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莱美药业:关于控股子公司获得药物临床试验批准通知书的公告
2023-09-14 09:23
证券代码:300006 证券简称:莱美药业 公告编号:2023-035 重庆莱美药业股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 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。 近日,重庆莱美药业股份有限公司(以下简称"公司")控股子公司四川康 德赛医疗科技有限公司(以下简称"康德赛")的一款基于患者肿瘤新生抗原的 mRNA 编辑 DC(树突状细胞)肿瘤治疗性疫苗产品 CUD002 注射液获得由国家 药品监督管理局(以下简称"药监局")核准签发的《药物临床试验批准通知书》, 现将相关情况公告如下: 一、药品基本情况 药品名称:CUD002 注射液 申请人:四川康德赛医疗科技有限公司 通知书编号:2023LP01824 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,CUD002 注射液符合药品注册的有关要求,同意开展难治性/耐药复发性卵巢癌的临床试 验。 二、药品的其他相关情况 CUD002 注射液作为基于肿瘤新生抗原的 mRNA 编辑 DC(树突状细胞)肿 瘤治疗性疫苗,根据患者独特的突变信息定制设计并制造,能激发患者自身免疫 ...
莱美药业(300006) - 2023 Q2 - 季度财报
2023-08-23 16:00
Financial Performance - The company's operating revenue for the first half of 2023 was ¥453,859,975.46, representing an increase of 11.67% compared to ¥406,431,569.23 in the same period last year[19]. - The net loss attributable to shareholders for the first half of 2023 was ¥54,056,871.17, compared to a loss of ¥49,071,727.55 in the previous year[19]. - The net cash flow from operating activities improved to ¥4,361,552.15, recovering from a negative cash flow of ¥64,318,129.56 in the same period last year[19]. - The basic earnings per share for the first half of 2023 was -¥0.0512, compared to -¥0.0465 in the same period last year[19]. - The weighted average return on net assets was -2.58%, a decline from -2.30% in the previous year[19]. - The company's revenue for the reporting period was ¥453,859,975.46, representing an increase of 11.67% compared to the same period last year[41]. - Operating costs increased by 18.16% to ¥136,263,746.34, while sales expenses rose by 2.11% to ¥240,919,142.11[41]. - The net profit for the subsidiary, Laimei Pharmaceutical, was -53,721,440.00, a decrease of 5,000,770.00 compared to the previous year, primarily due to an extraordinary expense of 51,761,600.00 related to a legal dispute[67]. - The company reported a net loss of CNY 514,296,059.57 as of June 30, 2023, compared to a loss of CNY 460,239,188.40 at the beginning of the year[141]. - The company reported a total comprehensive income of 1,656.42 million yuan for the current period[171]. Assets and Liabilities - Total assets at the end of the reporting period were ¥2,920,717,355.66, a decrease of 4.40% from ¥3,054,984,574.17 at the end of the previous year[19]. - The net assets attributable to shareholders decreased by 2.45% to ¥2,072,336,385.37 from ¥2,124,446,116.48 at the end of the previous year[19]. - The company's total assets amounted to CNY 2,732,761,924.50, down from CNY 2,822,225,882.68 at the end of the previous period, a decrease of about 3.2%[145]. - Total liabilities decreased to CNY 344,570,873.57 from CNY 470,303,773.08, reflecting a reduction of approximately 26.7%[145]. - The company's total equity at the end of the reporting period was CNY 2,351 million, with a capital reserve of CNY 1,502 million[167]. Research and Development - The company has accelerated the development of innovative cancer-targeted drugs and cell immunotherapy technologies, enhancing research efficiency and the conversion of high-quality innovations[31]. - The company has established a multi-level research and innovation system to support the development of core products in the short, medium, and long term[27]. - The company has allocated CNY 140 million for research and development in the first half of 2023, aiming to innovate and improve existing product lines[164]. - Research and development expenses decreased to CNY 33,934,986.97 from CNY 39,568,050.54, showing a reduction of approximately 14.3%[147]. Market and Product Development - The company’s key product, Kanalin, has maintained its leading position in the thyroid disease market and has been recognized with multiple industry awards[27]. - The company