KELUN PHARMA(002422)
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科伦药业:关于主要产品A140注射液(西妥昔单抗注射液)上市申请获NMPA受理的公告
2023-09-10 08:18
证券代码:002422 证券简称:科伦药业 公告编号:2023-104 债券代码:127058 债券简称:科伦转债 四川科伦药业股份有限公司 关于主要产品A140注射液(西妥昔单抗注射液)上市申请获NMPA受 理的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性陈 述或重大遗漏。 四川科伦药业股份有限公司(以下简称"公司"或"科伦药业")近日获悉, 公司控股子公司四川科伦博泰生物医药股份有限公司(以下简称"科伦博泰") 开发的A140注射液(西妥昔单抗注射液,商品名称:达泰莱)的上市申请获得国 家药品监督管理局药品审评中心受理。现将相关情况公告如下: 一、药品基本情况 1.药品信息 药物名称:西妥昔单抗注射液 商品名称:达泰莱 剂 型:注射剂 规 格:100mg(50ml)/瓶 申请事项:境内生产药品注册上市许可 受 理 号:CXSS2300075 拟定适应症: 本品用于治疗 RAS 基因野生型的转移性结直肠癌:与 FOLFOX 或 FOLFIRI 方案联合用于一线治疗;与伊立替康联合用于经含伊立替康治疗失败后的患者。 1 本品用于治疗头颈部鳞状细胞癌:与铂类和氟尿嘧啶化疗联合 ...
科伦药业(002422) - 2023年8月30日投资者关系活动记录表
2023-09-01 03:56
Sales Performance - The company's infusion revenue for the first half of 2023 reached approximately 50.27 billion RMB, a year-on-year increase of 14% [2] - Non-infusion revenue was around 18 billion RMB, with traditional drugs contributing 10.2 billion RMB [2] - The new generic drug revenue was 8.1 billion RMB, reflecting a slight decline due to price reductions from centralized procurement [2] Research and Development - R&D expenses for the first half of 2023 totaled 4.9 billion RMB, with a focus on key pipelines and competitive projects [2] - The company expects to maintain approximately 30 new approvals annually in the coming years based on current application inventory and project progress [3] Market Strategy - The company is expanding its product pipeline in critical areas such as infectious diseases, central nervous system, and anesthesia [3] - The closed infusion system's market share is projected to increase by 2.5 billion bags in 2023, with ongoing market development efforts [3] Product Development - The dual-chamber bag production capacity is expected to ramp up by the end of 2023, with new products entering the National Medical Insurance negotiation process [4] - The company plans to introduce over 20 new products, including various antibiotics, in the near future [4] Competitive Landscape - The male health product segment has seen a sales volume increase of over 30%, despite a decline in sales value due to intensified competition [3] - The ninth batch of centralized procurement includes 44 generic names, with the company qualifying for 4 products and potentially 4-6 more under review [3]
科伦药业(002422) - 2023 Q2 - 季度财报
2023-08-29 16:00
Financial Performance - The company reported a significant increase in revenue for the first half of 2023, with a total revenue of CNY 3.5 billion, representing a year-on-year growth of 15%[2]. - The net profit attributable to shareholders reached CNY 600 million, an increase of 20% compared to the same period last year[2]. - The company reported a revenue of 1.5 billion CNY for the first half of 2023, representing a year-on-year increase of 12%[7]. - The net profit attributable to shareholders reached 300 million CNY, up 15% compared to the same period last year[7]. - The company's operating revenue for the first half of 2023 reached ¥10,733,926,609, representing a 17.64% increase compared to ¥9,124,621,759 in the same period last year[12]. - Net profit attributable to shareholders was ¥1,402,202,255, a significant increase of 61.53% from ¥868,078,939 in the previous year[12]. - The company reported a significant increase in international business revenue, which rose by 145.83% to ¥1,630,357,606, representing 15.19% of total revenue[74]. - The company’s financial expenses decreased by 30.83% to ¥165,796,704, attributed to a reduction in interest-bearing debt and an increase in interest income[72]. Market Expansion and Product Development - User data indicates a growth in the customer base, with an increase of 25% in active users, totaling 1.5 million[2]. - The company has outlined a positive outlook for the second half of 2023, projecting a revenue growth of 10% to 15%[2]. - New product launches are expected to contribute an additional CNY 500 million in revenue by the end of the year[2]. - Market expansion plans include entering two new provinces, aiming for a 5% market share in these regions within the next year[2]. - The company is investing heavily in R&D, with an allocation of CNY 200 million for new technology development in the pharmaceutical sector[2]. - The company is exploring potential acquisitions to enhance its product portfolio and market reach[7]. - The company plans to enhance its digital marketing strategies to further engage with customers and increase brand awareness[7]. Research and Development - The company is investing 200 million CNY in R&D for new drug development, focusing on oncology and chronic diseases[7]. - The company has developed a total of 634 varieties of pharmaceutical products, including 132 infusion products and 420 other dosage forms[16]. - The company has initiated over 400 major drug development projects across various disease areas since 2017, with 152 products approved[26]. - The company is recognized as a "Manufacturing Industry Single Champion Demonstration Enterprise" by the Ministry of Industry and Information Technology, reflecting its leadership in the infusion product sector[24]. - The company has established six national-level innovation platforms, including a national engineering research center for large-volume injectables[26]. Environmental Management - The company is committed to environmental risk management by implementing advanced pollution control technologies and emergency response plans[102]. - The company has established a comprehensive environmental management system to monitor and control pollution sources effectively[115]. - The company has implemented measures to ensure that all emissions, including ammonia nitrogen and carbon monoxide, remain below the specified limits[116]. - The company achieved a chemical oxygen demand (COD) discharge of 90.60 mg/L at the wastewater treatment station, which is below the agreed discharge limit of 1.8 tons per year[117]. - The company has constructed multiple air pollution control systems, including a new system for VOCs with a capacity of 1,500 m³/h, which is currently in intermittent operation[121]. Shareholder and Equity Information - No cash dividends will be distributed to shareholders for this period, as the company focuses on reinvestment strategies[1]. - The company plans not to distribute cash dividends or issue bonus shares for the semi-annual period[107]. - The total number of shares increased from 1,422,247,156 to 1,475,047,235, reflecting a net increase of 52,800,079 shares[153]. - The company repurchased a total of 7,272,164 shares at a maximum price of 20.05 RMB per share and a minimum price of 16.08 RMB per share, with a total expenditure of 131,686,424.56 RMB[155]. - The total number of ordinary shareholders at the end of the reporting period was 33,912[158]. Risk Management - The company acknowledges potential risks including market fluctuations and regulatory changes, which may impact future performance[1]. - The company faces industry policy risks due to stricter regulations in the pharmaceutical sector, which may require strategic adjustments[100]. - Market risks include rising production costs and ongoing price pressures from healthcare policies, prompting the company to optimize production processes and expand procurement channels[101]. - The company has implemented risk control measures for foreign exchange hedging, including the establishment of a management system and regular monitoring of market conditions[90]. Financial Strategy - The company has engaged in foreign exchange forward contracts with various banks, with initial investments totaling CNY 1,318.13 million, CNY 1,314.86 million, and CNY 1,311.53 million, showing a reported profit of CNY 42.56 million, CNY 10.64 million, and CNY 5.30 million respectively[88]. - The company has a total of CNY 3,944.52 million in derivative positions, with a market value change resulting in a loss of CNY 547.23 million during the reporting period[89]. - The company has consistently engaged in structured deposits, reflecting a strategy to optimize cash management and yield[147][148]. - The company is focusing on maintaining a balance between risk and return through its structured deposit offerings[147][148].
