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白云山:广州白云山医药集团股份有限公司关于分公司获得药品补充申请批件的公告
2024-11-06 10:05
证券代码:600332 证券简称:白云山 公告编号:2024-074 广州白云山医药集团股份有限公司 关于分公司获得药品补充申请批件的公告 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。 近日,广州白云山医药集团股份有限公司(以下简称"本公司")分 公司广州白云山医药集团股份有限公司白云山制药总厂(以下简称"白云 山制药总厂")收到国家药品监督管理局(以下简称"国家药监局")签 发的《药品补充申请批准通知书》。现将有关情况公告如下: 一、药品的基本情况 (一)枸橼酸西地那非片 药品通用名称:枸橼酸西地那非片 通知书编号:2024B05085 受理号:CYHB2301631 药品批准文号:国药准字H20247264 药品批准文号有效期:至2029年3月6日 剂型:片剂 规格:20mg(以C₂₂H₃₀N₆O₄S计) 注册分类:化学药品 药品注册标准编号:YBH27222024 上市许可持有人:(1)名称:广州白云山医药集团股份有限公司白 云山制药总厂;(2)地址:广州市白云区同和街云祥路88号 生产企业:(1)名称:广州白云山医药 ...
白云山:广州白云山医药集团股份有限公司关于分公司药品通过仿制药一致性评价的公告
2024-11-05 09:05
证券代码:600332 证券简称:白云山 公告编号:2024-072 广州白云山医药集团股份有限公司 关于分公司药品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法律责任。 近日,广州白云山医药集团股份有限公司(以下简称"本公司") 分公司广州白云山医药集团股份有限公司白云山制药总厂(以下简称"白 云山制药总厂")收到国家药品监督管理局核准签发的《药品补充申请 批准通知书》,头孢克肟分散片已通过仿制药质量和疗效一致性评价, 现将有关情况公告如下: 一、药品的基本情况 药总厂 ;(2)地址:广州市白云区同和街云祥路 88 号 药品通用名称:头孢克肟分散片 通知书编号:2024B05025、2024B05024 受理号:CYHB2350538、CYHB2350539 剂型:片剂 规格:0.1g、0.2g(按 C16H15N5O7S2计) 注册分类:化学药品 药品注册标准编号:YBH26762024 上市许可持有人名称:(1)名称:广州白云山医药集团股份有限公 司白云山制药总厂 ;(2)地址:广州市白云区同和街云祥 ...
白云山:广州白云山医药集团股份有限公司关于子公司《药品生产许可证》变更的公告
2024-11-05 09:05
证券代码:600332 证券简称:白云山 公告编号:2024-073 发证机关:广东省药品监督管理局 广州白云山医药集团股份有限公司 关于子公司《药品生产许可证》变更的公告 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。 近日,广州白云山医药集团股份有限公司(以下简称"本公司") 子公司广州白云山奇星药业有限公司(以下简称"奇星药业")收到 广东省药品监督管理局核准签发的《药品生产许可证》,同意奇星药 业委托广州白云山中一药业有限公司(以下简称"中一药业")生产 蛇胆川贝散、喉康散和复方余甘子利咽含片,委托广州白云山医药集 团股份有限公司白云山制药总厂(以下简称"白云山制药总厂")生 产健脾补血颗粒,现将相关情况公告如下: 一、《药品生产许可证》基本情况 企业名称:广州白云山奇星药业有限公司 许可证编号:粤 20160065 分类码:Bz 注册地址:广州市海珠区新港中路赤岗北路 33 号 有效期至:2025 年 9 月 21 日 生产地址和生产范围: 1、 受托方是广州白云山中一药业有限公司,生产地址是广州市 1 黄埔区云埔一 ...
