证券代码：601607 证券简称：上海医药 编号：临 2023-092 上海医药集团股份有限公司 关于阿普唑仑片通过仿制药一致性评价的公告 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"）全资子公司上 海上药信谊药厂有限公司（以下简称"上药信谊"）收到国家药品监督管理局（以下简称 "国家药监局"）颁发的关于阿普唑仑片（以下简称"该药品"）的《药品补充申请批准通 知书》（通知书编号：2023B05986），该药品通过仿制药一致性评价。 一、该药品的基本情况 药品名称：阿普唑仑片 剂型：片剂 规格：0.4mg 注册分类：化学药品 申请人：上海上药信谊药厂有限公司 原批准文号：国药准字H31021282 审批结论：本品通过仿制药质量和疗效一致性评价 二、该药品的相关信息 阿普唑仑片主要用于焦虑、紧张、激动，也可用于催眠或焦虑的辅助用药，也可作 为抗惊恐药，并能缓解急性酒精戒断症状，由 PHARMACIA AND UPJOHN CO 研发， 最早于 1981 年在美 ...

证券代码：601607 证券简称：上海医药 编号：临2023-091 上海医药集团股份有限公司 关于 I035 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。 通知书编号：2023LP02304, 2023LP02305, 2023LP02306 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，2023 年 9 月 6 日受理的 I035 颗粒剂符合药品注册的有关要求，同意本品开展临床试 验。 二、该项目研发及注册情况 I035 颗粒剂是一款免疫调节剂，能抑制肠道的炎症反应和增强肠道的免疫调 节。临床前研究显示I035颗粒剂能改善肠炎动物模型的症状和肠道的炎症反应。 该项目由上海医药自主研发，公司拥有完全知识产权。截至本公告披露日， 该项目已累计投入研发费用 5,105.74 万元人民币。 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"）自 主研发的"I035"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》，现将有关情况公 ...

2023 年 11 月 18 日，上海医药集团股份有限公司（以下简称"本公司"）董 事会收到周军先生的书面辞职报告。因个人原因，周军先生辞去本公司董事长、 非执行董事、董事会战略委员会召集人及委员等全部职务。辞职报告自送达本公 司董事会之日起生效。辞任后，周军先生将不再担任公司及下属企业任何职务。 按照《公司章程》规定，在过渡期间，暂由公司副董事长履行董事长职务。公司 将按照法定程序尽快完成董事补选、新任董事长选举等工作。 周军先生已确认其与董事会并无意见分歧，亦不存在任何与其辞任有关的事 项须提请公司股东注意。根据《中华人民共和国公司法》、《上海证券交易所股票 上市规则》、《公司章程》等相关规定，周军先生辞任未导致公司董事会成员低于 法定人数。公司拥有完善的治理和管理结构，以及内部控制机制，上述事项对公 司日常经营无重大影响。 证券代码：601607 证券简称：上海医药 公告编号：临2023-090 上海医药集团股份有限公司 关于董事长辞任的公告 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。 特此公告。 上海医药集团 ...

证券代码：601607 证券简称：上海医药 公告编号：临 2023-089 上海医药集团股份有限公司 关于召开 2023 年第三季度业绩说明会的公告 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法律责任。 重要内容提示： （网址：https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2023 年 11 月 13 日(星期一) 至 11 月 16 日(星期四)16:00 前 登录上证路演中心网站首页点击"提问预征集"栏目进行提问。公司将在说明 会上对投资者普遍关注的问题进行回答。 上海医药集团股份有限公司（以下简称"公司"）已于 2023 年 10 月 27 日发 布公司 2023 年第三季度报告，为便于广大投资者更全面深入地了解公司 2023 年第三季度经营成果、财务状况，公司计划于 2023 年 11 月 17 日上午 10:00-11: 00 举行 2023 年第三季度业绩说明会，就投资者关心的问题进行交流。 一、 说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 ...

