年度報告 目錄 2 公司資料 4 財務摘要 5 公司概覽 7 主席致辭 8 管理層討論及分析 28 公司管治報告 43 董事會報告 61 董事及高級管理人員簡歷 70 獨立核數師報告 75 綜合損益表 76 綜合全面收益表 77 綜合財務狀況表 79 綜合權益變動表 80 綜合現金流量表 82 財務報表附註 156 釋義 公司資料 董事會 執行董事 鍾慧娟女士 （主席兼首席執行官） 孫遠女士 呂愛鋒博士 獨立非執行董事 林國強先生 陳尚偉先生 楊東濤女士 審核委員會 陳尚偉先生 （主席） 林國強先生 楊東濤女士 薪酬委員會 楊東濤女士 （主席） 鍾慧娟女士 林國強先生 戰略及發展委員會 鍾慧娟女士 （主席） 呂愛鋒博士 陳尚偉先生 楊東濤女士 環境、社會及管治委員會 呂愛鋒博士 （主席） 楊東濤女士 陳尚偉先生 提名委員會 鍾慧娟女士 （主席） 林國強先生 陳尚偉先生 聯席公司秘書 鍾勝利女士 李昕穎女士1 譚思慧女士1, 2 黃浣琪女士2 授權代表 孫遠女士 李昕穎女士1 譚思慧女士1, 2 黃浣琪女士2 上市資料 普通股 香港聯合交易所有限公司 股份代號：3692 可換股債券 600,000,000美元於 ...

近日，由中国临床肿瘤学会(CSCO)和北京市希思科临床肿瘤学研究基金会联合主办的"2025CSCO诊疗 指南大会"发布了《CSCO原发性非小细胞肺癌诊疗指南(2025版)》，翰森制药原研创新药阿美乐(甲磺 酸阿美替尼片)新增一项针对EGFR突变阳性Ⅲ期不可切除非小细胞肺癌(NSCLC)患者放化疗后巩固治疗 的Ⅰ级推荐，成为首个获得该推荐等级的中国原研三代EGFR-TKI。 本次新增推荐主要基于阿美乐在POLESTAR研究中的积极结果。这是一项全国多中心、随机、双盲、对 照、Ⅲ期临床研究，旨在评估阿美乐在EGFR突变的Ⅲ期不可切除NSCLC患者放化疗后巩固治疗中的疗 效和安全性。该研究的中期分析结果曾以口头报告在2024年世界肺癌大会(WCLC)上发布。数据显示， 阿美乐组经独立评审委员会评估的中位无进展生存期(mPFS)为30.4个月，达到安慰剂组(mPFS=3.8个月) 的8倍，在研究者评估的mPFS中也观察到相似的获益，提示阿美乐的巩固治疗有效降低了85%的疾病进 展或死亡风险。值得关注的是，POLESTAR研究纳入的均为中国患者，显示了原研EGFR-TKI对国内患 者的显著疗效，对于中国临床实践具有较高 ...

Core Insights - A total of 10 first-class innovative drugs have received clinical trial approval in China from April 14 to April 19, covering various types including small molecules, antibody-drug conjugates (ADC), gene therapy, and cell therapy, targeting conditions such as advanced solid tumors, type 1 diabetes, spinal cord injury, Duchenne muscular dystrophy (DMD), and paroxysmal nocturnal hemoglobinuria [1] Group 1: Company-Specific Developments - Hansoh Pharmaceutical's HS-10529, a KRAS G12D small molecule inhibitor, has been approved for clinical trials to treat advanced solid tumors with KRAS G12D mutations, showing good preclinical efficacy and safety [2] - Kanghong Pharmaceutical's KH815, a TROP2-targeted dual-payload ADC, has received clinical approval for treating advanced solid tumors, demonstrating potential to overcome drug resistance [3] - Innovent Biologics' IBI3020, a CEACAM5-targeted dual-payload ADC, has been approved for clinical trials aimed at treating unresectable, locally advanced, or metastatic solid tumors [4] - Xinneng Pharmaceutical's BBM-D101, an AAV gene therapy drug, has been approved for clinical trials to treat Duchenne muscular dystrophy (DMD), aiming for long-term efficacy with a single administration [5] - Zhixin Haosheng's E-islet 01, a universal allogeneic islet regeneration product, has received clinical approval for treating type 1 diabetes, utilizing advanced cell reprogramming techniques [6] - Shizhe Biotechnology's XS228, an iPSC-derived neural precursor cell injection, has been approved for clinical trials to treat subacute spinal cord injury (SCI) [7] - Baili Pharmaceutical's BL-M09D1, an ADC drug, has been approved for treating locally advanced or metastatic solid tumors, sharing technology with another ADC [8] - Renfu Innovation's HWS116, a biological product, has received clinical approval for treating advanced solid tumors, although specific mechanisms are not yet disclosed [9]

