药物临床试验结果 - 罗氏宣布其乳腺癌药物Giredestrant的III期evERA研究达到主要终点 在晚期乳腺癌患者中显著延长无进展生存期(PFS) [1] - 该研究在ITT人群和ESR1突变亚组中均显示出具有统计学意义和临床意义的PFS延长效果 [1] - 总生存期(OS)数据尚未成熟 但已观察到明显的积极趋势 后续将继续随访进行系统分析 [1] 药物作用机制与试验设计 - Giredestrant是罗氏自主研发的一款下一代口服选择性雌激素受体降解剂和完全拮抗剂 通过阻止雌激素与受体结合并诱导其降解来减缓癌细胞生长 [2] - evERA研究是一项随机、开放标签、多中心临床试验 针对接受过CDK4/6抑制剂和内分泌疗法治疗的ER阳性且HER2阴性晚期乳腺癌患者 [2] - 试验主要终点为研究者评估的意向治疗人群和ESR1突变亚组的无进展生存期 该试验特别针对ESR1突变患者进行了扩充 在接受过CDK抑制剂治疗的患者中高达40%的ER+患者携带此突变 [2] 公司战略与管线发展 - 此次试验结果是罗氏今年计划公布的一系列药物试验数据的一部分 这些数据将决定公司未来的竞争力 [1] - 为加强在肥胖症及相关疾病治疗市场的产品管线 罗氏上周同意以高达35亿美元的价格收购生物制药公司89bio Inc [1]

公司研发进展 - 罗氏计划于2025年将其实验性减肥药CT-388推进至后期试验阶段 [1] - CT-388与礼来Zepbound作用机制相似，通过激活GLP-1和GIP受体来促进饱腹感和减少进食 [1] - 该药物在早期研究中曾因披露的恶心、呕吐等副作用数据导致公司股价大幅下挫，但公司后续强调其副作用发生率与竞品相近且费用水平无显著差异 [1] - CT-388若与Zealand Pharma的管线药物联用，可能形成耐受性更优的"同类最佳"治疗方案 [1] 公司战略布局 - 为加速布局减肥药市场，罗氏在2024年已与新西兰制药公司达成一项价值53亿美元的合作协议，共同开发Zealand的在研减肥药物 [1] - 除CT-388外，公司自身研发管线中还包含另一款在研减肥药物 [1] 行业市场前景 - 当前肥胖症市场由礼来和诺和诺德主导 [1] - 预计到2030年，该市场的年销售额将突破1000亿美元 [1] 公司市场表现 - 截至上周五，罗氏股价收涨1.46% [1] - 罗氏股价在2024年年内累计涨幅约为5.4% [1]

The pharmaceutical company said that giredestrant in combination with everolimus significantly improved progression-free survival in patients with advanced breast cancer. ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy. The s. ...

evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in post-CDK inhibitor setting, compared with standard of care plus everolimus The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed evERA is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor deg ...

收购交易结构 - 罗氏控股公司拟以每股14.50美元现金收购89bio公司全部股份 [1] - 交易额外包含每股最高6美元的非交易型或有价值权利支付 [1] - 总对价包含现金与或有支付两部分构成 [1] 交易调查动态 - 前路易斯安那州总检察长联合KSF律师事务所对收购案展开调查 [1] - 调查针对罗氏控股公司与89bio公司之间的交易条款 [1] - 调查主体为纳斯达克上市公司89bio(代码:ETNB)与场外交易市场罗氏(代码:RHHBY) [1]

Lunsumio provides high and long-lasting response rates, with approximately two-thirds of patients with a complete response in remission after four years1Subcutaneous Lunsumio has potential to substantially reduce treatment administration time with an approximately one minute injection, compared with 2-4 hours IV infusionIf approved, Lunsumio would be the first treatment available for people with follicular lymphoma after two or more lines of systemic therapy, which is both fixed-duration and subcutaneously ...

收购交易核心条款 - 罗氏以35亿美元收购89bio 交易预计2025年第四季度完成 [1][2] - 收购对价包含每股14.5美元现金 股权价值约24亿美元 另附最高每股6美元的或有价值权 [3][4] - 若全部里程碑达成 89bio股东将额外获得约10亿美元现金 总溢价达60日均价的52% [4][5] 标的资产技术价值 - 核心资产pegozafermin为FGF21类似物 针对F2-F4阶段MASH患者开展三期临床 [2][6] - 该药物采用独特作用机制 具备与肠促胰岛素药物联合开发的协同潜力 [6] - MASH作为肥胖常见并发症 有望为罗氏带来重大收入机会 [7] 战略布局深化 - 此次收购强化罗氏在心血管、肾脏及代谢疾病领域的产品组合 [1][6] - 公司近期通过收购Carmot Therapeutics获得三个肥胖/糖尿病临床阶段资产 [10] - 与Zealand Pharma合作开发减肥药物petrelintide 进一步拓展肥胖治疗领域 [9] 行业并购趋势 - 2025年医药行业并购活动显著加速 打破2024年低迷态势 [10] - 诺华制药14亿美元收购Tourmaline Bio 获得心血管三期候选药物pacibekitug [11] - 诺华6月以8亿美元收购Regulus Therapeutics 葛兰素史克7月收购efimosfermin alfa拓展肝病管线 [12][13]

On Thursday, Roche Holdings AG RHHBY agreed to acquire 89bio, Inc. ETNB for $2.4 billion. 89Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies for liver and cardiometabolic diseases.Roche will acquire the company for $14.50 per share, representing a premium of approximately 79% to 89bio’s closing stock price on September 17, 2025, the last trading day before the announcement of the transaction, and a premium of 52% to 89bio’s 60-day volume-weighte ...

RETIREMENT: Should You Take Social Security ASAP?Shares of small biotech 89bio (ETNB) nearly doubled Thursday after Roche (RHHBY) agreed to buy the MASH drug developer in a deal worth up to $3.5 billion.89bio is working on a treatment for MASH, or metabolic dysfunction-associated steatohepatitis, a form of fatty liver disease often associated with obesity, type 2 diabetes and high blood pressure. Its drug, pegozafermin, mimics a protein that helps regulate glucose and lipid metabolism.The acquisition underl ...