此外，信达生物综合管线矩阵丰富，多元化出海。心血管代谢及内分泌科来看：玛氏度肽、PCSK9已获 批，在研管线聚焦心血管相关的"四高"广阔人群;眼科：双抗分子有望通过差异化机制提升患者生存质 量;皮肤科及风湿科：匹康奇拜单抗(IL23p19)率先获批，具备BIC潜力;其余产品管线以FIC/BIC为目的解 决未满足需求。IBI3002为全球同类首创的免疫双抗分子，TSLP和IL4Rα为靶点，在哮喘患者初步展示 疗效信号。随着临床进展不断推进，有望持续拓展公司在创新管线的全球授权合作，同时获批产品和成 熟品种在全球多地区上市加速和拓展准入多元化公司出海模式，加速全球化布局。 中邮证券发布研报称，首次覆盖信达生物(01801)，给予"买入"评级，预计公司2025-2027年归母净利润 9.8/15.8/32.5亿元，对应PE为162/100/49。公司发布25年中期业绩公告，25H1公司收入59.5亿元，同比 +50.6%，其中产品收入52.3亿元，同比增长37.3%。EBITDA为14亿元，净利润为12亿元，在手现金146 亿元。信达在国内肿瘤药物领域具备领先地位，综合管线矩阵布局丰富，逐步获批上市有望双轮驱动业 ...

报告中称，公司IBI363获批开展全球三期临床，逐步验证新一代IO基石潜力。IBI363是由信达生物研发 的全球首创PD-1/IL-2α-bias双特异性融合蛋白，同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功 能。2025年8月公司宣布IBI363的IND获FDA批准，开展治疗鳞状非小细胞肺癌首个全球关键三期临床 研究：招募约600名患者，比较IBI363单药与多西他赛在IO经治的肺鳞癌的疗效与安全性，研究的主要 终点为总生存期(OS)。此前363在2025年ASCO上363亮相三项口头报告：对"免疫耐药"、"冷肿瘤"等具 备亮眼的疗效数据。公司开发策略清晰：优先瞄准IO经治的空白市场，在肺癌、黑色素瘤和三线肠癌 将在2025年陆续开展注册临床;在一线的肺癌、肠癌开展PoC研究，预计在2026读出。公司同步开展联合 疗法拓宽适应症，验证新一代IO基石的潜力。 此外，信达生物综合管线矩阵丰富，多元化出海。心血管代谢及内分泌科来看：玛氏度肽、PCSK9已获 批，在研管线聚焦心血管相关的"四高"广阔人群;眼科：双抗分子有望通过差异化机制提升患者生存质 量;皮肤科及风湿科：匹康奇拜单抗(IL23p19 ...

机构：中邮证券 研究员：盛丽华/徐智敏 事件 公司发布25 年中期业绩公告，25H1 公司收入59.5 亿元，同比+50.6%，其中产品收入52.3 亿元，同比增 长37.3%。EBITDA 为14 亿元，净利润为12 亿元，在手现金146 亿元。 投资要点 双轮驱动助力收入高增。产品层面来看，公司现有16 款商业化品种，肿瘤和综合管线双轮驱动。肿瘤 管线来看，公司持续巩固国内领先地位，达伯舒中国PD-(L)1 市场市占率第一，2 项NDA+NSCLC 的围 手术期治疗三期提供未来增长动力。同时三款靶向药上市（ROS1、EGFR TKI、BTK 抑制剂）凸显协 同效应。公司综合管线慢病商业化顺利启航，PCSK9 单抗系国内首个进医保的PCSK9 单抗、IGF-1R 和 GCG/GLP-1 成功上市/获批，为国内同类的首个药物。 运营效率优化盈利持续攀升。公司2024H1/2024H2/2025H1 的EBITDA 分别为-1.6/5.7/14.1 亿元，净利润 为-1.6/4.9/12.1 亿元，盈利持续攀升。25H1 来看，公司运营效率进一步提升：毛利率86.8%，同比 +2.7pct，销售及管理费率44. ...

