FDA 审批允许 JUUL 相关雾化产品继续在美销售，美国合规市场扩容趋势愈发清晰。7 月 17 日，FDA 官网发布最新版 的《获批电子烟产品清单》，JUUL 旗下一款雾化电子烟烟具及四款烟草味和薄荷味烟弹已正式获得市场销售授权（MGO）。 这意味着 JUUL 在 2022 年被 FDA 下达销售禁令后，重新获得在美国市场销售的合法地位。截止目前，FDA 已审批通过 的雾化电子烟产品总数由此前的 34 款增加至 39 款。 投资逻辑 HNB 市场规模持续增长，美国市场有望贡献显著增量。HNB 方面，欧洲市场风味禁令影响逐渐消退，菲莫 25Q2 欧洲市 场 HTU 销量恢复双位数增长，一定程度上验证口味的限制并不会显著影响 HNB 吸引力，这是 HNB 行业后续政策风险较 低且能健康长期成长的关键。后续重点期待美国 FDA 正式通过相关品牌的 HNB 产品，美国 HNB 市场开启并且扩容已是 大势所趋，有望显著打开行业成长空间。 合规审批加速与严厉打击非法产品并行，美国合规雾化市场扩容趋势依旧清晰。FDA 允许 JUUL 雾化电子烟继续在美 销售，表明 FDA 监管风向不是简单的一刀切，而是以维护行业健康发展 ...

如果所有项目均获得行使选择权且所有里程碑都实现，恒瑞将有资格获得未来基于成功开发、注册和销 售里程碑付款的潜在总金额约120亿美元（约合人民币860亿元）。恒瑞将有权向GSK收取相应的分梯度 的销售提成。 公开信息显示，HRS-9821是一款可用于治疗慢性阻塞性肺病（COPD，以下简称"慢阻肺病"）的创新 药，7月初已获国家药监局（NMPA）批准开展临床试验，目前正处于临床开发阶段。 21世纪经济报道记者季媛媛7月28日，继默沙东宣布以100亿美元收购Verona Pharma之后，恒瑞医药也 宣布与葛兰素史克（GSK）达成重磅协议，将共同开发至多12款涵盖呼吸、自免和炎症、肿瘤治疗领域 的创新药物。 根据协议条款，GSK将向恒瑞医药支付总计5亿美元的首付款。后者将自主研发的PDE3/4抑制剂创新药 HRS-9821和最多11个项目的全球独家权利（除中国大陆、香港、澳门及台湾地区以外）有偿许可给 GSK。 从双方此次合作来看，创新药"变现"领域已从肿瘤转向慢性病。对此，有券商医药行业分析师向21世纪 经济报道记者表示，肿瘤领域曾被视为生物医药创新的黄金赛道，如今却深陷同质化竞争的红海。2025 年上半年的数据 ...

Key Takeaways MRK will report Q2 results on July 29. Consensus estimates for sales are at $15.77B and EPS at $1.99.Keytruda, Lynparza and new drugs like Capvaxive are expected to boost Q2 pharmaceutical sales.Weak Gardasil demand in China, generic erosion and pipeline reliance may weigh on investor sentiment.Merck (MRK) will report its second-quarter 2025 earnings on July 29, before market open. The Zacks Consensus Estimate for second-quarter sales and earnings is pegged at $15.77 billion and $1.99 per shar ...

如果获得欧洲委员会(EC)的正式批准——欧洲委员会拥有最终决定权，Trixeo Aerosphere将成为欧盟首 款采用这种新型输送机制的吸入器。虽然欧洲委员会通常会遵循EMA的建议，但并不具有法律约束 力。 数据显示，该吸入器在2024年为阿斯利康带来了9.78亿美元的营收。慢阻肺领域的竞争产品还包括赛诺 菲(SNY.US)/再生元(REGN.US)的 Dupixent、葛兰素史克(GSK.US)的Trelegy Ellipta，以及Verona Pharma 的Ohtuvayre。阿斯利康表示，基于CHMP的支持，该公司将在欧洲启动Trixeo Aerosphere吸入器向新型 推进剂的转型工作。 该吸入器的旧版推进剂版本已在欧洲获批用于治疗慢性阻塞性肺病(COPD)成人患者。COPD通常被称 为"吸烟者肺"，因为该病主要影响吸烟人群，但也可能由空气污染和职业相关危害引起。 Trixeo Aerosphere的环保版本已于今年5月获得英国监管机构批准，成为全球首个此类产品，目前也正在 包括中国在内的其他国家接受审查。CHMP推荐批准该产品在欧盟上市的依据是临床试验结果。试验显 示，新推进剂在药物输送方面与 ...