白云山:广州白云山医药集团股份有限公司关于分公司药品通过仿制药一致性评价的公告
2024-11-01 10:43
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。 近日,广州白云山医药集团股份有限公司(以下简称"本公司") 分公司广州白云山医药集团股份有限公司白云山制药总厂(以下简称"白 云山制药总厂")收到国家药品监督管理局核准签发的《药品补充申请 批准通知书》,头孢克洛干混悬剂和注射用头孢呋辛钠已通过仿制药质 量和疗效一致性评价。现将相关情况公告如下: 一、药品的基本情况 证券代码:600332 证券简称:白云山 公告编号:2024-071 广州白云山医药集团股份有限公司 关于分公司药品通过仿制药一致性评价的公告 (一)头孢克洛干混悬剂 药品通用名称:头孢克洛干混悬剂 通知书编号:2024B04987 规格:0.125g(按C15H14CIN3O4S计) 注册分类:化学药品 药品注册标准编号:YBH26552024 上市许可持有人:(1)名称:广州白云山医药集团股份有限公司白 云山制药总厂;(2)地址:广州市白云区同和街云祥路88号 1 生产企业:(1)名称:广州白云山医药集团股份有限公司白云山制 药总厂;(2)地址:广州市白云区同和街 ...
白云山:H股公告(证券变动月报表)
2024-11-01 08:44
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2024年10月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 廣州白雲山醫藥集團股份有限公司 (「本公司」) 呈交日期: 2024年11月1日 I. 法定/註冊股本變動 1. 股份分類 普通股 股份類別 H 於香港聯交所上市 (註1) 是 證券代號 (如上市) 00874 說明 香港聯交所上市 H 股 法定/註冊股份數目 面值 法定/註冊股本 上月底結存 219,900,000 RMB 1 RMB 219,900,000 增加 / 減少 (-) RMB 本月底結存 219,900,000 RMB 1 RMB 219,900,000 (A). 股份期權(根據發行人的股份期權計劃) 不適用 | 2. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 600332 | 說明 | | 於上海證券交易所 (「 ...
白云山:广州白云山医药集团股份有限公司关于子公司《药品生产许可证》变更的公告
2024-10-29 09:42
企业名称:广州白云山奇星药业有限公司 许可证编号:粤 20160065 分类码:Bz 证券代码:600332 证券简称:白云山 公告编号:2024-070 广州白云山医药集团股份有限公司 关于子公司《药品生产许可证》变更的公告 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。 近日,广州白云山医药集团股份有限公司(以下简称"本公司") 子公司广州白云山奇星药业有限公司(以下简称"奇星药业")收到 广东省药品监督管理局核准签发的《药品生产许可证》,同意在奇星 药业委托广州白云山中一药业有限公司(以下简称"中一药业")生 产金丹丸的基础上,增加在生产车间"制造二部二区"包装。现将相 关情况公告如下: 一、《药品生产许可证》基本情况 二、药品生产许可证副本变更情况 同意奇星药业在原"委托广州白云山中一药业有限公司生产金 丹丸(国药准字 B20020525),委托生产地址:广州市黄埔区云埔一 路 32 号、广州市番禺区南村镇七星岗、广州市从化明珠工业园创业 大道南 4 号(除 K1 栋),委托生产车间:制造一部、制造二部、制 造三部、制 ...
白云山:广州白云山医药集团股份有限公司关于子公司通过GLP定期检查并获得《药物GLP认证证书》的公告
2024-10-28 09:07
证券代码:600332 证券简称:白云山 公告编号:2024-068 广州白云山医药集团股份有限公司 关于子公司通过GLP定期检查并获得 《药物GLP认证证书》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法律责任。 近日,广州白云山医药集团股份有限公司(以下简称"公司")全 资子公司广州医药研究总院有限公司(以下简称"广药总院")收到国 家药品监督管理局颁发新的《药物 GLP 认证证书》。现将相关情况公告 如下: 一、本次通过 GLP 定期检查及获得《药物 GLP 认证证书》的有关情 况 1、机构名称:广州医药研究总院有限公司 2、机构地址:广州市海珠区江南大道中 134 号 根据《中华人民共和国药品管理法》和《药物非临床研究质量管理 规范认证管理办法》的有关规定,国家药品监督管理局对广药总院药物 非临床评价研究中心执行《药物非临床研究质量管理规范》(以下简称 "GLP")的情况进行了定期认证检查。广药总院顺利通过本次 GLP 定期 检查,并获得了《药物 GLP 认证证书》,共 9 项认证资质。《药物 GLP 认证证书》有关情 ...
