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 ...

上海交通大学医学院附属胸科医院上海肺癌中心主任陆舜教授表示，赛沃替尼和奥希替尼的联合疗法获 批，是中国肺癌治疗领域应对复杂挑战的一个重要里程碑。在中国，非小细胞肺癌患者中EGFR突变较 为常见。对于在EGFR抑制剂治疗后出现MET扩增的患者，该联合疗法提供了一种持续全口服、去化疗 的治疗方案，有效应对关键的耐药机制。 此次获批是基于赛沃替尼和奥希替尼联合疗法的SACHI三期临床试验数据，该研究已在预设的中期分析 中达到预设的主要终点无进展生存期(PFS)。研究的主要结果已在2025年6月于美国临床肿瘤学会 (ASCO)年会上公布。该联合疗法于2024年获国家药监局纳入突破性治疗品种，2025年优先审评中也纳 入了该新药的上市申请。这也是赛沃替尼在中国获批的第三个适应症。 新京报讯(记者王卡拉)6月30日，阿斯利康宣布，赛沃替尼片(商品名：沃瑞沙)和甲磺酸奥希替尼片(商 品名：泰瑞沙)的联合疗法获中国国家药品监督管理局批准上市，用于治疗表皮生长因子受体(EGFR)基 因突变阳性、经EGFR酪氨酸激酶抑制剂(TKI)治疗后进展的、伴MET扩增的局部晚期或转移性非鳞状非 小细胞肺癌患者。 赛沃替尼是中国首个获批的选 ...

智通财经APP讯，和黄医药(00013)公布，沃瑞沙® (ORPATHYS® ，赛沃替尼/ savolitinib)和泰瑞沙® (TAGRISSO® ，奥希替尼/ osimertinib)的联合疗法的新药上市申请获中国国家药品监督管理局批准，用 于治疗表皮生长因子受体 (EGFR)基因突变阳性经EGFR酪氨酸激酶抑制剂(TKI)治疗后进展的伴MET扩 增的局部晚期或转移性非鳞状非小细胞肺癌患者 。沃瑞沙®是一种强效、高选择性的口服MET TKI 。 泰瑞沙®是一种不可逆的第叁代EGFR TKI 。此项批准亦将触发一项来自阿斯利康的1,100万美元的里程 碑付款 ，阿斯利康在中国同时负责沃瑞沙®和泰瑞沙®的销售 。 阿斯利康中国肿瘤业务总经理关冬梅女士表示："这是沃瑞沙®在中国获批的第三个适应症，标志着又 一个重要的里程碑。此次获批为在接受EGFR抑制剂治疗后出现MET扩增的肺癌患者带来了全新的治疗 选择。通过与和黄医药的合作，我们致力于扩大沃瑞沙®和泰瑞沙®联合疗法的覆盖范围，以应对一线 治疗后的疾病进展，惠及更多肺癌患者。" 和黄医药首席执行官兼首席科学官苏慰国博士表示："国家药监局的批准 ，标志着我们在解 ...

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.

