百济神州 20251013 摘要 百济神州采取全球商业化策略，立足中国，面向全球，利用中国患者资 源和高效临床执行，降低成本，加速全球临床试验，并与诺华、安进等 国际药企广泛合作。 泽布替尼作为核心产品，已在全球 70 多国获批，成为美国新患排名第 一的 BTK 抑制剂，成功超越一代 BTK 抑制剂伊布替尼，显著驱动公司 收入增长。 百济神州在实体瘤领域取得显著进展，ADC、ProTech 及 CDK 相关数 据即将公布，标志着公司从血液瘤向整个肿瘤治疗领域扩展，转型为跨 国大型药企。 百济神州利用中国临床试验的成本和效率优势，同步开展国内外临床试 验，其全球临床患者分布中，中国占比 25%，欧美占比超 40%，支持 产品国内外同步注册。 未来几年，百济神州将迎来多个里程碑事件，包括 ADC、ProTech 和 CDK 数据读出，以及 BCL-2 抑制剂在美国递交上市申请，有望提升一 线淋巴瘤患者治愈率。 Q&A 百济神州在中国创新药行业中的独特性体现在哪些方面？ 百济神州在中国创新药行业中具有显著的独特性。首先，它是唯一一家具备全 球研发和商业化能力的自主创新药公司，这使其在 A 股和港股市场中具有很强 的 ...

Core Viewpoint - The company announced that three of its self-developed clinical products, TY-302, TY-2699a, and TY-0540, have been accepted for presentation at the 2025 European Society for Medical Oncology (ESMO) conference, with detailed data to be published in the official ESMO journal, "Annals of Oncology" [1][2]. Group 1: Product Details - TY-302 is a potent, selective oral CDK4/6 inhibitor developed for treating advanced solid tumors such as breast and prostate cancer. It targets CDK4/6 to inhibit the phosphorylation of Rb, preventing cancer cell proliferation. Preclinical studies indicate lower gastrointestinal side effects and more controllable hematological toxicity compared to the leading CDK4/6 inhibitor, palbociclib. Phase I clinical data show significant efficacy and good safety when combined with tamoxifen for HR+/HER2- advanced breast cancer patients [1]. - TY-2699a is a selective CDK7 inhibitor aimed at treating advanced/metastatic solid tumors. Preclinical studies confirm its ability to precisely inhibit cancer cell growth at doses that do not affect normal cells. Initial clinical data demonstrate excellent safety and preliminary efficacy at similar dose levels. The data presented is from a Phase I multicenter monotherapy dose-escalation trial, with ongoing expansion trials for triple-negative breast cancer (TNBC) [2]. - TY-0540 is a selective CDK2 inhibitor intended for treating breast cancer, ovarian cancer, and other solid tumors. It shows strong inhibitory effects on key targets such as CDK2/CycA2 and CDK2/CycE1, while also exhibiting activity against related targets CDK4/CycD1 and CDK6/CycD3. Both preclinical and clinical studies indicate significant inhibitory effects and good safety profiles in various solid tumors, including models resistant to palbociclib. The data presented is from a Phase I multicenter open-label clinical trial, with ongoing Phase Ib/II studies [2].