证券代码：601607 证券简称：上海医药 编号：临 2023-088 一、药品的基本情况 药品名称：盐酸布比卡因注射液 剂型：注射剂 规格：10ml:75mg 注册分类：化学药品 申请人：上海禾丰制药有限公司 原批准文号：国药准字H31022839 审批结论：批准本品增加10ml:75mg规格的补充申请，核发药品批准文号，本品通 过仿制药质量和疗效一致性评价 上海医药集团股份有限公司 关于盐酸布比卡因注射液、重酒石酸间羟胺注射液、缩宫素注射 液、盐酸去氧肾上腺素注射液通过仿制药一致性评价的公告 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"）控股子公 司上海禾丰制药有限公司（以下简称"上药禾丰"）收到国家药品监督管理局（以下简 称"国家药监局"）颁发的关于盐酸布比卡因注射液、重酒石酸间羟胺注射液、缩宫素 注射液、盐酸去氧肾上腺素注射液的《药品补充申请批准通知书》（通知书编号： 2023B04551、2023B04006、2023B03886、2023B04 ...

证券代码：601607 证券简称：上海医药 编号：临 2023-087 上海医药集团股份有限公司 关于注射用胸腺法新通过仿制药一致性评价的公告 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"）全资子公 司上海上药第一生化药业有限公司（以下简称"上药第一生化"）收到国家药品监督管 理局（以下简称"国家药监局"）颁发的关于注射用胸腺法新（以下简称"该药品"） 的《药品补充申请批准通知书》（通知书编号：2023B05187），该药品通过仿制药质量 和疗效一致性评价。 一、该药品的基本情况 IQVIA 数据库显示，2022 年该药品医院采购金额为人民币 59,311 万元。2022 年， 上药第一生化该药品的销售收入为人民币 199 万元。 三、对上市公司影响及风险提示 根据国家相关政策，通过一致性评价的药品品种在医保支付及医疗机构采购等领域将 获得更大的支持力度。因此上药第一生化的注射用胸腺法新通过仿制药一致性评价，有利 于扩大该药品的市场份额，提升市场竞争力，同 ...

证券代码：601607 证券简称：上海医药 编号：临2023-086 上海医药集团股份有限公司 关于 B019 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。 申请事项：境内生产药品注册临床试验 受理号：CXSL2300535 通知书批号：2023LP02188 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，2023 年 8 月 1 日受理的靶向 CD19 和 CD22 的嵌合抗原受体自体 T 细胞注射液符合药 品注册的有关要求，同意本品开展临床试验。 二、该项目研发及注册情况 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，用于 治疗复发或难治性 B 淋巴细胞肿瘤。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，以发挥抗肿瘤作用。 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， 1 ...

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"）下属全 资子公司上药康丽（常州）药业有限公司（以下简称"上药康丽"）收到国家药品 监督管理局（以下简称"国家药监局"）颁发的关于拉考沙胺原料药（以下简称"该 药物"）的《化学原料药上市申请批准通知书》（通知书编号：2023YS00679）， 该药物获得批准生产。 一、该药物基本情况 证券代码：601607 证券简称：上海医药 公告编号：临2023-085 上海医药集团股份有限公司 关于拉考沙胺原料药上市申请获得批准的公告 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、准确性和完整性承担个别及连带责任。 二、该药品相关的信息 名称：拉考沙胺 注册标准编号：YBY67382023 包装规格：1KG/桶、5KG/桶、10KG/桶、20KG/桶、25KG/桶 拉考沙胺原料药可用于注射液及口服溶液的生产，适用于 4 岁及以上癫痫患 者部分性发作的联合治疗。最早由 UCB Pharma SA 研发，于 2008 年 8 月在欧洲 上市。2021 年 7 月，上药康丽就该原料药向国家药监局提出上市申请并获 ...

