Emrelis
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多款新药获批上市,数百款新药正在临床开发!这类疗法正在为癌症患者带来新曙光
Xin Lang Cai Jing· 2025-12-22 10:56
抗体偶联药物(ADC)凭借将细胞毒性药物精准递送至癌细胞的能力,正成为推动肿瘤领域新药研发的重点方向之一。公开资料显示,全球范围内有数百 款ADC疗法处于积极的临床研究阶段,其中包含了数十款双抗ADC,靶点涵盖了EGFR、HER2、HER3、c-Met 、ROR1、PD-L1、B7-H4、B7-H3等等,临 床开发适应症涉及一系列实体瘤和血液系统恶性肿瘤。 2025年以来,ADC新药研发管线迎来一系列新进展。其中,多款创新ADC获监管机构批准上市,为不同类型的乳腺癌、非小细胞肺癌等患者带来了新的治 疗选择。 比如,12月,美国FDA批准由阿斯利康和第一三共联合开发的靶向HER2的ADC疗法Enhertu联合帕妥珠单抗,用于一线治疗经FDA批准检测确定为不可切除 或转移性HER2阳性(IHC 3+或ISH+)乳腺癌的成人患者。 再如,10月,FDA批准葛兰素史克(GSK)靶向BCMA的ADC药物Blenrep,联合硼替佐米和地塞米松,用于治疗至少接受过两种既往疗法的复发或难治性 多发性骨髓瘤成年患者。5月,FDA批准艾伯维(AbbVie)靶向c-Met的ADC药物Emrelis上市,用于治疗c-Met蛋白高度表 ...
Here's How AbbVie's Oncology Drugs are Aiding Top-line Growth
ZACKS· 2025-12-11 13:51
Core Insights - AbbVie is significantly expanding its oncology presence, moving from a two-drug franchise to include solid tumors, with new drugs like Epkinly, Elahere, and Emrelis contributing to over 11% of total revenues in the first nine months of 2025, reflecting a 3% year-over-year growth [1][9] Expansion Strategies - The expansion is driven by both organic and inorganic strategies, with Emrelis being AbbVie's first internally developed solid tumor drug, while Epkinly and Elahere were acquired through collaborations [2] - Sales from newer drugs and rising Venclexta sales have offset the decline in Imbruvica sales due to competition from novel therapies [2] Pipeline Development - AbbVie has a diverse pipeline of new therapies for blood cancers and solid tumors, including antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [3] - A regulatory filing for the ADC therapy pivekimab sunirine is under FDA review for treating a rare blood cancer, which could add a third ADC to AbbVie's portfolio [4] - The company is also developing Temab-A for metastatic colorectal cancer and other cancers in various stages of clinical trials [4][5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for 43% of total revenues and growing 16% year-over-year [6] - Merck's Keytruda accounted for about 48% of its total revenues, while Pfizer's oncology revenues grew 7%, making up over 27% of its total revenues [7] Financial Performance - AbbVie shares have outperformed the industry year to date, trading at a slight discount with a P/E ratio of 15.87 compared to the industry average of 16.31 [8][11] - EPS estimates for 2025 and 2026 have declined in the past 60 days, indicating potential challenges ahead [13]
EGFRTKI治疗肺癌迭代发展,耐药挑战推动研发升级
Ping An Securities· 2025-12-01 07:27
Investment Rating - The report maintains an "Outperform" rating for the industry [2]. Core Insights - The third-generation EGFR TKI has become the first-line standard therapy for advanced EGFR mutation NSCLC, significantly extending median progression-free survival (mPFS) to 18.9-22.1 months compared to earlier generations [4][24]. - The domestic EGFR TKI market is expected to exceed 20 billion CNY in 2024, with third-generation EGFR TKIs accounting for 88% of the market share [4][30]. - There is an urgent need to address resistance mechanisms following third-generation EGFR TKI treatment, with ongoing exploration of fourth-generation TKIs, bispecific antibodies, and antibody-drug conjugates (ADCs) [5][32]. Summary by Sections 1. High Incidence of Lung Cancer in China - Lung cancer is the most common malignant tumor globally, with approximately 2.6 million new cases expected in 2024, including about 1.15 million in China [8]. - Non-small cell lung cancer (NSCLC) accounts for around 85% of lung cancer cases, with adenocarcinoma and squamous cell carcinoma being the most prevalent subtypes [8]. 2. Third-Generation EGFR TKI as First-Line Therapy - The third-generation EGFR TKI has established itself as the first-line treatment for advanced EGFR mutation NSCLC, with significant improvements in mPFS compared to first and second generations [4][16][24]. - The report highlights the efficacy of third-generation TKIs in overcoming common mutations and their favorable safety profile [4][24]. 3. Exploration of Resistance Mechanisms - The report discusses the complexity of resistance mechanisms to third-generation EGFR TKIs, including both EGFR-dependent and independent pathways [5][32]. - Current research focuses on developing fourth-generation TKIs targeting specific mutations and exploring combination therapies with bispecific antibodies and ADCs [5][32][39]. 4. Investment Recommendations - The report emphasizes the growth potential of third-generation EGFR TKIs and suggests monitoring companies like Hansoh Pharma and Eli Lilly for market penetration and sales growth [51]. - It also highlights the progress of ADCs and bispecific antibodies in clinical trials, indicating a robust pipeline for future treatments [51][52].
Should You Buy AbbVie Stock Ahead of Q3 Earnings Report?