Group 1 - The core index of the CSI Hong Kong Stock Connect Biotechnology Theme Index closed at 1134.61 points, with a decline of 3.59% over the past month, an increase of 24.05% over the past three months, and a year-to-date increase of 20.15% [1] - The index consists of 50 listed companies involved in biopharmaceuticals, pharmaceuticals, and biotechnology services, reflecting the overall performance of biotechnology theme companies within the Hong Kong Stock Connect [1] - The index was established on December 28, 2018, with a base point of 1000.0 [1] Group 2 - The top ten weighted companies in the index include: BeiGene (15.69%), WuXi Biologics (11.81%), Innovent Biologics (10.68%), CanSino Biologics (8.36%), CSPC Pharmaceutical Group (6.36%), China Biologic Products (5.81%), Hansoh Pharmaceutical (3.68%), Zai Lab (3.48%), 3SBio (3.22%), and WuXi AppTec (2.82%) [1] - The index's holdings are entirely composed of companies listed on the Hong Kong Stock Exchange, with a 100% allocation [1] Group 3 - In terms of industry composition, biopharmaceuticals account for 52.00%, chemical drugs for 25.67%, pharmaceutical and biotechnology services for 19.19%, and medical devices for 3.14% [2] - The index samples are adjusted semi-annually, with adjustments occurring on the next trading day after the second Friday of June and December each year, with a sample adjustment ratio generally not exceeding 20% [2] - Special adjustments may occur under certain circumstances, such as delisting or significant corporate actions like mergers or acquisitions [2]

Core Insights - The 34th Asia-Pacific Association for the Study of the Liver (APASL 2025) conference highlighted the academic achievements of Hansoh Pharmaceutical's oral antiviral drug, TMF (Amitriptyline), which is the first original research drug for hepatitis B in China [1][2] - TMF demonstrated significant efficacy in chronic hepatitis B patients, with a 95% cumulative HBV DNA suppression rate and a 68% HBeAg seroconversion rate over five years, the highest among current NAs [1] - The drug's safety profile remained stable, with no new drug-related adverse events reported during the study period [1] Group 1 - TMF's Phase IV study showed sustained benefits for chronic hepatitis B patients, particularly in virological response and HBeAg seroconversion [1] - The cumulative incidence of virological resistance after five years of treatment with TMF was 0% [1] - The immunological mechanism study indicated TMF's potential to modulate T cell responses and reduce viral load, contributing to its antiviral efficacy [1] Group 2 - Over 20 additional studies related to TMF were presented, covering its application in various subpopulations, including the elderly, pregnant women, and patients with liver cirrhosis and liver cancer [2] - A systematic review and network meta-analysis indicated TMF's superiority in ALT normalization and delaying liver fibrosis progression compared to other new-generation NAs [2] - TMF was shown to have good maternal-fetal safety and efficacy in treating hepatitis B in pregnant women, successfully preventing HBV mother-to-child transmission [2]

