证券代码：002422 证券简称：科伦药业 公告编号：2025-077 四川科伦药业股份有限公司 关于子公司在 2025 年欧洲肿瘤内科学会大会上 公布多项创新药物研究成果的公告 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。 芦康沙妥珠单抗(sac-TMT)对比含铂双药化疗用于表皮生长因子受体酪氨酸 激酶抑制剂(EGFR-TKI)治疗后进展的 EGFR 突变非小细胞肺癌(NSCLC)的随机、 多中 心 3 期 OptiTROP-Lung04 研究 结果( 报告 编号： LBA5 ，主 席论坛 II (Presidential Symposium II))以及芦康沙妥珠单抗(sac-TMT)对比研究者选择的化 疗治疗经治的局部晚期或转移性激素受体阳性且 HER2 阴性(HR+/HER2-)乳腺癌 (BC)的随机、多中心 3 期 OptiTROP-Breast02 研究结果(报告编号：LBA23，优选 论文专场 1—转移性乳腺癌)以口头报告的形式进行了展示。关键内容概述如下： OptiTROP-Lung04 共有376名患者被随机(1:1)分配接受芦康沙妥珠单抗 ...

Group 1: Novo Nordisk - Novo Nordisk's oral semaglutide (Rybelsus) has received FDA approval for a new indication to reduce cardiovascular risk in high-risk adults with type 2 diabetes, making it the first oral GLP-1 drug to do so [1] - The company has also submitted a supplemental new drug application for daily oral semaglutide (Wegovy) for obesity treatment, with approval expected later this year [1] - This new approval is expected to further solidify Novo Nordisk's market position in the GLP-1 segment [1] Group 2: Sunshine Guohe - Sunshine Guohe plans to invest 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, focusing on CAR-T cell therapy and nucleic acid drugs [2] - Yuanma Zhiyao specializes in the innovation and development of circular mRNA CAR-T nucleic acid drugs and is advancing towards clinical research [2] - This investment aligns with Sunshine Guohe's strategic layout in the CAR-T field and is expected to create synergies between the two companies [2] Group 3: Pian Zai Huang - Pian Zai Huang reported a 28.82% year-on-year decline in net profit for Q3, with revenue of 2.064 billion yuan, down 26.28% year-on-year [3] - For the first three quarters, the company’s revenue was 7.442 billion yuan, a decrease of 11.93%, and net profit was 2.129 billion yuan, down 20.74% [3] - The decline in performance is attributed to reduced sales in the pharmaceutical manufacturing industry and a decrease in gross margin [3] Group 4: Kelun Pharmaceutical - Kelun Pharmaceutical's subsidiary, Kelun Botai, received approval for its core product, trastuzumab deruxtecan (Bodutuzumab), for treating HER2-positive breast cancer [4] - The product showed significant improvement in progression-free survival compared to T-DM1 in interim analysis, indicating strong clinical efficacy [4] - This approval marks a key breakthrough for Kelun Botai in the breast cancer field and is expected to accelerate market penetration for the product [4]