Philip Morris (PM) reported $10.14 billion in revenue for the quarter ended June 2025, representing a year-over-year increase of 7.1%. EPS of $1.91 for the same period compares to $1.59 a year ago.The reported revenue represents a surprise of -1.12% over the Zacks Consensus Estimate of $10.25 billion. With the consensus EPS estimate being $1.85, the EPS surprise was +3.24%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street ...

Core Viewpoint - Philip Morris International Inc. is expected to report growth in both revenue and earnings for the second quarter of 2025, with earnings anticipated to be released on July 22, before market opening [1]. Revenue and Earnings Estimates - The Zacks Consensus Estimate for revenues is approximately $10.3 billion, reflecting an 8.3% increase from the same quarter last year [2]. - The consensus estimate for quarterly earnings has risen to $1.85 per share, indicating a 16.4% increase compared to the previous year [2]. Earnings Performance and Predictions - Philip Morris has a trailing four-quarter average earnings surprise of 3.6%, with the last quarter's earnings exceeding the Zacks Consensus Estimate by 5% [3]. - The company has an Earnings ESP of -0.04% and a Zacks Rank of 2 (Buy) [4]. Factors Influencing Q2 Earnings - Strong pricing strategies have been a significant driver of revenue and operating income growth, as smokers tend to accept price increases due to the addictive nature of cigarettes [5]. - Smoke-free products contributed to 44% of the gross profit in Q1 2025, highlighting the success of the IQOS ILUMA device and other innovations like ZYN nicotine pouches and VEEV ONE e-vapor [6]. Smoke-Free Product Growth - The Zacks Consensus Estimate for total smoke-free product revenues for Q1 is $4,225.9 million, up from $3,530 million in the previous year [7]. - Management anticipates a 10% growth in IQOS HTU adjusted IMS for Q2, with ZYN shipments expected to maintain levels from Q1 [8]. Earnings Forecast - The company forecasts adjusted earnings between $1.80 and $1.85 for Q2, including a favorable currency impact of 6 cents per share [9][11]. Stock Performance - Philip Morris shares have increased by 9.7% over the past three months, underperforming the Zacks industry growth of 10.2% but lagging behind the S&P 500's 19.5% increase [12]. - Compared to major tobacco players, Philip Morris outperformed Altria but was outpaced by Turning Point Brands and British American Tobacco [13]. Valuation Analysis - Philip Morris is trading at a premium with a forward 12-month price-to-earnings ratio of 22.39X, above the industry average of 15.21X [15]. - Despite the premium valuation, the company's growth profile and strategic transformation make it an attractive option for investors [16].

2025 年 7 月 21 日 证券研究报告 行业周报 行业评级： | 报告期：2025.7.7-2025.7.20 | | | --- | --- | | 投资评级 | 看好 | | 评级变动 | 维持评级 | 行业走势： 分析师： huchenxi@gwgsc.com 执业证书编号：S0200518090001 联系电话：010-68085205 分析师 魏钰琪 weiyuqi@gwgsc.com 执业证书编号：S0200525060001 联系电话：010-68099389 2 号院 1 号楼中国长城资产大厦 16 层 医药生物行业双周报 2025 年第 15 期总第 138 期 《2024 年全国医疗保障事业发展统计公报》发布 第十一批集采规则优化 行业回顾 本报告期医药生物行业指数涨幅为 5.89%，在申万 31 个一级行业中 位居第 3，跑赢沪深 300 指数（1.92%）。从子行业来看，医疗研发 外包、化学制剂涨幅居前，涨幅分别为 13.94%、8.43%；线下药店跌 幅居前，跌幅为 3.91%。 估值方面，截至 2025 年 7 月 18 日，医药生物行业 PE（TTM 整体法， 剔除负值）为 ...

