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甘李药业:第四届董事会第十四次会议决议公告
2023-08-24 10:26
证券代码:603087 证券简称:甘李药业 公告编号:2023-070 甘李药业股份有限公司 第四届董事会第十四次会议决议公告 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法律责任。 一、董事会会议召开情况 甘李药业股份有限公司(以下简称"公司")第四届董事会第十四次会议于 2023 年 8 月 13 日以电子邮件方式发出会议通知和会议材料,2023 年 8 月 23 日 在公司五层会议室以现场结合通讯方式召开。本次会议由董事长甘忠如先生主持。 应出席董事 9 名,实际出席董事 9 名。本次会议的召开符合《公司法》和《公司 章程》的有关规定,会议决议合法有效。 二、董事会会议审议情况 经与会董事审议表决,一致通过如下议案: (一)审议通过了《关于公司 2023 年半年度报告及摘要的议案》 同意《甘李药业股份有限公司 2023 年半年度报告》及其摘要。 独立董事对该事项发表了同意的独立意见。 同意《甘李药业股份有限公司 2023 年半年度募集资金存放及实际使用情况 专项报告》。 具体内容详见公司于同日在上海证券交易所网站披露的《甘李药业 ...
甘李药业:关于欧洲子公司甘精胰岛素注射液上市许可申请获得欧洲EMA正式受理的公告
2023-08-21 08:37
证券代码:603087 证券简称:甘李药业 公告编号:2023-069 甘李药业股份有限公司 关于欧洲子公司甘精胰岛素注射液上市许可申请 获得欧洲 EMA 正式受理的公告 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。 甘李药业股份有限公司(以下简称"公司"、"甘李药业")全资子公司甘李药 业欧洲有限责任公司(Gan & Lee Pharmaceuticals Europe GmbH,以下简称"甘 李欧洲")此前向欧洲药品管理局(European Medicines Agency,以下简称"EMA") 递交了甘精胰岛素注射液的上市许可申请(Marketing Authorisation Application, 以下简称"MAA"),并于近日收到 EMA 的正式受理通知,进入科学评估阶段。 现将相关情况公告如下: 一、药物基本情况 4、申请人:甘李药业欧洲有限责任公司 二、药物其他相关情况 甘精胰岛素作为一种长效胰岛素类似物,又称基础胰岛素。其经过修饰后可 在较长时间内提供稳定水平的血浆胰岛素,仅需每天注射一次。由于其吸收缓慢 ...
甘李药业:关于召开2023年半年度业绩说明会的公告
2023-08-18 08:19
证券代码:603087 证券简称:甘李药业 公告编号:2023-068 甘李药业股份有限公司 关于召开 2023 年半年度业绩说明会的公告 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。 重要内容提示: 会议召开时间:2023 年 8 月 28 日(星期一)下午 15:00-16:00 会议召开地点:上海证券交易所上证路演中心(网址:http://roadsho w.sseinfo.com/) 会议召开方式:上证路演中心网络互动 投资者可于 2023 年 8 月 25 日(星期五)至 8 月 27 日(星期日)16:00 前登 录上证路演中心网站首页点击"提问预征集"栏目或通过甘李药业股份有限公司 (以下简称"公司")邮箱 ir@ganlee.com 进行提问。公司将在信息披露允许的范 围内,在说明会上对投资者普遍关注的问题进行回答。 公司定于 2023 年 8 月 25 日在上海证券交易所网站(www.sse.com.cn)披露 《2023 年半年度报告》。为使广大投资者更加全面、深入地了解公司情况,公司 决定于 2023 ...
