香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 本公告僅供參考之用，並不構成收購、購買或認購本公司任何證券之邀請或要約。 信達生物制藥 本公告由本公司根據香港聯合交易所有限公司證券上市規則第13.09條及第13.28 條以及香港法例第571章證券及期貨條例第XIVA部作出。 與武田製藥達成全球戰略合作，加速本公司新一代IO及ADC療法推向全 球市場 董事會欣然宣佈，於2025年10月22日（香港時間），信達生物與武田製藥（透過 武田製藥全資附屬公司Takeda Pharmaceuticals International AG）達成全球戰略 合作，旨在加速推進信達生物新一代IO及ADC療法開發，拓展全球市場價值。 本次合作包括兩款後期在研療法IBI363 (PD-1/IL-2α-bias)及IBI343 (CLDN18.2 ADC)，以及一款早期研發項目IBI3001 (EGFR/B7H3 ADC)的選擇權。 根據合作，信達生物與武田製藥將在全球範圍內 ...

Summary of Innovent Biologics Conference Call Company Overview - **Company**: Innovent Biologics - **Industry**: Biotechnology - **Focus**: Development and commercialization of innovative therapies, particularly in oncology and metabolic diseases Key Takeaways 1. Product Differentiation and Market Positioning - **Mazdutide**: Launched for obesity in July and recently approved for diabetes, it is positioned as a differentiated GLP-1 dual agonist targeting both GLP-1 and GIP pathways, significantly reducing liver fat, which is crucial for Chinese patients with high hepatic fat despite lower BMI [2][18] - **Pricing Strategy**: The 4mg and 6mg doses are priced approximately 30% below tirzepatide and 30% above semaglutide, aiming to balance affordability with premium positioning [2][18] 2. Market Potential and Commercialization Strategy - **Addressable Market**: There are approximately 300 million overweight and 160 million obese adults in China, presenting a significant market opportunity [3][20] - **Multi-Channel Distribution**: Innovent is utilizing a broad distribution strategy that includes public hospitals, private hospitals, retail pharmacies, and online platforms, with non-hospital channels expected to drive incremental growth [3][18] 3. Financial Projections - **Revenue Targets**: Innovent aims for Mazdutide to contribute at least 25% of its RMB 20 billion revenue target by 2027, with an expected RMB 1 billion in the first 12 months [2][21] - **Financial Forecasts**: Projected revenues for FY 2024, 2025, 2026, and 2027 are RMB 9.42 billion, RMB 12.62 billion, RMB 15.46 billion, and RMB 20.03 billion respectively, with net profits expected to turn positive by 2025 [6] 4. Competitive Landscape - **Increasing Competition**: The GLP-1 market in China is becoming more competitive with generics and multinational entrants. Innovent's strategy focuses on brand equity and differentiated mechanisms to maintain market share [5][19] - **Regulatory Environment**: Inclusion in the National Reimbursement Drug List (NRDL) is critical for diabetes treatments, while obesity and specialty indications may rely on cash-pay models and emerging commercial insurance [5][27] 5. Pipeline and Future Developments - **Oncology and Autoimmune Pipeline**: Innovent is advancing a broad pipeline including next-generation immuno-oncology therapies and autoimmune treatments, with key assets like IBI363 and L23 progressing toward pivotal trials [4][28] - **Oral GLP-1 Development**: An oral GLP-1 candidate is in early-stage development, with FDA IND clearance expected and enrollment in China anticipated in the second half of 2025 [4][24] 6. Sustainability and Corporate Governance - **Sustainability Goals**: Innovent has set targets to reduce water and energy consumption and greenhouse gas emissions by 5% and 10% respectively by 2030, aiming for zero waste landfill by 2030 [17] 7. Investment Recommendation - **Rating**: Innovent is rated as a "Buy" with a price target of HK$105.00, reflecting a potential upside of 13% from the current price [7][31] 8. Risks and Challenges - **Market Risks**: Potential risks include fierce competition, pipeline delays, and regulatory challenges that could impact the achievement of financial targets [31][15] Conclusion Innovent Biologics is positioned strongly within the biotechnology sector, particularly with its innovative product Mazdutide. The company is leveraging a multi-channel commercialization strategy to tap into a vast market while navigating competitive dynamics and regulatory landscapes. The robust pipeline and sustainability initiatives further enhance its investment appeal, although risks remain that could affect future performance.

