KELUN PHARMA(002422)
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科伦药业(002422) - 关于子公司ITGB6 ADC SKB105新药临床试验申请获国家药品监督管理局批准的公告
2026-01-05 00:04
证券代码:002422 证券简称:科伦药业 公告编号:2026-001 SKB105 是一款靶向 ITGB6 的差异化 ADC,以拓扑异构酶 1 抑制剂为有效 载荷。ITGB6 在多种实体瘤中高表达,而在大多数正常组织中低表达或无表达, 因此有降低系统毒性及脱靶风险的潜力。在药物设计上,SKB105 采用了专有 Kthiol®不可逆偶联技术,将靶向 ITGB6 的全人源免疫球蛋白 G1(IgG1)单克隆抗 体与稳定且经临床验证的可裂解连接子偶联,旨在增强药物稳定性及肿瘤特异性 载荷递送能力,同时减少不良反应。临床前研究显示,SKB105 在疗效、安全性 和药代动力学(PK)方面均表现出良好特性。 二、关于 SKB118(亦称 CR-001) SKB118/CR-001 是一款四价双特异性抗体,目前正开发用于治疗实体瘤。 其结合了肿瘤学中两种互补且经过验证的作用机制——PD-1 和 VEGF 阻断,其 中对 PD-1 检查点的抑制可恢复 T 细胞识别和摧毁肿瘤细胞的能力,而 VEGF 阻 断可减少对肿瘤细胞的血液供应并抑制肿瘤生长。在临床前研究中, SKB118/CR-001 在 VEGF 存在的情况下显示出提 ...
科伦药业(002422) - 关于子公司核心产品TROP2 ADC芦康沙妥珠单抗(sac-TMT)联合免疫疗法帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌获国家药品监督管理局突破性疗法认定的公告
2026-01-05 00:04
证券代码:002422 证券简称:科伦药业 公告编号:2026-002 四川科伦药业股份有限公司 关于子公司核心产品TROP2 ADC芦康沙妥珠单抗(sac-TMT)联合免 疫疗法帕博利珠单抗一线治疗 PD-L1 阳性局部晚期或转移性非小细 胞肺癌获国家药品监督管理局突破性疗法认定的公告 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。 突破性疗法认定主要授予对于尚无有效治疗手段的,该药物可以提供有效防 治手段或与现有治疗手段相比具有明显临床优势的治疗方案。对于纳入突破性治 疗药物程序的药物,在符合相关条件的情况下,可以在申请药品上市许可时提出 附条件批准申请和优先审评审批申请。 二、药品基本情况 此前,科伦博泰公布了芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗一线治 疗 PD-L1 阳性 NSCLC 的 3 期 OptiTROP-Lung05 临床试验结果,其在主要终点 无进展生存期(PFS)显示出统计学意义和临床意义的显着改善,并在总生存期(OS) 1 可瑞达®(帕博利珠单抗)为美国新泽西州罗威市默克公司的附属公司 Merck Sharp & Dohme ...
国泰海通医药2026年1月月报:景气延续,持续重点推荐创新药械产业链-20260104
GUOTAI HAITONG SECURITIES· 2026-01-04 05:37
Investment Rating - The report maintains an "Overweight" rating for the innovative pharmaceutical and medical device industry chain [4][8]. Core Viewpoints - The report continues to recommend the innovative pharmaceutical and medical device industry chain, highlighting a selection of A-share and H-share stocks with an "Overweight" rating [2][8][11]. - The performance of the pharmaceutical sector in December 2025 was weaker than the broader market, with the SW Pharmaceutical Biotechnology index declining by 4.1% compared to a 2.1% increase in the Shanghai Composite Index [18][30]. - The report notes that the premium level of the pharmaceutical sector relative to the entire A-share market is currently at a normal level, with a relative premium rate of 63.2% as of December 31, 2025 [29][32]. Summary by Sections A-Share Recommendations - The report lists the following A-share stocks with an "Overweight" rating: - 恒瑞医药 (Hengrui Medicine) - 科伦药业 (Kelun Pharmaceutical) - 华东医药 (East China Pharmaceutical) - 恩华药业 (Enhua Pharmaceutical) - 特宝生物 (Tebao Biological) - 京新药业 (Jingxin Pharmaceutical) - 益方生物 (Yifang Biological) - 药明康德 (WuXi AppTec) - 泰格医药 (Tigermed) - 乐普医疗 (Lepu Medical) - 联影医疗 (United Imaging) - 微电生理 (Microelectrophysiology) [8][9]. H-Share Recommendations - The report maintains an "Overweight" rating for the following H-share stocks: - 翰森制药 (Hansoh Pharmaceutical) - 三生制药 (3SBio) - 科伦博泰生物 (Kelun-Botai Biological) - 康方生物 (CanSino Biologics) - 映恩生物 (InnoCare Pharma) - 百济神州 (BeiGene) [11][12]. Performance Analysis - The report indicates that the 国泰海通医药 monthly portfolio outperformed the pharmaceutical index in December 2025, with an average decline of 1.8% compared to a 3.9% decline in the overall pharmaceutical index [14][15]. - The report highlights the best-performing stocks in December 2025, with 泰格医药 (Tigermed) increasing by 11.2%, 特宝生物 (Tebao Biological) by 7.5%, and 惠泰医疗 (Huitai Medical) by 3.9% [15][18].
