2025 年 9 月 4 日 公司研究 产品矩阵强大丰富，多款后期临床项目取得重要里程碑 ——信达生物（1801.HK）2025 年半年报点评 买入（维持） 当前价：107.00 港元 作者 分析师：王明瑞 执业证书编号：S0930520080004 021-52523867 wangmingrui@ebscn.com 分析师：张瀚予 执业证书编号：S0930523070010 021-52523861 zhanghanyu@ebscn.com 资料来源：Wind 相关研报 替妥尤单抗注射液上市申请获得受理，商业 化前景可期——信达生物（1801.HK）公告 点评（2024-05-23） 要点 事件： 公司发布 2025 年半年报，2025H1 实现营业收入 59.53 亿元，同比+50.6%。其中 产品销售收入为 52.34 亿元，同比+37.3%，授权费收入为 6.66 亿元；净利润为 8.34 亿元，去年同期为净亏损 3.93 亿元，实现转亏为盈。 | 市场数据 | | | --- | --- | | 总股本(亿股) | 17.13 | | 总市值(亿港元)： | 1833 | | 一年最低/最高(港元 ...

Group 1 - The core viewpoint of the report is that the operational profitability of Innovent Biologics (01801) in the first half of 2025 exceeded expectations, leading to an upward revision of the net profit forecast for 2025 by 84.3% to 871 million yuan [1] - The company reported a revenue of 5.95 billion yuan in 1H25, representing a year-on-year increase of 50.65%, which met expectations, while the net profit attributable to shareholders was 834 million yuan, significantly exceeding forecasts due to scale effects and improved operational efficiency [2] - The sales revenue from innovative products reached 5.23 billion yuan in 1H25, up 37.3% year-on-year, with strong performance from the oncology product portfolio, including a revenue of 275 million USD for Sintilimab, which grew by 16% year-on-year [3] Group 2 - The company achieved significant progress in its new generation pipeline, with promising proof of concept (PoC) data for IBI363 presented at the 2025 ASCO conference, and has initiated key clinical trials for various cancers [4] - The company is exploring a multi-dimensional innovative product portfolio, including new ADCs and oral GLP-1 therapies, which are expected to enter phase I clinical trials, indicating potential for future growth [5]

Core Viewpoint - CICC has raised its net profit forecast for Innovent Biologics (01801) for 2025 by 84.3% to 871 million yuan, maintaining the 2026 net profit forecast at 1.3 billion yuan, while increasing the target price by 24.1% to HKD 118.3, indicating a 30.0% upside potential from the current stock price [1]. Group 1 - The company's 1H25 performance exceeded expectations, with revenue of 5.95 billion yuan, a year-on-year increase of 50.65%, and a net profit of 834 million yuan, significantly surpassing CICC's expectations due to scale effects and improved operational efficiency [2]. - The sales revenue from the company's products in 1H25 reached 5.23 billion yuan, up 37.3% year-on-year, with a gross margin of 86.0%, an increase of 3.1 percentage points year-on-year, driven by the strong performance of the oncology product portfolio [3]. Group 2 - The company has successfully commercialized five new drugs as of mid-2025, expanding its product portfolio to 16, with significant contributions expected from new products like Masituzumab and the potentially approved Pikanqi monoclonal antibody in the second half of the year [3]. - The company has made notable progress in its next-generation pipeline, with promising proof-of-concept data for IBI363 presented at the 2025 ASCO conference, and ongoing clinical trials for various indications, including colorectal cancer and non-small cell lung cancer [4]. Group 3 - The company is exploring a multi-dimensional innovative product portfolio, with new ADCs and oral GLP-1 candidates entering phase I clinical trials, indicating potential for more growth points in the future [5].

