giredestrant
优于标准疗法 罗氏口服乳腺癌新药giredestran三期成功
罗氏 evERA 三期试验达成共同主要终点：giredestrant合依维莫司在 ER+/HER2- 转移性乳腺癌中显著改善 PFS，尤其对 ESR1 突变人群疗效突出。结果有望改变 CDK4/6 失败后的临床治疗格局。
SDW Editor
giredestrant
Roche Reports Positive Phase III for Giredestrant Combo After CDK4/6 Progression
Roche’s Phase III evERA trial met its co-primary endpoints, with giredestrant + everolimus delivering significant PFS benefit in ER+/HER2- metastatic breast cancer after CDK4/6 inhibitor therapy. Results mark the first positive late-stage head-to-head study of an oral SERD regimen in this setting.
歌礼制药
歌礼ASC47联合司美格鲁肽减重提升56.2%，显著改善胃肠耐受性
歌礼制药公布ASC47-103研究顶线结果：ASC47联合司美格鲁肽在肥胖患者中较单药减重效果提升高达56.2%，并降低LDL-C，改善胃肠耐受性，停药后反弹更轻。
Ascletis Pharma
Ascletis’ ASC47 Combo with Semaglutide Shows 56% Greater Weight Loss, Better GI Safety
Ascletis Pharma reported topline results from its ASC47-103 study in obesity: ASC47 plus semaglutide enhanced weight loss by up to 56.2% versus semaglutide alone, reduced LDL-C, improved GI tolerability, and showed reduced rebound post-treatment.
Metsera
辉瑞73亿美元收购Metsera，布局潜在月度给药的新一代减肥疗法
辉瑞 ($PFE) 宣布将收购 Metsera ($MTRS)，交易总价值最高达 73 亿美元，获得其核心资产 MET-097i，这是一款新一代 GLP-1 受体激动剂，超长效、可潜在月度给药，12 周体重下降可达 11.3%，耐受性良好。
Metsera
Pfizer Finalizes $7.3B Metsera Buy for Next-Gen Obesity Therapy with Monthly Dosing
fizer has entered into a definitive agreement to acquire Metsera for up to $7.3B, gaining MET-097i, a next-gen GLP-1 therapy with ultra-long acting, potentially monthly dosing, strong Phase 2a efficacy, and promising tolerability.
2025 FDA新药
盘点2025 年 FDA 获批新药：中国创新药企缔造多项历史突破！
全面盘点 2025 年 FDA 批准新药（1–9 月，持续更新），共28款新药，涵盖抗肿瘤、罕病及神经系统等关键领域。聚焦中国创新药企(迪哲医药,康方生物 和 葆元医药)亮眼表现与全球新药研发趋势，包括适应症、作用机制及临床意义。
全球首款巴思综合征治疗药物
全球首款罕见病巴思综合征疗法：Elamipretide获FDA加速批准
Elamipretide（Forzinity）成为全球首个获FDA批准的巴思综合征疗法，为患者带来全新希望。本文回顾其意外发现、公司的研发历程、临床数据及监管挑战。
Forzinity
From Discovery to FDA Approval: Forzinity Becomes First Therapy for Barth Syndrome
Forzinity (elamipretide) makes history as the first FDA-approved therapy for Barth syndrome. Learn about Hazel Szeto’s discovery, Stealth Biotherapeutics’ development journey, and the clinical evidence supporting approval.
劲方医药
劲方医药成功上市港交所：KRAS靶向创新引领中国药企
劲方医药在港交所成功上市，首日收盘上涨106%。公司核心资产GFH925(氟泽雷塞)去年获批NSCLC，成为中国首款、全球第三款该类靶点药物。GFH375显示KRAS G12D早期高ORR. 本文回顾公司KRAS靶向管线与行业竞争，洞察未来发展机遇。
GenFleet Therapeutics
GenFleet Therapeutics’ Blockbuster IPO Highlights China’s KRAS Innovation and G12D Ambitions
GenFleet Therapeutics raised HK$1.82B in its HKEX IPO, surging 106% on debut. With GFH925 approved for NSCLC and GFH375 showing strong early ORR in KRAS G12D NSCLC, the company is advancing its pipeline, partnerships, and competitive position in global oncology.
K药皮下注射剂
1~2分钟完成给药! 默沙东K药皮下注射剂获FDA批准
默沙东K药皮下注射剂（MK-3475A，Keytruda Qlex）获FDA批准，可实现成人肿瘤患者1~2分钟快速给药。