新一批31家总部企业认定
Xin Lang Cai Jing· 2026-01-02 22:39
Core Insights - The number of headquarters enterprises in Sichuan has expanded, with 31 companies recognized, bringing the total to 128 [1] - Headquarters enterprises are defined as those registered in Sichuan that conduct cross-regional operations and contribute significantly to local taxes and the economy [1] Group 1: Enterprise Distribution - The newly recognized 31 enterprises are primarily located in six cities, with a majority being private enterprises (48.4%), followed by state-owned enterprises (41.9%), foreign enterprises (6.5%), and mixed-ownership enterprises (3.2%) [2] - The main sectors represented are manufacturing (51.6%), services (32.3%), and construction (9.7%), aligning with Sichuan's modern industrial development [2] - Among these enterprises, seven have annual revenues exceeding 10 billion, and one exceeds 100 billion [2] Group 2: Classification of Headquarters - Sichuan classifies headquarters enterprises into three categories: comprehensive headquarters, functional headquarters, and growth headquarters [2] - Comprehensive headquarters must meet large enterprise standards in terms of revenue, total assets, and workforce [2] - Five functional headquarters are controlled by large enterprises from outside the province or abroad, requiring a minimum registered capital of 50 million [2] Group 3: Support Policies - Sichuan will utilize various policy tools, including fiscal, financial, technological, and talent support, to promote the development of headquarters enterprises [3] - There is an emphasis on policy coordination across provincial, municipal, and county levels to enhance the effectiveness of support measures [3]
科伦药业涨2.05%,成交额3.50亿元,主力资金净流入1797.41万元
Xin Lang Cai Jing· 2025-12-31 06:44
Group 1 - The core viewpoint of the news is that Kelun Pharmaceutical's stock has shown fluctuations in price and trading volume, with a recent increase of 2.05% on December 31, reaching 29.42 yuan per share, and a total market capitalization of 47.015 billion yuan [1] - As of September 30, 2025, Kelun Pharmaceutical reported a revenue of 13.277 billion yuan, a year-on-year decrease of 20.92%, and a net profit attributable to shareholders of 1.201 billion yuan, down 51.41% year-on-year [2] - The company has a diverse revenue structure, with 48.37% from non-infusion products, 41.28% from infusion products, 7.01% from research projects, and 3.33% from other sources [1] Group 2 - Kelun Pharmaceutical has distributed a total of 6.898 billion yuan in dividends since its A-share listing, with 3.587 billion yuan distributed in the last three years [3] - The number of shareholders increased to 37,100 as of September 30, 2025, reflecting an 8.35% rise, while the average number of circulating shares per person decreased by 7.70% to 35,200 shares [2] - Major shareholders include China Europe Medical Health Mixed A, holding 40.0624 million shares, and Hong Kong Central Clearing Limited, holding 34.728 million shares, both of which have seen a reduction in their holdings compared to the previous period [3]
成都市新都区:“新工赛场”锻造区域发展新引擎
Si Chuan Ri Bao· 2025-12-29 22:39
园区赛事激发基层活力。通过示范引领、经费补助、联合办赛等方式,新都区持续激发基层办赛 积极性。联动新都高新区在2025年开展劳动和技能竞赛5场,覆盖80余家重点产业链企业。 重点企业积极参与岗位练兵。中国航发成都发动机有限公司(简称中国航发成发)、四川科伦药 业股份有限公司(简称科伦药业)、成都正恒动力股份有限公司(简称正恒动力)、中粮可口可 乐饮料(四川)有限公司(简称中粮可口可乐四川公司)、航空工业泛华等重点企业开展岗位练 兵和技能比武超过40场,参与班组超200个,参与职工达1.1万人次,打通了成都百万职工技能大 赛至生产一线的"最后一公里"。 □新工号 2025年5月22—23日,2025年成都百万职工技能大赛新都区数控铣工、焊工技能比赛在成都市现代 制造职业技术学校举行,来自四川成都新都高新技术产业园区(简称新都高新区)的近100名高技 能职工选手展开对决。 "技能比赛为我们提供了很好的平台,我从中级工晋升到高级工,还获得成都工匠称号。"四川泛 华航空仪表电器有限公司(简称航空工业泛华)的数控车工龙涛说。他曾在2024年成都百万职工 技能大赛数控车工技能比赛中获得冠军。 一组组扎实数据、一个个鲜活案 ...