is actively developing new channels for traditional products in a competitive procurement environment and expanding into third-party markets[31]. - The company’s product, Tranexamic Acid Injection, won the bid in the eighth batch of national centralized procurement at a price of CNY 13.95 per box, with an actual procurement volume of 8,000 boxes in the first half of 2023[32]. - The company has several key products under development, including Omeprazole Magnesium and Esomeprazole Magnesium, both currently in the application stage[33]. Risk Management - The company faces risks related to industry policies, drug price reductions, product quality and safety, technology development, and external investments[4]. - The company will actively adjust its business strategy and introduce new products and technologies to respond to changes in industry policies[72]. - The company has not reported any differences in net profit and net assets between international and Chinese accounting standards during the reporting period[20]. Environmental and Social Responsibility - The company has implemented a wastewater treatment system with a capacity of 500m³/d and seven exhaust gas treatment devices, all operating normally in the first half of 2023[86]. - The company achieved a VOCs emission of 29.46 tons, with no exceedance of discharge standards reported[85]. - The company emphasizes the protection of shareholder and investor rights, ensuring timely and accurate information disclosure in compliance with relevant laws and regulations[89]. - The company actively engages in social responsibility and public welfare activities, promoting sustainable development through green and low-carbon initiatives[91]. Corporate Governance - The company has no stock incentive plans or employee stock ownership plans in place during the reporting period[81]. - The company has established an emergency response plan for environmental incidents and completed the filing with environmental protection authorities[87]. - The financial report was approved by the board of directors on August 22, 2023[178]. - The semi-annual financial report has not been audited, indicating a need for further financial scrutiny[137]. Shareholder Information - The total number of common shareholders at the end of the reporting period is 34,436[126]. - The largest shareholder, Guangxi Wuzhou Zhongheng Group, holds 23.43% of the shares, amounting to 247,426,064 shares[126]. - The report states that there were no changes in the holdings of directors, supervisors, and senior management during the reporting period[129]. - The total number of shares held by the top 10 unrestricted shareholders is significant, indicating a concentrated ownership structure[128].
莱美药业:关于公司及子公司诉讼事项进展暨提起上诉的公告
2023-08-21 09:17
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。 重庆莱美药业股份有限公司(以下简称"公司"、"莱美药业")与全资子 公司重庆市莱美医药有限公司(以下简称"莱美医药")前期收到长春新区人民 法院出具的《民事判决书》(2022)吉 0193 民初 85 号,该诉讼事项一审判决具 体内容详见公司在巨潮资讯网发布的《关于公司及子公司诉讼事项一审判决结果 的公告》(公告编号 2023-025)。公司与莱美医药因不服一审判决结果,分别向 吉林省长春市中级人民法院提起上诉,在收到吉林省长春市中级人民法院出具的 《交纳诉讼费用通知书》后,已均于 2023 年 8 月 18 日缴纳上诉费,现将有关情 况公告如下: 证券代码:300006 证券简称:莱美药业 公告编号:2023-028 重庆莱美药业股份有限公司 关于公司及子公司诉讼事项进展暨提起上诉的公告 3、被上诉人(一审原告):长春海悦药业股份有限公司(以下简称"海悦 药业") 法定代表人:任泽波,董事长兼总经理(截至目前,董事长兼总经理已变更 为辛运宏) 4、管辖法院:吉林省长春市中级人民法院 5、案件所处的诉讼阶段:已缴 ...
莱美药业:关于控股子公司获得政府补助的公告
2023-08-16 09:08
关于控股子公司获得政府补助的公告 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。 一、获得政府补助的基本情况 重庆莱美药业股份有限公司(以下简称"公司")控股子公司西藏莱美德济 医药有限公司(以下简称"莱美德济")依据《拉萨经济技术开发区关于进一步 促进产业高质量发展 1+N 政策的实施意见》的相关规定,于 2023 年 8 月 14 日 收到西藏拉萨经济技术开发区管理委员会下发的 2022 年度产业发展扶持资金, 共计 41,593,315.00 元,占公司最近一年经审计净利润绝对值的 54.52%。本次获 得政府补助具体情况如下: | | | | | | | | | 是 否 与公 | 是否 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 获得补 | 提供补助 | 补助的原 | 补助 | 补助金额 | | 计入 | 是否 | 司 日 常经 | 具有 | | 助的主 | | | | | 补助依据 | 会计 | 实际 | | | | | 的主体 | 因或项目 | 形式 | (元) ...
