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海外消费周报:多项政策出台支持创新药高质量发展,商保创新药目录有望于年内落地-20250704
申万宏源证券· 2025-07-04 16:41
报告行业投资评级 - 海外医药看好;海外教育未提及明确评级;海外社服未提及明确评级 [3] 报告的核心观点 - 多项政策支持创新药高质量发展,商保创新药目录有望年内落地;新东方教育业务利润率回升,常态化回购或提振估值;2025下半年港股消费服务可关注茶饮新股,把握出行链机会 [3][17][22] 各行业总结 海外医药 - **市场回顾**:本周恒生医疗保健指数上涨3.37%,跑赢恒生指数4.42个百分点 [7] - **重点事件** - **政策**:国家医保局、卫健委发布《支持创新药高质量发展的若干措施》,全链条支持创新药;国家医保局发布2025年医保目录和商保创新药目录调整相关征求意见稿,符合条件的独家药品和罕见病药物可申报商保创新药目录 [8] - **国内公司进展**:恒瑞医药RDC药物启动临床;再鼎医药贝玛妥珠单抗III期研究数据阳性;和黄医药联合疗法获批上市;宜明昂科双抗IND获FDA批准 [4][12] - **海外公司进展**:艾伯维收购Capstan Therapeutics;阿斯利康启动B7 - H4 ADC治疗子宫内膜癌III期临床;FDA加速批准再生元双抗上市 [5][13] - **建议关注**:创新药关注商业化、出海及重点管线临床进展相关公司;Pharma关注创新转型公司 [14] 海外教育 - **市场回顾**:本周教育指数下跌4.2%,跑输恒生国企指数2个百分点;年初至今累计涨幅6.72%,跑输11.92个百分点 [17] - **数据更新**:本周东方甄选及其子直播间抖音平台GMV约1.3亿元,日均1871万元,环比上升20%,并给出各直播间GMV构成情况 [18] - **投资分析意见**:关注中概教培公司、港股职教公司、港股高教公司 [19] 海外社服 - **投资策略**:现制茶饮板块比拼供应链;在线旅游国内竞争改善,布局出境和海外;澳门博彩收入有韧性,估值处底部 [22] - **重点关注**:古茗、蜜雪集团、携程集团、美高梅中国 [23] 盈利预测与估值 海外医药 - 给出创新药、Pharma、医疗服务、CXO等子行业多家公司市值、PE、收入、归母净利润等盈利预测与估值数据 [27] 海外教育 - 给出多家教育公司市值、PE、利润预测、利润复合增速等盈利预测与估值数据 [28] 海外社服 - 给出在线旅游、餐饮、博彩等子板块多家公司市值、P/E、收入、净利润、EV/EBITDA、息税折摊前利润等盈利预测与估值数据 [30] 东方甄选数据 - 展示东方甄选GMV、SKU、月度总GMV、日均GMV、直播商品情况、累计粉丝数、粉丝年龄和性别分布等数据 [32][33][35][37][39][43][45][46][48]
FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
ZACKS· 2025-07-03 22:20
Key Takeaways REGN gained FDA approval for Lynozyfic to treat relapsed or refractory multiple myeloma. Lynozyfic showed a 70% response rate and 45% complete response rate in the LINKER-MM1 trial. The approval makes Lynozyfic the first FDA-cleared BCMAxCD3 bispecific with biweekly or monthly dosing.Regeneron Pharmaceuticals, Inc. (REGN) obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).The regulatory body granted accelerated approval to lin ...
Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma
Globenewswire· 2025-07-02 23:00
TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval bas ...
Regeneron, SNY Report Mixed Results From Late-Stage COPD Studies
ZACKS· 2025-05-30 23:21
Regeneron Pharmaceuticals, Inc. (REGN) and partner Sanofi (SNY) announced mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD).The candidate is being jointly developed by Regeneron and Sanofi. It is currently in clinical development programs for chronic rhinosinusitis with nasal polyps (phase III), non-cystic fibrosis bronchiectasis (phase II) and chronic rhinosinusitis without nasal polyps (phase II).Year to date, ...
Regeneron Pharma Margins Tighten As Competition Grows, Stock Slides
Benzinga· 2025-04-30 02:52
财务表现 - 第一季度调整后每股收益为8 22美元 同比下降14% 低于市场预期的8 82美元 [1] - 第一季度营收为30 3亿美元 同比下降4% 低于市场预期的32 9亿美元 [1] - 美国市场Eylea HD和Eylea净销售额同比下降26%至10 4亿美元 其中Eylea HD贡献3 07亿美元 [1] - 2025年GAAP毛利率预期下调至83%-84% 此前为84%-85% 调整后毛利率预期下调至86%-87% 此前为87%-88% [4] 产品销售 - Eylea HD第一季度净销售额同比增长 主要受销量提升推动 [2] - Eylea净销售额同比下降 主要受其他抗VEGF产品(包括生物类似药)竞争加剧影响 以及患者向Eylea HD转移 [2][7] - 与赛诺菲合作收入同比增长 从2024年第一季度的8 04亿美元增至2025年第一季度的10 18亿美元 主要得益于Dupixent销售利润增长 [3] 研发与监管进展 - 欧洲委员会有条件批准Lynozyfic(linvoseltamab)用于治疗复发难治性多发性骨髓瘤成人患者 [5] - 美国FDA受理linvoseltamab生物制品许可申请 目标审评日期为2025年7月10日 [5] 产能扩张 - 与FUJIFILM Diosynth Biotechnologies达成新协议 扩大其商业生物制剂原料药生产能力 [4] 市场反应 - 股价下跌6 38%至571 90美元 [5]
Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma
Globenewswire· 2025-04-28 19:01
Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory ...