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同和药业:关于公司原料药通过CDE审批的公告
2024-11-13 08:09
江西同和药业股份有限公司(以下简称"公司")近日从国家药 品监督管理局药品审评中心(CDE)"原辅包登记信息公示"平台查 询获悉,公司提交的"美阿沙坦钾"原料药通过了CDE审批。具体情 况如下: 二、 其他相关信息 美阿沙坦钾适用于治疗成人原发性高血压。 证券代码:300636 证券简称:同和药业 公告编号:2024-063 江西同和药业股份有限公司 关于公司原料药通过 CDE 审批的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完 整,没有虚假记载、误导性陈述或重大遗漏。 受市场环境等因素影响,上述原料药品种的具体销售情况存在一 定的不确定性。公司将按照相关法律法规的要求对后续进展情况履行 信息披露义务。敬请广大投资者理性投资,注意投资风险。 特此公告。 江西同和药业股份有限公司董事会 二〇二四年十一月十三日 1/ 1 一、 原料药登记信息 登记号 Y20220001325 品种名称 美阿沙坦钾 企业名称 江西同和药业股份有限公司 企业地址 江西奉新高新技术产业园区天工大道888号 产品来源 境内生产 与制剂共同审评审批结果 A(已批准在上市制剂使用的原料) 三、 对公司的影响及风险提示 公司" ...
同和药业:关于公司通过药品GMP符合性检查的公告
2024-11-12 08:49
证券代码:300636 证券简称:同和药业 公告编号:2024-062 江西同和药业股份有限公司 关于公司通过药品 GMP 符合性检查的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、 完整,没有虚假记载、误导性陈述或重大遗漏。 江西同和药业股份有限公司(以下简称"公司")于近日收到江 西省药品监督管理局的"江西省药品监督管理局药品 GMP 符合性检查 结果告知书(2024 年第 57 号)",获悉经现场检查和综合评定,公司本 次检查原料药克立硼罗符合药品 GMP,具体信息如下: | 企业名称 | 江西同和药业股份有限公司 | | --- | --- | | 生产地址 | 江西奉新高新技术产业园区天工大道888号 | | 检查范围 | 原料药(克立硼罗) | | 检查日期 | 2024年9月11-13日 | | 检查结论 | 本次检查原料药(克立硼罗)符合药品GMP | 克立硼罗适用于2岁及以上轻度至中度特应性皮炎患者的局部外 用治疗。 公司原料药克立硼罗通过药品GMP符合性检查,有利于公司拓展 产品在国内市场的销售,形成国内国外市场同步销售的良好格局。 受市场环境等因素影响,上述原料药品种的具体销 ...
同和药业:2024年三季报点评:业绩符合预期,新产品驱动公司步入新成长周期
Huachuang Securities· 2024-11-06 05:23
Investment Rating - The report maintains a "Strong Buy" rating for the company with a target price of 12 yuan, compared to the current price of 8.66 yuan [5] Core Views - The company's Q3 2024 performance met expectations, with revenue of 570 million yuan (+1.84% YoY) and net profit attributable to shareholders of 95.74 million yuan (+21.72% YoY) [1] - Non-contract custom business grew by 13.8% YoY in the first three quarters of 2024, while contract custom business declined by 44.7% due to early termination by some clients [2] - Overseas sales contributed significantly, with export revenue reaching 460 million yuan (+6.63% YoY), while domestic sales declined by 15% to 107 million yuan [2] - New production capacity is expected to support the company's growth, particularly for new API products such as Ticagrelor, Vildagliptin, and Apixaban [3] Financial Performance - Revenue for 2024 is projected to be 795 million yuan (+10.1% YoY), with net profit attributable to shareholders of 135 million yuan (+27.3% YoY) [4] - The company's revenue is expected to grow to 1.15 billion yuan by 2026, with a net profit of 226 million yuan [4] - The company's PE ratio for 2024-2026 is estimated at 27x, 21x, and 16x, respectively [3] Business Outlook - The company is entering a new growth cycle driven by new products, with overseas API business expected to grow steadily as patents expire [2] - Domestic sales are expected to benefit from an increasing pipeline of registered products [2] - The company's new production facilities are expected to support the expansion of its API product portfolio [3] Valuation - The report suggests a 2025 PE multiple of 30x, implying a target price of 12 yuan [3] - The company's current valuation is considered reasonable given its growth prospects [3]
同和药业:关于取得发明专利证书的公告
2024-10-29 08:10
证券代码:300636 证券简称:同和药业 公告编号:2024-061 江西同和药业股份有限公司 关于取得发明专利证书的公告 克立硼罗临床用于3个月及以上婴幼儿以及成人的中重度湿疹的 治疗,疗效和安全性俱佳。 本发明提供一种新的克立硼罗的制备方法。与现有技术相比, 具有反应条件温和、收率高、产品质量好、生产成本低的优势,特 别适合于工业化大生产。 上述发明专利的取得不会对公司近期生产经营产生重大影响, 但有利于发挥公司自主知识产权技术优势,完善知识产权保护体 系,从而增强公司核心竞争力。 专利号:ZL 2020 1 1525126.2 专利类型:发明专利 专利申请日:2020.12.22 授权公告日:2024.10.29 专利权人:江西同和药业股份有限公司 注:专利权自授权公告之日起生效。专利权期限为二十年,自申请日起 算。 本公司及董事会全体成员保证信息披露的内容真实、准确、 完整,没有虚假记载、误导性陈述或重大遗漏。 江西同和药业股份有限公司(以下简称"公司")于近日收到 中华人民共和国国家知识产权局颁发的发明专利证书,具体情况如 下: 发明名称:一种克立硼罗中间体、制备方法及其在制备克立硼 罗中的应用 ...
同和药业20241024
2024-10-28 00:29
Summary of Conference Call Company Overview - The company reported a sales revenue of 519.99 million yuan, a year-on-year increase of 1.84% [1] - International sales reached 416.33 million yuan, up by 6.63% [1] - Domestic sales were 10.66 million yuan, down by 14.82% [1] - New products generated sales of 217.40 million yuan, a growth of 9.89% [1] - The CGMO segment saw a revenue decline of 44.66%, totaling 6.35 million yuan [1] - Net profit was 95.74 million yuan, an increase of 21.72% [1] - The gross margin improved to 33.66%, up by 2.37 percentage points [1] Key Points Financial Performance - The company achieved a net profit of 95.74 million yuan, with a net profit margin of 16.8%, an increase of 2.74 percentage points year-on-year [1] - R&D expenses were 39.20 million yuan, down by 17.12%, representing 6.88% of total revenue [1] - Sales expenses increased by 6.34%, while management expenses decreased by 3.93% [1] Product Performance - New product sales growth was attributed to non-contract custom products, which saw a revenue increase of 13.83% and a gross margin increase of 4.89 percentage points [1][2] - Contract custom projects experienced a revenue decline of 44.66% due to early termination of contracts by some clients [1][2] - Pharmaceutical raw materials sales increased by 17.02%, with a gross margin increase of 6.09% [1] Market Challenges - The company faced significant challenges in Q3, including a decline in CDMO projects and price drops in mature products despite increased sales volume [2] - The domestic sales decline was primarily due to price reductions in the domestic market [1][2] Future Outlook - The company plans to enhance its domestic raw material market presence and continue submitting more API varieties for domestic registration [2] - New product exports will focus on becoming a leading supplier of mainstream generic drugs globally [2] - The company aims to maintain high R&D investment levels, targeting around 10 new projects annually [3] Production Capacity - The second phase of the new plant is under construction, which will include seven new production workshops and a research building [4] - The first phase of the new plant is expected to significantly increase production capacity for various new products [4] Competitive Landscape - The company is facing increased competition from Indian manufacturers, particularly in the raw material sector [13] - The pricing environment remains competitive, with ongoing pressure on margins due to price declines in mature products [10][12] Currency and Market Dynamics - Currency fluctuations, particularly the strength of the US dollar against the yuan, have impacted financial performance, with expectations of stabilization in the future [7][14] - The company is cautiously optimistic about the recovery of emerging markets, although significant challenges remain [14] Conclusion - The company remains committed to improving its operational efficiency and expanding its market share despite facing various challenges in the current economic environment [17] - There is a strong focus on leveraging new product development and enhancing production capabilities to drive future growth [17]
同和药业(300636) - 2024 Q3 - 季度财报
2024-10-23 07:49
