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？ ...

Group 1 - The company reported a revenue of 5.953 billion yuan for the first half of 2025, representing a year-on-year increase of 50.6%, with product revenue at 5.23 billion yuan, up 37.3% [1] - Net profit reached 1.21 billion yuan, driven by the launch of new products and a 666 million yuan upfront payment from Roche [1] - The gross margin was 86.8%, an increase of 2.7 percentage points, while the ratio of selling and administrative expenses decreased by 7.9 percentage points to 44.2% [1] Group 2 - The oncology pipeline is transitioning from a leading position in China to global innovation, with new generation IO+ADC frameworks established [1] - Three new oncology products were launched: Daberu (ROS1 inhibitor), Aoyixin (EGFR TKI), and Jiepal (non-covalent BTK inhibitor) [1] - IBI363 (PD-1/IL-2 dual antibody) showed significant efficacy in three oral reports at ASCO, with multiple registration clinical studies initiated [1] Group 3 - IBI343 (CLDN18.2 ADC) became the first ADC drug to enter Phase III trials for pancreatic cancer globally [2] - Several ADC products, including IBI3009 (DLL3 ADC) and IBI3001 (EGFR/B7H3 ADC), are advancing into global development [2] - The company has multiple major products entering commercialization, including Torelis monoclonal antibody and the first approved dual-target weight loss drug [2] Group 4 - The company is positioned as a leading innovative drug developer in China, with a workforce of 7,500 employees globally [3] - Revenue projections for 2025-2027 are 12.074 billion yuan, 15.046 billion yuan, and 20.584 billion yuan, with growth rates of 28.15%, 24.61%, and 36.81% respectively [3] - Expected net profit for the same period is 939 million yuan, 1.665 billion yuan, and 3.072 billion yuan [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company achieved total revenue of 5.953 billion yuan in H1 2025, representing a year-on-year increase of 50.6%. The net profit reached 834 million yuan, a significant turnaround from a loss of 393 million yuan in H1 2024. The Non-IFRS net profit was 1.213 billion yuan, compared to a loss of 160 million yuan in the same period last year [6] - The company has successfully commercialized five new drugs during the reporting period, marking a significant breakthrough in its product line. The approval of Masitide (a GLP-1/GCG dual-target agonist) for long-term weight management in adults and the approval of Tezotuzumab for thyroid eye disease fill a 70-year treatment gap in the domestic market [7] - The company is advancing its global innovation pipeline, with IBI363 (a next-generation IO therapy) receiving FDA approval for a pivotal clinical trial, and IBI343 (an ADC) entering a Phase III clinical trial for pancreatic cancer, showcasing the global value of its ADC platform [8] Financial Summary and Valuation Metrics - For 2025, the company is projected to achieve a net profit of 988 million yuan, with earnings per share (EPS) of 0.6 yuan. The price-to-earnings (P/E) ratio is expected to be 137.8 times [9] - The company's revenue is forecasted to grow to 11.55 billion yuan in 2025, with a year-on-year growth rate of 22.6%. The gross margin is expected to be 83.5% [9] - The company’s total assets are projected to reach 24.567 billion yuan by 2025, with total liabilities of 11.156 billion yuan, indicating a healthy balance sheet [11]

