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上海医药: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
2023-10-31 09:19
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 ...
上海医药(601607) - 2023 Q3 - 季度财报
2023-10-27 16:00
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]
上海医药(02607) - 2023 Q3 - 季度业绩
2023-10-27 09:00
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]
上海医药:上海医药集团股份有限公司关于与上海医药(集团)有限公司续签《房屋租赁框架协议》暨日常关联交易/持续关连交易的公告
2023-10-27 08:08
上海医药集团股份有限公司 关于与上海医药(集团)有限公司续签《房屋租赁框架协 证券代码:601607 证券简称:上海医药 编号:临 2023-084 议》暨日常关联交易/持续关连交易的公告 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。 重要内容提示: 2023年10月27日,上海医药与上药集团续签了《房屋租赁框架协议》。根 据《上交所上市规则》,该框架协议项下的日常关联交易的最高年度上限占本公 司最近一期经审计净资产绝对值低于0.5%,无需提交公司董事会审议。本次公告 的刊发是根据《联交所上市规则》第14A.07条,框架协议项下的日常关联交易的 最高年度上限适用百分比率超过0.1%但低于5%,仅须遵守申报、年度审核及公 告要求,豁免遵守独立股东批准要求。 本交易无需提交股东大会审议 该框架协议的签署系本公司日常经营所需,属于正常经营行为,交易价格 参照市场价格商定,定价公允、合理,对本公司持续经营能力、盈利能力及资产 独立性等不会产生不利影响,且不会对关联方形成较大依赖。 一、日常关联交易基本情况 (一)日常关联交易履 ...
上海医药:上海医药集团股份有限公司关于与永发印务有限公司续签《采购框架协议》暨日常关联/持续关连交易的公告
2023-10-27 08:07
证券代码:601607 证券简称:上海医药 公告编号:临 2023-083 上海医药集团股份有限公司 关于与永发印务有限公司续签《采购框架协议》暨日常关联 /持续关连交易的公告 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。 重要内容提示: 交易概述:2023 年 10 月 27 日,上海医药与关联方永发印务续签了《采 购框架协议》,由永发印务向本公司提供药品的印刷包装材料,自 2024 年 1 月 1 日起至 2024 年 12 月 31 日止,采购金额年度上限为人民币 9,000 万元。 2023 年 10 月 27 日,上海医药集团股份有限公司(包括附属公司,以下简 称"公司" 、"本公司"或"本集团")与关联方永发印务有限公司(包括附属公司, 以下简称"永发印务"或"永发印务集团")续签了《采购框架协议》("框架协议")。 根据框架协议,自 2024 年 1 月 1 日起至 2024 年 12 月 31 日止,本公司向永发印 1 务采购药品的印刷包装材料,采购金额年度上限为人民币 9,000 万元。 (二)前次日 ...
上海医药:独董独立意见
2023-10-27 08:07
1、本次目常关联交易/持续关连交易符合《公司法》、《证券法》、《上海证券交易所股 票上市规则》和《公司章程》等有关规定; 2、本次日常关联交易/持续关连交易系公司在目常经营业务中发生的交易,符合公司正常 生产经营的需要,为正常的商业安排;交易价格严格遵循公开、公平、公正及市场化定价原则, 不存在损害公司及股东特别是中、小股东利益的情形。 3、公司设有适当的内部监控程序,对本次日常关联交易/持续关连交易的定价原则、交易 条款以及实际交易金額进行持续监察以及定期评估; 上海医药集团股份有限公司 独立董事的独立意见 根据《中华人民共和国公司法》、《中华人民共和国证券法》、《上海证券交易所股票上 市规则》等相关法律法规和《上海医药集团股份有限公司章程》(以下简称"《公司章程》") 的相关规定,我们作为上海医药集团股份有限公司(以下简称"公司")的独立董事,基于独 立客观判断,对公司第八届董事会第四次会议相关事项发表如下独立意见; 一、关于与永发印务有限公司续签<采购框架协议>暨日常关联/持续关连交易的独立意见 4、本次日常关联交易/持续关连交易已经获得独立董事事前认可; 5、该议案无需提交公司股东大会审议。 二、关于 ...
