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除了流感,RSV病毒同样值得关注!解析RSV的F与G蛋白入侵细胞的机制
生物世界· 2025-12-16 04:11
呼吸道合胞病毒 ( RSV ) 作为三大呼吸道病毒之一,在每年的冬季和早春季节流行。 RSV 属于 RNA 病 毒,通过空气传播,对儿童、老年人及免疫功能受损的成年人健康威胁较大。美国国立卫生研究院 ( NIH) 数据显示,美国几乎所有的儿童在两岁前都曾感染过 RSV ,每年导致 5.8 万名 5 岁以下儿童住 院。在全球范围内, RSV 每年影响 6400 万人,导致 16 万人死亡。 从中国疾控中心公布的 "全国急性呼吸道传染病哨点监测情况" ( 2025 年第 49 周 ) 数据来看, 2025 年 12 月 1 日 - 12 月 7 日 , 流感样病例呼吸道样本检测阳性率前三位病原体为 流感病毒 ( 54.2% ) 、 鼻病毒 ( 5.2% ) 、 呼吸道合胞病毒 ( 4.0% ) ;住院严重急性呼吸道感染病例呼吸道样本检测阳 性率前三位病原体为流感病毒 ( 22.1% ) 、呼吸道合胞病毒 ( 7.5% ) 、鼻病毒 ( 7.1% ) 。总的来 说 ,我国目前已进入呼吸道传染病高发季,总体处于上升趋势。流感病毒处于高流行水平, RSV 、鼻病 毒也存在一定的感染率。 什么是呼吸道合胞病毒? 呼吸道合 ...
GSK gets EU regulator backing for expanded use of RSV vaccine
Reuters· 2025-12-12 14:02
Core Viewpoint - GSK's RSV vaccine, Arexvy, has received backing from a panel of the European Medicines Agency for use in all adults over the age of 18, indicating a significant step towards broader vaccine availability [1] Group 1 - The European Medicines Agency's panel supports the use of Arexvy for adults aged 18 and older, which may enhance GSK's market position in the respiratory vaccine sector [1] - This endorsement could lead to increased sales and revenue opportunities for GSK as the demand for respiratory vaccines rises [1]
GSK Stock Up Almost 19% in 3 Months: Should You Buy, Hold or Sell?
ZACKS· 2025-12-11 15:15
Core Insights - GSK's stock has increased by 18.6% over the past three months, driven by strong Q3 results that exceeded earnings and sales estimates, along with raised sales and profit guidance for the year [1][9] - The drug and biotech sector has seen a recovery, with major companies like Pfizer and AstraZeneca entering drug pricing agreements with the Trump administration [2] - GSK's Specialty Medicines unit is a key growth driver, with sales rising 16% in the first nine months of 2025, supported by successful launches in Oncology and long-acting HIV medicines [4][6] Specialty Medicines Growth - The Specialty Medicines unit's sales growth is attributed to strong demand for new long-acting HIV medicines and oncology drugs, with key products like Nucala and Dovato contributing significantly [5][6] - GSK expects Specialty Medicines sales to grow at a mid-teens compound annual growth rate (CAGR) in 2025, up from previous low-teens expectations, and anticipates this segment will account for over 50% of total revenues by 2031 [6][26] Promising Pipeline - GSK is increasing R&D investments in long-acting and specialty medicines, with several recent drug approvals, including Penmenvy and Blujepa, expected to drive growth in the coming years [7][8] - The company plans to launch five new products/line extensions in 2025, with several already approved in the U.S. [12] Vaccine Sales Decline - GSK's vaccine sales in the U.S. have declined by 11% at constant exchange rates (CER) in 2025, primarily due to lower demand for its shingles and RSV vaccines [13][15] - Despite the decline in the U.S., sales of these vaccines have risen in Europe, indicating a mixed performance across regions [15] Stock Performance and Valuation - GSK's stock has outperformed the industry and the S&P 500, rising 43.1% year-to-date compared to an industry increase of 11.7% [17] - The stock is trading at a price/earnings ratio of 10.02, which is lower than the industry average of 16.31, indicating an attractive valuation [20] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings has increased from $4.38 to $4.49 per share for 2025, reflecting analysts' optimism about profit growth [23][24] - GSK expects to achieve over 7% sales growth and more than 11% core operating profit growth on a CAGR basis through 2026 [27]
三千多一针的网红疫苗排队打,却被国内企业忽略了?
