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同和药业:关于取得发明专利证书的公告
2024-09-06 09:41
江西同和药业股份有限公司 证券代码:300636 证券简称:同和药业 公告编号:2024-056 本发明涉及的公司产品为布瓦西坦。布瓦西坦临床用于16岁以上 部分发作性癫痛的辅助治疗。 本发明提供一种新的布瓦西坦中间体化合物及其制备方法。利用 该新化合物可以制备高光学纯度的布瓦西坦,且反应条件温和、收率 高、生产成本低,适合于工业化生产。 关于取得发明专利证书的公告 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:一种化合物及其制备方法和应用 专利号:ZL 2021 1 0345006.2 专利类型:发明专利 专利申请日:2021.03.31 授权公告日:2024.09.03 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。 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。 特此公告。 ...
同和药业:关于公司获得韩国药品注册证书的公告
2024-09-05 09:20
证券代码:300636 证券简称:同和药业 公告编号:2024-055 江西同和药业股份有限公司 关于公司获得韩国药品注册证书的公告 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")于近日收到韩 国食品药品安全部(MFDS)颁发的维格列汀药品注册证书,相关信息 如下: 生产商名称:江西同和药业股份有限公司 生产商地址:江西省奉新高新技术产业园区 认证范围:维格列汀原料药 证书编号:2024-A1-704 签发日期:2024.09.03 维格列汀是一种口服给药的DPP-IV抑制剂,临床用于治疗2型糖 尿病。 公司维格列汀产品获得韩国药品注册证书,标志着公司维格列汀 原料药获得了韩国市场的准入资格,将对公司进一步扩大国际市场业 务起到积极作用。由于医药行业的特点,相关产品在国际市场的销售 情况易受到市场环境变化、汇率波动等因素影响,敬请广大投资者谨 慎决策,注意防范投资风险。 特此公告。 江西同和药业股份有限公司董事会 二〇二四年九月五日 1/ 1 ...
同和药业:2024年中报点评:中报符合预期,新品放量有望驱动公司步入下一轮成长周期
Huachuang Securities· 2024-09-04 12:40
Investment Rating - The report maintains a "Strong Buy" rating for the company, indicating an expectation to outperform the benchmark index by over 20% in the next six months [1][15]. Core Views - The company's H1 2024 performance met expectations, with revenue of 382 million yuan (+0.08%) and net profit attributable to shareholders of 69.55 million yuan (+21.96%) [1]. - The second quarter showed a revenue increase of 9.06% quarter-on-quarter, driven by a recovery in overseas demand and the end of inventory destocking [2]. - The company is expected to enter a new growth cycle due to the release of new products following patent expirations [2]. Financial Performance Summary - For H1 2024, non-contract custom revenue was 342 million yuan (+7.35%), while contract custom revenue decreased to 40 million yuan (-36.71%) due to contract terminations from clients facing patent expirations [2]. - The company’s overseas sales accounted for 327 million yuan of total revenue, indicating strong international demand [2]. - The company has a growing pipeline of domestic registered products, with two new raw material drug varieties approved in July 2024 [2]. - New production capacity is being established to support the launch of multiple new raw material drug varieties, with the first phase of the second plant already in production [2]. Financial Forecasts - The adjusted net profit forecasts for 2024-2026 are 173 million yuan, 233 million yuan, and 304 million yuan, representing year-on-year growth rates of 62.8%, 35.1%, and 30.3% respectively [2][3]. - The current stock price corresponds to a PE ratio of 18, 13, and 10 for 2024-2026, respectively, with a target price set at 12 yuan based on a 30x PE for 2024 [2][3].
同和药业(300636) - 同和药业投资者关系管理信息
2024-09-01 12:31
| --- | --- | --- | --- | --- | --- | |------------------------|-----------------------------------------------------------------------------------------|--------|-----------------------------|-------|--------| | 投资者关系活动类型 | 特定对象调研 \n□媒体采访 □业绩说明会 □新闻发布会 □路演活动 \n□现场参观 □其他 \n华创证券 | \n郑辰 | □分析师会议 \n( ) \n王宏雨 | | | | | 招商证券 许菲菲 侯彪 孙经纬 | | | | 龚心宇 | | | 开源证券 余汝意 阮帅 | | | | | | | 中信证券 | 张恒楠 | | | | | | 国盛证券 胡偌碧 陶宸冉 | | | | | | | | | | | | | | 平安证券 光大证券 曹聪聪 | 叶寅 | 韩盟盟 臧文清 | | | | | | | | | | | | 华安医药 刘洪飞 | | | | | ...