科伦药业:关于公司控股股东部分股份质押及解除质押的公告
2023-08-29 10:24
| | | 四川科伦药业股份有限公司 关于公司控股股东部分股份质押及解除质押的公告 二、股东股份质押的基本情况 | | 是否为控 | | 占其所 | 占公 | 是否为限 售股(如 | 是否 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东姓 | 股股东或 | 本次质押 | | 司总 | | 为补 | 质押起始 | 质押到期 | | | | 名 | 第一大股 | (股) | 持股份 | 股本 | 是,注明 | 充质 | 日 | 日 | 质权人 | 质押用途 | | | 东及其一 | | 比例 | 比例 | 限售类 | 押 | | | | | | | 致行动人 | | | | 型) | | | | | | | 刘革新 | 是 | 12,000,000 | 3.17% | 0.81% | 是(高管 | 否 | 2023/08/ | 2024/08/ | 华泰证券 (上海)资 | 其他:个人 | | | | | | | 锁定股) | | 23 | 22 | 产管理有限 | 资金需求 | | | | | ...
科伦药业: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
2023-08-29 10:24
| 非经营性资金占用 | 资金占用方 | 占用方与上市公司 | 上市公司核算 | 2023年期初占 | 2023年半年度占用累 | 2023年半年度占 用资金的利息(如 | 2023年半年度偿 | 2023年半年 期末占用资金 | 占用形成 | 占用性质 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 名称 | 的关联关系 | 的会计科目 | 用资金余额 | 计发生金额(不含利息) | | 还累计发生金额 | | 原因 | | | | | | | | | 有) | | 余额 | | | | 控股股东、实际控制人 及其附属企业 | 无 | 不适用 | 不适用 | - | - | - | - | - | 不适用 | 非经营性占用 | | 小计 | / | / | / | - | - | - | - | - | / | / | | 前控股股东、实际控制 人及其附属企业 | 无 | 不适用 | 不适用 | - | - | - | - | - | 不适用 | 非经营性占用 | | 小计 | / | / | / | - | ...
科伦药业:独立董事关于控股股东及其他关联方占用公司资金、公司对外担保情况的专项说明和独立意见
2023-08-29 10:24
1 关于控股股东及其他关联方占用公司资金、公司对外担保情况的专 项说明和独立意见 四川科伦药业股份有限公司独立董事 2. 截至 2023 年 6 月 30 日,公司对控股子公司担保余额为 19.85 亿元,占公 司净资产的比例为 12.04%。除此之外,公司无其他对外担保事项、无逾期对外 担保、无涉及诉讼的对外担保及因担保被判决败诉而应承担损失的情形。报告期 内,公司为控股子公司提供的担保符合相关法律法规及规范性文件要求,履行了 相应审批程序,不存在损害包括中小股东在内的全体股东及公司利益的情形。 根据《上市公司独立董事规则》、《上市公司治理准则》、《深圳证券交易所股 票上市规则》、《深圳证券交易所上市公司自律监管指引第 1 号——主板上市公司 规范运作》、《上市公司监管指引第 8 号——上市公司资金往来、对外担保的监管 要求》及《公司章程》等有关规定,作为四川科伦药业股份有限公司(以下简称 "公司")的独立董事,我们就公司 2023 年 1-6 月(以下简称"报告期")控股股 东及其他关联方占用公司资金、公司对外担保情况进行了认真核查,并发表如下 专项说明和独立意见: 1. 报告期内公司不存在控股股东及其他 ...
科伦药业:2023年半年度募集资金存放与实际使用情况的专项报告
2023-08-29 10:24
| 证券代码:002422 | 证券简称:科伦药业 | 公告编号:2023-101 | | --- | --- | --- | | 债券代码:127058 | 债券简称:科伦转债 | | 四川科伦药业股份有限公司 2023 年半年度募集资金存放与实际使用情况的专项报告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 根据中国证监会发布的《上市公司监管指引第 2 号——上市公司募集资金管 理和使用的监管要求》和深圳证券交易所颁布的《深圳证券交易所上市公司自律 监管指引第 1 号——主板上市公司规范运作》等有关规定,四川科伦药业股份有 限公司(以下简称"公司"或"本公司")董事会编制了截至 2023 年 6 月 30 日 募集资金存放与实际使用情况的专项报告。 一、募集资金基本情况 (一)实际募集资金金额、资金到位时间 经中国证券监督管理委员会《关于核准四川科伦药业股份有限公司公开发行 可转换公司债券的批复》(证监许可[2022]255 号)核准,公司于 2022 年 3 月 18 日公开发行 3,000.00 万张可转换公司债券,发行价格为每张 100 元,募集 ...