甘李药业:关于使用闲置募集资金进行现金管理到期赎回的公告
2023-08-17 08:16
一、本次使用闲置募集资金购买理财产品到期赎回的情况 证券代码:603087 证券简称:甘李药业 公告编号:2023-067 甘李药业股份有限公司 关于使用闲置募集资金进行现金管理到期赎回的公 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。 甘李药业股份有限公司(以下简称"公司")于 2023 年 8 月 7 日召开第四届 董事会第十三次会议及第四届监事会第十二次会议审议通过了《关于继续使用闲 置募集资金进行现金管理的议案》,同意在保障资金安全及确保不影响募集资金 投资项目建设和使用计划的前提下,继续使用不超过 2.5 亿元的暂时闲置募集资 金适时购买安全性高、流动性好、满足保本要求的投资产品(包括协定性存款、 结构性存款、定期存款、大额存单、收益凭证等),且该等投资产品不得用于质 押,不用于以证券投资为目的的投资行为。同时不影响募集资金投资计划正常进 行。期限自董事会审议通过之日起不超过 12 个月。在上述期限及额度范围内, 资金可循环滚动使用。具体内容详见公司在上海证券交易所网站披露的《甘李药 业股份有限公司关于继续使用 ...
甘李药业(603087) - 2023 Q1 - 季度财报
2023-04-27 16:00
Financial Performance - The company's revenue for Q1 2023 was approximately ¥558 million, representing a decrease of 19.13% compared to the same period last year[4]. - Net profit attributable to shareholders was approximately ¥49 million, down 56.55% year-on-year[4]. - Total operating revenue for Q1 2023 was approximately ¥558 million, a decrease of 19.0% compared to ¥690 million in Q1 2022[21]. - Net profit for Q1 2023 was approximately ¥49 million, a decline of 56.5% from ¥113 million in Q1 2022[21]. - Basic earnings per share for Q1 2023 were ¥0.09, down from ¥0.20 in Q1 2022, reflecting a decrease of 55.0%[22]. Cash Flow and Liquidity - The net cash flow from operating activities was negative at approximately -¥16 million, a decline of 106.98% compared to the previous year[4]. - Cash flow from operating activities showed a net outflow of approximately ¥16 million in Q1 2023, compared to a net inflow of approximately ¥233 million in Q1 2022[23]. - Cash and cash equivalents at the end of Q1 2023 were approximately ¥333 million, down from ¥529 million at the end of Q1 2022[23]. - The company reported cash and cash equivalents of approximately ¥2.74 billion as of March 31, 2023, down from ¥2.89 billion at the end of 2022[19]. Sales and Market Performance - Domestic sales revenue decreased by ¥158 million, primarily due to significant price reductions following the implementation of centralized procurement in May 2022[8]. - International sales revenue increased by 192.64% year-on-year, with international sales reaching approximately ¥38 million[9]. - The volume of domestic insulin products sold increased by 173.98% year-on-year, with non-long-acting insulin products seeing a volume increase of 552.36%[13]. - The marketing team expansion and academic promotion strategies led to significant sales growth in the current quarter[14]. - The company plans to continue enhancing the efficiency of sales expenses and focus on grassroots market penetration[14]. Costs and Expenses - Total operating costs increased to approximately ¥528 million in Q1 2023, up 5.6% from ¥500 million in Q1 2022[21]. - The sales expense ratio decreased from 63.46% in 2022 to 40.27% in the current reporting period, indicating improved efficiency in sales expenditure[14]. - The company reported a significant increase in sales expenses, which totaled approximately ¥225 million in Q1 2023, down from ¥288 million in Q1 2022, a decrease of 21.7%[21]. - Research and development expenses rose to approximately ¥120 million in Q1 2023, an increase of 22.5% compared to ¥98 million in Q1 2022[21]. Assets and Liabilities - The total assets at the end of the reporting period were approximately ¥10.60 billion, a slight decrease of 0.10% from the previous year[4]. - Total assets amounted to ¥10.60 billion as of March 31, 2023, slightly down from ¥10.61 billion at the end of 2022[20]. - The company’s total liabilities decreased from approximately ¥1.02 billion in 2022 to ¥950.58 million in the current period[20]. - The company’s inventory increased to approximately ¥688.68 million from ¥648.65 million year-over-year[19]. - The total liabilities to equity ratio as of January 1, 2023, is approximately 10.65%[26]. Shareholder Information - The number of common shareholders reached 78,598 by the end of the reporting period[15]. - The company’s net profit retained increased to approximately ¥6.28 billion from ¥6.23 billion year-over-year[20]. New Projects and Developments - The company is in the clinical stage for several new drug projects, including GZR101 and GZR4, which are expected to enter the market upon approval[14]. Accounting and Reporting Changes - The company implemented new accounting standards starting January 1, 2023, affecting the presentation of financial statements[24].
