年報 2024 ANNUAL REPORT 目錄 | 公司簡介 | 2 | | --- | --- | | 公司資料 | 3 | | 主席報告 | 5 | | 財務摘要 | 7 | | 業務摘要 | 10 | | 管理層討論與分析 | 13 | | 董事會報告 | 38 | | 董事及高級管理層 | 76 | | 企業管治報告 | 82 | | 獨立核數師報告 | 100 | | 綜合損益及其他全面收入表 | 106 | | 綜合財務狀況表 | 107 | | 綜合權益變動表 | 109 | | 綜合現金流量表 | 110 | | 綜合財務報表附註 | 112 | | 五年財務摘要 | 212 | | 釋義 | 214 | 公司簡介 概覽 信達生物製藥集團成立於2011年，以開發出老百姓用得起的 高質量生物藥為使命和目標，公司成長為一家領先的生物製藥 公司，並已打造符合全球質量標準的全面集成生物製藥平台， 集研發、臨床開發、生產製造及商業化能力於一體。本公司致 力於開發、生產和銷售腫瘤、CVM、自身免疫、眼科等重大 疾病領域的創新藥物。本公司已建立起一條豐富的產品管線， 涵蓋一系列創新藥物形式（包括單克隆抗體 ...

Core Insights - Innovent Biologics is showcasing preclinical data on multiple novel bispecific antibodies, tri-specific antibodies, and bispecific antibody-drug conjugates (ADCs) at the AACR Annual Meeting 2025, highlighting its advancements in oncology research [1][2] Research Highlights - IAR037, a novel CD40/PD-L1 bispecific antibody, shows potent anti-tumor efficacy in PD-1-resistant models and has a favorable safety profile in cynomolgus monkeys [3][4] - IBI3010, a FRα targeting biparatopic ADC, demonstrates superior cytotoxicity compared to existing treatments and is being developed for FRα-expressing tumors [5][6] - IBI3014, a TROP2xPD-L1 bispecific ADC, integrates tumor killing with immune checkpoint blockade, showing promising efficacy and safety in preclinical models [8][9] - IBI3022 targets Trop2 and B7H4, exhibiting improved efficacy and safety profiles for gynecologic cancers [10][11] - IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, shows potential as a new immuno-oncology therapy with strong immune activation [12][13] - IBI3019, a tri-specific antibody for colorectal cancer, demonstrates potent efficacy and an excellent safety profile in preclinical studies [16][17] - A novel PD1-IFNα fusion protein shows superior anti-tumor efficacy compared to PD1 mAb alone, potentially benefiting patients with ICB-refractory cancers [18][19][20] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, having launched 15 products and with multiple assets in clinical trials [21]

Core Viewpoint - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for limertinib as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, marking a significant advancement in cancer treatment options in China [1][5]. Group 1: Drug Approval and Clinical Trial Results - The approval of limertinib is based on positive outcomes from a Phase 3 clinical trial involving 337 treatment-naïve patients, which demonstrated significant improvements in progression-free survival (PFS) compared to gefitinib [2][3]. - Limertinib achieved a median PFS of 20.7 months versus 9.7 months for gefitinib, indicating a 56% risk reduction in disease progression or death [3]. - In patients with central nervous system (CNS) lesions, limertinib also showed a median CNS PFS of 20.7 months compared to 7.1 months, representing a 72% risk reduction for CNS progression or death [3]. Group 2: Safety Profile and Efficacy - The safety profile of limertinib aligns with known EGFR-targeted therapies, with adverse events primarily mild to moderate and no new safety signals identified during the trial [4]. - The drug has shown exceptional efficacy as a first-line therapy, particularly in patients with brain metastases, addressing a critical clinical need in this population [5]. Group 3: Company Strategy and Collaborations - Innovent has established a commercial collaboration with ASK Pharm for limertinib in Mainland China, enhancing its market presence and treatment accessibility [1][9]. - The company is focused on expanding its portfolio of precision therapies for lung cancer, which includes limertinib and other targeted therapies [6]. - ASK Pharm is also advancing a clinical trial for limertinib in combination with a cMET inhibitor for NSCLC patients resistant to third-generation EGFR-TKIs, indicating ongoing innovation and collaboration in treatment development [6]. Group 4: Industry Context - Lung cancer is one of the most common and deadly cancers globally, with NSCLC accounting for approximately 85% of cases, and EGFR mutations are prevalent among Asian NSCLC patients [7]. - EGFR-TKIs are the standard of care in the first-line setting, with third-generation EGFR-TKIs like limertinib offering broad treatment applicability [7]. Group 5: About Innovent - Innovent Biologics, founded in 2011, aims to provide affordable, high-quality biopharmaceuticals and has launched 15 products, with several more under regulatory review or in clinical trials [10]. - The company collaborates with over 30 global healthcare companies, enhancing its research and development capabilities [10].