白云山:广州白云山医药集团股份有限公司关于药品通过仿制药一致性评价的公告
2024-10-28 09:07
证券代码:600332 证券简称:白云山 公告编号:2024-069 广州白云山医药集团股份有限公司 关于药品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法律责任。 近日,广州白云山医药集团股份有限公司(以下简称"本公司")分 公司广州白云山医药集团股份有限公司白云山制药总厂(以下简称"白云 山制药总厂")、全资子公司广州白云山明兴制药有限公司(以下简称"明 兴药业") 分别收到国家药品监督管理局签发的《药品补充申请批准通知 书》,注射用头孢唑肟钠、缩宫素注射液已通过仿制药质量和疗效一致性 评价。现将有关情况公告如下: 一、药品的基本情况 (一)注射用头孢唑肟钠 规格:0.5g (按C13H13N5O5S2计) 注册分类:化学药品 药品注册标准编号:YBH26022024 上市许可持有人:(1)名称:广州白云山医药集团股份有限公司白云 1 山制药总厂;(2)地址:广州市白云区同和街云祥路88号 生产企业:(1)名称:广州白云山医药集团股份有限公司白云山制药 总厂;(2)地址:广州市白云区同和街云祥路88号 ...
白云山(00874) - 2024 Q3 - 季度业绩
2024-10-25 10:36
Financial Performance - Operating revenue for the third quarter was RMB 18,017,185 thousand, a decrease of 1.08% compared to the same period last year[3] - Net profit attributable to shareholders was RMB 609,412 thousand, down 37.82% year-on-year[3] - Net profit attributable to shareholders after deducting non-recurring gains and losses was RMB 514,998 thousand, a decrease of 38.70% compared to the previous year[3] - Basic and diluted earnings per share were both RMB 0.375, reflecting a decline of 37.82% year-on-year[3] - The weighted average return on equity was 1.70%, a decrease of 1.17 percentage points compared to the same period last year[3] - Total operating revenue for the first three quarters of 2024 reached RMB 59.06 billion, a slight increase of 1.5% compared to RMB 58.18 billion in the same period of 2023[20] - Total operating costs increased to RMB 55.41 billion, up 3.0% from RMB 53.78 billion year-over-year[20] - Net profit for the first three quarters of 2024 was RMB 3.29 billion, a decrease of 16.3% from RMB 3.93 billion in the same period of 2023[21] - Basic and diluted earnings per share for the first three quarters of 2024 were both RMB 1.943, down from RMB 2.332 in the same period of 2023[22] - The total comprehensive income for the first three quarters of 2024 was RMB 3.29 billion, a decrease from RMB 3.92 billion in the same period of 2023[22] Assets and Liabilities - Total assets at the end of the reporting period were RMB 79,255,540 thousand, an increase of 0.85% from the end of the previous year[3] - Current liabilities reached RMB 36,260,578,892.35, showing a slight increase from RMB 36,235,290,500.95 in the previous period[16] - Total liabilities decreased to RMB 41,202,453,235.03 from RMB 41,909,053,857.29, indicating a reduction of approximately 1.7%[17] - The company's total assets as of September 30, 2024, were RMB 79,255,540,499.70, compared to RMB 78,586,877,764.09 at the end of 2023, reflecting a growth of 0.9%[18] - Cash and cash equivalents decreased to RMB 17,187,621,128.03 from RMB 21,308,844,204.44, a decline of 19.5%[14] - Accounts receivable increased to RMB 16,682,453,602.94, up from RMB 15,112,494,798.69, representing an increase of 10.4%[14] - The company’s long-term borrowings decreased to RMB 2,645,148,946.45 from RMB 3,323,717,917.22, a reduction of 19.5%[17] - The total equity attributable to shareholders was RMB 38,053,087,264.67, an increase from RMB 36,677,823,906.80, indicating a growth of 3.7%[19] Cash Flow - Cash flow from operating activities showed a net outflow of RMB 751,362 thousand, a significant increase of 183.33% compared to the previous year[3] - Cash flow from operating activities amounted to RMB 55.02 billion, an increase from RMB 53.47 billion year-over-year[23] - The net cash flow from operating activities for the first three quarters of 2024 was (RMB 751,362,230.20), a decline from RMB 901,626,427.54 in 2023[24] - Cash inflow from financing activities in the first three quarters of 2024 was RMB 8,534,366,363.04, down