Revenue and Profitability - Revenue for Q3 2024 increased by 5.61% year-on-year, totaling CNY 569,933,408.38[2] - Net profit attributable to shareholders rose by 21.10% to CNY 95,736,461.60, with a year-to-date increase of 21.72%[2] - Basic earnings per share increased by 19.54% to CNY 0.2280, with diluted earnings per share showing a similar increase of 18.63%[2] - Net profit for the third quarter was ¥95,736,461.60, representing a 21.76% increase from ¥78,653,167.86 in the previous year[16] - Earnings per share increased to ¥0.2280, compared to ¥0.2143 in the same quarter last year[16] Cash Flow - Cash flow from operating activities reached CNY 162,163,824.25, reflecting a significant increase of 53.38%[2] - The net cash flow from operating activities increased by 53.38% to ¥162,163,824.25 compared to ¥105,729,138.58 in the same period last year, primarily due to a decrease in cash paid for goods and services[8] - Total cash inflow from operating activities is ¥521,186,224.17, down 6.5% from ¥557,523,692.04 in the previous period[17] - Cash outflow from operating activities decreased to ¥359,022,399.92, a reduction of 20.5% from ¥451,794,553.46 in the previous period[17] Assets and Liabilities - Total assets as of the end of Q3 2024 amounted to CNY 3,221,439,738.99, representing a 2.29% increase from the previous year[2] - Total assets amounted to ¥3,295,084,846.88, up from ¥3,221,439,738.99 at the end of the previous year[14] - Total liabilities decreased to ¥985,719,380.69 from ¥994,990,614.72 year-on-year[14] - The company's equity attributable to shareholders reached ¥2,309,365,466.19, an increase from ¥2,226,449,124.27 in the previous year[14] Accounts Receivable and Inventory - The company reported a 50.19% increase in accounts receivable, totaling CNY 106,289,452.65, primarily due to unsettled payments[5] - Accounts receivable increased to ¥106,289,452.65 from ¥70,771,939.06 in the previous period[12] - Inventory rose to ¥561,229,478.14 from ¥523,416,724.31, indicating a growth in stock levels[12] Borrowings and Financial Expenses - Long-term borrowings increased by 59.40% to CNY 398,500,000.00, attributed to new long-term loans taken during the period[6] - The company reported a decrease in short-term borrowings to ¥329,428,036.67 from ¥429,312,470.41 year-on-year[15] - Financial expenses showed a significant change, with a net income of -¥13,031,592.68 compared to -¥4,044,746.02 in the previous year[15] Tax and Investment Income - Tax and additional charges rose by 91.99% year-on-year, reaching CNY 5,380,972.73, mainly due to increased property tax[7] - Investment income surged by 100% to CNY 606,704.78, driven by higher financial management returns[7] Cash and Cash Equivalents - The company's cash and cash equivalents decreased significantly from ¥512,753,422.59 at the beginning of the period to ¥132,148,876.62 at the end of the period[12] - The ending balance of cash and cash equivalents is ¥116,345,276.10, down from ¥367,231,637.75 in the previous period[18] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 15,352[9] - The largest shareholder, Mr. Pang Zhengwei, holds 15.66% of the shares, totaling 66,009,954 shares, with 49,507,465 shares under pledge[9] Research and Development - Research and development expenses were ¥39,204,527.63, down from ¥47,477,333.47 in the same period last year[15] Audit Status - The company has not undergone an audit for the third quarter report[19]
同和药业:关于公司控股股东、实际控制人股份减持计划实施完成的公告
2024-10-15 12:05
证券代码:300636 证券简称:同和药业 公告编号:2024-059 江西同和药业股份有限公司 关于公司控股股东、实际控制人减持计划实施完成的公告 公司控股股东、实际控制人之一庞正伟先生保证向本公司提 供的信息内容真实、准确、完整,没有虚假记载、误导性陈述或 重大遗漏。 一、 股东减持情况 | | | 本公司及董事会全体成员保证信息披露的内容与信息披露义 务人提供的信息一致。 江西同和药业股份有限公司(以下简称"公司")于2024年9月9 日披露了《关于控股股东、实际控制人之一减持股份的预披露公告》 (公告编号:2024-057)。 公司于近日收到控股股东、实际控制人之一庞正伟先生出具的 《减持公司股票计划实施完成的告知函》。截至本公告日,庞正伟 先生股份减持计划已实施完成。现将具体情况公告如下: | 股东名 | 减持方式 | 减持期间 | | 减持均价 | 减持股数 | 占公司总股 | | --- | --- | --- | --- | --- | --- | --- | | 称 | | | (元) | | (股) | 本比例 | | 庞正伟 | 大宗交易 | 2024 年 10 | 月 6.97 | | ...