公司基本情况 证券研究报告：医药生物 | 公司点评报告 股票投资评级 买入|首次覆盖 个股表现 资料来源：Wind，中邮证券研究所 -50% 0% 50% 100% 150% 2024-10 2024-12 2025-03 2025-05 2025-07 2025-10 信达生物 恒生指数 | 最新收盘价（港元） | 104.70 | | --- | --- | | 总股本/流通股本（亿股）17.14/17.14 | | | 总市值/流通市值（亿港 | 1794/1794 | | 元） | | | 52 周内最高/最低价 | 109.10/ 28.65 | | 资产负债率(%) | 38.88 | | 市盈率 | 144.43 | | 第一大股东 | 俞德超 | 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 研究助理:徐智敏 SAC 登记编号:S1340125080012 Email: xuzhimin@cnpsec.com 信达生物(1801.HK) 内生收入高增利润表现亮眼，全球化战略高效推进 事件 公司发布 25 年中期业 ...

Group 1: Chinese Innovative Pharmaceuticals - The development of innovative pharmaceuticals in China is driven by a significant increase in high-quality graduates in relevant fields, with the number of R&D personnel in the biotech sector rising from 150,000 in 2015 to 450,000 in 2023 [11][16][22] - Chinese biotech companies are experiencing rapid growth in early clinical pipelines, with a notable increase in the number of original innovative drugs (FIC) entering clinical stages, surpassing the United States in the number of original innovative drugs approved for clinical trials from 2015 to 2024 [16][18] - The number of Chinese companies participating in global academic conferences like AACR has increased significantly, with 126 companies presenting nearly 300 new drug research results at the 2025 AACR conference [16][18] Group 2: Market Opportunities and Trends - The global market for immune-oncology (IO) therapies is substantial, with sales projected to reach approximately $56.27 billion by 2024, indicating a strong growth trajectory [33][40] - The second-generation IO therapies are expected to replace first-generation therapies and address unmet clinical needs, with a market size estimated to approach $738 billion [40][43] - The self-immune targeted drug market is projected to reach nearly $200 billion, with several blockbuster products emerging, indicating a lucrative opportunity for pharmaceutical companies [43][48] Group 3: Business Development and Collaborations - There has been a surge in business development (BD) transactions involving Chinese pharmaceutical companies, particularly in high-barrier products like ADCs and bispecific antibodies, with transaction amounts reaching new highs [27][52] - Notable BD transactions include significant upfront payments and milestone payments for innovative drug projects, showcasing the increasing value of Chinese assets in the global market [29][52] - The pricing of products from Chinese companies is generally lower compared to their overseas counterparts, suggesting that Chinese assets are undervalued and present attractive investment opportunities [52][54]

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]

信达生物 20250925 摘要 信达生物肿瘤免疫产品 IBI363 在 2025 年 SCO 大会上获得多个高级别 口头报告，其三线数据表现出色，如肺癌三线 12 个月 OS 率为 70.9%，MSS 结直肠癌三线 9.4 个月 OS 率为 82.2%，媲美一线标准 疗法，一线适应症前景值得期待。 信达生物在非肿瘤领域推出玛仕度肽、替妥尤单抗和托莱西单抗等产品， 形成强大的非肿瘤产品群，进入加速发展期。玛仕度肽作为处方药，通 过提供优秀用药体验和综合代谢管理，有望快速占据市场头部位置，预 计销售峰值超 80 亿元。 IBS-363 药物在治疗热肿瘤和冷肿瘤方面表现出色，有望超越第一代免 疫检查点抑制剂。其独特之处在于增加了白介素 2（IL-2），通过弱化 IL-2 与 βγ 受体的结合力，降低毒性，提高安全性，在临床前研究中显 示出高效杀伤肿瘤且控制毒性的效果。 信达生物的药物在临床试验中表现出色，DCR 超过 60%，DOR 较长， 反映出患者使用该药后不容易耐药，从而延长了获益时间。在肺鳞癌、 结直肠癌和黑色素瘤等多种癌症类型中，信达生物产品均表现优异。 Q&A 信达生物在过去几年中取得了哪些重要成就？ ...

