抗体偶联药物（ADC）凭借将细胞毒性药物精准递送至癌细胞的能力，正成为推动肿瘤领域新药研发的重点方向之一。公开资料显示，全球范围内有数百 款ADC疗法处于积极的临床研究阶段，其中包含了数十款双抗ADC，靶点涵盖了EGFR、HER2、HER3、c-Met 、ROR1、PD-L1、B7-H4、B7-H3等等，临 床开发适应症涉及一系列实体瘤和血液系统恶性肿瘤。 2025年以来，ADC新药研发管线迎来一系列新进展。其中，多款创新ADC获监管机构批准上市，为不同类型的乳腺癌、非小细胞肺癌等患者带来了新的治 疗选择。 比如，12月，美国FDA批准由阿斯利康和第一三共联合开发的靶向HER2的ADC疗法Enhertu联合帕妥珠单抗，用于一线治疗经FDA批准检测确定为不可切除 或转移性HER2阳性（IHC 3+或ISH+）乳腺癌的成人患者。 再如，10月，FDA批准葛兰素史克（GSK）靶向BCMA的ADC药物Blenrep，联合硼替佐米和地塞米松，用于治疗至少接受过两种既往疗法的复发或难治性 多发性骨髓瘤成年患者。5月，FDA批准艾伯维（AbbVie）靶向c-Met的ADC药物Emrelis上市，用于治疗c-Met蛋白高度表 ...

Core Viewpoint - The company announced that its wholly-owned subsidiary, Shanghai Youlu, has initiated clinical trials for a new biopharmaceutical, YLSH003, targeting advanced solid tumors, with the first patient successfully enrolled for treatment [1] Group 1: Product Development - YLSH003 is a novel antibody-drug conjugate targeting tissue factor, and the company has submitted an international patent application for the related technology [1] - The clinical trials consist of Phase I and Phase II studies, with Phase I focusing on safety and tolerability, while Phase II will assess efficacy [1] - The drug is expected to be accepted and approved by 2025, with the first patient already enrolled in Phase I and recruitment for additional subjects ongoing [1] Group 2: Market Context - The pharmaceutical development process is characterized by high risks, and the timeline for project approval and outcomes remains uncertain [1]

Group 1 - The report highlights that the ADC (Antibody-Drug Conjugate) market is experiencing rapid growth, with the global market size surpassing $14 billion and expected to exceed $66 billion by 2030, reflecting a CAGR of 30.3% [2][19][26] - In China, the ADC market is also developing rapidly, projected to exceed 60 billion RMB by 2030, driven by increasing clinical demand and government support [2][26][30] - The report emphasizes the rigid clinical demand for ADCs, particularly in treating breast cancer and lymphoma, with over 2.4 million new cases globally each year, indicating a clear trend towards replacing traditional chemotherapy [2][19] Group 2 - The report outlines that multiple ADC products have been included in China's medical insurance directory for 2024, marking a significant step in the commercialization of ADCs in the country [11][15] - The Chinese government has implemented various policies to accelerate the development and commercialization of ADCs, including guidelines from the National Medical Products Administration [9][10][11] - The report notes that the domestic ADC industry has formed a complete industrial chain, with upstream and midstream companies poised to benefit significantly from this growth [27][28]