| 证券代码：002422 | 证券简称：科伦药业 | 公告编号：2023-110 | | --- | --- | --- | | 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 关于子公司注射用头孢他啶阿维巴坦钠获得药品注册批准的公告 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"）子公司广 西科伦制药有限公司的化学药品"注射用头孢他啶阿维巴坦钠"于近日获得国家 药品监督管理局的药品注册批准，现将相关情况公告如下： 一、药品基本情况 1.药品名称：注射用头孢他啶阿维巴坦钠 剂型：注射剂 规格：2.5g（C22H22N6O7S2 2.0g与C7H11N3O6S 0.5g） 申请事项：药品注册（境内生产） 注册分类：化学药品4类 注射用头孢他啶阿维巴坦钠为辉瑞开发的β-内酰胺/β-内酰胺酶抑制剂复 方制剂，2015年美国首获批，2019年中国批准进口，用于敏感革兰阴性菌引起 的复杂性腹腔感染、医院获得性肺炎和呼吸机相关性肺炎等多种感染。 受理号：CYHS2200206 药品批 ...

证券代码：002422 证券简称：科伦药业 公告编号：2023-109 大会网站刊发研究结果的口头报告摘要的公告 债券代码：127058 债券简称：科伦转债 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。 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"）将在于 2023 年 10 月 20 日至 24 日在西班牙马德里举行的 2023 年欧洲 肿瘤内科学会(ESMO)大会上，以口头报告的形式公布创新 TROP2-ADC（SKB264， 亦称为 MK-2870）用于治疗激素受体阳性(HR+)和人表皮生长因子受体 2 阴性 (HER2-)转移性乳腺癌(mBC)患者的 1/2 期篮子研究的研究结果。口头报告定于当 地时间 2023 年 10 月 22 日上午八时三十五分至八时四十分进行。摘要亦已于当 地时间 2023 年 10 月 16 日发布于 ESMO 大会的官方网站上（报告编号：380MO）。 四川科伦药业股份有限公司 一、研究结果概述 关于子公司创新药物 S ...

| 证券代码：002422 | 证券简称：科伦药业 | 公告编码：2023-108 | | --- | --- | --- | | 债券代码：127058 | 债券简称：科伦转债 | | 根据中国证监会《关于上市公司实施员工持股计划试点的指导意见》《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》等相关规 定，现将本员工持股计划第一个锁定期届满及其解锁情况公告如下： 一、本员工持股计划的基本情况 公司于 2022 年 8 月 25 日召开第七届董事会第十六次会议和第七届监事会 第十一次会议，审议通过了《关于<四川科伦药业股份有限公司 2022 年员工持股 计划（草案）>及其摘要的议案》等相关议案，上述相关议案公司已于 2022 年 9 月 13 日召开的 2022 年第一次临时股东大会审议通过。 本次员工持股计划持有人为公司（含控股子公司）核心员工，主要为四川科 伦药物研究院有限公司及其子公司（以下简称"科伦药物研究院"）的核心员工， 合计不超过 121 人。股票来源为公司回购专用证券账户回购的科伦药业 A 股普 通股股票，本员工持股计划账户共计持有公司股票 315.4 万股。 本员工 ...

| 证券代码：002422 | 证券简称：科伦药业 | 公告编号：2023-106 | | --- | --- | --- | | 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 关于子公司科伦博泰与西南医科大学附属医院就放射性核素药 物偶联物TBM-001订立独占性许可协议的公告 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 陈述或者重大遗漏。 TBM-001是由西南医大附属医院核医学科自主研发的创新RDC药物，拟用于 肿瘤骨转移的早期诊断及精准靶向治疗。RDC是基于放射性核素靶向配体分子 偶联技术开发的一种新兴肿瘤精准诊疗药物。RDC利用肿瘤靶向特异性分子作 1 为载体，引导放射性核素对肿瘤进行精准近距离内放射治疗，在肿瘤的早期诊 断及治疗方面具有独特优势。 一、 合同签署情况 四川科伦药业股份有限公司（以下简称"公司"）近日从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"）获悉，科伦博泰于2023年 9月14日与西南医科大学附属医院（以下简称"西南医大附属医院"）就放射性 核素药物偶联物（RDC）TBM-001订立独占性 ...

| 证券代码：002422 | 证券简称：科伦药业 公告编号：2023-105 | | --- | --- | | 债券代码：127058 | 债券简称：科伦转债 | | | 是否为控股 股东或第一 | 本次质押数 | 占其所 | 占公 司总 | 是否为限 售股（如 | 是否 为补 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | | | 持股份 | | 是，注明 | | 质押起始日 | 质押到期日 | 质权人 | 质押用途 | | 名称 | 大股东及其 | 量（股） | 比例 | 股本 | 限售类 | 充质 | | | | | | | 一致行动人 | | | 比例 | | 押 | | | | | | | | | | | 型） | | | | | | | 雅安 | | | | | | | | | | | | 国资 | 否 | 6,000,000 | 6.40% | 0.41% | 否 | 否 | 2023-09-14 | 2024-09-14 | 中信证券 | 债权类投资 | | 公司 | ...

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 ...

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]

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].

| | | 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 | | | | | ...

| 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 | / | / | / | - | ...