Core Insights - The study published in the International Journal of Molecular Sciences reveals that the GLP-1 receptor agonist, polyethylene glycol-liraglutide (brand name: Fulaimei), accelerates diabetic wound healing through a dual mechanism: systemic anti-inflammatory regulation and restoration of endothelial progenitor cell (EPC) function [1][2]. Group 1: Research Findings - Diabetes is a leading cause of death and disability globally, with vascular complications such as chronic wound healing delays posing significant clinical challenges [1]. - The research utilized a mouse model to compare wound healing in diabetic mice treated with Fulaimei, untreated diabetic mice, and normal mice, demonstrating that Fulaimei improves metabolic disorders, accelerates wound healing, regulates systemic inflammation, and restores EPC function [2]. - Previous in vitro studies indicated that liraglutide can improve EPC damage and mitochondrial dysfunction via the SIRT3/Foxo3 signaling pathway [2]. Group 2: Clinical Implications - The study provides theoretical support for the use of Fulaimei in treating diabetic vascular complications and offers a new strategy for chronic wound treatment in diabetes [2]. - The findings expand the clinical application prospects of GLP-1 receptor agonists, suggesting potential use in other diseases related to mitochondrial dysfunction [2]. - Future research will further explore the efficacy and molecular regulatory networks of Fulaimei in human subjects [2].

Core Insights - Hansoh Pharmaceutical reported a total revenue of approximately 12.261 billion RMB for 2024, representing a year-on-year growth of about 21.3%, and a net profit attributable to shareholders of 4.372 billion RMB, up 33.4% year-on-year [1] - The proportion of innovative drugs in total revenue increased significantly from less than 20% at the time of the company's Hong Kong listing to 77.3% in 2024, highlighting the successful transition to an innovation-driven pharmaceutical company [1][5] - The company achieved revenue of 9.477 billion RMB from innovative drugs and collaborative products, marking a year-on-year increase of 38.1% [1] Revenue Breakdown - In 2024, revenue from various therapeutic areas included approximately 8.122 billion RMB from oncology, 1.464 billion RMB from anti-infection, 1.379 billion RMB from central nervous system disorders, and 1.296 billion RMB from metabolic and other diseases, accounting for 66.2%, 11.9%, 11.3%, and 10.6% of total revenue respectively [1] R&D Investment - The company invested 2.702 billion RMB in R&D, which accounted for 22% of total revenue, focusing on major disease areas such as oncology, central nervous system disorders, metabolism, and autoimmune diseases [2] - Key products in development include the lung cancer treatment Amelot, which has three indications entering NDA stage, and other drugs like HS-20094 and HS-10374 progressing to Phase III clinical trials [2] Business Development (BD) Cooperation - In 2024, revenue from BD cooperation reached 1.573 billion RMB, including a 185 million USD upfront payment from GSK for HS-20093 [4] - The company secured a global exclusive license for an oral GLP-1 small molecule from Merck, receiving an upfront payment of 112 million USD and potential milestone payments of up to 1.9 billion USD [4] - Collaborations with international pharmaceutical companies like GSK and Merck are aimed at accelerating global market expansion [4] Strategic Direction - The company aims to continue its transformation from generics to innovative drugs, leveraging R&D and international strategies while enhancing BD cooperation to optimize its global market presence [5]

