从 ADC 药物领域的全球突围到合成生物赛道的商业化领跑，科伦药业正以全链条创新能力，在创新驱动发展的浪潮中交出了一份亮眼的 " 仿创转型 " 硬核答卷，书写了中国药企创新转型的典范篇章。 由子公司科伦博泰自主开发的芦康沙妥珠单抗（佳泰莱®）是国内首个获得完全批准上市，且具有全球知识产权的国产ADC药物。继2024年11月首个 适应症获批上市以后，芦康沙妥珠单抗在今年3月和10月分别有新的适应症获批。据悉，通过与国际药企默沙东的合作，芦康沙妥珠单抗已启动15项全 球III期研究，覆盖肺癌、乳腺癌等高发癌种，彰显其全球化创新潜力。 科伦药业目前还梯次布局了多条ADC药物管线，其中，SKB518、SKB500以及一款双抗ADC药物SKB571均进入II期临床，而作为公司又一款重磅 ADC药物，博度曲妥珠单抗（HER2 ADC舒泰莱 ® ）针对二线及以上HER2阳性乳腺癌适应症的NDA也已于10月获批上市，头对头对比传统标准药物 T-DM1的III期研究显示，该款新药疗效指标优势显著。 为进一步提升核心竞争力，科伦药业积极拥抱 AI 技术，利用人工智能深度赋能合成生物学研发、工厂大罐发酵和实验室小试发酵的过程优化， ...

由子公司科伦博泰自主开发的芦康沙妥珠单抗（佳泰莱®）是国内首个获得完全批准上市，且具有全球知识产权的国产ADC药物。继2024年11月首个适应症 获批上市以后，芦康沙妥珠单抗在今年3月和10月分别有新的适应症获批。据悉，通过与国际药企默沙东的合作，芦康沙妥珠单抗已启动15项全球III期研 究，覆盖肺癌、乳腺癌等高发癌种，彰显其全球化创新潜力。 从ADC药物领域的全球突围到合成生物赛道的商业化领跑，科伦药业正以全链条创新能力，在创新驱动发展的浪潮中交出了一份亮眼的"仿创转型"硬核答 卷，书写了中国药企创新转型的典范篇章。 ADC赛道铸就全球创新力 在炙手可热的ADC药物领域，科伦凭借技术研发和产业化的持续突破，成为国内该领域的代表性企业之一。 为进一步提升核心竞争力，科伦药业积极拥抱AI技术，利用人工智能深度赋能合成生物学研发、工厂大罐发酵和实验室小试发酵的过程优化，实现生产工 艺的升级和降本增效，进一步增强产品的市场优势。 持续的技术创新正快速转化为商业价值，目前公司已有红没药醇、5-羟基色氨酸、麦角硫因、依克多因、角鲨烷、肌醇、植物鞘氨醇、PHA 等多个产品进 入生产、销售阶段，成为国内首批实现产品交付的合 ...

Core Insights - Sichuan Kelun-Botai Biopharmaceutical Co., Ltd. (Kelun-Botai) won the "Outstanding Hong Kong Stock Company Golden Bull Award" at the 2025 Xiamen Industry Development Conference, recognizing its exceptional management, market performance, and innovation in the biopharmaceutical sector [1][2] Company Performance - The "Outstanding Hong Kong Stock Company Golden Bull Award" is the highest honor in the evaluation, aimed at companies excelling in financial performance, corporate governance, social responsibility, industry leadership, and investor returns [2] - Since its IPO on the Hong Kong Stock Exchange in July 2023 at an issuance price of HKD 60.6, Kelun-Botai's stock price surged to HKD 434.2 as of November 5, 2025, with a market capitalization exceeding 100 billion [2] Commercialization Progress - Kelun-Botai focuses on the research, manufacturing, and commercialization of innovative drugs in oncology, immunology, and other therapeutic areas, being a pioneer in antibody-drug conjugates (ADC) with over 10 years of experience [3] - The company has successfully launched four leading products, including the world's first approved TROP2 ADC for lung cancer and the first PD-L1 monoclonal antibody for nasopharyngeal carcinoma [3] - In the first half of this year, Kelun-Botai achieved a revenue of 950 million, with its core product generating over 300 million, demonstrating strong commercial performance [3] Future Outlook - Several brokerage reports suggest that Kelun-Botai is expected to reach a profitability inflection point by 2027, driven by successful commercialization and global clinical research progress [4] - The company aims to continue advancing the research, registration, and commercialization of innovative drugs, focusing on unmet clinical needs globally while creating long-term value for stakeholders [4]