莱美药业(300006) - 2023 Q1 - 季度财报
2023-04-21 16:00
Revenue and Financial Performance - Revenue for the first quarter of 2023 increased by 14.06% to 226,654,528.42 yuan compared to the same period last year[2] - Total revenue for the quarter was 226.65 million yuan, an increase from 198.71 million yuan in the same period last year[20] - Sales revenue from goods and services was 220.995 million USD, a decrease from 259.388 million USD in the previous year[24] Net Profit and Loss - Net loss attributable to shareholders of the listed company decreased to -3,634,060.91 yuan from -26,403,512.18 yuan year-over-year[2] - Net profit for the first quarter of 2023 was -7.606 million USD, a significant improvement from -28.991 million USD in the same period last year[21] Cash Flow - Operating cash flow turned positive at 9,591,286.80 yuan, compared to -12,698,605.55 yuan in the same period last year[2] - Net cash flow from operating activities was 903.78 million yuan, compared to 846.29 million yuan at the beginning of the year[16] - Operating cash flow for the first quarter of 2023 was 9.591 million USD, compared to -12.699 million USD in the same period last year[25] - Investment cash flow improved significantly, with a net inflow of 38,635,590.92 yuan compared to a net outflow of 81,194,088.89 yuan last year[11] - Investment cash flow for the first quarter of 2023 was 38.636 million USD, a significant improvement from -81.194 million USD in the same period last year[25] - Financing cash flow for the first quarter of 2023 was 9.701 million USD, compared to 138.912 million USD in the same period last year[25] - Cash and cash equivalents at the end of the first quarter of 2023 were 852.320 million USD, an increase from 794.829 million USD at the beginning of the quarter[25] Assets and Liabilities - Total assets increased by 0.94% to 3,083,794,077.47 yuan compared to the end of the previous year[2] - The company's total assets increased to 3.08 billion yuan, up from 3.05 billion yuan at the beginning of the year[18] - Total liabilities increased to 902.18 million yuan, up from 870.02 million yuan at the beginning of the year[18] - The company's total equity decreased slightly to 2.18 billion yuan, down from 2.18 billion yuan at the beginning of the year[18] - The company's inventory decreased to 192.77 million yuan, down from 202.40 million yuan at the beginning of the year[17] - The company's accounts receivable increased to 359.72 million yuan, up from 331.45 million yuan at the beginning of the year[17] - The company's long-term loans decreased to 133.00 million yuan, down from 149.00 million yuan at the beginning of the year[18] R&D and Expenses - R&D expenses decreased by 34.81% to 15,677,120.11 yuan due to different stages of R&D projects[9] - R&D expenses for the first quarter of 2023 were 15.677 million USD, a decrease from 24.047 million USD in the same period last year[21] - Sales expenses for the first quarter of 2023 were 125.912 million USD, an increase from 113.151 million USD in the same period last year[21] - Management expenses for the first quarter of 2023 were 28.511 million USD, a decrease from 29.479 million USD in the same period last year[21] Financial Expenses and Income - Financial expenses showed a significant improvement, with a net income of 2,981,316.04 yuan compared to an expense of 1,858.23 yuan last year[9] Government Subsidies - The company received government subsidies of 10,930,854.65 yuan during the reporting period[4] Shareholders and Ownership - The number of ordinary shareholders at the end of the reporting period was 34,995[12] - Guangxi Wuzhou Zhongheng Group Co., Ltd. holds 23.43% of the company's shares, making it the largest shareholder[12] Product and Regulatory Approvals - The company's product, Tranexamic Acid Injection, was selected in the 8th National Drug Centralized Procurement[14] - The company received approval from the National Medical Products Administration for the transfer of the drug approval of Triptorelin Acetate Injection[14] Audit Status - The company's first quarter report for 2023 was not audited[26]
莱美药业:莱美药业业绩说明会、路演活动信息
2023-04-04 10:28
证券代码:300006 证券简称:莱美药业 重庆莱美药业股份有限公司 投资者关系活动记录表 编号:2023-001 | 投资者关系活动类 | □特定对象调研 □分析师会议 | | --- | --- | | 别 | □媒体采访 √业绩说明会 | | | □新闻发布会 □路演活动 | | | □现场参观 | | | □其他 (请文字说明其他活动内容) | | 参与单位名称及人 | 线上参与公司莱美药业"2022 年度网上业绩说明会"的 | | 员姓名 | 投资者 | | 时间 | 2023 年 4 月 4 日(星期二)下午 15:00-17:00 | | 地点 | "莱美药业投资者关系"微信小程序 | | 上市公司接待人员 | 董事长:梁建生先生 | | 姓名 | 副董事长、副总经理:冷雪峰先生 | | | 独立董事:陈耿先生 | | | 总经理:邱戎钊先生 | | | 财务总监:赖文女士 | | | 董事会秘书、副总经理:崔丹先生 | | | 保荐机构代表:阎华通先生 | | | 公司于 2023 年 4 月 4 日(星期二)15:00-17:00 通 过约调研平台在"莱美药业投资者关系"微信小程序举 | | ...