证券研究报告 医药生物 | 生物制品 港股|公司点评报告 hyzqdatemark 2025 年 04 月 10 日 | 基本数据 | 2025 | 年 04 | 月 | 09 | 日 | | --- | --- | --- | --- | --- | --- | | 收盘价（港元） | | | | 42.20 | | | 一年内最高/最低（港 | | | 52.15/28.65 | | | | 元） | | | | | | | 总市值（百万港元） | | | | 69,552.86 | | | 流通市值（百万港元） | | | | 69,552.86 | | | 资产负债率（%） | | | | 39.28 | | | 资料来源：聚源数据 | | | | | | 信达生物(01801.HK) 投资评级： 买入（维持） ——超预期实现盈利，全球化布局加速推进 投资要点： 风险提示：竞争格局恶化风险、销售不及预期风险、行业政策风险等。 | 盈利预测与估值（人民币） | | | | | | | --- | --- | --- | --- | --- | --- | | | 2023 | 2024 | 2025E ...

Investment Rating - The investment rating for the company is "Buy" and is maintained [8]. Core Insights - The company achieved its first Non-IFRS profit in 2024, with total revenue of 9.42 billion RMB (up 51.8% year-on-year), product revenue of 8.23 billion RMB (up 43.6% year-on-year), net profit of 330 million RMB, EBITDA of 410 million RMB, and a gross margin of 84.9% (up 2.1% year-on-year). The sales and administrative expense ratio decreased to 50.9% (down 7.1% year-on-year), with cash on hand of 10.22 billion RMB and R&D investment of 2.5 billion RMB [2][5][8]. Summary by Sections Financial Performance - In 2024, the company reported a total revenue of 9.42 billion RMB, marking a 51.8% increase year-on-year. Product revenue reached 8.23 billion RMB, reflecting a 43.6% year-on-year growth. The net profit was 330 million RMB, with an EBITDA of 410 million RMB and a gross margin of 84.9% [2][5][8]. Strategic Goals - The company has set clear strategic goals for the next decade, aiming for a product revenue of 20 billion RMB by 2027 and plans for five pipelines to enter global multi-center Phase III clinical trials by 2030 [8]. Product Development - The company has seen significant growth in new products, with strong sales performance from its main products, including 达伯舒® (信迪利单抗注射液) and others. The product portfolio is expanding with new targeted drugs, including 达伯特® (KRAS G12C) and others. Notable new drug approvals include 信必乐® and 信必敏® [8]. Long-term Growth Drivers - The long-term growth is driven by the oncology and comprehensive product lines, with expectations of reaching 20 billion RMB in product revenue by 2027. The company plans to leverage at least 20 approved products and expand into new clinical innovations and indications [8]. Profit Forecast - The company forecasts net profits of 631 million RMB, 1.142 billion RMB, and 1.570 billion RMB for 2025, 2026, and 2027 respectively, with corresponding EPS of 0.38 RMB, 0.69 RMB, and 0.95 RMB [8].