甘李药业:关于召开2023年第一季度业绩说明会的公告
2023-04-27 10:08
证券代码:603087 证券简称:甘李药业 公告编号:2023-037 甘李药业股份有限公司 关于召开 2023 年第一季度业绩说明会的公告 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。 重要内容提示: 会议召开时间:2023 年 5 月 9 日(星期二)上午 10:00-11:00 会议召开地点:上海证券交易所上证路演中心(网址:http://roadsho w.sseinfo.com/) 会议召开方式:上证路演中心网络互动 投资者可于 2023 年 4 月 28 日(星期五)至 5 月 8 日(星期一)16:00 前登 录上证路演中心网站首页点击"提问预征集"栏目或通过甘李药业股份有限公司 (以下简称"公司")邮箱 ir@ganlee.com 进行提问。公司将在信息披露允许的范 围内,在说明会上对投资者普遍关注的问题进行回答。 公司于 2023 年 4 月 28 日在上海证券交易所网站(www.sse.com.cn)披露了 《2023 年第一季度报告》。为使广大投资者更加全面、深入地了解公司情况,公 司决定于 2023 ...
甘李药业(603087) - 2022 Q4 - 年度财报
2023-03-30 16:00
Financial Performance - In 2022, the net profit attributable to shareholders of the listed company was negative, leading to a decision not to distribute profits or increase capital reserves[7]. - The company reported a total revenue of 1.2 billion in 2022, representing a year-over-year growth of 15%[17]. - The company's operating revenue for 2022 was CNY 1.71 billion, a decrease of 52.60% compared to CNY 3.61 billion in 2021[26]. - The net profit attributable to shareholders for 2022 was a loss of CNY 439.52 million, a decline of 130.25% from a profit of CNY 1.45 billion in 2021[26]. - The net cash flow from operating activities decreased by 72.48% to CNY 296.68 million, down from CNY 1.08 billion in the previous year[26]. - The company reported a significant increase in sales expenses and R&D expenses during the reporting period, contributing to the net loss[28]. - The company achieved a gross margin of 60% for 2022, maintaining a stable margin compared to 2021[121]. - The company’s revenue has been impacted by price reductions due to the implementation of centralized procurement policies, leading to a noticeable decline in operating income[54]. Research and Development - The company is committed to high investment in R&D to enhance treatment efficacy and patient compliance in diabetes care[4]. - The company has allocated 200 million for R&D in 2023, focusing on innovative drug development[18]. - In 2022, the company invested a total of 718.54 million RMB in R&D, a 30.80% increase year-on-year, accounting for 41.96% of sales revenue[37]. - The company’s capitalized R&D investment reached 15,606.68 million RMB, a significant increase of 108.73% year-on-year[37]. - Major R&D projects include insulin aspart and insulin lispro, both in the preparation for market application stage, with respective investments of CNY 5.91 million and CNY 5.68 million[91]. - The company is focusing on innovative drug development in autoimmune and oncology fields, alongside its diabetes treatment advancements[37]. - The company is actively investing in drug research and development to continuously break through the treatment ceiling for diabetes[49]. Market Expansion and Strategy - The company aims to expand its product line and become a leading innovative pharmaceutical company globally, with new drugs entering clinical trials[4]. - The company is expanding its market presence in Europe, targeting a 30% market share by 2025[17]. - The company is exploring partnerships with international firms to enhance its global distribution network[18]. - The company aims to increase production capacity by 40% in the next two years to meet growing demand[17]. - The company is committed to expanding its international market presence and increasing brand awareness through strategic partnerships and participation in global diabetes-related events[40]. - The company is actively pursuing international expansion and collaboration with local partners to enhance its global market presence[53]. - The company is focusing on expanding its product line through external acquisitions while managing costs and quality to counteract price declines from centralized procurement[108]. Product Development and Innovation - The company’s long-acting insulin product, Insulin Glargine (秀霖®), has been approved in China since 2005 and is now under review by the FDA for marketing in the U.S.