莱美药业(300006) - 2022 Q4 - 年度财报
2023-03-17 16:00
Financial Performance - The net profit attributable to shareholders for 2022 was -68.71 million yuan, primarily impacted by national centralized procurement policies and continued high R&D investment[5]. - The company's operating revenue for 2022 was ¥884,586,776.10, a decrease of 27.80% compared to ¥1,225,224,188.67 in 2021[15]. - The net profit attributable to shareholders was -¥68,709,119.36, improving from -¥100,528,177.01 in 2021[15]. - The net cash flow from operating activities was ¥57,133,949.52, down 47.24% from ¥108,281,302.47 in 2021[15]. - The total assets at the end of 2022 were ¥3,054,984,574.17, an increase of 4.38% from ¥2,926,773,933.76 at the end of 2021[15]. - The net assets attributable to shareholders decreased by 1.48% to ¥2,124,446,116.48 from ¥2,156,345,435.92 in 2021[15]. - The company reported a basic earnings per share of -¥0.0651, an improvement from -¥0.1010 in 2021[15]. - The company received government subsidies amounting to ¥53,912,277.96 in 2022, compared to ¥59,795,254.67 in 2021[21]. - The company reported a significant decline in the medical circulation segment, with revenue of ¥93,003,518.09, a decrease of 30.95% from ¥134,697,425.74 in the previous year[46]. - The company reported a total of 70,130,000 CNY in debt repayment, with a completion rate of 100.19%[77]. Research and Development - The company’s R&D investment remains significant, reflecting its commitment to innovation despite financial losses[5]. - The company has established a multi-level research and innovation system to enhance its competitive edge in the pharmaceutical market[30]. - The company is focusing on the development of innovative technologies such as cell immunotherapy and nano carbon iron, while also actively seeking quality projects through external investment platforms[28]. - The company is currently developing multiple key products, including omeprazole magnesium and terlipressin injections, with several projects in the application stage[42]. - The company has several products under research and development, including personalized tumor vaccines and anti-fibrosis therapies, indicating a focus on innovative treatments[42]. - The company has 119 R&D personnel, with a proportion of 13.15% of total employees, up from 12.73% in 2021[61]. - The company’s R&D investment amounted to ¥102,161,660.16 in 2022, representing 11.55% of its operating revenue, an increase from 9.63% in 2021[61]. Market Position and Strategy - The company continues to explore market expansion opportunities and strategic partnerships to enhance its competitive position[5]. - The company aims to optimize its product structure and strengthen its market share in key segments through a dual-engine sales model of "hospital + OTC"[33]. - The company plans to enhance terminal market development and accelerate the establishment of OTC marketing channels to mitigate the impact of centralized procurement on product sales[33]. - The company aims to achieve registration for several new products, including the Esomeprazole Magnesium Enteric-coated Tablets and the Injection of Terlipressin, to expand its offerings[60]. - The company aims to enhance its medical device segment, focusing on the development of a disposable visual endoscope to replace imported products[44]. - The company is committed to high-quality development and innovation-driven growth as its fundamental motivation[92]. - The company aims to maintain a leading position in the specialty and anti-infection disease sectors, focusing on upgrading traditional pharmaceutical industries in China[92]. Governance and Compliance - The management team remains committed to ensuring the accuracy and completeness of financial reporting and disclosures[5]. - The company emphasizes investor relations management, actively engaging with investors through various