KELUN PHARMA(002422)

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科伦药业(002422) - 关于持股5%以上股东以金融机构专项增持贷款和自有资金增持公司股份实施结果的公告
2025-03-27 10:00
证券代码:002422 证券简称:科伦药业 公告编号:2025-019 四川科伦药业股份有限公司 关于持股 5%以上股东以金融机构专项增持贷款 和自有资金增持公司股份实施结果的公告 本公司 5%以上股东雅安市国有资产经营有限责任公司保证向本公司提供的信息内容 真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 1.四川科伦药业股份有限公司(以下简称"公司"、"科伦药业")于 2025 年 3 月 1 日披露了《关于持股 5%以上股东以金融机构专项增持贷款和自有资金 增持公司股份计划的公告》(公告编号:2025-015)。雅安市国有资产经营有限 责任公司(以下简称"雅安国资公司")计划于 2025 年 3 月 1 日起六个月内通 过深圳证券交易所允许的方式增持公司股份(拟增持价格不超过 37.60 元/股), 本次增持金额不低于 5,000 万元人民币(含本数),且不超过 9,900 万元人民币 (含本数)。 2.截至本公告日,持股 5%以上股东雅安国资公司通过深圳证券交易所交易 系统集中竞价交易方式累计增持公司股份 3,182,100 股 ...
科伦药业(002422) - 关于子公司放射性核素偶联药物(RDC)SKB107新药临床试验申请获国家药品监督管理局批准的公告
2025-03-25 12:01
证券代码:002422 证券简称:科伦药业 公告编号:2025-018 四川科伦药业股份有限公司 公司近日获悉,科伦博泰已于 2025 年 3 月 25 日收到国家药品监督管理局药 品审评中心批准 SKB107 新药临床试验申请的临床试验通知书。 一、药品基本情况 SKB107 是由科伦博泰及西南医大附属医院核医学科共同开发的,以小分子 作为靶向配体,搭配适宜的连接技术、螯合剂和治疗用放射性同位素而组成的新 型 RDC 药物,拟用于治疗晚期实体瘤骨转移。 二、风险提示 创新药物研发过程周期长、环节多、能否开发成功及商业化具有一定的不确 定性,敬请广大投资者谨慎决策,注意防范投资风险。公司将根据后续进展情况 及时履行信息披露义务。 特此公告。 四川科伦药业股份有限公司董事会 2025 年 3 月 26 日 关于子公司放射性核素偶联药物(RDC)SKB107 新药临床试验申请 获国家药品监督管理局批准的公告 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。 四川科伦药业股份有限公司(以下简称"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" ...
科伦药业(002422) - 关于部分回购股份注销完成暨股份变动的公告
2025-03-17 09:31
四川科伦药业股份有限公司 关于部分回购股份注销完成暨股份变动的公告 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。 特别提示: 四川科伦药业股份有限公司(以下简称"公司"或"科伦药业"),本次注 销部分已回购股票的数量为3,444,001股,占本次注销前总股本1,601,497,373股的 比例为0.22%。本次注销部分回购股份完成后,公司总股本由1,601,497,373股变 更为1,598,053,372股。截至目前,公司已在中国证券登记结算有限责任公司深圳 分公司完成上述部分已回购股票的注销手续。 证券代码:002422 证券简称:科伦药业 公告编号:2025-017 三、公司股本结构变动情况 一、已履行的相关审批流程 (一)公司于2021年7月21日召开的第七届董事会第一次会议审议通过了《关 于回购公司股份的议案》,确定回购的股份将用作员工持股或股权激励计划。但 若公司未能在本次回购完成之后36个月内将全部或部分回购股份用于上述用途, 则尚未使用的股份将在依法履行程序后予以注销。公司在指定信息披露网站巨潮 资讯网(www.cninfo.com.cn)、 ...