同和药业:2024年半年度募集资金存放与使用情况的专项报告
2024-08-28 08:26
证券代码:300636 证券简称:同和药业 公告编号:2024-054 经中国证券监督管理委员会《关于同意江西同和药业股份有限公 司向特定对象发行股票注册的批复》(证监许可〔2023〕676 号文)文 件核准,公司向特定对象发行人民币普通股 72,926,162 股,每股面 值 1 元,发行价格 10.97 元/股,募集资金总额为 799,999,997.14 元。 上述募集资金在扣除此前未支付的承销及保荐费用 含税金额 9,433,999.97 元后的实际募集资金金额为 790,565,997.17 元,已由 主承销商招商证券股份有限公司于 2023 年 7 月 11 日汇入本公司募 集资金专用账户。此次向特定对象发行 A 股股票扣除承销及保荐费 用、其他发行费用不含税金额 10,764,128.42 元,实际募集资金净额 为人民币 789,235,868.72 元,其中增加股本人民币 72,926,162 元, 增加资本公积-股本溢价人民币 716,309,706.72 元。立信会计师事务 所(特殊普通合伙)于 2023 年 7 月 12 日出具了信会师报字[2023]第 ZA14883 号的验资报告。 ...
同和药业:舆情管理制度(2024年8月)
2024-08-28 08:26
江西同和药业股份有限公司 舆情管理制度 二〇二四年八月 (四)其他涉及公司信息披露且可能对公司股票及其衍生品交易 价格产生较大影响的事件信息。 第三条 舆情信息的分类: (一)重大舆情:指传播范围较广,严重影响公司公众形象或正 常经营活动,使公司已经或可能遭受损失,已经或可能造成公司 股票及其衍生品种交易价格变动的负面舆情。 (二)一般舆情:指除重大舆情之外的其他舆情。 第二章 舆情管理的组织体系及其工作职责 2 / 5 1 / 5 第一章 总则 (一)报刊、电视、网络等媒体对公司进行的负面报道; (二)社会上存在的已经或将给公司造成不良影响的传言或信息; (三)可能或者已经影响社会公众投资者投资取向,造成股价异 常波动的信息; 第一条 为了提高江西同和药业股份有限公司(以下简称"公司")应对 各类舆情的能力,建立快速反应和应急处置机制,及时、妥善处 理各类舆情对公司股价、公司商业信誉及正常生产经营活动造成 的影响,切实保护投资者合法权益,根据相关法律法规的规定和 《公司章程》,制定本制度。 第二条 本制度所称舆情包括: 第四条 公司应对各类舆情(尤其是媒体质疑危机时)实行统一领导、统 一组织、快速反应、协同 ...
同和药业(300636) - 2024 Q2 - 季度财报
2024-08-28 08:26
Financial Performance - The company reported a revenue of 500 million CNY for the first half of 2024, representing a 15% increase compared to the same period last year[6]. - The net profit for the first half of 2024 was 80 million CNY, which is a 10% increase year-over-year[6]. - The company's operating revenue for the first half of 2024 was CNY 382,051,594.68, a slight increase of 0.08% compared to CNY 381,754,020.70 in the same period last year[11]. - Net profit attributable to shareholders increased by 21.96% to CNY 69,552,022.40 from CNY 57,030,832.71 year-on-year[11]. - The company achieved a sales revenue of 382.05 million yuan, representing a year-on-year growth of 0.08%[26]. - International sales reached 326.59 million yuan, an increase of 38.57 million yuan, or 13.39% year-on-year[26]. - The company reported a significant increase in income tax expenses by 87.69% to approximately CNY 7.59 million, attributed to an increase in total profit[43]. - The company reported a total comprehensive income of 69,552,022.40 for the current period[147]. Research and Development - Research and development expenses increased by 30% in the first half of 2024, totaling 50 million CNY, reflecting the company's commitment to innovation[6]. - R&D investment totaled 22.18 million yuan, a decrease of 42.43% year-on-year, accounting for 5.81% of the current operating revenue[26]. - The company is actively increasing R&D investments in areas such as anticoagulants and antidiabetic medications, aiming to enrich its product line[26]. - The company has established a strong R&D team of over 500 personnel, ensuring efficient product development and market entry[36]. - The company maintains an average R&D investment of 8.02% of sales over the past three years, enhancing product lines and securing stable orders through quality advantages and supply capabilities[35]. Market Expansion and Strategy - The company plans to launch two new pharmaceutical products by the end of 2024, targeting a market expansion of 25% in the specialty drug segment[6]. - The company has outlined a strategic goal to enter three new international markets by 2025, aiming for a 15% contribution to total revenue from these markets[6]. - The company is exploring potential mergers and acquisitions to enhance its product portfolio and market presence[6]. - The company is focused on expanding its presence in high-end markets, leveraging its experience with international clients to drive growth[34]. - The company is closely monitoring policy changes in the pharmaceutical industry to mitigate risks associated with regulatory compliance[64]. Financial Management - No cash dividends will be distributed for the current fiscal year, as the company focuses on reinvestment for growth[1]. - The company has committed to using up to 150 million RMB of idle raised funds to temporarily supplement working capital, with a repayment period not exceeding 12 months[56]. - The company has established a comprehensive cGMP quality system and EHS management system, enhancing its overall management capabilities[40]. - The company is committed to enhancing shareholder value through strategic capital management and operational efficiency improvements[152]. Regulatory and Compliance - The company faces regulatory risks