from RMB 10,798,825,985.69 in 2023, representing a decrease of about 21%[26] - The net cash flow from financing activities improved to RMB 587,309,332.49 in 2024, compared to a negative cash flow of (RMB 916,775,454.39) in 2023[26] - The total cash outflow for investment activities in the first three quarters of 2024 was RMB 4,239,805,542.16, compared to RMB 2,209,174,427.17 in 2023, indicating a significant increase in investment outflows[25] - The company received cash from investment activities totaling RMB 4,938,146,046.98 in 2024, compared to RMB 4,569,762,461.76 in 2023, showing an increase of about 8%[25] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 87,322[8] - The largest shareholder, Guangzhou Pharmaceutical Group Co., Ltd., holds 732,305,103 shares, representing 45.04% of the total shares[9] - HKSCC Nominees Limited, the second-largest shareholder, holds 219,787,142 shares, accounting for 13.52%[9] - The top ten shareholders collectively hold a significant portion of the company's shares, with the top three alone accounting for over 62%[9] - Guangzhou Pharmaceutical Group Co., Ltd. has no restricted shares, indicating full liquidity of its holdings[11] - The company has not reported any significant changes in the shareholding structure due to margin trading activities[12] Operational Insights - The decrease in net profit was primarily due to macroeconomic fluctuations, market competition, and industry policies affecting subsidiary sales revenue[7] - There are no other important reminders regarding the company's operational situation during the reporting period[13] - The company has not provided any audited financial statements for the quarter[13] Tax and Expenses - The company reported a decrease in tax expenses to RMB 716.60 million from RMB 823.71 million in the previous year, reflecting a 12.9% reduction[21] - The company reported a decrease in tax payments, with RMB 2,251,415,772.94 in 2024 compared to RMB 2,415,414,380.29 in 2023, indicating a reduction of approximately 6.8%[24] - Research and development expenses remained stable at RMB 578.51 million, slightly down from RMB 579.48 million in the previous year[20] - The company recorded an increase in investment income to RMB 191.40 million, down from RMB 257.94 million year-over-year[20] - Other comprehensive income after tax for the first three quarters of 2024 was RMB 5.45 million, compared to a loss of RMB 6.77 million in the same period of 2023[21]
白云山(600332) - 2024 Q3 - 季度财报
2024-10-25 08:54
Financial Performance - The company's operating revenue for Q3 2024 was CNY 18,017,185, a decrease of 1.08% compared to the same period last year[3]. - The net profit attributable to shareholders for Q3 2024 was CNY 609,412, reflecting a decline of 37.82% year-on-year[3]. - The basic earnings per share for Q3 2024 was CNY 0.375, down 37.82% from the previous year[3]. - The company reported a decrease of 16.68% in net profit attributable to shareholders for the year-to-date period, totaling CNY 3,158,977[3]. - The total profit for Q3 2024 is CNY 4,006,037,802.35, a decrease from CNY 4,752,432,969.83 in Q3 2023, representing a decline of approximately 15.7%[17]. - The net profit attributable to shareholders of the parent company is CNY 3,158,976,998.91, down from CNY 3,791,250,189.92 in the same period last year, reflecting a decrease of about 16.7%[17]. - The basic and diluted earnings per share for Q3 2024 are both CNY 1.943, compared to CNY 2.332 in Q3 2023, indicating a decline of approximately 16.7%[18]. - The company's total profit margin for Q3 2024 is approximately 81.9%, down from 