上海医药:上海医药集团股份有限公司第八届董事会第四次会议决议公告
2023-10-27 08:07
表决结果:赞成 9 票,反对 0 票,弃权 0 票。 证券代码:601607 证券简称:上海医药 公告编号:临2023-082 上海医药集团股份有限公司 第八届董事会第四次会议决议公告 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。 一、董事会会议召开情况 上海医药集团股份有限公司(以下简称"本公司")第八届董事会第四次会 议(以下简称"本次会议")于 2023 年 10 月 27 日在上海市太仓路 200 号上海医 药大厦以现场结合通讯方式召开。本次会议应到董事 9 名,亲自出席董事 8 名, 非执行董事陈发树先生因其他公务委托执行董事董明先生代为出席并行使表决 权。本公司监事和其他高级管理人员列席本次会议。本次会议由周军董事长主持。 二、董事会会议审议情况 1. 《2023 年第三季度报告》 独立董事对上述交易发表独立意见表示同意。 2. 《关于与永发印务有限公司续签<采购框架协议>暨日常关联/持续关连 交易的议案》(内容详见公告临 2023-083 号) 同意公司与永发印务续签《采购框架协议》,协议约定上海医药的任 ...
上海医药:上海医药集团股份有限公司关于拉考沙胺注射液及口服溶液获得批准生产的公告
2023-10-24 08:21
证券代码:601607 证券简称:上海医药 编号:临2023-081 上海医药集团股份有限公司 关于拉考沙胺注射液及口服溶液获得批准生产的公告 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。 药物名称:拉考沙胺注射液 剂型:注射剂 规格:20ml : 0.2g 注册分类:化学药品 4 类 药品批准文号:国药准字 H20234250 审批结论:批准注册,发给药品注册证书。 药物名称:拉考沙胺口服溶液 剂型:口服溶液剂 规格:200ml : 2g 注册分类:化学药品 4 类 药品批准文号:国药准字 H20234264 审批结论:批准注册,发给药品注册证书。 二、 该药品相关的信息 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 属全资子公司上海上药第一生化药业有限公司(以下简称"上药第一生化")的 拉考沙胺注射液及口服溶液(以下简称"该药品")分别收到国家药品监督管理 局(以下简称"国家药监局")颁发的《药品注册证书》(证书编号:2023S01528、 2023S01543),该药品获得批准生产。 一 ...
上海医药:上海医药集团股份有限公司关于2019年A股股票期权激励计划首次授予股票期权第二个行权期及预留股票期权第一个行权期2023年第三季度自主行权结果公告
2023-10-09 08:38
个行权期及预留股票期权第一个行权期 2023 年第三季度自主行权结果公告 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。 重要内容提示: 一、本次股权激励计划已履行的相关审批程序 证券代码:601607 证券简称:上海医药 编号:临2023-080 上海医药集团股份有限公司 关于 2019 年 A 股股票期权激励计划首次授予股票期权第二 1、2019 年 9 月 30 日,公司召开第七届董事会第五次会议及第七届监事会 第三次会议,审议通过了《关于 2019 年股票期权激励计划(草案)及其摘要的 议案》(以下简称"《股票期权激励计划(草案)》")、《关于 2019 年股票期权激 1 上海医药集团股份有限公司(以下简称"上海医药"或"公司")2019 年 A 股股票期权激励计划("本次股权激励计划")首次授予股票期权第二个行 权期可行权股票数量为 7,421,700 份,预留股票期权第一个行权期可行权 的股票期权数量 755,700 份,二者均自 2023 年 2 月 14 日进入行权期,前 者行权期于 2024 年 2 月 ...
上海医药:上海医药集团股份有限公司关于双氯芬酸钠缓释片通过仿制药一致性评价的公告
2023-09-25 07:51
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。 上海医药集团股份有限公司 关于双氯芬酸钠缓释片通过仿制药一致性评价的公告 证券代码:601607 证券简称:上海医药 编号:临 2023-079 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")颁发的关于双氯芬酸钠缓释片(以下简称"该药品")的《药 品补充申请批准通知书》(通知书编号:2023B04592),该药品通过仿制药质量和疗 效一致性评价。 规格:0.1g 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H20010604 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 双氯芬酸钠缓释片主要用于缓解类风湿关节炎、骨关节炎;各种软组织风湿性疼痛 以及急性的轻、中度疼痛。由诺华研发,最早于1974年在日本上市。2022年07月,上药 信谊就该药品仿制药一致性评价向国家药监局提出申请并获受理。截至本公告 ...