platforms and events to enhance communication[108]. - The company has implemented a robust internal control system to enhance governance and compliance with relevant laws and regulations[106]. - The company has established a comprehensive information disclosure management system to ensure timely and accurate communication with all stakeholders[107]. - The company has a clear and transparent process for the selection and appointment of directors, ensuring compliance with legal requirements[106]. - The company has maintained effective internal controls related to financial reporting as of December 31, 2022, with no significant deficiencies identified[163]. Environmental Responsibility - The company complies with various environmental protection laws and standards, including the Comprehensive Emission Standard for Air Pollutants[165]. - Laime Longyu's wastewater treatment system has a capacity of 500m³/d, achieving a removal efficiency of 95% using iron-carbon physical reduction and ABR biochemical treatment processes[168]. - In 2022, Laime Longyu's wastewater and exhaust gas emissions met standards 100% of the time throughout the year[168]. - The company has implemented a self-monitoring plan for pollutant emissions, with regular testing conducted by a qualified third-party organization[170]. - The company actively engages in social responsibility, ensuring the protection of shareholder and employee rights[172]. Challenges and Risks - The company is exposed to risks related to industry policies, drug price reductions, product quality, technology development, and external investments[6]. - The company faces challenges from intensified competition and regulatory changes in the pharmaceutical industry, necessitating innovation and strategic adaptation[26]. - The company faces industry policy risks due to increasing regulatory requirements, which may impact production, research, and distribution processes[98]. - The company is exposed to drug price risks as centralized procurement policies may lead to significant changes in bidding and pricing, potentially compressing profit margins[98]. Subsidiaries and Investments - The company added four new subsidiaries during the reporting period, including Chongqing Laimei Zhenyu Pharmaceutical Co., Ltd.[54]. - The company has established a partnership with AglaeaPharma to develop a multi-target small molecule drug screening platform and early disease detection technologies[43]. - The company has completed the use of raised funds totaling CNY 106,451,000.00 as of December 31, 2022[76]. - The company has confirmed that there were no non-operating fund occupations by controlling shareholders or other related parties during the reporting period[191]. Human Resources - The total number of employees at the end of the reporting period was 905, with 445 in the parent company and 460 in major subsidiaries[150]. - The employee composition includes 151 production staff, 221 sales personnel, and 257 technical staff, reflecting a diverse workforce[150]. - The company has a remuneration management system that determines compensation based on performance, work ability, and job responsibilities[138]. - The company has not reported any penalties from securities regulatory agencies for its directors and supervisors in the past three years[137].
莱美药业:关于举行2022年度网上业绩说明会的公告
2023-03-17 12:28
为便于广大投资者进一步了解公司经营情况,公司将于2023年4月4日(星期 二)15:00至17:00在"莱美药业投资者关系"小程序举行"2022年度网上业绩说 明会"。本次网上业绩说明会将采用网络远程方式举行,投资者可登陆"莱美药 业投资者关系"小程序参与互动交流。为广泛听取投资者的意见和建议,现提前 向投资者征集问题,投资者可通过以下方式提出所关注的问题,提问通道自本公 告发出之日起开放。 证券代码:300006 证券简称:莱美药业 公告编号:2023-014 重庆莱美药业股份有限公司 关于举行2022年度网上业绩说明会的公告 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。 重庆莱美药业股份有限公司(以下简称"公司")于2023年3月18日在巨潮 资讯网(http://www.cninfo.com.cn)披露了《2022年年度报告》。 重庆莱美药业股份有限公司 董事会 2023 年 3 月 17 日 参与方式:在微信小程序中搜索"莱美药业投资者关系"或者用微信扫描以 下二维码: 依据提示,投资者授权登入"莱美药业投资者关系"小程序后,即可参与交 流。 出席本 ...