83.5% in Q3 2023, reflecting a decline in profitability[17]. Cash Flow and Investments - The net cash flow from operating activities for the year-to-date period was CNY -751,362, representing a significant decrease of 183.33%[3]. - The net cash flow from operating activities for Q3 2024 is negative CNY 751,362,230.20, compared to a positive CNY 901,626,427.54 in Q3 2023[20]. - Cash flow from operating activities for the first nine months of 2024 is CNY 55,018,985,333.25, an increase from CNY 53,474,666,968.88 in the same period of 2023[19]. - The company reported a net cash outflow from investing activities of CNY 4,239,805,542.16 for Q3 2024, compared to a net outflow of CNY 2,209,174,427.17 in Q3 2023[20]. - The company’s cash inflow from financing activities for Q3 2024 is CNY 8,534,366,363.04, compared to CNY 10,798,825,985.69 in Q3 2023, indicating a decrease of approximately 21%[20]. - As of September 30, 2024, the company's cash and cash equivalents amounted to ¥17.19 billion, a decrease of 19.9% from ¥21.31 billion at the end of 2023[12]. - The total cash and cash equivalents at the end of Q3 2024 is CNY 15,424,695,678.20, down from CNY 18,587,127,376.32 at the end of Q3 2023, a decrease of approximately 17.5%[22]. Assets and Liabilities - Total assets at the end of the reporting period amounted to CNY 79,255,540, an increase of 0.85% from the end of the previous year[3]. - The company's total assets reached CNY 79,255,540,499.70, compared to CNY 78,586,877,764.09 in the previous year, showing a growth of approximately 0.9%[14]. - Non-current assets totaled CNY 26,205,268,332.03, up from CNY 22,603,164,039.00 year-over-year, marking an increase of about 15.5%[14]. - Total liabilities amounted to CNY 41,202,453,235.03, a slight decrease from CNY 41,909,053,857.29 in the previous year[14]. - Short-term borrowings increased to CNY 9,414,703,611.84 from CNY 7,799,035,643.76, representing a rise of about 20.7%[14]. Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 87,322[8]. - The company reported a total of 732,305,103 shares held by Guangzhou Pharmaceutical Group Co., Ltd., representing a significant portion of the free-floating shares[10]. - The top ten shareholders collectively held a significant number of shares, with the largest shareholder holding 732,305,103 shares[10]. - The company has not disclosed any significant changes in the relationships among major shareholders[10]. - There were no significant changes in the borrowing and lending of shares among the top shareholders during the reporting period[10]. Operational Highlights - The company has not reported any new strategies or significant developments in product or technology during the quarter[11]. - The company received government subsidies amounting to CNY 16,371 during the reporting period, contributing to other income[4]. Operating Costs - Total operating revenue for the first three quarters of 2024 reached CNY 59,060,000,304.02, an increase from CNY 58,184,549,516.02 in the same period of 2023, representing a growth of approximately 1.5%[14]. - Total operating costs for the first three quarters of 2024 were CNY 55,409,270,136.71, compared to CNY 53,778,646,989.34 in 2023, indicating an increase of about 3.0%[16]. - Operating profit for the first three quarters of 2024 was CNY 4,001,068,355.99, down from CNY 4,756,262,185.04 in the previous year, reflecting a decrease of approximately 15.9%[16]. Research and Development - Research and development expenses for the first three quarters of 2024 were CNY 578,513,078.86, slightly down from CNY 579,480,533.51 in the same period of 2023[16].