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 ...

Group 1 - The core viewpoint of the reports indicates a recovery in domestic innovative drug research and development due to the resurgence of capital market financing and an increase in overseas transactions for innovative drugs [1] - The price of experimental monkeys, essential for innovative drug research, has risen from approximately 85,000 yuan in mid-2024 to about 90,000 yuan [1] - The CXO industry is expected to see performance recovery in the second half of 2025, driven by the continuous upward momentum of innovative drugs primarily from overseas partners pushing clinical pipelines [1] Group 2 - The report highlights a shift in global early-stage drug innovation research from Europe and the US to China, with multinational pharmaceutical companies increasingly sourcing innovative pipelines from Chinese biotech firms [1] - The proposed administrative order by the Trump administration to restrict the import of experimental treatments from China has sparked intense lobbying from two opposing groups: US biotech investors facing competition from Chinese innovations and large pharmaceutical companies benefiting from low-cost Chinese drugs [1] - The report emphasizes that the income and profit scale of large US pharmaceutical companies far exceed that of US biotech firms, suggesting they may have greater lobbying influence [1] Group 3 - The announcement of a 100% tariff on patented drugs unless pharmaceutical companies build factories in the US is expected to have a limited impact on the CXO sector, as many multinational companies already have plans to establish facilities in the US [2] - Significant investment plans have been announced by several multinational pharmaceutical companies for building factories and R&D facilities in the US, including Eli Lilly's $27 billion and Roche's $50 billion investments over the next five years [2] - The report notes that the construction of factories in the US typically takes over five years, and the progress may be affected by political and market uncertainties [2]

Core Insights - The Hong Kong stock market is experiencing a significant surge in refinancing activities, driven by ample liquidity, valuation recovery, and corporate strategic expansion needs [1][4][5] Group 1: Refunding Scale - Hong Kong listed companies have raised over 280 billion HKD through various refinancing methods this year, marking a year-on-year increase of over 400% compared to 2022 [1][4] - The total amount raised has already surpassed the entire annual figure for 2024, which was 990.73 billion HKD [4] - Placement of shares has become the primary method for refinancing, accounting for 87.81% of the total, with 249.5 billion HKD raised through this method [4] Group 2: New Economy Enterprises - New economy enterprises are leading the refinancing trend, with BYD raising 43.38 billion HKD, marking the largest equity refinancing project in the global automotive industry in the past decade [6][7] - Xiaomi Group follows closely with 42.6 billion HKD raised, surpassing its total fundraising since its 2019 IPO and setting a record for Chinese tech hardware companies in overseas equity refinancing [7] - Other tech companies like Horizon Robotics and WuXi AppTec have also raised significant amounts, focusing on sectors such as biomedicine and artificial intelligence [7] Group 3: International Capital Involvement - The current refinancing wave has seen unprecedented participation from international institutional investors, including GIC and Al-Futtaim family office [9][10] - BYD's placement attracted numerous top long-term investors, with Al-Futtaim investing 3.5 billion HKD as a strategic investor [9] - Notable long-term funds like Wujin Capital have been actively investing in various companies, indicating strong international interest in the Hong Kong market [10]

Core Viewpoint - The potential imposition of a 100% tariff on imported brand and patented drugs by the Trump administration starting October 1, 2025, has raised concerns among pharmaceutical companies, particularly those in China, leading to a decline in their stock prices [2][3]. Group 1: Impact on Pharmaceutical Companies - The announcement of the tariff has caused significant declines in the stock prices of Chinese pharmaceutical companies, with Heng Rui Pharmaceutical dropping 3.03% in A-shares and 2.23% in Hong Kong shares, and BeiGene falling 4.38% in A-shares and 1.55% in Hong Kong shares [2]. - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma, which dropped 5.82%, and 3SBio, which fell by 5.34% [3]. - Industry experts suggest that the impact of the tariff on Chinese pharmaceutical companies may be limited, as many are focused on generic drugs and active pharmaceutical ingredients (APIs) [4]. Group 2: Industry Perspectives - Some industry leaders believe that the tariff policy may not be implemented as proposed, citing the high cost of drugs in the U.S. and the potential for political changes in future administrations [4][5]. - Companies like Heng Rui Pharmaceutical indicated that their current exports primarily consist of generics and APIs, suggesting minimal impact from the proposed tariffs [4]. - Other companies, such as Lepu Biopharma, noted that their licensing partnerships would shield them from significant effects [5]. Group 3: U.S. Policy Context - The Trump administration has previously threatened to impose tariffs on imported drugs, with discussions around a 200% tariff and subsequent smaller tariffs leading to a potential increase over time [6][7]. - Major multinational pharmaceutical companies have responded to the tariff threats by committing to significant investments in U.S. manufacturing, with companies like Novartis and Roche pledging $23 billion and $50 billion respectively over the next five years [8].

