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]

Core Viewpoint - Kelong Pharmaceutical's subsidiary, Sichuan Kelong Botai Biopharmaceutical Co., has received breakthrough therapy designation from the National Medical Products Administration of China for its ADC drug targeting TROP2 in combination with Merck's PD-1 monoclonal antibody for treating specific types of non-small cell lung cancer (NSCLC) [1] Group 1 - Kelong Pharmaceutical announced that its subsidiary Kelong Botai's ADC drug, Lukanosatuzumab, has been granted breakthrough therapy designation for first-line treatment of PD-L1 tumor proportion score (TPS) ≥ 1% in EGFR gene mutation-negative and ALK-negative locally advanced or metastatic NSCLC [1] - The company also reported that its ADC drug SKB105 (also known as CR-003), targeting integrin β6, has received approval for clinical trials from the National Medical Products Administration for the treatment of advanced solid tumors [1]

Core Viewpoint - The company has received approval for its clinical trial application for the targeted integrin β6 antibody-drug conjugate SKB105 (also known as CR-003) for the treatment of advanced solid tumors from the National Medical Products Administration (NMPA) in China [1] Group 1 - The company's subsidiary, Sichuan Kelun Biopharma Co., Ltd. (Kelun Biopharma), is responsible for the development of SKB105 [1] - A strategic collaboration has been established between Kelun Biopharma and Crescent Biopharma, Inc. regarding SKB105/CR-003 and SKB118 (a bispecific antibody targeting PD-1 and VEGF, also known as CR-001) [1] - Under the collaboration, Kelun Biopharma grants Crescent exclusive rights to research, develop, manufacture, and commercialize SKB105/CR-003 outside of Greater China, while Crescent grants Kelun Biopharma exclusive rights for SKB118/CR-001 within Greater China [1] Group 2 - Kelun Biopharma plans to submit an IND application for SKB118/CR-001 to the NMPA in the near future [1]

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 ...

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].