3 6 Ke· 2025-12-08 00:02
今年的呼吸道合胞病毒(RSV)流行季似乎格外长,从仲夏一直持续到了隆冬。 与以往只能通过物理隔离来保护幼小的孩子不同,今年家长们多了一个选择,即注射3000多元一针的网红疫苗,来降低RSV感染引发重症的可能性。但他 们也多了一份焦虑。网红疫苗尽管昂贵,却不易接种。目前,国内只有少数社区医院和私立儿童医院有针,并且通常需要预约等针,排队时间往往会超过 一个月。 这款网红疫苗,实际上是赛诺菲开发的尼塞韦单抗。尼塞韦单抗本质是直接的抗体药物,而不是需要激活自身免疫系统来抵御病毒的传统疫苗,它一旦进 入人体,即时发挥作用,副作用也很小。2023年底,尼塞韦单抗在国内获批。在上一个RSV流行季中,尼塞韦单抗主要在上海的几家儿童医院试点应用, 到今年RSV感染流行期间,尼塞韦单抗开始在北京、天津、湖北等地扩大基层接种点覆盖,引发了接种热潮。 在此之前,尼塞韦单抗早已在欧美国家狂揽数十亿美元收入。原研商赛诺菲甚至表示,尼塞韦单抗上市后,造成了前所未有的供不应求的局面。 01 一针难求的重磅炸弹 即便如此,帕利珠单抗上市后仍快速打开市场,为MedImmune创造了十分可观的商业价值。2007年,阿斯利康以150亿美元高价收购 ...
Moderna Q3 Earnings Beat, Stock Up on Revised '25 Spending Plans
ZACKS· 2025-11-06 18:01
Core Insights - Moderna reported a loss of $0.51 per share in Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $2.15, compared to an EPS of $0.03 in the same period last year [1][10] - Total revenues for the quarter were $1.02 billion, exceeding the Zacks Consensus Estimate of $860 million, but representing a 45% decline year over year due to lower net product sales [1][10] Revenue Breakdown - Moderna has three marketed vaccines: Spikevax, mNexspike, and mResvia. Product sales fell nearly 47% year over year to $973 million [2] - Sales from COVID-19 vaccines amounted to $971 million, down 46% year over year, attributed to lower vaccination rates and the transition of COVID-19 to a seasonal market [2] - mResvia sales were only $2 million, significantly below the estimated $30 million, and down 80% year over year due to competition from GSK's Arexvy and Pfizer's Abrysvo [3] Operating Costs and Efficiency - SG&A expenses decreased by 5% year over year to $268 million, primarily due to cuts in consulting and external services [5] - R&D expenses were reduced by 30% to $801 million, reflecting a focus on efficiency and prioritization of clinical development [5] Guidance and Outlook - Moderna revised its total revenue guidance for 2025 to a range of $1.6-$2.0 billion, down from $1.5-$2.2 billion [6] - The company also lowered its R&D expense guidance to $3.3-$3.4 billion, from a previous estimate of $3.6-$3.8 billion, while maintaining SG&A and capital expenditure guidance at approximately $1.1 billion and $0.3 billion, respectively [7] Market Reaction - Shares of Moderna rose by 10% in pre-market trading, likely due to the company's cost-cutting measures and improved liquidity outlook, now projected to be between $6.5-$7.0 billion by year-end 2025 [8] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, including a personalized cancer therapy in collaboration with Merck [12][16] - The company discontinued development of mRNA-1647 for CMV prevention after failing to meet primary efficacy endpoints but continues to study it in mid-stage trials for bone marrow transplant patients [13] - Positive results from a phase III study for mRNA-1010, a standalone influenza vaccine, have led to plans for regulatory submissions in early 2026 [14] - The company is also working on mRNA-1083, a combination vaccine for COVID-19 and influenza, and is awaiting further guidance from the FDA [15]
Should You Buy Moderna Stock Ahead of Q3 Earnings Report?
