科伦药业公告称，公司第八届董事会第十一次会议审议通过回购股份方案。公司拟以自有资金，通过集 中竞价交易方式回购股份，用于员工持股计划或股权激励，若未能在回购完成后规定时间内使用则注 销。回购资金不低于5000万元且不超过1亿元，回购价不超规定上限，预计可回购股份占总股本 0.09%-0.18%。回购期限自董事会通过方案之日起12个月内，公司董事会授权管理层办理相关事项。 ...

科伦药业公告，拟以5000万元-1亿元回购公司股份，回购价格不超过35元/股。 ...

Investment Rating - The report maintains an "Outperform" rating for the following A-share targets: Jiangsu Heng Rui Medicine, Sichuan Kelun Pharmaceutical, Huadong Medicine, Jiangsu Nhwa Pharmaceutical, Xiamen Amoytop Biotech, Zhejiang Jingxin Pharmaceutical, Innovent Biologics, WuXi AppTec, Hangzhou Tigermed Consulting, Lepu Medical, MicroPort EP MedTech [5][36][8] - The report also maintains an "Outperform" rating for the following H-share targets: Hansoh Pharmaceutical Group, 3SBio, PATEO Biotech, Akeso, and related targets: Innovent Biologics, WuXi AppTec [8][36] Core Insights - The report continues to recommend the innovative drug and device industry and its supply chains, indicating a positive outlook for this sector [1][36] - In December 2025, the pharmaceutical sector underperformed the market, with the SW Pharmaceutical and Biological index falling by 4.1%, while the SHCOMP rose by 2.1%, ranking 26th among Shenwan primary industries [15][37] - The report highlights that the premium level of the pharmaceutical sector relative to all A-shares is currently at a normal level, with a relative premium rate of 63.2% as of the end of December 2025 [25][37] Summary by Sections A-Share Targets - The report includes a monthly portfolio of A-share targets that outperformed the pharmaceutical index, with a monthly average decline of 1.8% compared to the overall pharmaceutical index decline of 3.9% in December 2025 [11][36] - The top three stock gains in December 2025 were Luyan Pharma (+118.8%), CareRay Digital Medical Technology Co., Ltd. (+36.6%), and Hubei Hongyuan Pharmaceutical Technology Co., Ltd. (+34.0%) [24][37] H-Share Targets - The report notes that the Hong Kong stock pharmaceutical sector also underperformed the market, with the Hang Seng Healthcare index falling by 9.5% and the Hong Kong Biological Technology index falling by 10.6% in December 2025 [26][38] U.S. Market Performance - In December 2025, the U.S. pharmaceutical sector underperformed the market, with the S&P 500 Healthcare Select Sector declining by 1.5% while the S&P 500 fell by only 0.1% [26][39]

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 2.01% on January 5, 2025, and a total market capitalization of 478.46 billion yuan [1] - As of January 5, 2025, the stock price is reported at 29.94 yuan per share, with a trading volume of 1.64 billion yuan and a turnover rate of 0.43% [1] - The company has experienced a year-to-date stock price increase of 2.01%, but has seen declines of 1.77% over the last five trading days, 12.20% over the last 20 days, and 16.68% over the last 60 days [1] Group 2 - For the period from January to September 2025, Kelun Pharmaceutical reported a revenue of 13.277 billion yuan, representing 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 distributed a total of 6.898 billion yuan in dividends since its A-share listing, with 3.587 billion yuan distributed over the past three years [2] Group 3 - As of September 30, 2025, the number of shareholders for Kelun Pharmaceutical increased to 37,100, marking an 8.35% rise from the previous period, while the average number of circulating shares per person decreased by 7.70% to 35,200 shares [2] - Among the top ten circulating shareholders, notable changes include a decrease in holdings for several institutional investors, such as China Europe Medical Health Mixed Fund and Industrial Bank Frontier Medical Stock A [3]

同时，科伦药业公告称，公司近日获悉，公司控股子公司科伦博泰自主研发的靶向整合素β6(ITGB6)抗 体偶联药物(ADC)SKB105(亦称CR-003)的新药临床试验申请已获中国国家药品监督管理局药品审评中 心批准，用于治疗晚期实体瘤。 北京商报讯(记者丁宁)1月5日早间，科伦药业（002422）发布公告称，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)的抗体偶 联药物(ADC)芦康沙妥珠单抗联合默沙东的抗程序性细胞死亡蛋白1(PD-1)单克隆抗体帕博利珠单抗一 线治疗程序性细胞死亡配体1(PD-L1)肿瘤比例分数(TPS)≥1%的表皮生长因子受体(EGFR)基因突变阴性 和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移性非小细胞肺癌(NSCLC)，已获中国国家药品监督管 理局药品评审中心授予突破性疗法认定。 ...

2025年12月 ，科伦博泰与 Crescent Biopharma, Inc. ("Crescent ")就SKB105/CR-003 与 SKB118 (程序性细 胞死亡蛋白-1(PD-1) x 血管内皮生长因子(VEGF)双特异性抗体，亦称 CR-001)达成战略合作，其中科伦 博泰授予Crescent 在美国、欧洲及所有其他大中华地区以外市场研究、开发、生产和商业化 SKB105/CR-003 的独家权 利，Crescent 则授予科伦博泰在大中华地区研究、开发、生产和商业化 SKB118/CR-001 的独家权利。 科伦博泰计划于近期向中国国家药品监督管理局药品审评中心递交SKB118/CR-001的IND申请。 格隆汇1月5日丨科伦药业(002422.SZ)公布，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")自主研发的靶向整合素β6 (ITGB6)抗体偶联药物(ADC) SKB105(亦称CR-003)的新药临床试验(IND)申请已获中国国家药品监督管 理局(NMPA)药品审评中心(CDE)批准，用于治疗晚期实体瘤。 ...

Core Viewpoint - The company, Kelun Pharmaceutical, has received breakthrough therapy designation from the National Medical Products Administration (NMPA) in China for its antibody-drug conjugate (ADC) SKB264/MK-2870, in combination with Merck's PD-1 monoclonal antibody, for the treatment of specific types of non-small cell lung cancer (NSCLC) [1]. Group 1 - Kelun Pharmaceutical's subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., is involved in the development of the ADC targeting TROP2 [1]. - The combination therapy is aimed at patients with locally advanced or metastatic NSCLC who are negative for EGFR gene mutations and ALK [1]. - The therapy is specifically for patients with a tumor proportion score (TPS) of ≥1% for PD-L1 [1].

2025年12月，科伦博泰与 Crescent Biopharma, Inc. ("Crescent")就 SKB105/CR-003 与 SKB118 (程序性细 胞死亡蛋白-1(PD-1) x 血管内皮生长因子 (VEGF)双特异性抗体，亦称CR-001)达成战略合作，其中科伦 博泰授予Crescent 在美国、欧洲及所有其他大中华地区(包括中国内地、香港、澳门及台湾)以外市场研 究、开发、生产和商业化SKB105/CR-003的独家权利，Crescent则授予科伦博泰在大中华地区研究、开 发、生产和商业化SKB118/CR-001的独家权利。科伦博泰计划于近期向中国国家药品监督管理局药品审 评中心递交 SKB118/CR-001 的 IND 申请。 智通财经APP讯，科伦药业(002422.SZ)发布公告，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")自主研发的靶向整合素β6(ITGB6)抗体偶联药物(ADC)SKB105(亦 称 CR-003)的新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)批准， 用于治疗晚期实体瘤。 ...

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 ...

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 ...