Investment Rating - The report maintains a "Buy" rating for the company [3][4]. Core Insights - The company achieved a significant revenue growth of 51.8% in 2024, with product revenue increasing by 43.6%, primarily driven by strong sales of its core product, Sintilimab, and the commercialization of new products [3][4]. - The company reported a narrowed net loss of 0.95 billion yuan, a 90.79% improvement year-on-year, and achieved Non-IFRS net profit of 0.33 billion yuan, marking a milestone in profitability [3][4]. - The product portfolio expanded to 15 commercialized products, including three new lung cancer targeted therapies and the world's first non-covalent BTK inhibitor [3][4]. - The company is accelerating its global expansion in the oncology field, with several clinical trials underway for innovative therapies [3][4]. - The report forecasts revenue growth for the company to reach 108.18 billion yuan in 2025, 143.06 billion yuan in 2026, and 200.22 billion yuan in 2027, with corresponding net profits of 1.87 billion yuan, 15.17 billion yuan, and 41.06 billion yuan respectively [4][6]. Financial Summary - In 2024, the company reported total revenue of 94.22 billion yuan, with a gross margin of 84.0% and a sales expense ratio of 46.1% [3][4]. - Research and development expenses amounted to 26.81 billion yuan, with cash reserves of 102.21 billion yuan [3][4]. - The projected earnings per share (EPS) are expected to improve from -0.06 yuan in 2024 to 2.51 yuan in 2027 [4][6]. - The company's estimated market value range is between 929.56 billion yuan and 1,232.13 billion yuan, translating to approximately 1,007.41 billion to 1,335.31 billion Hong Kong dollars [3][4].

Investment Rating - The report maintains a "Buy" rating for the company, expecting a relative return of over 20% within the next six months [7]. Core Insights - The company achieved a total revenue of 9.42 billion RMB in 2024, representing a year-on-year growth of 51.8%. Product revenue reached 8.23 billion RMB, up 43.6% year-on-year. The company also reported its first positive Non-IFRS profit of 330 million RMB and an EBITDA of 410 million RMB, with IFRS losses narrowing by 90.8% [1]. - The company has seen a decrease in various expense ratios, with sales expenses at 4.347 billion RMB (46.14% of revenue, down 3.83 percentage points), R&D expenses at 2.681 billion RMB (28.45%, down 7.45 percentage points), and administrative expenses at 738 million RMB (7.83%, down 4.25 percentage points). This reduction in expense ratios is attributed to significant revenue growth [2]. - The company is expected to launch six new drugs in 2025, with one drug entering the medical insurance system. Several products are nearing commercialization, which will serve as a significant growth driver. Recently, five new products were approved for market, including drugs targeting various cancers and conditions [3]. - The company has promising products in the pipeline, particularly in the weight loss sector with the drug Masitide, which is expected to yield data from ongoing studies by the end of 2025. In oncology, early data from several products have shown strong potential, with international clinical trials underway [4]. - Revenue forecasts for 2025-2026 have been revised upwards, with expected revenues of 11.518 billion RMB and 14.721 billion RMB, respectively. Net profit estimates for the same period have also been increased to 515 million RMB and 1.830 billion RMB. The revenue for 2027 is projected to reach 20.020 billion RMB, with net profit expected at 3.109 billion RMB [5].

