华福证券发布研报称，维立志博基于激动剂平台+TCE平台+ADC，全面布局下一代肿瘤免疫疗法。从 2015年的X-body平台、2016年的LeadsBody平台，到后续双抗、三抗技术积累，公司始终以"技术平台 +创新靶点"为核心，覆盖免疫检查点、多特异性抗体等前沿领域，构建差异化管线。 本文源自：智通财经网 消息面上，维立志博宣布，1月27日，公司基于TCE技术平台LeadsBody自主研发的具有独特2:1结构和 条件性激活的GPRC5D/CD3双特异性抗体LBL-034获得美国食品药品监督管理局(FDA)授予快速通道资 格认定，用于治疗复发/难治性多发性骨髓瘤。 智通财经获悉，维立志博-B(09887)再涨超8%，截至发稿，涨7.29%，报64.75港元，成交额4491.77万港 元。 ...

Core Viewpoint - Huafu Securities initiates coverage on Weili Zhibo (09887) with a "Buy" rating, projecting revenue for 2025-2027 to be 1.80, 0.94, and 0.10 million yuan, with growth rates of 833%, -48%, and -90% respectively [1] Group 1: Company Overview - The company is focused on next-generation tumor immunotherapy through its agonist platform, TCE platform, and ADC, establishing a comprehensive layout [1] - The company has consistently emphasized "technology platform + innovative targets" since 2015, covering cutting-edge fields such as immune checkpoints and multi-specific antibodies, thereby building a differentiated pipeline [1] Group 2: Clinical Developments - LBL-024 (PDL1/4-1BB bispecific antibody) shows historical best data in lung neuroendocrine carcinoma, with excellent efficacy in first-line SCLC and promising preliminary efficacy in NSCLC [1] - LBL-024 enhances the efficacy of second-generation CAR-T therapy, demonstrating low liver toxicity with ≥3 grade liver enzyme elevation at only 1.3%, comparable to PD-1 monoclonal antibodies, indicating superior safety and a broad therapeutic window [1] - LBL-024 is the first 4-1BB targeted molecule to reach critical clinical stages globally, with ongoing clinical research approved in multiple cancer types including SCLC, BTC, OC, and NSCLC, showing encouraging clinical results [1] Group 3: Additional Pipeline Insights - LBL-034 (GPRC5D/CD3 bispecific antibody) demonstrates improved safety and dosage intensity, with a 2:1 structure enhancing TAA binding while balancing efficacy and safety [2] - In I/II clinical studies, LBL-034 achieved an ORR of 77.8% at a dosage of 400μg/kg and 90.9% at 800μg/kg, comparable to CAR-T efficacy [2] - Other pipeline developments include BDCA2×TACI with IND expected in the second half of 2025, and CD19/BCMA/CD3 trispecific antibody IND anticipated in Q1 2026 [2]

LBL-024（PDL1/4-1BB双抗）在肺外神经内分泌癌展现历史最佳数据 一线SCLC疗效优异，NSCLC初步疗效振奋：4-1BB明显提升二代CAR-T疗效，LBL-024采用2:2结构设 计，弱化了4-1BB亲和力，在同类双抗中LBL-024的肝毒性低。≥3级的肝酶升高仅为1.3%，与PD-1单抗 相当，证明了LBL-024卓越的安全性和广阔的治疗窗口。同类双抗中LBL-024的临床进展领先，是全球 首款达到关键临床阶段的4-1BB靶向分子。除EP-NEC外，在有大量未满足临床需求的SCLC、BTC、 OC、NSCLC、ESCC、TNBC等领域均已获批开展临床研究，并已在SCLC、BTC、OC等多个癌种看到 令人振奋的临床效果，有望成为一款具有前景的针对广泛适应症的有效抗肿瘤药物，1年内迎来关键临 床节点。 LBL-034(GPRC5D/CD3)双抗：更优安全性与剂量强度支撑更大空间 2:1的结构放大了TAA的结合，空间位阻使TAA结合才暴露激活CD3，同时弱化CD3亲和力，做到有效 性和安全性的平衡，在最高剂量800μg/kg下未观察到DLT或≥3级CRS。在I/II期临床研究中，LBL-034剂 量 ...

Core Viewpoint - The strategic collaboration between Innovent Biologics and Takeda Pharmaceutical has officially commenced, marking a significant milestone in China's innovative drug industry with a potential deal value of up to $11.4 billion, setting a record for Chinese innovative drugs going global [1][3]. Group 1: Collaboration Details - Innovent Biologics will receive an upfront payment of $1.2 billion, which includes a $100 million strategic equity investment and up to $10.2 billion in milestone payments [1]. - The collaboration focuses on the global development and commercialization of next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) therapies, specifically IBI363 and IBI343, along with early-stage project IBI3001 [1][7]. - IBI363 is recognized as one of the fastest-developing PD-1/IL-2 products globally, with ongoing clinical trials, including a pivotal Phase III study for squamous non-small cell lung cancer [6][10]. Group 2: Market Position and Financial Performance - Innovent Biologics has become one of the largest biopharmaceutical companies in China since its establishment in 2011, with a diverse product portfolio covering oncology, autoimmune diseases, metabolism, and ophthalmology [10]. - The company reported a revenue of 5.953 billion yuan in the first half of the year, a 50.6% year-on-year increase, and achieved profitability with a profit of 834 million yuan [11]. - As of the end of July, Innovent had over 14 billion yuan in cash reserves, positioning itself well for future growth and development [10].

Core Insights - The company is positioned as a leader in next-generation tumor immunotherapy, focusing on addressing diseases that current therapies, such as PD-1/PD-L1 antibodies, cannot treat [1] - The company has established a robust R&D pipeline with 14 new drugs, including 6 in clinical stages and 4 with leading global clinical progress [1] - The 4-1BB co-stimulation signal market has significant potential, with the drug LBL-024 showing promising clinical data and competitive advantages over existing treatments [1][2] Group 1 - The company utilizes three major technology platforms to develop a comprehensive pipeline of tumor drugs, including ADC, IO2.0, and TCE [1] - LBL-024, a 4-1BB targeting drug, has demonstrated a doubling of median overall survival (mOS) in later-line ep-NEC compared to existing therapies and shows superior clinical data in 1L SCLC [1] - The company is expanding LBL-024's indications to include 8 additional cancers, indicating a broad potential market space [1] Group 2 - The TCE technology platform has been validated through clinical data, with LBL-034 showing potential efficacy and safety advantages over competitors [2] - The CD3/GPRC5D TCE drug LBL-034 activates T cells conditionally in tumor microenvironments, with upcoming ASH2025 data expected to further confirm its advantages [2] - The company has plans for new generation TCE and TCE ADC platforms targeting solid tumors, with the CD3/MUC16 TCE positioned as a top contender globally [2] Group 3 - The company is currently in a new drug development investment phase, with projected revenues of 175 million, 314 million, and 187 million yuan for 2025, 2026, and 2027 respectively [2] - The net profit forecast indicates losses of 200 million, 99 million, and 262 million yuan for the same years, reflecting the ongoing investment in R&D [2] - The company is recognized as a leader in 4-1BB co-stimulation and has a rich reserve of TCE platform projects, receiving an "Accumulate" rating for its first coverage [2]