[4]. - New product GZR101, a novel insulin combination therapy, is currently in Phase I clinical trials[18]. - The company plans to launch a new GLP-1 receptor agonist, GZR18, in Q3 2023[18]. - The company is developing a new ultra-long-acting insulin formulation, GZR4, which is expected to require only one injection per week, improving patient compliance and quality of life[48]. - The company launched the phosphate sitagliptin tablet, the first approved oral DPP-4 inhibitor, in June 2022, expanding its diabetes product line and enhancing market competitiveness[38]. - The company has multiple innovative research projects in clinical stages, including GZR101, GZR4, and GZR18, aimed at expanding treatment options for diabetes patients[49]. Regulatory and Compliance - The company successfully passed the new EU medical device regulations and obtained CE marking for its insulin pen and disposable pen needles, becoming one of the first Chinese manufacturers to achieve MDR certification[40]. - The company has implemented a comprehensive safety management system to ensure stable operations and prevent safety incidents[42]. - The company is enhancing its quality management system and has integrated quality culture initiatives to enhance employee awareness of quality standards[41]. - The company has established a robust internal control system to ensure compliance with laws and regulations, enhancing governance and operational transparency[113]. Corporate Governance and Shareholder Relations - The company has a clear and complete decision-making process for profit distribution, ensuring the protection of minority shareholders' rights[144]. - The company has established a remuneration and assessment committee responsible for evaluating the performance of senior management based on annual operational goals[148]. - The company has committed to a 36-month lock-up period for major shareholders, with automatic extensions under specific conditions, ensuring stability in shareholding[168]. - The company has not faced any penalties from securities regulatory authorities in the past three years[127]. - The company has established measures to stabilize stock prices if the closing price falls below the audited net asset value per share for 20 consecutive trading days[172]. Social Responsibility and Environmental Impact - The company invested CNY 9.24 million in environmental protection during the reporting period[152]. - The company has committed to a 36-month lock-up period for major shareholders, with automatic extensions under specific conditions, ensuring stability in shareholding[168]. - The company donated 10 million yuan to support education in economically underdeveloped areas, specifically in Gansu Province[164]. - The company has implemented carbon reduction measures, resulting in a reduction of 508 tons of CO2 equivalent emissions[160]. - The company completed the environmental self-monitoring plan for 2022, with all monitored pollutants meeting discharge standards[158].
甘李药业:关于召开2022年年度业绩说明会的公告
2023-03-30 13:31
证券代码:603087 证券简称:甘李药业 公告编号:2023-029 甘李药业股份有限公司 关于召开 2022 年年度业绩说明会的公告 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。 重要内容提示: 会议召开时间:2023 年 4 月 7 日(星期五)上午 10:00-11:00 会议召开地点:上海证券交易所上证路演中心(网址:http://roadsho w.sseinfo.com/) 会议召开方式:上证路演中心网络互动 本次投资者说明会以网络互动形式召开,公司将针对 2022 年年度的经营业 绩、公司战略等具体情况与投资者进行互动交流和沟通,在信息披露允许的范围 内就投资者普遍关注的问题进行回答。 1 二、说明会召开的时间、地点 1、会议召开时间:2023 年 4 月 7 日(星期五)上午 10:00-11:00 2、会议召开地点:上海证券交易所上证路演中心(网址:http://roadsho w.sseinfo.com/) 3、会议召开方式:上证路演中心网络互动 三、说明会出席人员 投资者可于 2023 年 3 月 3 ...