Core Viewpoint - The company is entering a new development stage with a dual focus on oncology and chronic diseases, showcasing strong competitiveness in both commercialization and early pipeline assets, such as Xinlidi (信迪利单抗), Marsudotide (玛仕度肽), and Tislelizumab (替妥尤单抗) [1][2] Oncology Development - The company maintains a leading position in China's PD-1 market, with Xinlidi showing excellent commercialization results. The early pipeline asset IBI363 (PD1/IL2α) has demonstrated outstanding data in non-small cell lung cancer, colorectal cancer, and melanoma, indicating potential for internationalization [1][2] - IBI363 is positioned as a "super blockbuster" with the potential to capture a significant share of the global $100 billion immuno-oncology market, improving upon the first-generation PD-1 drugs by enhancing immune activation in both "hot" and "cold" tumors [2][5] Chronic Disease Development - In the chronic disease sector, the core weight loss/diabetes product Marsudotide has been approved for weight loss indications, with promising commercialization prospects. Additionally, Tislelizumab and Toripalimab are progressing smoothly in commercialization, contributing to new revenue streams [2][3] - The pipeline includes promising candidates like IBI128 for gout and Pikanqibai monoclonal antibody for psoriasis, which are expected to provide new treatment options and further enhance commercialization potential [2][3] Pipeline and Revenue Forecast - The company has established a robust pipeline with nearly 20 products, balancing immediate sales with long-term potential projects. Key products like Marsudotide are expected to achieve peak sales exceeding 8 billion yuan, while Tislelizumab and Toriqalimab are projected to exceed 2 billion yuan each [3][4] - Revenue forecasts for the company are projected to reach 11.806 billion yuan, 15.382 billion yuan, and 21.092 billion yuan for the years 2025 to 2027, respectively, with a DCF valuation suggesting a reasonable market capitalization of 220.8 billion HKD and a target price of 129.15 HKD [3][4] Strategic Positioning - The company is well-positioned for international expansion, having established a strong competitive edge in both oncology and chronic disease sectors. The dual focus on these areas is expected to accelerate growth and enhance its global presence [5][6] - The company is anticipated to lead the second-generation immuno-oncology drug market, with IBI363 expected to be a key player in this competitive landscape [6]

Core Viewpoint - CICC maintains the profit forecast for Innovent Biologics (01801) at 472 million yuan for 2025 and 1.299 billion yuan for 2026, while upgrading the target price by 38.1% to 95.3 HKD, indicating a 21.6% upside potential from the current stock price [1] Company Updates - On June 27, the company announced that its cardiovascular and metabolic (CVM) product, Xinermet (Mastudutide injection), became the world's first GCG/GLP-1 dual receptor agonist weight loss drug approved for sale in China [2] - On June 30, the company held an oncology innovation R&D day, showcasing its strategies in next-generation immunotherapy (IO) and antibody-drug conjugates (ADC), along with clinical progress and data interpretation, including IBI363 (PD-1/IL-2) [2] Product Breakthrough - The approval of Mastudutide marks a breakthrough in the domestic GLP-1 receptor agonist weight loss sector. The III phase clinical trial GLORY-1 showed that treatment with 6 mg of Mastudutide for 48 weeks resulted in a weight loss of 14.84% from baseline, and in subjects with baseline liver fat content ≥10%, the average liver fat content decreased by 80.2% from baseline [3] Next-Generation Strategy - IBI363 is leading the company's next-generation "IO+ADC" strategy. Data presented at the 2025 American Society of Clinical Oncology (ASCO) meeting showed promising results for IBI363 in melanoma, IO-treated lung cancer, and colorectal cancer. The median overall survival (mOS) for the low-dose group in IO-treated squamous non-small cell lung cancer was 15.3 months, and 17.5 months for adenocarcinoma. The mOS for IBI363 in monotherapy for colorectal cancer was 16.1 months, with a significant survival event rate compared to the combination therapy with Bevacizumab [4] Internationalization Goals - The company aims to have five pipeline products enter global multi-center clinical III trials by 2030. The successful launches of major products like Teyuanzhu and Mastudutide in the CVM field, along with the anticipated approval of Pikangqibai, highlight the company's progress. The early pipeline, including IBI3030, also shows promise. IBI363 is expected to become a next-generation IO blockbuster, and the ADC platform continues to yield results [5]

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]