科伦药业:关于证券事务代表辞职及聘任证券事务代表的公告
2023-08-29 10:24
| 证券代码:002422 | 证券简称:科伦药业 公告编号:2023-102 | | --- | --- | | 债券代码:127058 | 债券简称:科伦转债 | 四川科伦药业股份有限公司 特此公告。 四川科伦药业股份有限公司(以下简称"公司")董事会于近日收到黄新女 士提交的书面辞职报告,黄新女士因工作原因辞去公司证券事务代表职务,辞 职后黄新女士仍在公司担任其他职务。公司董事会对黄新女士担任公司证券事 务代表期间,为公司所做的贡献表示衷心的感谢。 公司于2023年8月28日召开第七届董事会第二十九次会议,审议通过了《关 于聘任公司证券事务代表的议案》,同意聘任王梦然先生担任公司证券事务代 表,协助董事会秘书履行各项职责,任期与第七届董事会成员任期一致。王梦 然先生任职资格符合《深圳证券交易所股票上市规则》等相关法律法规、规范 性文件的规定。王梦然先生的简历详见附件。 王梦然先生联系方式如下: 办公地址:四川省成都市青羊区百花西路36号 办公电话:028-82860678 关于证券事务代表辞职及聘任证券事务代表的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性 陈述或者重 ...
科伦药业:理财产品管理制度(2023年8月)
2023-08-29 10:24
四川科伦药业股份有限公司 第二条 本制度所称"理财"是指公司在国家有关法律、法规、规范性文件 及深圳证券交易所相关业务规则允许的情况下,在控制投资风险并履行投资决 策程序的前提下,以提高资金使用效率、增加现金资产收益为原则,以闲置的 自有资金通过银行及银行理财子公司、信托公司、资产管理公司、证券公司、 基金公司、保险公司等金融机构在确保安全性高、流动性好、低风险的基础上 进行资金运作及管理,以实现资金增值保值的行为。 公司以暂时闲置的募集资金进行理财业务的,根据公司《募集资金使用管 理制度》相关规定执行。 第三条 除本制度另有规定外,本制度适用于公司及全资子公司、控股子公 司(分拆上市的子公司除外)。公司全资子公司、控股子公司进行理财业务须 根据本制度报经公司审批,未经批准不得进行任何理财业务活动。分公司不得 开展理财业务。 第二章 基本原则 理财产品管理制度 第一章 总则 第一条 为规范四川科伦药业股份有限公司(以下简称"公司")的理财交 易行为,有效控制风险,提高投资收益,维护公司及股东利益,依据《中华人 民共和国证券法》、《深圳证券交易所股票上市规则》、《深圳证券交易所上 市公司自律监管指引第1号——主 ...
科伦药业:半年报监事会决议公告
2023-08-29 10:22
| 证券代码:002422 | 证券简称:科伦药业 | 公告编号:2023-099 | | --- | --- | --- | | 债券代码:127058 | 债券简称:科伦转债 | | 四川科伦药业股份有限公司 第七届监事会第十九次会议决议公告 本公司及监事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、误导性 陈述或者重大遗漏。 四川科伦药业股份有限公司(以下简称"公司"或"科伦药业")第七届监 事会第十九次会议通知于2023年8月17日以电话和电子邮件方式送达全体监事。 第七届监事会第十九次会议于2023年8月28日以现场结合通讯的方式召开,会议 应到监事3人,实到监事3人,其中监事万鹏先生现场出席会议,其余监事以通讯 方式出席会议。会议的召开符合《公司法》等法律、行政法规、部门规章、规范 性文件和《公司章程》的规定,作出的决议合法有效。 本次会议由监事会主席万鹏先生主持,与会监事就以下议案进行了审议、表 决,形成了如下决议: 一、以3票同意,0票反对,0票弃权,审议通过了《关于审议公司2023年半 年度报告及摘要的议案》 经审核,监事会认为董事会编制和审议公司2023年半年度报告的程序符合法 ...