Core Viewpoint - Zhongyou Securities initiates coverage on Innovent Biologics (01801.HK) with a "Buy" rating, highlighting the company's leading position in the domestic oncology drug sector and its diverse pipeline that is expected to drive high growth in performance [1] Company Analysis - Innovent Biologics is recognized for its comprehensive pipeline layout in the oncology drug market, which is anticipated to support sustained high growth in revenue [1] - The company is projected to achieve net profits attributable to shareholders of 980 million, 1.58 billion, and 3.25 billion yuan for the years 2025, 2026, and 2027 respectively [1] - Corresponding price-to-earnings (PE) ratios are expected to be 162, 100, and 49 for the same years [1]

Core Viewpoint - Zhongyou Securities initiates coverage on Innovent Biologics (01801) with a "Buy" rating, projecting net profits of 0.98 billion, 1.58 billion, and 3.25 billion yuan for 2025-2027, corresponding to P/E ratios of 162, 100, and 49 respectively [1] Group 1: Financial Performance - In the first half of 2025, the company reported revenue of 5.95 billion yuan, a year-on-year increase of 50.6%, with product revenue at 5.23 billion yuan, up 37.3% [1] - EBITDA for the same period was 1.4 billion yuan, and net profit reached 1.2 billion yuan, with cash on hand amounting to 14.6 billion yuan [1] Group 2: Product Pipeline and Innovation - The company’s IBI363 has been approved to conduct global Phase III clinical trials, showcasing its potential as a next-generation IO cornerstone [2] - IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein, targeting both PD-1/PD-L1 pathways and activating the IL-2 pathway [2] - The clinical trial aims to recruit approximately 600 patients to compare the efficacy and safety of IBI363 against docetaxel in treating squamous non-small cell lung cancer [2] Group 3: Diverse Pipeline and Global Expansion - Innovent's pipeline is rich and diversified, with products in cardiovascular, metabolic, and endocrine fields, including approved drugs like Ma Shidu peptide and PCSK9 [3] - The company is focusing on unmet needs with its pipeline, including IBI3002, a first-in-class immune bispecific molecule targeting TSLP and IL4Rα, showing preliminary efficacy signals in asthma patients [3] - The ongoing clinical advancements are expected to enhance global licensing collaborations and accelerate the market entry of approved products across various regions [3]

Core Viewpoint - Zhongyi Securities initiates coverage on Innovent Biologics (01801) with a "Buy" rating, projecting net profits of 9.8 billion, 15.8 billion, and 32.5 billion yuan for 2025-2027, corresponding to PE ratios of 162, 100, and 49 respectively [1] Financial Performance - For the first half of 2025, the company reported revenue of 59.5 billion yuan, a year-on-year increase of 50.6%, with product revenue at 52.3 billion yuan, up 37.3% [1] - EBITDA stood at 14 billion yuan, and net profit was 12 billion yuan, with cash reserves of 146 billion yuan [1] Product Pipeline and Innovation - The company holds a leading position in the domestic oncology drug market, with a rich pipeline that is expected to drive high growth through gradual approvals [1] - IBI363, a globally innovative PD-1/IL-2α-bias bispecific fusion protein, has received approval to initiate global Phase III clinical trials, targeting squamous non-small cell lung cancer [2] - The development strategy focuses on addressing unmet needs in the IO-treated market, with plans for registration trials in lung cancer, melanoma, and third-line colorectal cancer in 2025 [2] Diversification and Global Expansion - The company has a diverse pipeline in cardiovascular, metabolic, and endocrine areas, with products like Marsdu and PCSK9 already approved [3] - The pipeline also includes dual antibodies aimed at improving patient quality of life in ophthalmology, and the first approved product in dermatology and rheumatology, showcasing BIC potential [3] - IBI3002, a globally first-in-class immune dual antibody, has shown preliminary efficacy signals in asthma patients, indicating ongoing clinical progress and potential for global partnerships [3]

Core Viewpoint - The company reported a strong performance in the first half of 2025, with significant revenue growth driven by its oncology and comprehensive pipelines, indicating a robust market position and future growth potential [1][4]. Financial Performance - The company achieved a revenue of 5.95 billion yuan in 25H1, representing a year-on-year increase of 50.6%, with product revenue at 5.23 billion yuan, up 37.3% [1]. - EBITDA for the period was 1.4 billion yuan, and net profit reached 1.2 billion yuan, with cash on hand amounting to 14.6 billion yuan [1]. - The company’s EBITDA projections for 2024H1, 2024H2, and 2025H1 are -160 million, 570 million, and 1.41 billion yuan respectively, with net profits of -160 million, 490 million, and 1.21 billion yuan, indicating a trend of increasing profitability [2]. Product Pipeline and Innovation - The company has 16 commercialized products, with a strong focus on oncology, maintaining a leading position in the domestic market, particularly with its PD-(L)1 product, which holds the largest market share in China [1]. - The approval of IBI363 for global phase III clinical trials marks a significant step in validating its potential as a next-generation immuno-oncology treatment [3]. - The company is expanding its product pipeline in cardiovascular, metabolic, and endocrine areas, with several products already approved and in development, aiming to address unmet medical needs [3]. Strategic Outlook - The company emphasizes innovation with multiple products in development that have first-in-class (FIC) and best-in-class (BIC) potential, providing a strong long-term growth impetus [4]. - The company is expected to maintain high growth rates driven by its comprehensive pipeline and successful product launches, with projected net profits of 980 million, 1.58 billion, and 3.25 billion yuan for 2025-2027 [4].