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **Chinese innovative drug industry** and its current trends, particularly focusing on the **CRO (Contract Research Organization)** and **CDMO (Contract Development and Manufacturing Organization)** sectors [1][3][13]. Core Insights and Arguments - **Valuation Trends**: The valuation of Chinese innovative drugs is currently lower than historical peaks, with a static PS (Price to Sales) ratio around 7 times, compared to a high of 9.3 times. However, due to global competitiveness, the theoretical static PS is expected to exceed previous levels, driven by significant product cycles [2][4]. - **BD Activity**: There has been a surge in business development (BD) transactions among domestic innovative drug companies, with upfront payments in the first nine months of the year reaching **6.58 billion yuan**, surpassing the total of **6 billion yuan** for the entire previous year. The total transaction amount also exceeded **56.4 billion yuan** compared to **48.9 billion yuan** last year [4]. - **Immunotherapy and ADC Developments**: Chinese companies are showing strong global competitiveness in the dual-antibody sector, with significant clinical advancements. For instance, **AK12** from Kangfang Biotech has multiple ongoing Phase III trials, and **IBI363** from Innovent has received FDA approval for a global Phase III study in lung cancer [5][6]. - **Weight Loss Sector**: The weight loss sector is highlighted as a competitive area, with promising data from Eli Lilly's oral GLP-1 molecule, **ofgliprant**, providing opportunities for Chinese companies to improve their offerings [8][10]. Additional Important Insights - **CRO and CDMO Recovery**: The CRO industry has moved past its most challenging period, with increased investment activity and a recovery in overseas demand for Chinese CDMO companies. Key players such as WuXi AppTec and Tigermed are recommended for attention [3][13]. - **Upstream Pharmaceutical Chain Recovery**: There are signs of recovery in the upstream pharmaceutical supply chain, particularly in R&D, with companies like **BaiPuSiSi** experiencing a resurgence in market demand [14]. - **Global Competitiveness Strategies**: Chinese innovative drug companies are encouraged to enhance their global competitiveness through overseas sales, R&D, and potential licensing opportunities. Companies like BeiGene and Legend Biotech are highlighted for their performance in this regard [12]. Conclusion The conference call provides a comprehensive overview of the current state and future prospects of the Chinese innovative drug industry, emphasizing the importance of global competitiveness, active BD transactions, and the recovery of the CRO and CDMO sectors. The insights presented indicate a positive outlook for the industry, driven by innovation and strategic partnerships.

Investment Rating - The investment rating for the company is "Buy" (maintained) due to rapid performance growth and accelerated internationalization [5]. Core Views - The company achieved a significant revenue increase of 50.6% year-on-year in the first half of 2025, reaching 5.95 billion RMB, and turned a profit with a net profit of 834 million RMB [7]. - The product revenue was 5.23 billion RMB, reflecting a year-on-year growth of 37.3%, driven by strong performance in oncology and a diverse product pipeline [7]. - The company has 16 commercialized products and is well-positioned for future growth with a robust commercialization team [7]. - IBI363, a dual-target antibody, is expected to become a cornerstone of immuno-oncology therapy, with multiple clinical trials ongoing [7]. - The company has a strong pipeline in metabolic, autoimmune, and ophthalmic areas, with several catalysts expected in the near future [7]. - Revenue forecasts for 2025-2027 are 11.49 billion RMB, 15.37 billion RMB, and 20.60 billion RMB respectively, indicating a strong growth trajectory [8]. Financial Summary - The company is projected to achieve a net profit of 1.27 billion RMB in 2025, with a staggering growth rate of 1443.7% compared to the previous year [8]. - The earnings per share (EPS) is expected to be 0.74 RMB in 2025, increasing to 1.90 RMB by 2027 [8]. - The return on equity (ROE) is forecasted to improve from -0.7% in 2024 to 16.7% in 2027, indicating a strong recovery and profitability [8].

Core Viewpoint - Company maintains a "Buy" rating for Innovent Biologics (01801), highlighting its unique global R&D and commercialization capabilities as a leading innovative drug company in China [1] Financial Performance - In H1 2025, total revenue reached 5.953 billion yuan, a year-on-year increase of 50.6%, with profit turning positive at 834 million yuan [1] - Product revenue was 5.234 billion yuan, up 37.3% year-on-year, while licensing fee income surged to 666 million yuan, a 474% increase [2] - Gross margin improved to 86.0%, up 3.1 percentage points, and R&D expenses were optimized to 1.009 billion yuan, down 28% [2] - As of June 30, 2025, cash reserves were approximately 11 billion yuan, providing solid support for global innovation [2] Pipeline Development - The core pipeline IBI363 has initiated a global Phase III clinical trial for squamous NSCLC, with promising data presented at the ASCO annual meeting [3] - Significant progress in multiple pipelines includes the initiation of Phase III studies for IBI343 in pancreatic cancer and IBI354 in ovarian cancer [4] - The company is advancing its collaboration with Roche on IBI3009, conducting MRCT clinical studies in Australia, China, and the U.S. [4]