Group 1: Novo Nordisk - Novo Nordisk's oral semaglutide (Rybelsus) has received FDA approval for a new indication to reduce cardiovascular risk in high-risk adults with type 2 diabetes, making it the first oral GLP-1 drug to do so [1] - The company has also submitted a supplemental new drug application for its once-daily oral semaglutide (Wegovy) for obesity treatment, with approval expected later this year [1] - The approval of the new indication for oral semaglutide is expected to further solidify Novo Nordisk's market position in the GLP-1 segment [1] Group 2: Sunshine Guohe - Sunshine Guohe plans to invest 15 million yuan to acquire an 8.20% stake in Yuanma Zhiyao, focusing on CAR-T cell therapy and nucleic acid drugs [2] - Yuanma Zhiyao specializes in the innovation and research of circular mRNA CAR-T nucleic acid drugs and is advancing towards clinical research [2] - This investment aligns with Sunshine Guohe's strategic layout in the CAR-T field and is expected to create synergies between the two companies [2] Group 3: Pian Zai Huang - Pian Zai Huang reported a 28.82% year-on-year decline in net profit for Q3, with revenue of 2.064 billion yuan, down 26.28% year-on-year [3] - For the first three quarters, the company recorded a revenue of 7.442 billion yuan, a decrease of 11.93%, and a net profit of 2.129 billion yuan, down 20.74% [3] - The decline in performance is attributed to reduced sales in the pharmaceutical manufacturing industry and a decrease in gross margin [3] Group 4: Kelun Pharmaceutical - Kelun Pharmaceutical's subsidiary, Kelun Botai, received approval for its core product, trastuzumab deruxtecan (舒泰莱), for treating HER2-positive breast cancer [4] - The product showed significant improvement in progression-free survival (PFS) compared to T-DM1 in interim analysis, indicating strong clinical efficacy [4] - This approval marks a key breakthrough for Kelun Botai in the breast cancer field and highlights the ongoing advancements of domestic ADCs in high-end oncology treatment [4]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [3] Core Viewpoints - The report emphasizes that the fourth quarter is expected to see a rebound in innovative drugs, driven by a concentration of business development (BD) activities and upcoming events such as the ESMO conference and medical insurance negotiations [4][16] - The Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs significantly opening new growth avenues for Chinese pharmaceutical companies [16][35] - The report suggests that the demand for healthcare will continue to rise due to an aging population, and the payment side is also expected to grow steadily, supported by the development of a multi-tiered payment system [35] Summary by Sections 1. BD + ESMO - The number of license-out transactions in China has been increasing, with 135 transactions occurring from January 1, 2025, to October 17, 2025, totaling $10.2996 billion [8][9] - The report highlights that the international pharmaceutical industry recognizes the value of Chinese innovative drug assets, which are characterized by high quality and low cost [8][9] - The ESMO conference will showcase 23 studies led by Chinese scholars, indicating a significant increase in international recognition of Chinese innovation [12][13] 2. Industry Perspective - The report maintains that innovative drugs will remain the main focus for the year, with attention on manufacturing, overseas expansion, and aging-related consumption [16][35] - The pharmaceutical index has shown a decline of 2.48% in the past week, but an increase of 18.85% year-to-date, indicating a mixed performance [16] - The report lists several companies to watch, including innovative drug manufacturers and those involved in the supply chain [38]

Investment Rating - The report indicates a current overall valuation of the pharmaceutical sector at 30.1 times earnings, ranking it 10th among 31 primary sectors in the market [5][8]. Core Insights - The pharmaceutical sector experienced a decline of 2.5% this week, underperforming compared to the Shanghai Composite Index, which fell by 1.5% [3][5]. - The report highlights significant corporate activities, including BMS's acquisition of Orbital Therapeutics for $1.5 billion, which includes a promising CAR-T therapy candidate and proprietary RNA platform technology [4][13]. - The report emphasizes the importance of the 2025 ESMO conference, where multiple Chinese pharmaceutical companies are expected to present clinical data, suggesting a focus on innovative drug sectors and companies with improving performance in medical devices and upstream sectors [4][19]. Market Performance Summary - The pharmaceutical sector's performance this week ranked 16th among 31 sub-industries, with various segments showing mixed results: - Raw materials (-2.3%) - Chemical preparations (-1.7%) - Traditional Chinese medicine (+0.4%) - Medical devices (-5.4%) [3][8]. - The report notes that the pharmaceutical sector's index has seen a decline of 2.5%, while the overall market (excluding financials and oil) dropped by 4.2% [3][5]. Key Events Recap - BMS's acquisition of Orbital Therapeutics is a notable event, as it aims to enhance its capabilities in CAR-T therapies [4][13]. - The approval of new indications for Pegasys by Teva Biopharma is expected to strengthen its market position in hepatitis treatment [4][15]. - Mindray Medical announced plans to issue H shares and list on the Hong Kong Stock Exchange to support its international strategy [4][15]. Clinical Data Highlights - The report includes a summary of clinical data presented at the 2025 ESMO conference, showcasing various drugs and their efficacy in treating different cancers, which may present investment opportunities [19][22].