Core Viewpoint - The company announced the presentation of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1: Clinical Research Results - The clinical studies include data on the antibody-drug conjugate (ADC) targeting Trophoblast Cell Surface Antigen 2 (TROP2), sac-TMT (佳泰莱®) [1] - The research also covers the ADC targeting Human Epidermal Growth Factor Receptor 2 (HER2), known as A166 (舒泰莱®) [1] - Additionally, data on Claudin18.2 (CLDN18.2) ADC SKB315 is presented [1]

Market Overview - The stock market is experiencing a phase of alternating trends, with US stocks showing signs of weakness while domestic markets are strengthening, as evidenced by the Hong Kong stock market rising by 1.84% [1] - The Federal Reserve is likely nearing the end of its quantitative tightening policy, with indications that interest rate cuts may occur at upcoming meetings based on current conditions [1] - The focus of tensions has shifted to sanctions and counter-sanctions, particularly regarding rare earth materials, with the EU also seeking to address these issues [1] Sector Performance - Insurance stocks have become market leaders, driven by strong earnings, with companies like Xinhua Insurance and China Taiping seeing gains of over 8% [2] - The Chinese yuan has strengthened, with the central parity rate rising to 7.10, benefiting the aviation sector, as airlines like China Eastern and China Southern saw increases of over 7% [2] - The international oil price has dropped significantly, with WTI crude futures falling over 19% from September, further supporting airline stocks [2] Technology and Innovation - New Kai's subsidiary launched two domestically developed EDA software products, which are crucial for semiconductor design, leading to stock increases for companies like Huahong Semiconductor and SMIC [3] - Strategic collaborations are emerging in the tech sector, such as the partnership between SenseTime and Cambricon to enhance cloud computing capabilities, resulting in stock gains for both companies [3] Automotive Industry - JD.com, GAC Group, and CATL have launched a new electric vehicle model, targeting the mainstream market with a price range of 150,000 to 250,000 yuan, leading to an 11% increase in GAC Group's stock [4] - Tesla's reported order for linear actuators from a Chinese supplier has resulted in significant stock price increases for the supplier, Sanhua Intelligent Controls [4] Construction and Materials - The issuance of 1.3 trillion yuan in special government bonds for infrastructure has boosted market expectations for demand in construction materials, with companies like China National Building Material and Anhui Conch Cement seeing stock increases of over 7% [5] - Steel stocks are also performing well due to favorable conditions in iron ore purchasing, with companies like Ansteel and Maanshan Iron & Steel rising over 7% [5] Healthcare Sector - The upcoming ESMO conference is expected to showcase significant clinical research results, with several domestic innovative drug companies set to present key findings [6] - Companies like Kelun-Biotech and Innovent Biologics have important studies included in the conference, which could attract investor interest [6] Automotive Sales - Geely Automobile reported record sales of 2,953,452 vehicles in the first three quarters of 2025, a 29% year-on-year increase, with electric vehicle sales growing by 68% [7] - The company has raised its annual sales target from 2.71 million to 3 million vehicles, reflecting strong growth momentum [8]

