证券代码：002422 证券简称：科伦药业 公告编号：2024-127 四川科伦药业股份有限公司 该项批准是基于一项用于既往至少接受过 2 种系统治疗(其中至少 1 种治疗 针对晚期或转移性阶段)的不可切除的局部晚期或转移性 TNBC 成人患者的随机、 对照 3 期 OptiTROP-Breast01 研究的积极结果。与化疗相比，sac-TMT 在无进展 生存期(PFS)和总生存期(OS)方面均显示出具有显著统计学意义和临床意义的改 善。该研究结果已在 2024 年 5 月举行的美国临床肿瘤学会(ASCO)年会的新一代 ADCs 临床科学专题研讨会上公布。 此前，NMPA 已经受理了两项补充新药申请(sNDA)，分别是芦康沙妥珠单 抗(sac-TMT)单药治疗经 EGFR-TKI 治疗后进展或经 EGFR-TKI 和含铂化疗治疗 后进展的局部晚期或转移性 EGFR 突变非小细胞肺癌(NSCLC)患者的申请。 一、关于芦康沙妥珠单抗(sac-TMT) (佳泰莱®) 作为科伦博泰的核心产品，芦康沙妥珠单抗(sac-TMT)是一款科伦博泰拥有 自主知识产权的新型 TROP2 ADC，针对 NSCLC、乳腺癌(BC) ...

证券代码：002422 证券简称：科伦药业 公告编号：2024-126 四川科伦药业股份有限公司 关于子公司 SKB501 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"）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"）已于 2024 年 11 月 25 日收到国家药品监督管理局同意其开发的创新药物 SKB501 临床试验申请的 临床试验通知书。 一、药品基本情况 SKB501 是一款由科伦博泰针对靶点生物学特点，利用 OptiDCTM 平台技术 研发的具有自主知识产权的新型 ADC 药物，在临床前研究中显示出良好的疗效 和安全窗，拟用于治疗晚期实体瘤。 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 2024 年 11 月 26 日 ...

Group 1 - Zhejiang Kelun Yongnian Health Industry Co., Ltd. has been established with a registered capital of 20 million yuan, focusing on food production, health food production, special medical purpose formula food production, and drug production [1] - The legal representative of the newly established company is Feng Hao [1] - Kelun Pharmaceutical holds 100% ownership of the new company [2]

公司就认购科伦博泰本次发行的内资股尚需履行缴纳出资款、办理股份登记 及相关境内外监管部门要求的其他相关程序。敬请广大投资者注意投资风险。 特此公告。 四川科伦药业股份有限公司董事会 证券代码：002422 证券简称：科伦药业 公告编号：2024-124 四川科伦药业股份有限公司 关于认购控股子公司科伦博泰定向发行的内资股股份的进展公告 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"）于2024年5月7日第七届董 事会第三十七次会议审议通过了《关于认购控股子公司科伦博泰定向发行的内资 股股份的议案》，同意公司就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"）定向发行的内资股予以全部认购。双方于2024年5月8日签 订《定向发行股份认购协议》，认购价格考虑汇率因素后按照科伦博泰在香港联 交所发行的H股的价格确定，为136.21元人民币/股（按照2024年5月7日中国外汇 交易中心受权公布的银行间外汇市场人民币汇率中间价，即1港元对人民币 0.90806元，换算所得以港币计价的价格为150.00港元/股 ...

证券代码：002422 证券简称：科伦药业 公告编号：2024-125 四川科伦药业股份有限公司 关于 2021 年员工持股计划存续期即将届满的提示性公告 本公司及董事会全体成员保证信息披露的内容真实、准确、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"）于 2021 年 11 月 29 日召开了 第七届董事会第六次会议和第七届监事会第四次会议，审议通过了《关于<四川科 伦药业股份有限公司 2021 年员工持股计划（草案）>及其摘要的议案》等相关议 案；公司于 2021 年 12 月 7 日召开了第七届董事会第七次会议和第七届监事会第 五次会议，审议通过了《关于<四川科伦药业股份有限公司 2021 年员工持股计划 （草案修订稿）>及其摘要的议案》等相关议案；公司于 2022 年 5 月 5 日召开了 2021 年度股东大会，审议通过了《关于<四川科伦药业股份有限公司 2021 年员工 持股计划（草案修订稿）>及其摘要的议案》等相关议案，具体内容详见公司于"巨 潮资讯网"（www.cninfo.com.cn）上披露的相关公告。 鉴于公司 2021 年员工持股计划（以下简 ...

