B019注射液用于治疗复发或难治性急性B淋巴细胞白血病、复发或难治性B细胞非霍奇金淋巴瘤这两个 适应症的临床试验申请已分别于2023年10月、2024年12月获得国家药监局批准。 ...