Core Viewpoint - CICC maintains the profit forecast for Innovent Biologics (01801) at RMB 472 million for 2025 and RMB 1.298 billion for 2026, with an outperform rating for the industry [1] - The target price is raised by 12.2% to HKD 66, indicating a potential upside of 20.2% from the current stock price [1] Group 1: Revenue Growth and Product Launches - The company reported product revenue exceeding RMB 2.4 billion in Q1 2025, achieving over 40% year-on-year growth, aligning with CICC's expectations [1] - Core product Sintilimab generated sales of USD 137.5 million (approximately RMB 1 billion) in Q1 2025, reflecting a 19% year-on-year growth after excluding exchange rate effects [2] - Four new drugs were launched in the quarter, contributing to revenue growth, with a total of 15 products approved and 3 under review as of April 2025 [2] Group 2: Upcoming Data and Product Pipeline - IBI363 is set to present pivotal data at the 2025 ASCO, with three major indications (melanoma, colorectal cancer, and non-small cell lung cancer) accepted for oral presentation [3] - The early data for IBI363 shows promise, and the maturity of the PoC data may unlock significant global commercialization potential [3] Group 3: ADC Platform Development - The ADC platform continues to gain recognition, with IBI343 (CLDN18.2 ADC) data presented at ASCO, following its previous oral report at ESMO Asia [4] - Other ADC candidates, including HER2 ADC IBI354 and TROP2 ADC IBI130, were also selected for poster presentations [4] - The company announced the completion of the first patient dosing in the Phase I trial of the globally first CEACAM5 dual payload ADC (IBI3020), enhancing its "IO+ADC" technology platform [4]

Investment Rating - The report maintains a "Buy" rating for the company, expecting a relative return of over 20% within the next six months [7]. Core Insights - The company achieved a total revenue of 9.42 billion RMB in 2024, representing a year-on-year growth of 51.8%. Product revenue reached 8.23 billion RMB, up 43.6% year-on-year. The company also reported its first positive Non-IFRS profit of 330 million RMB and an EBITDA of 410 million RMB, with IFRS losses narrowing by 90.8% [1]. - The company has seen a decrease in various expense ratios, with sales expenses at 4.347 billion RMB (46.14% of revenue, down 3.83 percentage points), R&D expenses at 2.681 billion RMB (28.45%, down 7.45 percentage points), and administrative expenses at 738 million RMB (7.83%, down 4.25 percentage points). This reduction in expense ratios is attributed to significant revenue growth [2]. - The company is expected to launch six new drugs in 2025, with one drug entering the medical insurance system. Several products are nearing commercialization, which will serve as a significant growth driver. Recently, five new products were approved for market, including drugs targeting various cancers and conditions [3]. - The company has promising products in the pipeline, particularly in the weight loss sector with the drug Masitide, which is expected to yield data from ongoing studies by the end of 2025. In oncology, early data from several products have shown strong potential, with international clinical trials underway [4]. - Revenue forecasts for 2025-2026 have been revised upwards, with expected revenues of 11.518 billion RMB and 14.721 billion RMB, respectively. Net profit estimates for the same period have also been increased to 515 million RMB and 1.830 billion RMB. The revenue for 2027 is projected to reach 20.020 billion RMB, with net profit expected at 3.109 billion RMB [5].

行业评级： | 报告期：2025.3.3-2025.3.16 | | | --- | --- | | 投资评级 | 看好 | | 评级变动 | 维持评级 | 医药生物行业双周报 2025 年第 6 期总第 129 期 创新和出海仍是全年投资主线之一 近期关注消费医疗板块 行业回顾 本报告期医药生物行业指数涨幅为 2.85%，在申万 31 个一级行业中 位居第 21，跑输沪深 300 指数（3.00%）。从子行业来看，线下药店、 医药流通涨幅居前，涨幅分别为 8.35%、4.05%；医疗设备跌幅居前， 跌幅为 0.08%。 行业走势： 估值方面，截至 2025 年 3 月 14 日，医药生物行业 PE（TTM 整体法， 剔除负值）为 27.31x（上期末为 26.54x），估值上行，低于均值。医 药生物申万三级行业 PE（TTM 整体法，剔除负值）前三的行业分别 为诊断服务（103.77x）、医院（43.66x）、其他医疗服务（36.92x）， 中位数为 28.51x，医药流通（15.99x）估值最低。 XXXX@gwgsc.com 本报告期，两市医药生物行业共有 28 家上市公司的股东净减持 82.05 亿元 ...