Investment Rating - The report maintains a "Buy" rating for Kelun Pharmaceutical (002422 SZ) [4][6] Core Views - Kelun Pharmaceutical achieved steady growth in Q3 2024 with revenue of 4 96 billion yuan (+0 4% YoY) and net profit of 670 million yuan (+19 9% YoY) [1] - The company's gross margin and net margin in Q3 2024 were 49 4% and 14 2% respectively with significant optimization in expense ratios [1] - SKB264 a core innovative drug is expected to receive approval soon with multiple clinical trials underway globally [2] - The company's international cooperation with Merck continues to progress with a 37 5 million USD payment received for SKB571 [2] Financial Performance - For the first three quarters of 2024 Kelun Pharmaceutical achieved revenue of 16 79 billion yuan (+6 6% YoY) and net profit of 2 47 billion yuan (+25 9% YoY) [1] - The company's sales expense ratio decreased significantly to 14 0% in Q3 2024 (-7 3pct YoY) due to the implementation of national drug procurement policies [1] - Non infusion drug sales reached 2 02 billion yuan in H1 2024 (+6 38% YoY) [2] Business Segments - The large infusion business remains the industry leader with stable profit levels expected [2] - The antibiotic intermediate business through Sichuan Kelun achieved revenue of 1 26 billion yuan (+8 3% YoY) and net profit of 310 million yuan (+24 2% YoY) in Q3 2024 [2] - The generic drug business focusing on anti infection CNS endocrine metabolism and andrology is expected to stabilize [2] Innovation Pipeline - SKB264 has multiple indications under review in China including TNBC and NSCLC with global phase 3 clinical trials initiated by Merck [2] - Other innovative drugs such as A166 SKB315 SKB410 and SKB518 are progressing through clinical trials [2] Financial Forecast - The report adjusted net profit forecasts for 2024-2026 to 3 04/3 47/3 99 billion yuan respectively [4] - Revenue is expected to grow at a CAGR of 9 7% from 2024 to 2026 reaching 28 30 billion yuan by 2026 [5] - EPS is projected to increase from 1 90 yuan in 2024 to 2 49 yuan in 2026 [5]

