公司报告 | 公司专题研究 百济神州（688235） 证券研究报告 CDK4 抑制剂展现出优异早期疗效信号，后续将进入 注册临床研究阶段 CDK4 抑制剂 BGB-43395 具有更优抑制效力。目前 CDK4i 领域 FIC 的药物是 进入 III 期临床的辉瑞的 PF-07220060，在 MCF-7 增殖实验中，BGB-43395 的抑制细胞增殖效力IC₅₀为126 nM，比PF-07220060 更强（后者为544 nM）， 活性提升 4.3 倍，展现出卓越疗效。 后续随访时间延长，整体响应率有望大幅提升 从辉瑞披露的数据可以看到，CDK4 抑制剂 Atirmociclib 的中位起效时间是 3.6M。所以对同靶点药物，百济神州的 CDK4i 来说，3 个月的中位随访时 间还未到中位起效时间。过往数据提示 CDK4/6i 的应答率随时间延长逐 步提升，在 9 个月时达到最高应答概率。BGB-43395 在 3 个月的评估时间 看到 240mg、400mg、600mg BID 联用组 SD+PR 为 67%(8/12)，83%（5/6）， 75%（6/8），趋势较好。 盈利预测与投资评级 我们预计 202 ...

化学制药 创新药动态更新 领先大市-B(维持) 相关报告： 魏赟 2025 年 6 月 30 日 行业研究/行业快报 化学制药行业近一年市场表现 资料来源：最闻 首选股票 评级 BGB-43395≥240 mg 每日两次剂量具有生物活性。BGB-43395 表现出快 速吸收和线性药代动力学特征，平均消除半衰期为 13 小时，与氟维司群或 来曲唑进行联合用药不会影响 BGB-43395 暴露量。氟维司群联合治疗队列 中，≥240mg 每日两次剂量组获得具有临床意义的药效学作用，≥240 mg 每 日两次剂量组观察到早期（C2D1）ctDNA 降低。 邮箱：zhangzhiyong@sxzq.com BGB-43395 是一款百济神州自主研发的 CDK4 抑制剂。BGB-43395 是 CDK4 的高度选择性抑制剂，靶向控制细胞分裂的检查点蛋白以阻止癌细胞 生长。相比 CDK4/6 抑制剂哌柏西利、瑞波西利、阿贝西利及 CDK4 抑制剂 Atirmociclib，BGB-43395 展现出最高的 CDK4 抑制性和选择性。BGB-43395 具有潜在同类最佳血液学安全性特征，在既往接受过多线治疗的 CDK4/6 ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [1] Company Developments - On May 1, 2025, Arvinas announced the removal of plans for a Phase 3 first-line combination trial with atirmociclib and a Phase 3 second-line combination trial with a CDK4/6 inhibitor from its joint development plan with Pfizer [3] - The decision to remove these trials was based on a review of emerging information, external data results, the evolving treatment landscape in metastatic breast cancer, and long-term capital allocation [3] - Arvinas also announced a workforce reduction of approximately one-third to streamline operations and enable efficient progression of its portfolio, with completion planned for the second quarter of 2025 [3] - Following this news, Arvinas's stock price fell by $2.39 per share, or 24.84%, closing at $7.23 per share on May 1, 2025 [3]

Updated interim data remain consistent, showing 10.3-month median PFS overall and 11.0-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer Data continue to support planned initiation of pivotal study in mid-2025 Next-generation triplet combinations with atirmociclib (CDK4-selective) & ribociclib ongoing CAMBRIDGE, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery pro ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [1] Group 1: Company Developments - On May 1, 2025, Arvinas announced the removal of plans for a Phase 3 first-line combination trial with atirmociclib and a second-line combination trial with a CDK4/6 inhibitor from its joint development plan with Pfizer [2] - The decision to remove these trials was based on a review of emerging information, external data results, the evolving treatment landscape in metastatic breast cancer, and long-term capital allocation [2] - Arvinas also announced a workforce reduction of approximately one-third to streamline operations and enable efficient progression of its portfolio, with completion planned for the second quarter of 2025 [2] - Following this news, Arvinas's stock price fell by $2.39 per share, or 24.84%, closing at $7.23 per share on May 1, 2025 [2]

Cash runway extended into 2029 Initiation of Phase 3 ReDiscover-2 trial on track for mid-2025 Initiated Phase 1 RLY-2608 vascular malformations clinical trial in Q1 Extended cash runway expected to fully fund the Company meaningfully past topline data for ReDiscover-2 trial and through clinical proof-of-concept data in Vascular Malformations Approximately $710 million in cash, cash equivalents and investments at end of Q1 2025 CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nas ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [1] Group 1: Company Developments - On May 1, 2025, Arvinas announced the removal of plans for a Phase 3 first-line combination trial with atirmociclib and a second-line combination trial with a CDK4/6 inhibitor from its joint development plan with Pfizer [3] - The decision to remove these trials was based on a review of emerging information, external data results, the evolving treatment landscape in metastatic breast cancer, and long-term capital allocation [3] - Arvinas also announced a workforce reduction of approximately one-third to streamline operations and enable efficient progression of its portfolio, with completion planned for the second quarter of 2025 [3] - Following this news, Arvinas's stock price fell by $2.39 per share, or 24.84%, closing at $7.23 per share on May 1, 2025 [3]