ZACKS· 2025-11-04 14:41
Core Insights - Moderna (MRNA) is expected to report Q3 2025 earnings on November 6, with sales estimated at $860 million and a loss of $2.15 per share, indicating a significant decline from the previous year [1] - The consensus estimate for loss per share has widened from $9.50 to $9.74 over the past month [1] Earnings Performance - Moderna has beaten earnings estimates in the last four quarters, with an average surprise of 37.78%, including a 28.76% surprise in the last reported quarter [2][3] Revenue Expectations - The majority of Q3 revenues are anticipated to come from COVID-19 vaccines, with combined sales estimated at $762 million, reflecting a significant decline due to reduced demand for boosters [5][6] - Minimal sales of the RSV vaccine, mResvia, are expected at $30 million, significantly lower than competitors GSK's Arexvy and Pfizer's Abrysvo [7] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, with a focus on updates following the recent setback in the CMV vaccine program [8] - The pivotal Phase III study for mRNA-1647 failed to meet primary efficacy endpoints, leading to its discontinuation, although it continues to be studied in mid-stage trials [9] - Investors are also focused on mRNA-1083, a COVID-19/influenza combination vaccine, which is on track for FDA resubmission [10] - Intismeran autogene, a personalized cancer therapy developed with Merck, is undergoing pivotal studies, and updates on its progress are anticipated [11] Stock Performance and Valuation - Year-to-date, Moderna's shares have decreased by 40%, underperforming the industry and the S&P 500 [13][14] - The stock is trading at a premium valuation, with a price/sales ratio of 3.14 compared to the industry average of 2.33 [16] Investment Outlook - Despite significant declines in revenue, Moderna's cash position of approximately $7.5 billion allows for continued investment in pipeline development [18] - The recent CMV vaccine setback has raised concerns about the company's growth trajectory and reliance on other late-stage assets [19][20] - Plans to launch 10 new marketed products by 2028 targeting a market exceeding $30 billion are now clouded by the CMV failure and underwhelming sales of mResvia [21] - Current premium valuation and downward revisions to earnings estimates suggest caution for investors considering building positions in Moderna stock [22]
GSK's Q3 Earnings & Sales Beat Estimates, Stock Up on Raised '25 View
ZACKS· 2025-10-29 16:50
Core Insights - GSK plc reported third-quarter 2025 core earnings of $1.48 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.26, with core earnings increasing 11% year over year on a reported basis and 14% at a constant exchange rate (CER) [1][10] - Quarterly revenues rose 7% on a reported basis and 8% at CER to $11.52 billion (£8.55 billion), driven by rising sales across all business segments, particularly in HIV, oncology, and respiratory medicines, surpassing the Zacks Consensus Estimate of $11.16 billion [2][10] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 16%, General Medicines rose by 4%, and Vaccine sales were up by 2% [3] - HIV sales rose 12% during the quarter, driven by increased demand for Dovato and long-acting medications like Apretude and Cabenuva, with Dovato sales increasing by 24% [4][5] - Oncology sales surged by 39%, led by strong demand for Jemperli, which saw a 79% increase due to expanded treatment indications [6][7] - Respiratory drug Nucala sales increased by 14%, while Benlysta sales rose by 17%, reflecting strong demand across markets [9] Financial Guidance - GSK raised its 2025 guidance, now expecting sales growth of 6-7%, up from a previous forecast of 3-5%, and core EPS growth of 10-12% [10][17][19] - Specialty Medicines are now expected to grow at a mid-teens percentage at CER, while General Medicines are anticipated to remain stable [18] - The company reiterated its guidance for R&D and SG&A expenses, with R&D expected to grow slightly faster than sales [20] Long-term Strategy - GSK is focusing on HIV, immunology/respiratory, and oncology therapeutic areas, with 80 assets in clinical development, including 16 in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions this year, with four already approved by the FDA [25] - GSK aims to launch 15 new drugs between 2025 and 2031, each with peak sales potential exceeding £2 billion [26]
GSK Upgrades 2025 Financial Outlook, CEO Says Positioned Well For 2026
Benzinga· 2025-10-29 13:08