继续推荐创新药械产业链
Haitong Securities International· 2025-12-29 05:01
Investment Rating - The report maintains an "Outperform" rating for several companies in the pharmaceutical sector, including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical [5][6]. Core Insights - The report emphasizes the high prosperity in innovative drugs and continues to recommend companies with promising pipelines and performance growth in the Biopharma/Biotech sector, maintaining an "Outperform" rating for Innovent Biologics, WuXi XDC Cayman, and others [5][23]. - It highlights the performance of the A-Shares pharmaceutical sector, which underperformed the market, with the SW Pharma & Bio index falling by 0.2% while the SHCOMP rose by 1.9% [7][18]. - The report notes that the premium level of the pharmaceutical sector relative to all A-Shares is currently at a normal level of 66.7% as of December 26, 2025 [13][17]. Summary by Sections 1. Continued Recommendation for Innovative Drugs and Industry Chain - The report continues to recommend innovative drugs and the associated industry chain, highlighting the high demand and potential for revaluation in the pharmaceutical sector [5][23]. - Specific companies recommended include Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, 3SBio, Sichuan Kelun Pharmaceutical, and Jiangsu Nhwa Pharmaceutical, all rated as "Outperform" [5][6]. 2. A-Shares Pharmaceutical Sector Performance - In the fourth week of December 2025, the A-Shares pharmaceutical sector underperformed the broader market, with a decline of 0.2% compared to a 1.9% increase in the SHCOMP index [7][18]. - The best-performing sub-sectors included chemical raw materials (+2.0%) and medical equipment (+0.1%), while biological products saw a slight decline of -0.1% [9][18]. 3. Hong Kong and U.S. Market Performance - The Hong Kong pharmaceutical sector also underperformed, with the Hang Seng Healthcare index down by 1.8% and the Hang Seng Biotechnology index down by 2.3% [18]. - In contrast, the U.S. pharmaceutical sector performed similarly to the market, with the S&P Healthcare Select Sector increasing by 1.0% [18].
中国创新药 2025 “破圈”全球
Guo Ji Jin Rong Bao· 2025-12-29 03:13
Core Insights - 2025 marks a pivotal year for China's innovative pharmaceuticals, with a significant increase in international collaborations and licensing agreements, indicating a shift from a pharmaceutical giant to a stronghold in the industry [1][3] - The total amount of outbound licensing agreements exceeded $100 billion, with upfront payments reaching $8.1 billion, showcasing a transition to multi-layered cooperation models [1][3] - China's biopharmaceutical market remains the second largest globally, with innovative drugs accounting for approximately 30% of global research, reflecting a critical leap from following to competing on a global scale [1][3] Internationalization - The internationalization of China's pharmaceutical industry saw explosive growth in 2025, highlighted by a surge in business development (BD) transactions and the popularity of "A+H" listings [3][4] - The total amount of outbound licensing for innovative drugs reached over $100 billion, a 75% increase from 2024, indicating a shift from merely selling products to actively engaging in global markets [3][4] - Notable BD transactions include significant agreements between major Chinese pharmaceutical companies and international firms, such as a $12.5 billion deal between Hengrui Medicine and GSK [3][4] Innovation - In 2025, advancements in cutting-edge technologies such as antibody-drug conjugates (ADC) and dual antibodies have shown promising results in cancer treatment [7][8] - The third-generation ADC technology has become mainstream, with significant efficacy demonstrated in treating solid tumors [7] - The dual antibody sector continues to lead, with Chinese companies achieving remarkable results in clinical trials, such as a 91% improvement in progression-free survival compared to existing treatments [8] Policy Support - The policy support for innovative drugs in China has reached unprecedented levels, with a notable increase in the number of approved innovative drugs [10][11] - The National Medical Products Administration approved 69 innovative drugs in 2025, a 44% increase from the previous year, covering various therapeutic areas [10] - The payment system for innovative drugs has been significantly upgraded, enhancing accessibility and affordability for patients [10][11] Mergers and Acquisitions - The pharmaceutical sector has seen a surge in mergers and acquisitions, with over 400 transactions announced globally, totaling approximately $111 billion, marking a 50% increase from 2024 [13][14] - Domestic mergers also showed strong activity, with significant deals indicating a shift towards quality improvement and resource consolidation among leading companies [13][14] - The trend reflects a transition from scale expansion to enhancing quality and efficiency, with companies focusing on high-value clinical pipelines [14]
医药生物行业跟踪周报:2026年战略性布局创新药,其性价比高-20251228
Soochow Securities· 2025-12-28 13:26
Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The number of innovative drugs listed in China continues to grow, with domestic products accounting for approximately half of the total market share. The R&D capabilities for innovative drugs in China are also increasing, attracting global attention. Notably, the number and value of domestic innovative drug business development (BD) transactions have reached new highs, with ADC, bispecific antibodies, small nucleic acids, and CAR-T being the four key R&D directions to watch in 2026 [15][21][22] - The Chinese innovative drug market has seen a significant increase in the number of new drug applications (NDA), with domestic products making up a growing proportion. From 2017 to 2024, the number of innovative drugs listed in China rose from 41 to 92, with domestic products accounting for 50% of the total by 2024 [17][21] - The report highlights that the license-out transaction volume and total amount for Chinese companies reached $92.03 billion in the first three quarters of 2025, a 77% increase compared to the total for 2024. The upfront payment for license-out transactions has also surpassed the total financing amount in the primary market for the same period [22][25] Summary by Sections Industry Trends - The A-share pharmaceutical index has shown a year-to-date increase of 14.29%, while the Hang Seng Healthcare Index has surged by 62.29% [3][8] - The report notes that the pharmaceutical sector has experienced fluctuations, with raw materials and medical devices showing positive growth [8] R&D Progress and Company Dynamics - The report provides an overview of the R&D progress for innovative and modified drugs, including approvals and clinical applications [5] - It lists key companies to watch in various sub-sectors, including innovative drugs, research services, and medical devices, with specific recommendations for companies like Innovent Biologics, Hengrui Medicine, and WuXi AppTec [11][12] Market Insights and Regulatory Observations - The report tracks the price-to-earnings ratio of the pharmaceutical index, noting that it is currently lower than historical averages [5] - It emphasizes the importance of the regulatory environment and market dynamics in shaping the future of the pharmaceutical industry [5]
科伦药业跌2.00%,成交额2.63亿元,主力资金净流出4999.54万元
Xin Lang Zheng Quan· 2025-12-26 02:53
今年以来科伦药业已经2次登上龙虎榜,最近一次登上龙虎榜为4月30日,当日龙虎榜净买入3187.92万 元;买入总计2.54亿元 ,占总成交额比17.58%;卖出总计2.22亿元 ,占总成交额比15.37%。 资料显示,四川科伦药业股份有限公司位于四川省成都市青羊区百花西路36号,成立日期2002年5月29 日,上市日期2010年6月3日,公司主营业务涉及开发、生产和销售大输液产品。主营业务收入构成为: 非输液48.37%,输液41.28%,研发项目7.01%,其他3.33%。 科伦药业所属申万行业为:医药生物-化学制药-化学制剂。所属概念板块包括:幽门螺杆概念、熊去氧 胆酸、抗流感、原料药、医药电商等。 截至9月30日,科伦药业股东户数3.71万,较上期增加8.35%;人均流通股35200股,较上期减少7.70%。 2025年1月-9月,科伦药业实现营业收入132.77亿元,同比减少20.92%;归母净利润12.01亿元,同比减 少51.41%。 12月26日,科伦药业盘中下跌2.00%,截至10:44,报29.87元/股,成交2.63亿元,换手率0.67%,总市值 477.34亿元。 资金流向方面,主力资金 ...