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [1]. Core Insights - The company has demonstrated significant revenue growth, with a 50.6% year-on-year increase in revenue for the first half of 2025, reaching 5.95 billion yuan, driven by strong performance in its oncology and chronic disease product lines [4][5]. - The company is focusing on a global strategy, with the approval of IBI363 for a pivotal Phase III clinical trial, indicating its commitment to innovation and market expansion [6][8]. - The financial outlook is positive, with projected net profits increasing significantly from 979 million yuan in 2025 to 3.25 billion yuan by 2027, reflecting a robust growth trajectory [10][11]. Company Overview - The latest closing price is 104.70 HKD, with a total market capitalization of 179.4 billion HKD [3]. - The company has a debt-to-asset ratio of 38.88% and a price-to-earnings ratio of 144.43, indicating a relatively high valuation compared to its earnings [3]. Financial Projections - Revenue is expected to grow from 9.42 billion yuan in 2024 to 21.16 billion yuan by 2027, with a compound annual growth rate of approximately 34% [10]. - EBITDA is projected to increase from 409 million yuan in 2024 to 4.83 billion yuan in 2027, showcasing improved operational efficiency [10]. - The company anticipates a significant turnaround in net profit, moving from a loss of 95 million yuan in 2024 to a profit of 3.25 billion yuan in 2027 [10][11]. Investment Thesis - The company is well-positioned in the domestic oncology market, with a diverse product pipeline that is expected to drive sustained high growth [8]. - The focus on innovation and the development of first-in-class and best-in-class products provide a strong foundation for long-term growth [8].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年9月30日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 信達生物製藥 | | | | | | 呈交日期: | 2025年10月8日 | | | | | | I. 法定/註冊股本變動 | | | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 (註1) | 是 | | 證券代號 (如上市) | 01801 | 說明 | 普通股 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) ...

公司簡介 2025 INTERIM REPORT 中期報告 目錄 | 公司簡介 | 2 | | --- | --- | | 公司資料 | 3 | | 財務摘要 | 5 | | 業務摘要 | 8 | | 管理層討論與分析 | 12 | | 其他資料 | 35 | | 簡明綜合財務報表審閱報告 | 55 | | 簡明綜合損益及其他全面收入表 | 56 | | 簡明綜合財務狀況表 | 57 | | 簡明綜合權益變動表 | 59 | | 簡明綜合現金流量表 | 60 | | 簡明綜合財務報表附註 | 62 | | 釋義 | 91 | 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、多特異性抗體、 細胞因子、ADC、細胞治療及小分子藥物等）。 「始於信，達於行」，本公司秉持最高標準的行業規 ...

Summary of the Conference Call Industry Overview - The global PD-1/PD-L1 market is projected to reach $52.5 billion in 2024, with a year-on-year growth of 12.3% [2][4] - Merck's Keytruda holds a dominant market share of 56%, with sales of $29.48 billion, while BMS's Opdivo ranks second with a 19% market share and sales of $10.2 billion [4] - The top four products collectively account for over 90% of the market, indicating a high level of market concentration [2][4] Core Insights and Arguments - First-generation immuno-oncology (I/O) therapies have limited efficacy in solid tumors, benefiting only about 20% of patients, and are highly dependent on PD-L1 expression levels [2][7] - There is a pressing need for breakthrough treatment strategies to address primary and acquired resistance issues associated with first-generation therapies [8] - The second-generation I/O therapy market is expected to reach $200 billion, with innovative dual-target products like PD-VEGF and PD-IL2 emerging, particularly from Chinese companies such as Hengrui Medicine and BeiGene [2][9] Company-Specific Developments - Innovent Biologics' IBI363 is the world's first next-generation dual antibody, designed to provide breakthroughs in treating both hot and cold tumors, as well as resistant populations [2][9] - IBI363 extends the half-life of PD-1 monoclonal antibodies and employs alpha-bias IL-2 design to reduce peripheral toxicity while effectively stimulating CD8+ T cells [2][10] - Clinical data presented at the 2025 ASCO conference indicates that IBI363 shows broad therapeutic potential in various immune-resistant solid tumors, including melanoma, colorectal cancer, and non-small cell lung cancer [2][11] Mechanisms and Innovations - The mechanism of PD-1/PD-L1 inhibitors involves blocking the PD-1/PD-L1 signaling axis, which restores T cell function and enhances anti-tumor immune responses [5][6] - First-generation I/O therapies face limitations, particularly in cold tumors where CD8 T cells are restricted or absent, leading to low response rates [7] - The innovative alpha-bias design of IBI363 effectively stimulates activated CD8+ T cells, enhancing tumor-killing capabilities while minimizing side effects [10][12] Additional Important Points - The choice of alpha-bias design for IBI363 is based on the discovery that the IL-2 receptor alpha subunit is also highly expressed in activated CD8+ T cells, which can enhance tumor-killing efficiency [12] - The combination of PD-1 monoclonal antibodies with IBI363 is crucial for improving overall efficacy, as it targets key tumor-killing cells that express PD-1, CD25, and CD8 [13]