Core Insights - GSK reported strong third-quarter results with sales of $11.53 billion, an 8% increase at constant currency, surpassing analyst expectations of $11.16 billion [1] - Core earnings rose 15% at constant currency to $1.48 per share, exceeding the consensus forecast of $1.26 [1] Sales Performance - Vaccine sales increased by 1% to 2.68 billion pounds, driven by strong demand for Shingrix and Arexvy, despite lower sales in Established and Influenza vaccines [2] - Arexvy sales reached 251 million pounds, up 34%, while Meningitis vaccine sales increased 4% to 541 million pounds [3] - Shingrix sales were 830 million pounds, up 12%, and Specialty Medicines sales grew by 15% to 3.41 billion pounds, reflecting strong performance across various therapeutic areas [3] Guidance Update - GSK raised its full-year 2025 guidance, expecting sales growth of 6% to 7%, up from the previous 3% to 5% range [6] - Core operating profit is anticipated to grow between 9% to 11%, and core earnings per share are expected to increase by 10% to 12% [6] - Specialty Medicine sales are projected to increase at a mid-teens percentage, an upgrade from the prior low teens guidance [6] Market Response - Following the positive earnings report and upgraded guidance, GSK stock rose by 2.56% to $44.82 in premarket trading [7] Tariff Considerations - GSK acknowledged the ongoing U.S. investigation regarding the impact of pharmaceutical imports on national security and indicated potential European tariffs of 15% [5] - The company is prepared to address the financial implications of these tariffs with identified mitigation options [5]
GSK(GSK) - 2025 Q3 - Earnings Call Presentation
2025-10-29 12:00
29 October 2025 Q3 2025 Results Conference call and webcast for investors and analysts gsk.com Agenda Q3 2025 strong performance improves further Emma Walmsley Performance: growth drivers 2 Cautionary statement regarding forward-looking statements Luke Miels and Deborah Waterhouse Q3 2025 financial performance Julie Brown Summary and Q&A Emma Walmsley, Luke Miels, Deborah Waterhouse, Julie Brown, Tony Wood and David Redfern This presentation may contain forward-looking statements. Forward-looking statements ...
Merck's Non-Oncology Drugs Q3 Performance: What to Expect
ZACKS· 2025-10-24 15:06
Core Insights - Merck (MRK) is set to report its third-quarter 2025 results on October 30, with a focus on the sales performance of its leading cancer drug, Keytruda, which contributed over 50% of the company's pharmaceutical sales in the first half of 2025 [1][9] - The company is also monitoring the performance of its non-oncology drugs, particularly the newly approved 21-valent pneumococcal conjugate vaccine, Capvaxive, and the pulmonary arterial hypertension (PAH) drug, Winrevair, both of which showed strong sales in the first half of 2025 [2][9] Sales Performance - Keytruda remains a significant revenue driver, but its exclusivity is set to expire in 2028, prompting investors to pay attention to non-oncology products [2] - Capvaxive generated sales of $236 million, while Winrevair achieved $615 million in sales during the first half of 2025 [2] Growth Projections - The new drugs are expected to perform well in Q3 2025, supported by their strong initial uptake [3] - Merck's Animal Health business is also contributing to revenue growth, with an estimated compound annual growth rate (CAGR) of 5.9% over the next three years [3] Product Launches and Approvals - Merck's RSV antibody, Enflonsia, was approved in the U.S. in June 2025 and is under review in the EU, with plans for launch to protect infants during their first RSV season [4] - A fixed-dose combination for HIV treatment is also under review, with an FDA decision expected in April next year [4] Competitive Landscape - Winrevair faces competition in the PAH market from major players like United Therapeutics and Johnson & Johnson, which reported significant revenues from their PAH products [5][6] - Enflonsia will compete with AstraZeneca/Sanofi's RSV antibody, Beyfortus, and other vaccines approved for RSV prevention [6][7] Stock Performance and Valuation - Year-to-date, Merck's shares have declined by 12.3%, underperforming the industry and the S&P 500 [8] - The company's shares trade at a price/earnings ratio of 9.33, which is lower than the industry average of 15.56 and its 5-year mean of 12.63, indicating attractive valuation [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has slightly decreased from $8.94 to $8.92, while the estimate for 2026 has decreased from $9.55 to $9.44 over the past 60 days [11]