Investment Rating - The investment rating for the company is "Buy" with a target price of 95.42 HKD, compared to the last closing price of 74.25 HKD [1][10]. Core Views - The report highlights that the clinical data for IBI363, a dual-specific antibody fusion protein, has exceeded expectations in treating advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and melanoma [3][4][5][6]. - The company is expected to see significant revenue growth, with projected revenues of 94.22 billion HKD in 2024, increasing to 207.91 billion HKD by 2027, reflecting a growth rate of 51.82% in 2024 and 31.60% in 2027 [11][15]. Summary by Sections Company Overview - The total share capital is 1.65 billion shares, with a total market capitalization of 1,225 billion HKD [2]. - The company has a strong pipeline with multiple important developments expected in 2025, including approvals for various treatments [9]. Clinical Data - IBI363 showed a median progression-free survival (mPFS) of 9.3 months and a 12-month overall survival (OS) rate of 70.9% in patients with immune-resistant lung squamous cell carcinoma [4]. - In CRC patients, IBI363 demonstrated a median overall survival (mOS) of 16.1 months, indicating a significant improvement over existing treatment options [5]. - For melanoma, IBI363 achieved an mPFS of 5.7 months, with ongoing trials comparing it to pembrolizumab in treatment-naive patients [6]. Financial Projections - The company is projected to achieve a net profit of 6.23 billion HKD in 2025, with a significant increase to 30.77 billion HKD by 2027, reflecting a net profit growth rate of 132.26% in 2027 [11][15]. - The earnings per share (EPS) is expected to rise from -0.06 HKD in 2024 to 1.87 HKD in 2027 [11][15]. Valuation - The valuation methods used include DCF and NPV, resulting in a target market value of 1,574 billion HKD, which corresponds to the target stock price of 95.42 HKD [10].

Core Viewpoint - The company has presented preliminary data for IBI363 at the ASCO conference, demonstrating breakthrough efficacy in both hot tumors (NSCLC) and cold tumors (MSS CRC/mucosal melanoma) [1][2]. Group 1: Efficacy Data - In NSCLC, patients treated with IBI363 at a dose of 3 mg/kg showed a median progression-free survival (mPFS) of 7.3 months, indicating excellent performance [1][2]. - For MSS CRC, the median overall survival (mOS) reached 16.1 months in a mixed-dose single-agent treatment, approaching the benefits seen in first-line patients [1][3]. - In squamous NSCLC, the clinical objective response rate (cORR) was 36.7% with a disease control rate (DCR) of 90.0% [2]. - In cold tumors, IBI363 demonstrated an mOS of 16.1 months in MSS CRC, significantly exceeding the current treatment standard of 9-10 months [3][4]. Group 2: Safety Profile - The incidence of treatment-emergent adverse events (TEAEs) was reported at 99.3%, with 42.6% being grade 3 or higher [2]. - Only 6.6% of patients discontinued treatment due to TEAEs, and the mortality rate attributed to TEAEs was very low at 2.9% [2]. Group 3: Future Developments - The company plans to communicate with regulatory authorities regarding key registration clinical trials for squamous NSCLC, with expectations to initiate Phase III trials within the year [3][6]. - IBI363 is anticipated to reshape the immune environment for IO-resistant lung cancer patients, potentially replacing docetaxel as the new standard of care [2][4]. Group 4: Pipeline and Financial Outlook - The company is advancing its core pipeline, with expectations for multiple catalysts in 2025, including new indications for existing products [5][6]. - Revenue projections for the company are estimated at 11.856 billion, 15.613 billion, and 21.479 billion yuan for 2025-2027, with a target market valuation of 131.9 billion HKD [6].