Core Viewpoint - The potential implementation of a 100% tariff on all brand-name and patented drugs by the U.S. government starting October 1, 2025, unless companies are building drug manufacturing plants in the U.S. [2] Group 1: Market Reaction - Pharmaceutical stocks in multiple markets, including China, Japan, and South Korea, experienced a collective decline following the announcement [3] - Specific declines included a 3.03% drop in Hengrui Medicine (600276.SH/01276.HK) A-shares and a 2.23% drop in Hong Kong shares, while BeiGene (ONC.NASDAQ/06160.HK/688235.SH) saw a 4.38% drop in A-shares and a 1.55% drop in Hong Kong shares [3] - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma (600196.SH/02196.HK) down 5.82% and 3SBio (01530.HK) down 5.34% [4] Group 2: Industry Perspectives - Industry experts suggest that Chinese pharmaceutical companies aiming to expand internationally need to consider the potential implementation of this policy and explore possible solutions [5] - Some executives believe that the high cost of drugs in the U.S. may hinder the realization of this policy [5] - Hengrui Medicine's executive noted that the impact of the potential policy would be limited as their exports mainly consist of generic drugs and APIs [5] - Other companies, such as Lepu Biopharma, indicated that their licensing partnerships would not be significantly affected [5] - Investors pointed out that this is a political issue that could change with future administrations, suggesting that while there may be short-term negative impacts, the long-term effects may not be significant [5] Group 3: Historical Context - Historically, pharmaceuticals have been excluded from tariff lists, but President Trump has repeatedly threatened to impose tariffs on imported drugs this year [5] - The Trump administration initiated a "232 investigation" under the Trade Expansion Act of 1962, which allows for tariffs if imports threaten national security [6] - Previous statements from Trump indicated plans for escalating tariffs on imported drugs, with initial small tariffs leading to potential increases up to 250% [7] Group 4: Investment Commitments - In response to the tariff threats, several multinational pharmaceutical companies have committed to investing in U.S. manufacturing facilities, with significant investments announced by companies like Novartis, Roche, Sanofi, and AstraZeneca [8] - Notably, Novartis and Roche pledged $23 billion and $50 billion respectively over five years, while AstraZeneca committed to a $50 billion investment by 2030 [8]

Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The innovative drug sector is experiencing a positive trend with significant revenue growth and a reduction in losses, indicating a potential for sector-wide profitability [2][6] - The overall revenue for the innovative drug sector in H1 2025 reached 30.649 billion yuan, a year-on-year increase of 9.77%, while the net loss attributable to shareholders was 2.096 billion yuan, showing a substantial reduction in losses [6] - The sector's gross margin remains high at 84.43%, with a slight decrease compared to the previous year, but showing signs of recovery in Q2 2025 [3][6] Summary by Sections Innovative Drug Sector - The innovative drug sector's revenue for H1 2025 was 30.649 billion yuan, with a growth rate of 9.77% year-on-year. Q2 2025 revenue was 16.387 billion yuan, reflecting a 33.24% increase [5][6] - The sector's gross margin for H1 2025 was 84.43%, slightly down from the previous year, but Q2 2025 saw an increase to 84.73% [3][6] - The number of License-out transactions with upfront payments exceeding 10 million USD reached a new high, indicating that overseas rights have become a crucial funding source for Chinese companies [4][7] Financial Performance - The innovative drug sector's net loss for H1 2025 was 2.096 billion yuan, with a significant reduction in losses of 127.58% year-on-year. The adjusted net loss was 2.880 billion yuan, reflecting a 151.25% reduction in losses [5][6] - The sector's operating cash flow was positive at 210 million yuan, indicating improved financial health [5] Traditional Pharmaceutical Sector - The traditional pharmaceutical sector, comprising 136 listed companies, reported total revenue of 254.895 billion yuan in H1 2025, a decrease of 1.64% year-on-year. The net profit attributable to shareholders was 32.099 billion yuan, down 4.83% [26][32] - The gross margin for the traditional pharmaceutical sector was 51.05% in H1 2025, showing a slight increase compared to the previous year [27][32] - The sector is adapting to policy changes, with increased industry concentration and some leading companies achieving growth through transformation and international expansion [32]

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]

Group 1 - The top three stocks with net inflow of southbound funds are Yingfu Fund (02800) with 2.924 billion, Alibaba-W (09988) with 2.610 billion, and Hang Seng China Enterprises (02828) with 1.595 billion [1][2] - The top three stocks with net outflow of southbound funds are Meituan-W (03690) with -0.388 billion, Innovent Biologics (01801) with -0.292 billion, and CSPC Pharmaceutical Group (01093) with -0.261 billion [1][2] - In terms of net inflow ratio, Datang Renewable (01798) leads with 69.20%, followed by Gushengtang (02273) with 58.06%, and Anhui Wanshan Expressway (00995) with 55.69% [1][3] Group 2 - The top ten stocks with the highest net inflow include China Mobile (00941) with 0.481 billion and FIT HON TENG (06088) with 0.450 billion [2] - The top ten stocks with the highest net outflow include China Life (02628) with -0.196 billion and China Construction Bank (00939) with -0.174 billion [2] - The net outflow ratios for the top three stocks are led by Kangji Medical (09997) at -54.12%, followed by Liaogang Co. (02880) at -49.57%, and Zhenjiu Lidu (06979) at -48.65% [3]

沪港通（南向）十大活跃成交公司 | 公司名称 | 成交金额 | 净买入额 | | --- | --- | --- | | 阿里巴巴-W(09988) | 160.93 亿元 | +25.68 亿元 | | 中芯国际(00981) | 62.37 亿元 | +2.20 亿元 | | 山高控股(00412) | 47.93 亿元 | +6.32 亿元 | | 腾讯控股(00700) | 36.53 亿元 | +12.57 亿元 | | 小米集团-W(01810) | 24.12 亿元 | -4.33 亿元 | | 大众公用(01635) | 20.39 亿元 | +1009.21 万元 | | 美团-W(03690) | 19.72 亿元 | +1.77 亿元 | | 华虹半导体(01347) | 18.97 亿元 | -2622.09 万元 | | 优必选(09880) | 13.51 亿元 | -2360.66 万元 | | 中兴通讯(00763) | 11.46 亿元 | -3.54 亿元 | 智通财经APP获悉，2025年9月24日当天，阿里巴巴-W(09988)、中芯国际(00981)、山高控股(004 ...