Summary of Nuvation Bio (NUVB) FY Conference Call - May 28, 2025 Company Overview - **Company**: Nuvation Bio (NUVB) - **Focus**: Oncology, specifically targeting ROS1 positive lung cancer with the drug telotrectinib Key Industry Insights - **Upcoming Events**: Important PDUFA date for telotrectinib on June 23, 2025, and presentation at ASCO meeting regarding TRUST datasets [5][6] - **Market Dynamics**: Changes in NCCN guidelines have shifted treatment recommendations, potentially increasing the use of ROS1 agents [19][20] Core Data and Findings - **TRUST Studies**: TRUST one (China) and TRUST two (global) datasets show consistent efficacy and safety across different ethnic groups, with response rates of 89% in TKI naive patients and 52% in pretreated Asian patients [6][7][10] - **Comparative Efficacy**: Telotrectinib demonstrated a 58% reduction in risk of disease progression and a 52% reduction in risk of death compared to Roslitech, and a 52% reduction in PFS and 66% reduction in risk of death compared to crizotinib [11][12] - **Intracranial Response Rates**: 77% in naive patients and 66% in pretreated patients, highlighting the drug's effectiveness in addressing CNS metastases [16][17] Market Opportunities and Challenges - **Sales Growth**: TKI sales have increased by 20% since the new NCCN guidelines, indicating a growing market for ROS1 agents [20][21] - **Tolerability Issues**: Oktyra has faced challenges due to tolerability, with a 30% dropout rate per quarter, emphasizing the importance of good tolerability for long-term use [21][22] - **Patient Switching Dynamics**: Patients on first-generation TKIs may switch to telotrectinib if they experience intolerable side effects or disease progression [34][36] Regulatory and Approval Insights - **FDA Interactions**: Positive and responsive interactions with the FDA under breakthrough designation, with expectations for approval by the PDUFA date [37][38] - **Labeling Discussions**: Ongoing discussions regarding labeling, with no advisory committee required for approval [39][40] Future Plans and Partnerships - **European Market**: Actively seeking partnerships in Europe, with existing partnerships in Japan and China for telotrectinib [50][51] - **Pricing Strategy**: Anticipated pricing to be similar to existing competitors, with a monthly cost around $30,000 [53] Additional Research and Development - **IDH1 Mutant Product**: Ongoing phase two study for glioma, with plans for a pivotal study based on upcoming data [57][62] - **Response Rates in Glioma**: Previous ORR in low-grade glioma was 33%, significantly higher than the INDIGO study's 11% [59][60] Conclusion - **Commercial Focus**: Nuvation Bio is committed to launching telotrectinib effectively, leveraging experienced teams and focusing on patient therapy metrics as key indicators of success [47][48]

Core Viewpoint - Hansoh Pharmaceutical Group announced the approval of Amelot (Ametinib Mesylate Tablets) for a new indication, expanding its application to treat adult non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1][2] Group 1: Product Approval and Clinical Research - The new indication is for patients with stage II-III B NSCLC who have previously undergone surgical resection and may or may not receive adjuvant chemotherapy [1] - The approval is based on the ARTS (HS-10296-302) Phase III clinical study, which was presented at the 2025 American Association for Cancer Research (AACR) annual meeting [1] - The ARTS study demonstrated a significant improvement in disease-free survival (DFS) for patients receiving Amelot as adjuvant therapy, with a 2-year DFS rate of 90.2% [1] Group 2: Market Position and Expansion - Amelot, as China's first original third-generation EGFR-TKI, has been expanding its treatment areas since its launch five years ago [2] - The recent approval allows Amelot to cover early to mid-stage NSCLC (II-III stage), providing more treatment options for lung cancer patients in China [2]

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 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company reported a significant increase in revenue and net profit, with 2024 revenue reaching 35.58 billion yuan, up 76.29% year-on-year, and net profit of 14.30 billion yuan, up 121.97% year-on-year [4][5] - The first quarter of 2025 also showed strong performance, with revenue of 10.98 billion yuan, a 47.86% increase year-on-year, and net profit of 4.10 billion yuan, up 34.13% year-on-year [5] - The company is actively expanding its clinical pipeline for its drug, Vumetini, with multiple clinical trials and approvals in progress, indicating a strong focus on lung cancer treatment [6][8] - The company is enhancing its commercialization efficiency and expanding production capacity, with a new production line for Vumetini expected to support sales growth [7][8] - Revenue projections for 2025 to 2027 are 45.2 billion yuan, 53.8 billion yuan, and 61.2 billion yuan, respectively, with corresponding net profits of 15.9 billion yuan, 19.3 billion yuan, and 21.9 billion yuan [8] Financial Summary - In 2024, the company achieved a gross margin of 95.97% and a net profit margin of 40.2% [5][10] - The projected revenue growth rates for 2025, 2026, and 2027 are 27.0%, 19.0%, and 13.7%, respectively [10] - The expected net profit growth rates for the same period are 11.4%, 20.9%, and 13.5% [10] - The company's return on equity (ROE) is projected to be 27.1% in 2024, decreasing to 22.4% by 2027 [10]