Market Overview - On May 7, the Hang Seng Index opened significantly higher due to policy support from the "One Bank, One Commission, One Bureau" press conference, reaching a peak of 23,197 points before closing at 22,691 points, a slight increase of 30 points or 0.1%[1] - The Hang Seng Tech Index fell by 0.8%, closing at 5,200 points, with total market turnover exceeding HKD 240.1 billion and a net outflow of HKD 7.87 billion from the Stock Connect[1] Sector Performance - Major state-owned enterprises in banking, insurance, and telecommunications supported the market, with four major banks rising between 0.4% and 2.0%[1] - AIA (1299 HK) saw its stock price increase by 2.9% over four consecutive trading days following the release of Q1 operational data[1] - REITs like Link REIT (823 HK) and Prosperity REIT (778 HK) rose by 6.7% and 2.7%, respectively, after the announcement of including REITs in the Shanghai-Hong Kong Stock Connect[1] Policy Impacts - The People's Bank of China announced a 0.25 percentage point reduction in the personal housing provident fund loan rate, lowering the five-year first home loan rate from 2.85% to 2.6%[3] - The China Securities Regulatory Commission emphasized enhancing the role of the National Social Security Fund to stabilize the market, indicating a proactive approach to financial regulation[2] Real Estate Market Dynamics - New home transaction volume in 30 major cities reached 149 million square meters, a year-on-year increase of 42.2%, indicating a rebound in the real estate market[9] - The inventory-to-sales ratio for major cities was 98.4, higher than last year but lower than the previous week, suggesting a tightening market[11] Automotive Sector Insights - Li Auto (2015 HK) reported sales of 11,400 vehicles for the week ending May 4, up from 8,600 the previous week, indicating strong demand ahead of the launch of new models[4] - Geely Auto (175 HK) proposed a privatization offer for Zeekr (ZK US) at a 20% premium to its 30-day average price, which is expected to positively impact Geely's stock price[4]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company is expected to see significant revenue growth, with total revenue projected to reach CNY 11.49 billion in 2025, representing a year-on-year increase of 21.96% [1] - The company has entered a commercialization phase for its chronic disease pipeline, which is anticipated to create a second growth curve alongside its oncology products [8] - The company aims to achieve a domestic sales target of CNY 20 billion by 2027 and plans to have five pipelines enter global Phase III studies by 2030 [8] - The IBI363 product, targeting immune-oncology, is highlighted for its potential breakthroughs in various patient populations and has received two FDA Fast Track Designations [8] - The report emphasizes the company's ongoing internationalization efforts and the expected acceleration of its product portfolio [8] Financial Projections - Revenue forecasts for 2025 and 2026 are CNY 11.49 billion and CNY 15.18 billion, respectively, with net profit projections of CNY 574.47 million and CNY 2.19 billion [1] - The company is expected to achieve profitability as its product mix expands and costs are effectively managed, with a projected net profit of CNY 3.03 billion by 2027 [8] - The current market capitalization corresponds to a P/E ratio of 157 for 2025, 41 for 2026, and 30 for 2027 [8]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company is expected to see significant revenue growth, with total revenue projected to reach RMB 11.49 billion in 2025, representing a year-on-year increase of 21.96% [1] - The company has entered a commercialization phase for its chronic disease pipeline, which is anticipated to create a second growth curve alongside its oncology products [8] - The company aims to achieve a domestic sales target of RMB 20 billion by 2027 and plans to have five pipelines enter global Phase III studies by 2030 [8] - The IBI363 product, targeting immune-oncology, is highlighted for its potential breakthroughs in various patient populations and has received two FDA Fast Track Designations [8] - The report forecasts a net profit of RMB 574.47 million in 2025, with a substantial increase to RMB 3.03 billion by 2027, indicating a strong recovery and profitability trajectory [1] Financial Projections - Total revenue is projected to grow from RMB 9.42 billion in 2024 to RMB 20.09 billion by 2027, with a compound annual growth rate (CAGR) of approximately 32.36% [1] - The net profit is expected to turn positive in 2025, reaching RMB 574.47 million, and further increasing to RMB 3.03 billion by 2027 [1] - The earnings per share (EPS) is projected to improve from RMB -0.06 in 2024 to RMB 1.84 in 2027, reflecting a strong recovery in profitability [1]

Investment Rating - The report maintains a "Buy" rating for the company based on its growth potential and market positioning [16]. Core Insights - The report highlights the increasing government support for fertility policies, which is expected to boost the maternal and infant sector, leading to a rise in related consumption [12][11]. - The company is positioned to benefit from the growing demand for health and wellness products, particularly in the context of traditional Chinese medicine and modern health trends [16][14]. - The report emphasizes the importance of stable housing prices in driving consumer spending, linking real estate stability to overall economic recovery [15][12]. Summary by Sections Fertility and Maternal-Infant Sector - The government has introduced various policies to encourage childbirth, including financial subsidies and improved childcare services, which are expected to positively impact the maternal and infant market [12][11]. - Local governments are also implementing supportive measures, such as direct financial incentives for families with multiple children [12]. Real Estate and Consumer Spending - The report discusses the correlation between housing prices and consumer spending, noting that a stable real estate market is crucial for economic recovery [15]. - Recent government actions aim to stabilize housing prices and support consumer demand, indicating a proactive approach to economic management [15][12]. Company Performance and Market Position - The company has a diversified product portfolio that includes traditional health products and modern wellness items, positioning it well to capture market growth [16][14]. - The report forecasts significant revenue growth for the company, driven by the increasing demand for its health-related products and the expansion of its market reach [16].