Investment Rating - Maintain "Buy" rating [1][3] Core Views - Kelun Pharmaceutical achieved revenue of 16.789 billion yuan in the first three quarters of 2024, a year-on-year increase of 6.64%, with net profit attributable to the parent company of 2.471 billion yuan, up 25.85% year-on-year [1] - In Q3 2024, revenue was 4.962 billion yuan, a slight increase of 0.35% year-on-year, while net profit attributable to the parent company grew by 19.88% to 671 million yuan [1] - The company's innovation transformation is entering a harvest period, with four innovative products from Kelun-Biotech having submitted NDA applications, and potential for commercialization domestically [1] - Kelun's long-term investment logic remains strong, with upgrades in the large infusion industry, structural adjustments, and improved profitability [1] Financial Performance - Q1-3 2024 sales expense ratio decreased by 5.07 percentage points year-on-year to 15.57%, while R&D expense ratio dropped by 1.14 percentage points to 9.44% [1] - Q3 2024 sales expense ratio was 14.03%, down 7.33 percentage points year-on-year, and R&D expense ratio was 10.20%, down 1.58 percentage points [1] - Gross profit margin for Q1-3 2024 was 52.51%, a slight decrease of 0.43 percentage points year-on-year [1] - Net cash flow from operating activities for Q1-3 2024 was 3.275 billion yuan, down 22.97% year-on-year [1] Profit Forecast and Valuation - Forecasted net profit attributable to the parent company for 2024-2026 is 2.94 billion yuan, 3.23 billion yuan, and 3.83 billion yuan, with growth rates of 19.5%, 10.0%, and 18.7% respectively [1] - EPS for 2024-2026 is expected to be 1.83 yuan, 2.02 yuan, and 2.39 yuan, with corresponding P/E ratios of 18X, 16X, and 14X [1] Industry and Market Performance - Kelun Pharmaceutical operates in the chemical pharmaceutical industry [3] - The company's stock price has shown strong performance relative to the CSI 300 index [4] Financial Projections - Revenue for 2024E is projected to be 24.114 billion yuan, with a growth rate of 12.4% year-on-year [2] - Net profit attributable to the parent company for 2024E is expected to be 2.936 billion yuan, up 19.5% year-on-year [2] - ROE for 2024E is forecasted at 11.3%, with a P/E ratio of 17.8X [2]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 39.48 CNY based on a reasonable valuation level of 21 times the earnings for 2024 [3][6]. Core Insights - The company achieved a revenue of 16.789 billion CNY (+6.64%) and a net profit attributable to the parent company of 2.471 billion CNY (+25.85%) in the first three quarters of 2024, indicating rapid growth and improved profitability driven by optimized product structure in infusion products, rising volume and price of antibiotic intermediates, milestone payments from innovative drugs, and excellent cost control [1][2]. - The ADC platform is leading domestically, with products expected to enter a harvest phase soon. Notably, SKB264 (TROP-2 ADC) is anticipated to receive approval for treating triple-negative breast cancer by the end of this year, while several other ADC products are progressing well in development [1][2]. - The company has established an integrated layout from research to production in synthetic biology, with strong demand for antibiotics leading to increased volume and price, enhancing profitability [2]. Financial Summary - The company forecasts earnings per share (EPS) of 1.88 CNY, 2.11 CNY, and 2.36 CNY for 2024, 2025, and 2026 respectively. The projected revenue for 2024 is 23.337 billion CNY, with a year-on-year growth of 8.8% [3][5]. - The gross margin is expected to be 51.7% in 2024, with a net margin of 12.9% and a return on equity (ROE) of 14.1% [5][9].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index in the next six months [6][7]. Core Insights - The company reported a strong Q3 performance with a year-on-year revenue increase of 0.35% and a net profit growth of 19.88%. The main drivers for profit growth include reduced sales expenses, ongoing upgrades in large infusion packaging materials, and stable prices for intermediates [1][2]. - For the first three quarters of 2024, the company achieved a total revenue of 16.789 billion yuan, a year-on-year increase of 6.64%, and a net profit of 2.471 billion yuan, reflecting a year-on-year growth of 25.85% [1][3]. - The company is expected to continue its growth trajectory, with projected revenues of 22.967 billion yuan, 25.757 billion yuan, and 28.456 billion yuan for 2024, 2025, and 2026 respectively, representing growth rates of 7.05%, 12.15%, and 10.48% [3][5]. Financial Summary - The company's gross margin for Q1-3 2024 was 52.51%, with a net profit margin of 17.40%. In Q3 alone, the gross margin was 49.35% and the net profit margin was 14.21% [1][5]. - The report forecasts earnings per share (EPS) of 1.98 yuan, 2.21 yuan, and 2.56 yuan for 2024, 2025, and 2026, with corresponding price-to-earnings (P/E) ratios of 17, 15, and 13 [3][5]. - The company is also expected to benefit from the commercialization of 11 new products in 2024, contributing to its revenue growth [1][5].

Investment Rating - The report maintains a "Buy" rating for the company [3] Core Views - The company's profitability continues to improve, with a revenue of 16.789 billion yuan for the first three quarters of 2024, representing a year-on-year increase of 6.64%. The net profit attributable to shareholders reached 2.471 billion yuan, up 25.85% year-on-year [6][7] - The structure of infusion products is continuously optimized, with significant growth in the revenue of raw materials and intermediates. The revenue from antibiotic intermediates and raw materials reached 4.456 billion yuan, a year-on-year increase of 24.43% [7] - The commercialization of innovative products is imminent, with four innovative varieties expected to be launched in the next year. The commercialization team is fully prepared for the sales of these products [8] Summary by Sections Financial Performance - For the first three quarters of 2024, the company reported a revenue of 16.789 billion yuan, with a net profit of 2.471 billion yuan, reflecting a year-on-year growth of 25.85% [6] - The operating cash flow for the period was 3.275 billion yuan, down 22.97% year-on-year, indicating a need for monitoring cash flow management [6] Product and Market Analysis - The infusion product segment has shown stable revenue with significant profit growth, driven by a decrease in sales expenses and an increase in the proportion of closed infusion products [7] - The antibiotic intermediates and raw materials segment has seen a substantial increase in both volume and price, contributing to the overall revenue growth [7] Future Outlook - The company expects to maintain stable revenue growth, with projected revenues of 23.639 billion yuan, 25.875 billion yuan, and 28.042 billion yuan for 2024, 2025, and 2026 respectively [9] - The net profit attributable to shareholders is forecasted to be 2.917 billion yuan, 3.443 billion yuan, and 4.021 billion yuan for the same years, indicating a positive growth trajectory [9]