甘李药业(603087) - 2022 Q2 - 季度财报
2022-08-25 16:00
Financial Performance - In the first half of 2022, the company achieved revenue of 835 million CNY, a year-on-year decrease of 43.42%, and a net profit attributable to shareholders of -198 million CNY[2]. - The company's operating revenue for the first half of 2022 was ¥834,799,215.95, a decrease of 43.42% compared to ¥1,475,429,759.92 in the same period last year[18]. - The net profit attributable to shareholders of the listed company was -¥197,607,134.96, representing a decline of 153.01% from ¥372,769,630.83 in the previous year[18]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥208,858,516.23, down 161.45% from ¥339,870,808.38 in the same period last year[18]. - The net cash flow from operating activities was ¥281,247,985.16, a decrease of 36.94% compared to ¥445,995,750.73 in the previous year[18]. - The company's revenue decreased significantly due to the impact of the insulin centralized procurement results, leading to a decline in product prices[32]. - The company reported a total comprehensive loss of approximately ¥193.60 million for the first half of 2022, compared to a comprehensive income of ¥370.57 million in the same period of 2021[95]. Research and Development - Research and development investment reached 319.51 million CNY, accounting for 38.27% of sales revenue, with a year-on-year increase of 28.36%[3]. - The company completed the first human dosing in the Phase I clinical trial of its innovative GLP-1 analog GZR18 in the U.S. and China[4]. - The company is actively investing in research areas including chemical drugs, protein engineering, oncology, and cardiovascular diseases[22]. - The company is focusing on advanced research projects in diabetes and related fields to mitigate the risk of new product substitution[58]. - The company has a strong R&D team, with nearly 60% holding master's or doctoral degrees, and is enhancing its capabilities through partnerships with top universities[33]. Product Development and Market Strategy - The company plans to submit marketing authorization applications for its insulin products to the FDA and EMA, marking a significant step in its internationalization strategy[4]. - The company aims to expand its product line in diabetes diagnosis and treatment, enhancing its market competitiveness[22]. - The company has launched its first oral hypoglycemic drug, Phosphate Sitagliptin Tablets, which will enhance its competitiveness in the DPP-4 inhibitor market[30]. - The company is actively developing the fourth generation of insulin and other advanced diabetes treatments, with ongoing projects including GZR101, GZR4, and GZR18[30]. - The company has established a comprehensive product line covering long-acting, rapid-acting, and premixed insulin, with five insulin analogs and one human insulin product currently on the market[30]. Market Expansion and Procurement - The company secured a total procurement volume of 35.34 million insulin units in the first year of the procurement agreement, covering over 21,000 medical institutions[2]. - The company aims to leverage its high-ranking procurement results to rapidly increase market share in the upcoming year[2]. - The implementation of the insulin centralized procurement policy is expected to significantly reduce patient medication costs and reshape the competitive landscape of the insulin industry[26]. - The company achieved high-ranking bids for all six insulin products in the centralized procurement, aligning with the DRG/DIP payment reform direction, which encourages the selection of cost-effective products by medical institutions[26]. - The company is strategically positioning itself in the primary healthcare market to enhance its brand image among family doctors and increase its drug usage in initial consultations[26]. Financial Management and Investments - The company is implementing a cost leadership strategy by optimizing production processes and enhancing cost control across the entire supply chain[34]. - The company plans to enhance R&D investment and product pipeline in response to insulin procurement policies[55]. - The company aims to diversify its product structure to mitigate risks associated with reliance on insulin sales[56]. - The company is actively pursuing international clinical trials and market expansion to create new profit growth points[56]. - The company has received FDA approval for its first product, a single-use injection pen needle, which supports its global market expansion strategy[35]. Environmental and Governance Practices - The company is classified as a key pollutant discharge unit by environmental protection authorities, indicating its commitment to sustainable practices[64]. - The company has implemented low-nitrogen combustion technology in its boilers to ensure compliance with nitrogen oxide emission standards[66]. - The company has established a comprehensive emergency plan for sudden environmental incidents, filed with the local ecological environment bureau[69]. - The company has committed to resolving land ownership issues and competition in the industry, with long-term effectiveness of these commitments[74]. - The company has appointed new independent directors and management personnel as part of its governance restructuring[61]. Shareholder and Equity Information - The company reported a total share capital of 561,540,000 shares, with 48.62% being restricted shares and 51.38% being unrestricted shares[82]. - The largest shareholder, Gan Zhongru, holds 177,135,207 shares, representing 31.54% of the total shares[85]. - Major shareholders have pledged to limit their annual stock transfers to no more than 25% of their total holdings during their tenure and will not transfer shares within six months post-departure[75]. - The company has committed that any stock reduction by major shareholders will not occur below the initial public offering price, with a lock-up period extending if stock prices fall below this threshold[75]. - The company has not proposed any profit distribution or capital reserve increase plans for the half-year period[63].