Financial Performance - For the first nine months of 2023, the company achieved operating revenue of CNY 197.51 billion, a year-on-year increase of 13.11%[10] - The pharmaceutical industrial segment generated sales revenue of CNY 20.8 billion, growing by 5.09% year-on-year, while the pharmaceutical commercial segment reported sales of CNY 176.71 billion, up 14.14% year-on-year[10] - The net profit attributable to shareholders for the first nine months was CNY 3.797 billion, a decrease of 21.13% year-on-year, but the adjusted net profit excluding one-time items was CNY 4.265 billion, an increase of 8.57%[10] - The Chinese traditional medicine segment achieved industrial revenue of CNY 7.472 billion, reflecting a growth of 16.51% year-on-year[11] - Total operating revenue for Q3 2023 reached ¥197.51 billion, an increase of 13.09% compared to ¥174.61 billion in Q3 2022[30] - Net profit for Q3 2023 was ¥4.95 billion, a decrease of 17.26% from ¥5.98 billion in Q3 2022[31] - The company reported a total comprehensive income of ¥4.78 billion for Q3 2023, down from ¥5.61 billion in Q3 2022[32] - The net profit for the first three quarters of 2023 was CNY 1,594,396,493.16, compared to CNY 1,436,948,657.78 in the previous year, indicating a growth of approximately 11%[42] Shareholder Information - The number of ordinary shareholders at the end of the reporting period is 80,053[21] - The top shareholder, Shanghai Pharmaceutical Group, holds 716,516,039 shares, accounting for 19.34% of total shares[21] - The company reported a total of 80,053 shareholders, with 78,313 being A-share holders and 1,740 H-share holders as of the report date[22] - The total number of issued A-shares was 2,784,228,350, while H-shares totaled 919,072,704, bringing the total shares to 3,703,301,054[22] Assets and Liabilities - Total assets at the end of the reporting period amount to ¥213,146,380,397.62, showing a year-on-year increase of 7.58%[16] - The company's equity attributable to shareholders at the end of the reporting period is ¥68,509,809,654.05, an increase of 2.16% compared to the end of the previous year[16] - The total current liabilities rose to RMB 122.43 billion, compared to RMB 110.69 billion at the end of 2022, marking an increase of around 10.6%[26] - The company's total liabilities reached RMB 122.43 billion, indicating a significant portion of the total assets is financed through liabilities[26] - Total liabilities increased to ¥133.00 billion in Q3 2023, compared to ¥120.13 billion in Q3 2022, reflecting a growth of 10.73%[30] Cash Flow - The cash flow from operating activities for the year-to-date is ¥2,302,460,609.68, with no applicable data for the current reporting period[16] - Operating cash inflow for the first three quarters of 2023 reached ¥207.17 billion, up from ¥185.77 billion in the same period of 2022, representing an increase of approximately 11.5%[34] - Net cash flow from operating activities for Q3 2023 was ¥2.30 billion, a significant improvement compared to a negative cash flow of ¥158.75 million in Q3 2022[35] - The company reported a net cash flow from operating activities of CNY -229,646,633.04 for the first three quarters of 2023, slightly worse than CNY -224,878,559.54 in the same period of 2022[44] Research and Development - The company is advancing the clinical trial application for WST04, a novel oral microbial preparation for treating advanced malignant tumors, which was accepted by the National Medical Products Administration in September 2023[12] - The company is also developing I035, an immune modulator, with its clinical trial application accepted in September 2023[12] - Research and development expenses for Q3 2023 were ¥1.47 billion, compared to ¥1.39 billion in Q3 2022, indicating an increase of 5.00%[30] - The company’s research and development expenses for the first three quarters of 2023 were CNY 280,853,232.39, a decrease from CNY 323,183,649.00 in the previous year[41] Investment Activities - The company achieved an investment income of CNY 1,906,100,940.80, compared to CNY 1,801,456,578.38 in the same period of 2022, reflecting a growth of approximately 5.8%[41] - Cash received from financing activities in Q3 2023 was ¥59.46 billion, a decrease from ¥65.82 billion in Q3 2022, indicating a decline of about 9.1%[35] - Investment cash outflow for the first three quarters of 2023 was ¥28.63 billion, down from ¥36.88 billion in the same period of 2022, indicating a reduction of approximately 22.4%[35]