科伦药业20250312
2025-03-13 03:23
Summary of the Conference Call for Kelun Pharmaceutical Company Overview - Kelun Pharmaceutical is a highly regarded company in the capital market, primarily engaged in three main business segments: large-volume parenterals (LVP), active pharmaceutical ingredients (API), and innovative drugs. The company has shifted its focus to innovation since 2012, with Kelun Biotech becoming a leading player in the antibody-drug conjugate (ADC) field globally, backed by major firms like Merck [3][4][6]. Financial Performance - In the first half of 2024, LVP accounted for nearly 40% of total revenue, while API revenue was approximately 3.2 billion RMB, contributing around 28% [3][4]. - Despite the impact of centralized procurement on pricing, the gross margin for LVP remains around 60%, while the gross margin for APIs is 35.3% [4][9]. Market Position and Growth Potential - Kelun holds a leading position in the big data sector with a market share of about 40%. The penetration rate of high-end products is low, indicating significant growth potential in the future [4][5]. - The company expects stable profit trends through 2025, supported by the release of high-end products and cost control measures [4][7]. Innovation and R&D - Kelun Biotech is seen as a key driver of innovation, with domestic commercialization and overseas milestones expected to significantly enhance the company's valuation. The company anticipates that these developments will contribute to revenue and profit growth over the next three years [4][6][10]. - The company invests heavily in R&D, with expenditures nearing 2 billion RMB in 2024, representing about 9% of total revenue. This investment is expected to yield significant results, particularly in big data and innovative drug sectors [11]. Product Development and Market Trends - Kelun Biotech has received approvals for treatment options for triple-negative breast cancer and non-small cell lung cancer, with sales targets set between 800 million to 1 billion RMB for 2025. The collaboration with Merck on ADC drug development holds substantial potential, with a market size expectation of 90 billion RMB [12][20]. - The big data sector is characterized by high concentration, with the top five players holding 80% of the market share. The company is well-positioned to benefit from the ongoing consolidation and increasing demand for essential medications due to an aging population [13]. Competitive Landscape - The company faces challenges from centralized procurement, but it is optimistic about maintaining stable profits through operational optimization and cost reduction [9][10]. - The market for antibiotics, particularly penicillin, is stable with limited new entrants due to regulatory constraints, suggesting a favorable competitive environment for Kelun [16][18]. Future Outlook - The overall assessment indicates that Kelun's traditional business is resilient, while its innovative segments, particularly Kelun Biotech, have substantial untapped potential. The company is projected to generate stable cash flows of approximately 3 billion RMB annually from its big data and API segments, with a significant upside in market valuation expected over the next few years [4][10][20].
科伦药业(002422) - 关于子公司核心产品芦康沙妥珠单抗(sac-TMT)获国家药品监督管理局批准第二个适应症(用于EGFR突变非小细胞肺癌治疗)上市的公告
2025-03-10 11:31
四川科伦药业股份有限公司(以下简称"公司")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")靶向人滋养细 胞表面抗原 2(TROP2)的抗体药物偶联物(ADC)芦康沙妥珠单抗(sac-TMT,前称 SKB264/MK-2870)(佳泰莱®)获国家药品监督管理局(NMPA)批准第二个适应症, 用于治疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)和含铂化疗治疗后 进展的 EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC) 成人患者。这是全球首个在肺癌适应症获批上市的 TROP2 ADC 药物。与目前标 准治疗相比,芦康沙妥珠单抗(sac-TMT)显著延长此类患者的总生存获益。 本次批准是基于一项多中心、随机、对照关键临床研究(OptiTROP-Lung03), 评估芦康沙妥珠单抗(sac-TMT)单一疗法每两周(Q2W)5mg/kg 静脉注射对比多西 他赛用于治疗经 EGFR-TKI 和含铂化疗治疗(序贯或联合)失败后的局部晚期或转 移性 EGFR 突变 NSCLC 患者的有效性和安全性。在预设的期中分析结果显示, 与多西他赛相比,芦康沙妥珠单抗 ...
科伦药业:子公司产品芦康沙妥珠单抗(sac-TMT)获批第二个适应症
证券时报网· 2025-03-10 11:26
Core Viewpoint - Kelong Pharmaceutical's subsidiary, Sichuan Kelong Botai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT, marking it as the first TROP2 ADC drug approved for lung cancer indications globally [1] Company Summary - Kelong Pharmaceutical's ADC sac-TMT is now approved for a second indication, specifically for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy [1] - The approval signifies a significant advancement in treatment options, as sac-TMT has shown to significantly extend overall survival benefits compared to current standard treatments for this patient population [1]
科伦药业:传统Pharma华丽转型,加速迈向国际化-20250306
华源证券· 2025-03-06 07:23
Investment Rating - The report gives an initial investment rating of "Buy" for the company, indicating a positive outlook on its future performance [5][8]. Core Views - The company is successfully transitioning from generic to innovative pharmaceuticals, with significant R&D investments expected to yield results in the near future. It has established itself as a leading player in the fields of large-volume intravenous solutions, active pharmaceutical ingredients, and innovative drugs, particularly in the ADC (Antibody-Drug Conjugate) sector [7][10]. - The company has a strong pipeline of innovative drugs, with several products nearing commercialization, which presents substantial growth potential [7][10]. - The large-volume intravenous solutions segment is expected to maintain a stable competitive landscape, supported by an aging population and a solid market position [7][10]. Summary by Sections 1. "Large-volume IV solutions + Active Pharmaceutical Ingredients + Innovative Drugs" as Growth Drivers - The company has a well-structured operational platform consisting of large-volume IV solutions, active pharmaceutical ingredients, and innovative drugs, with a focus on high-end manufacturing and new materials [19]. - The company has established a comprehensive industrial production system in the antibiotic intermediate sector, leveraging regional advantages [19]. 2. Sustained High R&D Investment - The company has invested nearly 11.9 billion RMB in R&D over the past decade, which is expected to enhance its position in the global ADC market [7][10]. - The ADC development platform "OptiDC" has been recognized internationally, with multiple projects in various stages of clinical development [32][34]. 3. Stable Landscape for Large-volume IV Solutions - The market for large-volume IV solutions has stabilized, with the top five companies accounting for approximately 80% of the market share [7][10]. - The demand for large-volume IV solutions is expected to grow steadily due to demographic trends, despite short-term price fluctuations [7][10]. 4. Active Pharmaceutical Ingredients Supply and Demand - The antibiotic intermediate sector has seen a reduction in outdated production capacity, leading to a stable market environment [7][10]. - The company is a leading supplier of antibiotic intermediates, with a strong market position and stable demand for its products [7][10]. 5. Profit Forecast and Valuation - The company is projected to achieve net profits of 30.6 billion RMB, 28.0 billion RMB, and 36.2 billion RMB for the years 2024 to 2026, with corresponding growth rates of 24.6%, -8.4%, and 29.1% [6][8]. - The current price-to-earnings (P/E) ratios are estimated at 16, 18, and 14 for the years 2024 to 2026, indicating a favorable valuation compared to peers [8].