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company has shown significant results in its innovative transformation, with internationalization accelerating. The revenue from innovative products is growing rapidly, and the core product, Amivantamab, is expected to reach peak sales of 8 billion yuan. The company continues to benefit from overseas licensing agreements, contributing positively to its performance [5][8]. Financial Performance Summary - For the fiscal year 2024, the company reported total revenue of 12.261 billion yuan, a year-on-year increase of 21.3%. Product sales revenue was 10.688 billion yuan, while collaboration and licensing income was 1.573 billion yuan. The net profit attributable to shareholders was 4.372 billion yuan, reflecting a year-on-year growth of 33.4% [6]. - The company’s operating income and profit both achieved double-digit year-on-year growth, with product sales revenue increasing by 13.65% compared to 9.403 billion yuan in 2023 [6]. Revenue and Profit Forecast - The company’s revenue forecast for 2025 is 13.604 billion yuan, with a projected growth rate of 10.95%. The net profit attributable to shareholders is expected to be 4.421 billion yuan, with a growth rate of 1.14% [7]. - The earnings per share (EPS) for 2025 is projected to be 0.74 yuan, with a return on equity (ROE) of 13.4% [7]. Innovative Product Performance - The revenue from innovative drugs grew by 38.1% year-on-year, reaching 9.477 billion yuan in 2024, accounting for 77.3% of total revenue. The sales of innovative drugs, excluding licensing income, are expected to reach approximately 8 billion yuan, reflecting a year-on-year increase of 28.5% [8]. - The company has a rich pipeline of innovative products, with several expected to be approved soon, providing long-term support for its innovative transformation [8]. Market Position and Future Outlook - The company is well-positioned for future growth, with expectations that the proportion of revenue from innovative drugs will exceed 80% by 2025. The sales of Amivantamab are projected to reach 6 billion yuan, with an upward revision of peak sales to 8 billion yuan [8].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 25.00 [6][8][17] Core Insights - The company's revenue for 2024 is expected to increase by 21.3% to RMB 12.26 billion, with a net profit growth of 33.4%, exceeding expectations [1][6] - The oncology drug segment is projected to contribute 61.2% of the total product sales revenue in 2024, driven by strong performance from the core product Amelot, which is expected to see sales growth of 19.9% [2] - The company has established a partnership with Merck for the development and commercialization of a GLP-1 receptor agonist, which is expected to enhance its capabilities in the metabolic field [4] - The company is currently developing 40 innovative drugs, with several in late-stage clinical trials, indicating a promising pipeline for future growth [5] Financial Summary - The company's revenue is projected to grow from RMB 10.10 billion in 2023 to RMB 12.26 billion in 2024, with a compound annual growth rate (CAGR) of 21.3% [7][14] - Shareholder net profit is expected to rise from RMB 3.28 billion in 2023 to RMB 4.37 billion in 2024, reflecting a growth rate of 33.4% [7][14] - The gross margin is anticipated to improve by 1.2 percentage points, while sales and administrative expenses as a percentage of product sales revenue are expected to decrease [1][7] Product and Market Developments - The oncology drug business is expected to grow from approximately RMB 6.55 billion in 2024 to RMB 10.97 billion by 2027, with a CAGR of 18.8% [2] - The anti-infection drug revenue is projected to increase by 15.0% to RMB 1.46 billion in 2024, primarily driven by the strong sales of the hepatitis drug Hengmu [3] - The company has received multiple recommendations for its products in clinical guidelines, which is expected to support future sales growth [3]

Investment Rating - The report maintains a "Strong Buy" investment rating for the company [3][7]. Core Insights - The company achieved a revenue of 12.261 billion CNY in 2024, representing a year-on-year growth of 21.3%, and a profit of 4.372 billion CNY, up 33.4% year-on-year [1][2]. - The sales revenue from innovative drugs and collaborative products reached 9.477 billion CNY in 2024, a 38.1% increase, accounting for 77.3% of total revenue [7]. - The company has shown strong cost control, with a gross margin of 91% in 2024, an increase of 1.2 percentage points year-on-year [7]. - The company is actively pursuing global collaborations, enhancing its competitive edge, with significant partnerships established in 2024 [7]. Financial Data and Valuation - The company’s projected revenues for 2025-2027 are 13.714 billion CNY, 15.395 billion CNY, and 17.378 billion CNY, with respective year-on-year growth rates of 12%, 12%, and 13% [2][9]. - The projected net profits for 2025-2027 are 4.588 billion CNY, 5.152 billion CNY, and 5.930 billion CNY, with growth rates of 5%, 12%, and 15% respectively [7][9]. - The company’s PE ratios for 2025-2027 are projected to be 24.6, 21.9, and 19.1 [9]. Shareholder Information - The total market capitalization of the company is 120.5 billion HKD, with a total share capital of 5,936 million shares [3]. - The major shareholder, Sunrise Investment Advisors Limited, holds a 65.7% stake in the company [3]. Performance Metrics - The company’s return on equity (ROE) is reported at 15.2% for 2024, with a projected increase to 15.4% by 2027 [9]. - The asset-liability ratio is notably low at 9.4% in 2024, indicating strong financial stability [9].