Financial Performance - For the first nine months of 2023, the company achieved operating revenue of RMB 197.51 billion, representing a year-on-year growth of 13.11%[5] - The net profit attributable to shareholders was RMB 3.797 billion, a decrease of 21.13% year-on-year, while the adjusted net profit was RMB 4.265 billion, reflecting an increase of 8.57%[5] - The company’s net profit attributable to shareholders, excluding non-recurring gains and losses, was RMB 3.304 billion, a decrease of 10.64% year-on-year[5] - Net profit attributable to the parent company for the first three quarters of 2023 was approximately ¥3.63 billion, down 18.4% from ¥4.45 billion in the same period of 2022[24] - Operating profit for the first three quarters of 2023 was ¥6.56 billion, down 13.93% from ¥7.62 billion in the first three quarters of 2022[22] - Net profit for the first three quarters of 2023 was ¥4.95 billion, a decrease of 17.19% compared to ¥5.98 billion in the same period of 2022[22] - Total comprehensive income for the first three quarters of 2023 was approximately ¥4.78 billion, a decrease of 15% from ¥5.61 billion in the same period of 2022[24] Revenue Breakdown - The pharmaceutical industry segment generated sales revenue of RMB 20.8 billion, with a year-on-year increase of 5.09%[5] - The traditional Chinese medicine segment reported industrial revenue of RMB 7.472 billion, marking a year-on-year growth of 16.51%[6] - The pharmaceutical distribution business achieved sales revenue of RMB 177.194 billion, a year-on-year increase of 14.17%[7] - The pharmaceutical retail business generated sales revenue of RMB 6.532 billion, reflecting a year-on-year growth of 15%[7] - The innovative drug segment saw a sales increase of 21%, with 21 new import agency contracts signed in the first three quarters of 2023[7] Research and Development - The company has three new drug applications submitted for pre-NDA or market approval, including innovative drugs WST04 and I035, both of which have received acceptance from the National Medical Products Administration in September 2023[6] - The company has achieved a total of 55 products (79 specifications) that passed the consistency evaluation for generic drugs[6] - Research and development expenses for the first three quarters of 2023 were ¥1.47 billion, an increase of 5.71% from ¥1.39 billion in the same period of 2022[21] - Research and development expenses for the first three quarters of 2023 totaled ¥280,853,232.39, down from ¥323,183,649.00 in the same period of 2022, a decrease of about 13.1%[32] Assets and Liabilities - The total assets at the end of the reporting period were RMB 213.146 billion, a 7.58% increase from the previous year[9] - Total liabilities as of September 30, 2023, were RMB 122.43 billion, compared to RMB 110.69 billion at the end of 2022, marking an increase of around 10.7%[19] - Total liabilities as of September 30, 2023, amounted to ¥133.00 billion, an increase of 10.93% from ¥120.13 billion at the end of 2022[20] - The total assets of the company reached RMB 213.15 billion, up from RMB 198.13 billion, representing a growth of about 7.6%[18] - The company's total equity decreased to ¥40,213,707,935.12 as of September 30, 2023, down from ¥40,756,350,670.90 at the end of 2022, a decline of approximately 1.3%[31] Cash Flow - Cash inflow from operating activities for the first three quarters of 2023 was approximately ¥207.17 billion, an increase of 11.5% from ¥185.77 billion in the same period of 2022[26] - Cash outflow from operating activities for the first three quarters of 2023 was approximately ¥204.87 billion, compared to ¥185.93 billion in the same period of 2022, resulting in a net cash inflow of approximately ¥2.30 billion[27] - Cash inflow from investment activities for the first three quarters of 2023 was approximately ¥25.63 billion, an increase of 12.1% from ¥22.80 billion in the same period of 2022[27] - Cash inflow from operating activities for the first three quarters of 2023 was CNY 374,593,657.45, compared to CNY 331,682,201.19 in the same period of 2022, representing an increase of approximately 12.9%[35] - Net cash flow from operating activities was negative CNY 229,646,633.04 for the first three quarters of 2023, slightly worse than the negative CNY 224,878,559.54 in 2022[35] Shareholder Information - The company reported a total of 80,053 shareholders, with 78,313 holding A-shares and 1,740 holding H-shares as of the report date[15] - The company has issued a total of 3.70 billion shares, comprising 2.78 billion A-shares and 919 million H-shares[15]