科伦药业(002422) - 关于持股5%以上股东以金融机构专项增持贷款和自有资金增持公司股份计划的公告
2025-02-28 09:15
证券代码:002422 证券简称:科伦药业 公告编号:2025-015 四川科伦药业股份有限公司 关于持股 5%以上股东以金融机构专项增持贷款 和自有资金增持公司股份计划的公告 本公司 5%以上股东雅安市国有资产经营有限责任公司保证向本公司提供的信息内容 真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 特别提示: 1.四川科伦药业股份有限公司(以下简称"公司"、"科伦药业")于近 日收到持股 5%以上股东雅安市国有资产经营有限责任公司(以下简称"雅安国 资公司")通知,雅安国资公司拟于公告日起六个月内通过深圳证券交易所允许 的方式增持公司股份(拟增持价格不超过 37.60 元/股),本次增持金额不低于 5,000 万元人民币(含本数),且不超过 9,900 万元人民币(含本数),具体增持 资金总额以实际使用的资金总额为准。 公司于近日收到雅安国资公司出具的《关于对科伦药业增持的告知函》,现 将相关内容公告如下: 一、增持主体基本情况 1.增持主体:雅安市国有资产经营有限责任公司。 2.持股数量及持股比例:本次增持前,雅安国资公司持有公 ...
科伦药业(002422) - 关于公司控股股东部分股份质押及解除质押的公告
2025-02-21 11:15
证券代码:002422 证券简称:科伦药业 公告编号:2025-014 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 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")于近日收 到公司控股股东刘革新先生关于其持有的公司部分股份质押及解除质押的通知, 相关情况具体如下: | 股东姓 | 是否为控股股 东或第一大股 | 本次解除质 | 占其所持股 | 占公司总股 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 名 | 东及其一致行 | 押股份数量 (股) | 份比例 | 本比例 | 起始日 | 解除日 | 质权人 | | | 动人 | | | | | | | | 刘革新 | 是 | 10,800,000 | 2.85% | 0.67% | 2024/3/11 | 2025/2/21 | 华泰证券(上海) 资产管理有限公司 | | 合计 | - | 10,800,000 | 2.85% | 0.67% | - | ...
科伦药业(002422) - 关于公司副总经理辞职的公告
2025-02-21 10:00
四川科伦药业股份有限公司 证券代码:002422 证券简称:科伦药业 公告编号:2025-013 王亮女士在任职期间恪尽职守,勤勉尽责,公司董事会对其在任职期间为公 司发展所做出的贡献表示衷心的感谢! 特此公告。 四川科伦药业股份有限公司董事会 2025 年 2 月 22 日 关于公司副总经理辞职的公告 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。 四川科伦药业股份有限公司(以下简称"公司")董事会于近日收到副总经 理王亮女士提交的书面辞职报告,王亮女士因个人原因申请辞去公司副总经理职 务,辞职后不再担任公司及子公司的任何职务。王亮女士的辞职不会对公司的正 常运作、日常经营管理产生影响。根据《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》和《四川 科伦药业股份有限公司章程》等相关规定,王亮女士的辞职报告自送达公司董事 会之日起生效。 截至本公告披露日,王亮女士通过 2021 年限制性股票激励计划直接持有公 司股票 50,000 股,占公司总股本的 0.0031%。王亮女士承诺将继续遵守中国证监 会和深圳 ...