Investment Rating - The report maintains a "BUY" rating for Innovent Biologics, indicating a potential return of over 15% over the next 12 months [16]. Core Insights - Innovent Biologics is entering a phase of sustainable profitability, having achieved a full-year non-IFRS net profit of RMB332 million in FY24, driven by strong product revenue growth and one-off license fee income [8]. - The target price has been revised upwards from HK$57.67 to HK$61.71, reflecting a 33.6% upside potential from the current price of HK$46.20 [3][8]. - The company is advancing its next-generation immuno-oncology (IO) therapies and antibody-drug conjugates (ADCs), with significant clinical programs underway [8]. Financial Summary - Revenue is projected to grow from RMB6,206 million in FY23 to RMB11,356 million in FY25, representing a year-on-year growth of 51.8% [2][13]. - Net profit is expected to turn positive in FY25, reaching RMB445.7 million, with EPS projected at RMB0.27 [2][11]. - R&D expenses are forecasted to remain stable, while gross profit margin is expected to expand to 84.9% in FY24 from 82.8% in FY23 [2][8]. Share Performance - The market capitalization of Innovent Biologics is approximately HK$75.68 billion, with a 52-week high of HK$51.15 and a low of HK$30.00 [3][4]. - The stock has shown strong performance, with a 1-month absolute return of 14.2% and a 3-month return of 29.8% [5]. Pipeline and Growth Potential - Innovent has a robust pipeline with over 10 ADC clinical programs and is focusing on combination trials with its next-generation IO therapy, IBI363 [8]. - The company aims to initiate multiple Phase 3 trials by 2030, targeting global markets with its innovative therapies [8].

Investment Rating - The report maintains an investment rating of "Buy-A" for the company, with a 6-month target price of HKD 57.32 [5][4]. Core Insights - The company reported a revenue of HKD 94.2 billion for 2024, representing a year-on-year growth of 51.8%, with product revenue reaching HKD 82.3 billion, up 43.6% [1]. - The company is advancing its PD-1/IL-2 dual antibody IBI363, which is expected to showcase updated proof-of-concept data at the 2025 ASCO conference and initiate multiple registration clinical studies in 2025 [2]. - The company aims to achieve product revenue of HKD 20 billion by 2027, demonstrating strong confidence in the growth of its innovative drug portfolio [3]. Financial Projections - Revenue projections for the company are estimated at HKD 118.96 billion, HKD 157.49 billion, and HKD 199.78 billion for the years 2025, 2026, and 2027 respectively, with corresponding net profits of HKD 6.50 billion, HKD 17.75 billion, and HKD 28.78 billion [4][10]. - The company anticipates that five of its pipelines will enter global multi-center phase 3 clinical trials by 2030, indicating a robust pipeline for future growth [3]. Market Position and Strategy - The company is focusing on internationalization, with IBI363 positioned as a cornerstone drug for next-generation immuno-oncology therapies, highlighting its potential for overseas licensing [2]. - The company plans to launch several key products, including IBI311 and a GLP-1R/GCGR dual-target peptide product, which are expected to contribute significantly to revenue growth [3].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1][6][14] Core Insights - The company achieved a significant turnaround in 2024, with total revenue reaching 94.22 billion yuan, a year-on-year increase of 51.8%. Product revenue was 82.28 billion yuan, up 43.6% year-on-year, and the company reported a Non-IFRS net profit of 3.32 billion yuan, marking a 164.4% year-on-year improvement [6][9] - The company maintains a strong growth trajectory, with a target of 20 billion yuan in revenue by 2027, supported by the robust performance of its leading product, Sintilimab (PD-1), and the rapid commercialization of new products [7][9] - The company plans to accelerate its pipeline development, aiming to have five innovative products enter global Phase III clinical trials by 2030, indicating strong potential for international expansion [7] Financial Summary - In 2024, the company reported a gross profit of 79.12 billion yuan, a 56.1% increase year-on-year, and a net loss of 0.95 billion yuan, which represents a 90.8% reduction in losses [6][9] - The company's financial projections for 2025 to 2027 indicate a steady increase in revenue and profitability, with expected net profits of 1.62 billion yuan in 2025, 11.29 billion yuan in 2026, and 27.21 billion yuan in 2027 [6][9] - Key financial ratios show an improvement in profitability, with a projected net profit margin of 14.6% by 2027 and a return on equity (ROE) of 18.4% [9][11]