Core Viewpoint - Merck is facing pressure on its stock due to reliance on Keytruda, which will face a patent cliff by the end of the decade, prompting the company to seek ways to mitigate competition risks [1][2]. Group 1: Recent Acquisitions and Product Pipeline - Merck announced the acquisition of Verona Pharma for $10 billion to expand its portfolio with Ohtuvayre, a promising COPD treatment [4]. - Ohtuvayre has potential peak sales estimated at around $4 billion, but it may not be sufficient to replace Keytruda's $29.5 billion sales from last year [5][7]. - Merck's acquisition of Acceleron Pharma for $11.5 billion led to the launch of Winrevair, projected to have peak sales of around $3 billion [6]. - In 2023, Merck invested $10.8 billion in Prometheus Biosciences for a candidate targeting ulcerative colitis, MK-7240, which could enhance its portfolio if it gains FDA approval [8]. Group 2: Internal Development and Future Prospects - Merck is developing a subcutaneous version of Keytruda, which has shown noninferiority in a phase 3 trial, potentially attracting significant business [9][10]. - The company has over 80 programs in its phase 2 and phase 3 pipeline, indicating a strong potential for new product launches [12]. - A 25% success rate on new clinical compounds could lead to several novel launches in the next five years, demonstrating Merck's capability to move beyond Keytruda [13]. Group 3: Financial Considerations - Merck's shares are currently trading at 9.3 times forward earnings estimates, significantly lower than the healthcare sector average of 16.2 [14]. - The company offers a solid dividend yield of around 4%, with an 88.8% increase in payouts over the past decade [14]. - Despite lagging the market over the past year, Merck's long-term prospects remain strong for investors willing to hold the stock [15].

近期，港股创新药板块再掀涨停潮。三叶草生物-B四天暴涨65%，中生制药、石药集团等传统药企纷纷 走强，市场情绪陡然升温。上证创新药指数自4月以来涨幅已超过50%，成为年内最强主题之一。在这 样一片火热中，健康元和旗下丽珠医药的股价涨幅却仅约20%，显得"异常冷静"。但冷静的背后，或许 正孕育一场价值重估的暗涌。 在资本竞逐传统大赛道之际，健康元选择了一条看似"冷门"的吸入制剂之路，却悄然搭建起一个潜力巨 大的呼吸版图。这种"不凑热闹"的坚持，正在随着全球巨头的举动被重新认知。 默沙东收购激起千层浪，健康元踩对"呼吸节奏" 6月，默沙东以100亿美元收购呼吸药企Verona Pharma，成为全球医药圈最轰动的事件。这家标的公司 的核心产品Ohtuvayre?，是20年来首个用于COPD（慢性阻塞性肺病）的新机制疗法——PDE3/4双靶点 吸入抑制剂。收购消息一出，吸入制剂这一相对冷门的领域被瞬间拉入主流视野，投资者也开始将目光 投向那些早已布局此赛道的企业。 健康元便是其中的佼佼者。早在默沙东收购消息之前，公司就已构建出全球领先的吸入制剂矩阵。旗下 PDE4吸入制剂聚焦轻中度COPD患者，旨在精准抑制肺部炎症 ...

Core Insights - The U.S. stock market is anticipated to remain volatile due to rising inflation pressures from new tariffs and uncertainty surrounding corporate earnings [2] - A curated portfolio of low-beta stocks is recommended as a strategy to navigate this volatility [2][3] Stock Analysis - **Vipshop Holdings Limited (VIPS)**: The company utilizes the "Made for Vipshop" program, offering exclusive products from over 200 brands, which drives customer loyalty and demand [8][10] - **Alkami Technology Inc (ALKT)**: The firm is experiencing increased demand from banks and credit unions, particularly due to its acquisition of MANTL, which simplifies account opening processes [11][10] - **Futu Holdings Limited (FUTU)**: As a tech-driven company, Futu is enhancing its online investment platform, recently introducing Futubull AI, a smart assistant for investment inquiries [12][10] - **Verona Pharma plc (VRNA)**: The company's drug Ohtuvayre is a significant advancement in COPD treatment, being the first inhaled therapy with a new mechanism in over two decades, providing dual benefits of bronchodilation and anti-inflammatory effects [13][10] Screening Criteria - Stocks with a beta between 0 and 0.6 are prioritized for lower volatility compared to the market [6] - Additional criteria include positive price movement over the last month, average trading volume greater than 50,000, a minimum price of $5, and a Zacks Rank of 1 indicating strong buy potential [7]