同和药业:招商证券股份有限公司关于同和药业2024年半年度持续督导跟踪报告
2024-09-20 03:51
招商证券股份有限公司 关于江西同和药业股份有限公司 2024 年半年度持续督导跟踪报告 | 保荐机构名称:招商证券股份有限公司 | 被保荐公司简称:同和药业 | | --- | --- | | 保荐代表人姓名:孙经纬 | 联系电话:0755-82943666 | | 保荐代表人姓名:刘海燕 | 联系电话:0755-82943666 | 一、保荐工作概述 | 事 项 | 存在的问题 | 采取的措施 | | --- | --- | --- | | 2.公司内部制度的建立和执行 | 无 | 不适用 | | 3."三会"运作 | 无 | 不适用 | | 4.控股股东及实际控制人变动 | 无 | 不适用 | | 5.募集资金存放及使用 | 无 | 不适用 | | 6.关联交易 | 无 | 不适用 | | 7.对外担保 | 无 | 不适用 | | 8.收购、出售资产 | 无 | 不适用 | | 9.其他业务类别重要事项(包括 对外投资、风险投资、委托理财、 | 无 | 不适用 | | 财务资助、套期保值等) | | | | 10.发行人或者其聘请的中介机 | 无 | 不适用 | | 构配合保荐工作的情况 | | | | ...
同和药业:关于公司原料药通过CDE审批的公告
2024-09-10 08:09
证券代码:300636 证券简称:同和药业 公告编号:2024-058 江西同和药业股份有限公司 克立硼罗适用于2岁及以上轻度至中度特应性皮炎患者的局部外 用治疗。 关于公司原料药通过 CDE 审批的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完 整,没有虚假记载、误导性陈述或重大遗漏。 江西同和药业股份有限公司(以下简称"公司")近日从国家药 品监督管理局药品审评中心(CDE)"原辅包登记信息公示"平台查 询获悉,公司提交的"克立硼罗"原料药通过了CDE审批。具体情况 如下: 一、 原料药登记信息 | 登记号 | Y20220001177 | | --- | --- | | 品种名称 | 克立硼罗 | | 企业名称 | 江西同和药业股份有限公司 | | 企业地址 | 江西奉新高新技术产业园区 | | 产品来源 | 境内生产 | | 与制剂共同审评审批结果 | A(已批准在上市制剂使用的原料) | 二、 其他相关信息 三、 对公司的影响及风险提示 公司"克立硼罗"原料药通过CDE审批,表明该原料药符合中国 相关药品审评技术标准,已批准在国内上市制剂中使用,有利于公司 拓展产品在国内市场的销售,形 ...
同和药业:关于控股股东、实际控制人之一减持股份的预披露公告
2024-09-09 11:11
证券代码:300636 证券简称:同和药业 公告编号:2024-057 江西同和药业股份有限公司 关于控股股东、实际控制人之一减持股份的预披露公告 公司控股股东、实际控制人之一庞正伟先生保证向本公司提 供的信息内容真实、准确、完整,没有虚假记载、误导性陈述或 重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提 供的信息一致。 特别提示: 持有江西同和药业股份有限公司(以下简称"公司"或"同和药 业")股份66,009,954股(占公司总股本比例为15.66%)的控股股东、 实际控制人之一庞正伟先生计划在减持预披露公告披露之日起15个 交易日之后的3个月内(即2024年10月10日至2025年1月9日)以集中 竞价方式/大宗交易方式减持公司股份不超过400万股(即不超过公司 总股本的0.95%)。 公司于近日收到控股股东、实际控制人之一庞正伟先生的《减持 公司股票计划告知函》,现将有关情况公告如下: 一、 股东的基本情况 截至本公告日,庞正伟先生直接持有公司股份66,009,954股,占 公司总股本的15.66%。 庞正伟先生与梁忠诚先生、丰隆实业有限公司为一致行动人。截 至本公告日,丰隆实业有限 ...