Core Insights - The Hong Kong stock market's innovative pharmaceutical sector has seen a significant rebound this year, with net inflows of over 120 billion yuan into the pharmaceutical and biotechnology industry, driving funds towards more certain quality targets [1] - Kelun-Biotech (06990) has emerged as a key target for market investment, achieving a historical high in stock price and a market capitalization exceeding 100 billion HKD, with a year-to-date increase of 192.40%, entering the "100 billion club" of Hong Kong's innovative pharmaceuticals [1][3] Revenue Structure Transformation - Kelun-Biotech is transitioning from a biotech to a biopharma company, with its revenue structure evolving to be driven by both business development (BD) collaborations and self-commercialization [3][4] - In the first half of 2025, the company reported revenues of 950 million yuan, with cash reserves of 4.528 billion yuan, indicating a robust cash flow [4] - The sales revenue from its core product, Jiatailai® (TROP2 ADC), has shown strong market acceptance, contributing significantly to the company's revenue growth [5][6] Commercialization Strategy - The company has established a dual approach to commercialization, focusing on both licensing collaborations and self-sustaining revenue generation [4][5] - Kelun-Biotech has formed a professional marketing team of 350 people, achieving extensive coverage across 30 provinces and over 2,000 hospitals in China [7] - The company is actively pursuing national medical insurance access for its products, which could significantly enhance sales through payment leverage [7] R&D and Innovation - Kelun-Biotech has increased its R&D investment, reaching 612 million yuan in the first half of 2025, supporting its competitive edge in key therapeutic areas [8][9] - The company has developed three major technology platforms, enabling a pipeline of over 30 candidate drugs, with more than 10 in clinical stages [8] - International recognition of its R&D capabilities is reflected in its collaborations with various global partners, enhancing its innovation and market reach [9] Summary of Growth Path - Kelun-Biotech's mid-term performance illustrates a clear growth trajectory, with Jiatailai® providing cash flow and three technology platforms ensuring ongoing innovation [9] - The company's dual-driven model of BD collaboration and self-commercialization aligns with the core logic of pharmaceutical investment in Hong Kong, indicating its long-term potential for growth [9]

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company reported a revenue of 21.812 billion yuan in 2024, a year-on-year increase of 1.67%, and a net profit attributable to shareholders of 2.936 billion yuan, up 19.53% year-on-year [5] - In Q1 2025, the company achieved a revenue of 4.39 billion yuan, a decrease of 29.42% year-on-year, and a net profit of 584 million yuan, down 43.07% year-on-year, primarily due to a high base effect from the previous year [5][6] - The overall gross margin for 2024 was 51.69%, a decrease of 0.74 percentage points year-on-year, while the gross margin for Q1 2025 was 48.67%, down 7.17 percentage points year-on-year [6] Financial Performance - The company’s revenue for 2025 is projected to be 21.902 billion yuan, with a year-on-year growth of 0.4%, and net profit is expected to be 3.015 billion yuan, reflecting a growth of 2.7% [10] - The gross margin is expected to improve to 53.1% in 2025, with a gradual increase to 53.8% by 2027 [12] - The company’s operating cash flow for Q1 2025 was 449 million yuan, a decrease of 64.86% year-on-year [6] Business Segments - The infusion business generated sales of 8.912 billion yuan in 2024, a decline of 11.85% year-on-year, while non-infusion drug sales increased by 5.41% to 4.169 billion yuan [7] - The company’s antibiotic intermediates and raw materials achieved revenue of 5.856 billion yuan, up 20.90% year-on-year, driven by increased market demand [7] - The innovative drug "Jiatailai" (芦康沙妥珠单抗) was approved for commercialization, marking a new era for the company's innovative drug portfolio [8][9] Future Outlook - Revenue projections for 2025, 2026, and 2027 are 21.902 billion yuan, 23.356 billion yuan, and 23.979 billion yuan, respectively, with corresponding net profits of 3.015 billion yuan, 3.346 billion yuan, and 3.408 billion yuan [10][12] - The company aims to improve the structure of its infusion products and continue benefiting from its intermediates and raw materials business [6][7]