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]

Summary of the Conference Call for Innovent Biologics Company Overview - **Company**: Innovent Biologics - **Industry**: Biopharmaceuticals, specifically focusing on oncology and immunotherapy Key Points and Arguments Oncology Products - **IBI363 Performance**: - Achieved a 12-month overall survival (OS) rate of 70.9% in third-line treatment for lung cancer and 82.2% in MSS colorectal cancer, comparable to first-line therapies [2][6] - Expected to be a strong candidate for first-line indications due to its promising data and safety profile [6][11] - **Sales Projections**: - Anticipated sales for oncology products to exceed 8 billion RMB in 2024 and reach 11 billion RMB in 2025 [3] Non-Oncology Products - **Product Launches**: - Launched several key products including Masitide, Tisotumab vedotin, and Toripalimab, establishing a robust non-oncology portfolio [5] - Masitide is projected to achieve peak sales exceeding 8 billion RMB due to its strong market positioning and user experience [2][8] Clinical Trial Success - **Clinical Data**: - Innovent's drugs have shown a disease control rate (DCR) exceeding 60% and a long duration of response (DOR), indicating a lower likelihood of resistance [12][13] - The DOR for colorectal cancer is reported at 7.5 months, with progression-free survival (PFS) expected to be 3-4 months [14] Strategic Development - **R&D Strategy**: - Focus on major cancer types while expanding into other cold and hot tumor populations, with nearly 20 products in the pipeline [15] - Continuous clinical trials for various cancers including liver, stomach, and ovarian cancers [15] Market Potential - **IBI363 Internationalization**: - High potential for international market entry, expected to be a key player among second-generation immuno-oncology drugs [7] - **Financial Outlook**: - Projected to turn profitable in 2025, with revenues expected to reach 11.8 billion, 15.4 billion, and 21.1 billion RMB from 2025 to 2027, respectively [26] - Estimated net profits of 800 million, 1.2 billion, and 3 billion RMB for the same period [26] Valuation - **DCF Valuation**: - Estimated reasonable market capitalization of approximately 221.5 billion HKD, with a target price of 100.29 HKD per share [27] Other Notable Products - **Tisotumab vedotin**: - Demonstrated significant efficacy and safety in treating thyroid eye disease, with peak sales expected to reach 2 billion RMB [19] - **PCSK9 Inhibitor**: - Tric monoclonal antibody for treating primary hypercholesterolemia has been well-received since its launch in August 2023, with peak sales projected to exceed 2 billion RMB [20] - **L23 for Psoriasis**: - Expected to provide effective treatment options for psoriasis and other autoimmune diseases, with a peak sales forecast of over 3 billion RMB [21] Innovations - **IBI302 for Age-related Macular Degeneration**: - A dual-target drug showing a 40% reduction in new macular atrophy cases compared to existing treatments, currently in phase III trials [22][23] - **IBI3,002 for Autoimmune Diseases**: - A novel dual-antibody targeting IL-4 and TSLP, showing promising results in preclinical studies, with initial data expected by year-end [25] Conclusion - Innovent Biologics is positioned for significant growth in both oncology and non-oncology sectors, with a strong pipeline and promising clinical data supporting its market potential and financial outlook. The company is recommended as a strong investment opportunity in the innovative pharmaceutical sector [27]

Core Viewpoint - The approval of the second indication for the drug Masitide injection by the National Medical Products Administration marks a significant advancement for the company in the treatment of type 2 diabetes, following its earlier approval for weight management [2][3]. Group 1: Product Approval and Features - Masitide injection has received approval for blood sugar control in adult patients with type 2 diabetes, following its earlier approval for weight loss in June [2]. - The injection pen features a hidden needle design and is a single-use device, utilizing X-cut technology to reduce injection pain [2]. Group 2: Clinical Research and Efficacy - Masitide is the world's first approved dual receptor agonist for GCG/GLP-1, improving insulin secretion and insulin resistance [2]. - The approval is based on two phase III clinical studies conducted in China, demonstrating that Masitide outperforms placebo and Dulaglutide 1.5mg in blood sugar control and weight management for adult type 2 diabetes patients [2]. - The drug also shows improvements in various cardiovascular, liver, and kidney-related metabolic indicators [2]. Group 3: Weight Management Results - In weight management, clinical studies indicate that patients treated with Masitide experienced an average weight loss of 21%, over 80% reduction in liver fat content, and reductions in waist and neck circumference [3]. - Multiple health indicators, including blood sugar, blood pressure, blood lipids, uric acid, and transaminases, have also shown improvement [3]. Group 4: Ongoing Research - Currently, there are four ongoing phase III clinical studies for Masitide, targeting populations with moderate to severe obesity, metabolic-related fatty liver disease (MAFLD), and obstructive sleep apnea (OSA) associated with obesity [3]. - A head-to-head comparison study with Semaglutide is being conducted among obese type 2 diabetes patients [3].

每经记者｜许立波 每经编辑｜魏官红 近年来，GLP-1受体激动剂类药物因在血糖控制、体重管理以及心血管等方面的综合获益为2型糖尿病 患者提供了更好的治疗选择。 依据信达生物方面提供的新闻稿，玛仕度肽此次获批降糖适应证，主要基于两项在中国开展的Ⅲ期临床 研究结果：DREAMS-1研究验证了其单药治疗的疗效与安全性，DREAMS-2研究则考察了其与口服降糖 药联合应用的效果。两项研究覆盖了最常见的两类糖尿病患者群体——单药治疗患者和口服药物控制不 佳的患者。结果显示，玛仕度肽在血糖控制和体重管理方面均优于安慰剂或度拉糖肽1.5毫克，同时还 能改善多项心血管、肝脏及肾脏相关的代谢指标。 除上述已完成的3项研究外，玛仕度肽目前还有4项Ⅲ期临床研究正在进行，研究对象涵盖中重度肥胖、 超重或肥胖合并代谢相关脂肪性肝病（MAFLD）、合并肥胖的阻塞性睡眠呼吸暂停（OSA）等人群， 并在合并肥胖的2型糖尿病患者中开展与司美格鲁肽的头对头对比研究。 封面图片来源：视觉中国-VCG41182058084 在减重方面，玛仕度肽今年6月以信尔美的商品名在国内获批，成为全球首个GCG/GLP-1双受体激动减 重药物。作为首款国产GLP ...