根据公司公告，该联合疗法2023年获得美国FDA授予快速通道资格，合作方阿斯利康正在进行 SAFFRON全球三期临床试验，评估该联合疗法对比含铂双药化疗治疗奥希替尼经治进展的MET过表达 及/或扩增的非小细胞肺癌中的有效性，以支持赛沃替尼在美国和全球其它地区的潜在监管注册申请。 该行建议关注2026年SAFFRON数据读出情况及海外申报情况。 风险提示：研发失败，审评进展不及预期，竞争格局恶化。 根据公司公告：美国和欧洲的非小细胞肺癌患者中约有10-25%存在EGFR突变，而亚洲患者中该比例则 高达30-40%。MET扩增或过表达是EGFR突变的转移性非小细胞肺癌患者对EGFR TKI治疗产生获得性 耐药的主要机制之一，在第三代EGFR TKI治疗后出现疾病进展的患者中，约有15-50%的患者伴有MET 异常。该疗法成为国内获批的此类患者中唯一全口服联合疗法选择。 本次适应症获批基于SACHI三期研究，2025年美国肿瘤学会年会(ASCO)读出数据显示出较铂类化疗的 良好无进展生存期(PFS)获益 智通财经APP获悉，中金发布研报称，维持和黄医药(00013)2025年/2026年归母净利润预测3.6亿美 元 ...

Nuvation Bio (NUVB) FDA Announcement June 12, 2025 07:30 AM ET Speaker0 Good afternoon, and welcome to the Nuvation Bio First Quarter twenty twenty five Financial Results and Business Update Conference Call. Please be advised that today's conference call is being recorded. At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call for questions. I would now like to turn the call over to J. R. DeVita, Executive Director of Corporate Development and Investor ...

Summary of Zepzelca ASCO Data Webcast Company and Industry Overview - **Company**: Jazz Pharmaceuticals - **Industry**: Oncology, specifically focusing on small cell lung cancer (SCLC) Key Points and Arguments 1. **Clinical Data Presentation**: Jazz Pharmaceuticals presented compelling clinical data for Zepzelca at the ASCO Annual Meeting, focusing on its use in small cell lung cancer [2][5][6] 2. **Zepzelca's Current Indication**: Zepzelca is currently indicated for the treatment of small cell lung cancer and is expected to bring a new treatment regimen that shows clinically meaningful improvement over the current standard of care [6][30] 3. **Market Opportunity**: The oncology business is primarily driven by Zepzelca and Rylase, with a total revenue exceeding $1 billion in the previous year, indicating significant growth potential [7][8] 4. **INFORTE Trial Results**: The Phase III INFORTE trial demonstrated that the combination of lurbinectedin and atezolizumab significantly improved progression-free survival (PFS) from 2.1 months to 5.4 months, and overall survival (OS) from 10.6 months to 13.2 months [12][25][31] 5. **Safety Profile**: The combination therapy was generally well tolerated, with a low discontinuation rate due to adverse events (6.2% for the combination vs. 3.3% for atezolizumab alone) [23][31] 6. **Commercialization Strategy**: Jazz plans to incorporate Zepzelca into the first-line maintenance therapy for extensive stage SCLC, which is expected to increase patient eligibility and treatment duration [36][40] 7. **NCCN Guidelines Submission**: Jazz has submitted data to the National Comprehensive Cancer Network (NCCN) for consideration, which is crucial for broader uptake and reimbursement [34] 8. **FDA Submission**: A supplemental New Drug Application (sNDA) for Zepzelca's expanded indication has been accepted by the FDA, with a priority review assigned and a PDUFA date of October 7, 2025 [35] Additional Important Content 1. **Patient Population**: Approximately 30,000 patients are diagnosed with small cell lung cancer annually in the U.S., with about 70% having extensive stage disease [36][37] 2. **Treatment Landscape**: The current standard of care involves platinum-based chemotherapy and immunotherapy, but there is a high attrition rate, with up to 60% of patients not receiving second-line therapy [13][22] 3. **Future Development**: Jazz is exploring additional development opportunities for Zepzelca beyond SCLC, including combinations with other therapies [92][95] 4. **Competitive Dynamics**: The company acknowledges potential competition from other products but believes that Zepzelca's data will lead to rapid adoption in the frontline maintenance setting [48][76] 5. **Long-term Tracking**: There are plans to track long-term outcomes for patients receiving maintenance therapy with Zepzelca [60] This summary encapsulates the critical insights from the Zepzelca ASCO Data Webcast, highlighting the company's strategic direction, clinical advancements, and market potential in the oncology sector.

2025 年 05 月 12 日 行业走势图 投资评级：看好（维持） 数据来源：聚源 -36% -24% -12% 0% 12% 24% 2024-05 2024-09 2025-01 生物制品 沪深300 相关研究报告 生物制品 《重症肌无力：生物制剂打开治疗新 格局，AAN2025 泰它西普重磅 III 期 数 据 即 将 读 出 — 行 业 深 度 报 告 》 -2025.4.1 《DLL3：SCLC 高表达明星靶点，多 款国产新药未来可期 —行业深度报 告》-2024.12.30 《双抗&CAR-T：新一代 BCDT 疗法 新星，进军千亿自免蓝海市场—行业 深度报告》-2024.12.7 小细胞肺癌：中国管线全球领先，研发聚焦三大新领域 ——行业深度报告 | 余汝意（分析师） | 余克清（分析师） | 汪晋（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | wangjin3@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790123050 ...

2025年5月9日，翰森制药宣布其自主研发的I类新药甲磺酸阿美替尼片获得国家药品监督管理局批准，用于具有表皮生长因子受体(EGFR)外显子19缺 失或外显子21(L858R)置换突变阳性的非小细胞肺癌(NSCLC)成人患者肿瘤切除术后的辅助治疗。 | 序号 | 受理号 | 药品名称 | 申请人 | 批准文号 | 批准日期 | | --- | --- | --- | --- | --- | --- | | । | CXHS2300077 | 美洛昔康注射液 | 南京清普生物科技 | 国药准字 | 2025年04月30日 | | | | (II) | 有限公司 | H20250012 | | | S | CXHS2300080 | 注射用阿立哌唑微 | 珠海市丽珠微球科 | 国药准字 | 2025年04月30日 | | | | 球 | 技有限公司 | H20250011 | | | 3 | CXHS2400060 | 甲磺酸阿美替尼片 | 江苏豪森药业集团 | 国药准字 | 2025年04月30日 | | | | | 有限公司 | H20200004 | | | 4 | CXSS2300033 | 注射用重组人促 ...