Investment Rating - The report indicates a current investment rating for the pharmaceutical sector, with the overall valuation at 30.1 times earnings, ranking 10th among 31 primary industries [3][5]. Core Insights - The report highlights a decline of 2.5% in the Shenwan Pharmaceutical and Biological Index, which underperformed compared to the Shanghai Composite Index's decline of 1.5% and the overall A-share market's decline of 4.2% [3][5]. - Key events include BMS's acquisition of Orbital Therapeutics for $1.5 billion, which includes a candidate drug for CAR-T therapy and proprietary RNA platform technology [4][13]. - The report emphasizes the importance of the 2025 ESMO conference, where multiple Chinese pharmaceutical companies are expected to present clinical data, suggesting a focus on innovative drug sectors and companies with improving performance in medical devices and upstream sectors [4][18]. Market Performance Summary - The Shenwan Pharmaceutical and Biological Index fell by 2.5%, ranking 16th among 31 Shenwan primary sub-industries [3][5]. - The performance of various sub-sectors includes: - Raw materials (-2.3%) - Chemical preparations (-1.7%) - Traditional Chinese medicine (+0.4%) - Blood products (-1.6%) - Vaccines (-3.3%) - Other biological products (-3.6%) - Medical equipment (-5.4%) - Medical consumables (-1.7%) - In vitro diagnostics (-0.4%) - Pharmaceutical distribution (-1.5%) - Offline pharmacies (+0.6%) - Medical R&D outsourcing (-6.5%) - Hospitals (-1.5%) [3][8][5]. Key Events Review - BMS's acquisition of Orbital Therapeutics includes a candidate drug for CAR-T therapy and advanced RNA technology [4][13]. - The approval of a new indication for Peginterferon by Teva Biopharma enhances its market competitiveness in hepatitis B treatment [4][14]. - Mindray Medical announced plans to issue H shares and list on the Hong Kong Stock Exchange to support its international strategy [4][15]. - The report suggests monitoring companies presenting at the 2025 ESMO conference, particularly those in the innovative drug sector and those with improving performance metrics [4][18].

Core Viewpoint - The report by Zhiyan Consulting highlights the growth trends in China's chemical pharmaceutical industry, projecting a production increase in raw chemical drugs by 3.4% year-on-year in April 2025, with a cumulative growth of 3.9% from January to April 2025 [1] Industry Summary - In April 2025, China's production of raw chemical drugs reached 332,000 tons, marking a year-on-year increase of 3.4% [1] - The cumulative production of raw chemical drugs from January to April 2025 totaled 1,257,000 tons, reflecting a cumulative growth of 3.9% [1] - The report provides insights into the supply and demand dynamics of the chemical pharmaceutical industry in China from 2025 to 2031 [1] Company Summary - Listed companies in the report include Heng Rui Medicine, East China Pharmaceutical, Lijun Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical [1] - Zhiyan Consulting is recognized as a leading industry consulting firm in China, specializing in in-depth industry research and providing comprehensive consulting services for investment decisions [1]

（文章来源：证券日报） 证券日报网讯 10月17日晚间，科伦药业发布公告称，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靶向人类表皮生长因子受体2（HER2）的抗体偶联药物（ADC）博度曲妥珠单抗 （亦称A166）（舒泰莱®）获国家药品监督管理局（NMPA）批准用于既往接受过一种或一种以上抗 HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌（BC）患者。 ...

Core Viewpoint - Kolun Pharmaceutical has received approval from the National Medical Products Administration for its chemical drug "Rotigotine Patch" [2] Company Summary - Kolun Pharmaceutical announced the registration approval of its drug "Rotigotine Patch" [2]

Core Viewpoint - Kelong Pharmaceutical's subsidiary Sichuan Kelong Botai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its antibody-drug conjugate (ADC) A166 (also known as Trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] Group 1 - The approved drug targets the human epidermal growth factor receptor 2 (HER2) [1] - The indication is specifically for adult patients with a history of treatment with one or more anti-HER2 agents [1] - This approval represents a significant advancement in the treatment options available for HER2-positive breast cancer patients [1]