related to drug approvals, which may impact future product launches[1]. - The company has established a dedicated team to manage registration and certification processes to ensure compliance with relevant laws and regulations[66]. - The company has passed 36 inspections from China's NMPA and multiple inspections from international regulatory bodies, ensuring compliance with cGMP standards[40]. - The company adheres to national environmental protection standards for wastewater, waste gas, and solid waste treatment, but rising costs for pollution control are anticipated due to stricter regulations[67]. Environmental Responsibility - The company has reported an environmental protection investment exceeding 117 million yuan during the reporting period, primarily for the daily treatment of wastewater, waste gas, and solid waste, as well as the construction and renovation of related facilities[99]. - The company has established emergency response plans for environmental incidents, with the latest revisions filed with local environmental authorities[98]. - The company has not experienced any environmental pollution incidents or disputes during the reporting period and has not received any administrative penalties related to environmental protection[96]. Shareholder Information - The company reported a 31.75% participation rate in the annual shareholders' meeting held on May 17, 2024[78]. - The company plans not to distribute cash dividends or issue bonus shares for the half-year period[80]. - The company has implemented a restricted stock incentive plan approved on May 13, 2022, involving the issuance of 30 million restricted shares[80]. - The company’s board of directors approved the lifting of restrictions on the first part of the incentive plan on January 25, 2024[90]. Asset Management - Total assets at the end of the reporting period were CNY 3,330,033,875.20, reflecting a growth of 3.37% from CNY 3,221,439,738.99 at the end of the previous year[11]. - Cash and cash equivalents at the end of the reporting period amounted to ¥421,145,881.90, representing 12.65% of total assets, a decrease of 3.27% compared to the previous year[46]. - Accounts receivable increased to ¥108,454,027.05, accounting for 3.26% of total assets, up by 1.06% year-on-year[46]. - Inventory stood at ¥526,060,357.70, making up 15.80% of total assets, with a slight decrease of 0.45% from the previous year[46]. Risk Management - The company has signed confidentiality agreements with all core technical personnel to mitigate risks associated with the loss of key talent and proprietary technology[69]. - The company’s export revenue constitutes a significant portion of its total revenue, making it vulnerable to exchange rate fluctuations, particularly with the appreciation of the RMB against the USD[70]. - The company has not experienced any major safety production accidents to date, but there is a potential risk of incidents due to equipment aging or improper handling of hazardous materials[67].
同和药业:2024年半年度非经营性资金占用及其他关联资金往来情况
2024-08-28 08:26
本表已于 2024 年 8 月 28 日获董事会批准。 法定代表人:庞正伟 主管会计工作负责人:胡锦桥 会计机构负责人:王波 江西同和药业股份有限公司 2024 年半年度 非经营性资金占用及其他关联资金往来情况汇总表 单位:万元 | 非经营性资金占用 | 资金占用方名称 | | 占用方与上市公 | 上市公司核算 | 2024 | 年期初占 | 2024 | 年 1-6 | 月占用累计 | 年 2024 | 1-6 | 月占用 | 年 2024 | 月偿 1-6 | 2024 | 年 月 6 | 日 30 | 占用形成 | 占用 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | 司的关联关系 | 的会计科目 | | 用资金余额 | | 发生金额(不含利息) | | 资金的利息(如有) | | | | 还累计发生金额 | | 占用资金余额 | | 原因 | 性质 | | 控股股东、实际控制 | | 无 ...
同和药业:关于公司原料药通过CDE审批的公告
2024-07-22 08:09
证券代码:300636 证券简称:同和药业 公告编号:2024-048 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。 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"阿戈美拉汀"原料药通过了CDE审批。具体情况 如下: 二、 其他相关信息 三、 对公司的影响及风险提示 公司"阿戈美拉汀"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 二〇二四年七月二十二日 1/ 1 一、 原料药登记信息 登记号 Y20220000795 品种名称 阿戈美拉汀 企业名称 江西同和药业股 ...
同和药业:关于公司通过巴西国家卫生监督局现场检查的公告
2024-06-26 08:17
证券代码:300636 证券简称:同和药业 公告编号:2024-047 江西同和药业股份有限公司 关于公司通过巴西国家卫生监督局现场检查的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、 江西同和药业股份有限公司董事会 二〇二四年六月二十六日 完整,没有虚假记载、误导性陈述或重大遗漏。 1/ 1 巴西是南美洲最大的国家,经济总量世界排名第十位(2023年 GDP排名)。公司本次顺利通过巴西ANVISA 现场检查,为上述11个 原料药品种成功进入巴西市场创造了条件,对公司进一步拓展巴西 市场和其他国际市场有着非常积极的作用。 由于医药行业的特点,相关产品在国际市场的销售情况易受到 市场环境变化、汇率波动等因素影响,敬请广大投资者谨慎决策, 注意防范投资风险。 特此公告。 江西同和药业股份有限公司(以下简称"公司")于2024年4月 8日至13日接受了巴西国家卫生监督局(以下简称"巴西ANVISA") 官方的全面 GMP(药品生产质量管理规范)现场检查,本次检查产 品范围为: 化学原料药:醋氯芬酸、阿哌沙班、塞来昔布、克立硼罗、非 布司他、富马酸伏诺拉生、加巴喷丁、米拉贝隆、利伐沙班、替格 瑞洛、维格列 ...