ZACKS· 2025-10-28 13:50
Core Insights - AbbVie is expected to report Q3 2025 earnings on October 31, with sales estimated at $15.59 billion and earnings per share (EPS) at $1.80, although earnings estimates have declined from $12.02 to $10.81 in the past month [1][4][20] Financial Performance - AbbVie has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 2.46% [2][3] - The company anticipates adjusted earnings between $1.74 and $1.78 per share for Q3 2025, with net revenues around $15.5 billion [6] Product Performance - Sales growth is expected to be driven by newer immunology drugs, Skyrizi and Rinvoq, with consensus estimates for Skyrizi at $4.56 billion and Rinvoq at $2.16 billion [7] - Humira, AbbVie's blockbuster drug, is projected to generate $1.15 billion in sales, facing erosion due to lost patent protection [8] - In oncology, sales of Imbruvica are expected to decline due to competition, while Venclexta sales are anticipated to rise [9][10] - Neuroscience product sales are estimated at $2.74 billion, driven by strong performances from Botox, Vraylar, and new migraine drugs [12][11] - Aesthetics product sales are projected to recover to $1.27 billion, supported by stabilizing demand in the U.S. market [13] Stock Performance and Valuation - AbbVie's stock has increased over 28% this year, outperforming the industry and S&P 500 [15] - The stock is trading at a P/E ratio of 16.60, above the industry average of 15.58 and its five-year mean of 13.27 [18] Strategic Outlook - AbbVie is expected to achieve robust revenue growth in 2025, with a projected high single-digit revenue CAGR through 2029, driven by Skyrizi and Rinvoq [20] - Recent acquisitions and licensing deals have increased near-term expenses, impacting EPS estimates negatively [22][23] - Short-term investors may consider selling due to elevated IPR&D expenses, while long-term investors may remain optimistic about the company's growth potential [24]
AbbVie Inc. (ABBV): A Bull Case Theory
Yahoo Finance· 2025-10-22 18:31
Core Thesis - AbbVie Inc. is positioned for significant growth in its oncology portfolio, particularly through its antibody-drug conjugates (ADCs) Elahere and Emrelis, which target specific cancer types [1][4]. Oncology Portfolio - AbbVie is advancing its oncology portfolio with two ADCs: Elahere, approved for ovarian cancer, and Emrelis, approved for non-small cell lung cancer [2][3]. - Elahere generated global net revenues of $159 million in Q2 2025, marking a 24.2% sequential increase, with projected full-year 2025 sales of approximately $750 million [2]. - The global market opportunity for Elahere is estimated to exceed $1.7 billion by 2029 and could reach $6 billion by 2034 with continued adoption and additional indications [3]. Growth Potential - Emrelis is in the early stages of its commercial launch, with anticipated global sales ranging from $500 million to $1 billion by 2029 [3]. - The combination of Elahere's established market presence and Emrelis's potential positions AbbVie to capture meaningful growth in the oncology sector [4]. - Strong early adoption trends and a significant addressable market highlight AbbVie's capability to drive both near-term revenue growth and long-term strategic value in targeted cancer therapies [4]. Historical Performance - AbbVie’s stock price has appreciated approximately 17.9% since a previous bullish thesis in May 2025, which emphasized strong performance in immunology and oncology [5].
Here's What to Expect From AbbVie's Oncology Segment in Q3 Earnings
ZACKS· 2025-10-20 15:11
Core Insights - AbbVie has developed a significant oncology franchise, expanding from blood cancer drugs to include therapies for solid tumors, totaling five oncology products [1] - The oncology segment contributed over 11% to AbbVie's revenues in the first half of 2025, with a year-over-year growth of 5% [2] - Third-quarter 2025 oncology sales are estimated at $1.71 billion, reflecting nearly 2% growth year-over-year, despite declining sales of Imbruvica due to competition [3] AbbVie's Oncology Performance - AbbVie's oncology sales are projected to reach $1.71 billion in Q3 2025, with contributions from Venclexta, Epkinly, and Elahere, while Imbruvica continues to face challenges [7] - The recent approval of Emrelis for lung cancer is expected to provide modest revenue contributions in the upcoming quarter [3][7] Competitive Landscape - Major competitors in the oncology market include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for nearly 43% of its total revenues, growing 11% in the first half of 2025 [5] - Merck's Keytruda, a PD-L1 inhibitor, represented over 48% of its total revenues in the first half of 2025, highlighting its significance in the oncology space [6] - Pfizer's oncology revenues grew 9% operationally in the first half of 2025, driven by several key drugs, now making up over 25% of its total revenues [6]
Can Rinvoq and Skyrizi Sales Drive Another Strong Quarter for AbbVie?
ZACKS· 2025-10-14 16:11
Core Insights - AbbVie (ABBV) continues to lead in the immunology sector, driven by strong sales of its blockbuster drugs, Skyrizi and Rinvoq, which have helped the company achieve top-line growth despite the loss of exclusivity for Humira over two years ago [1][8] - The upcoming third-quarter results, scheduled for release on October 31, will be closely monitored by investors to assess the continuation of this growth momentum [1] Immunology Performance - Skyrizi and Rinvoq are approved for major indications previously covered by Humira, including a new indication for atopic dermatitis, and are performing well, particularly in the inflammatory bowel disease (IBD) segment, which includes ulcerative colitis (UC) and Crohn's disease (CD) [2] - Strong growth in the immunology market, market share gains, and new indications, such as Skyrizi's launch in UC and Rinvoq's approval for giant cell arteritis (GCA), are expected to enhance Q3 performance, with estimated sales of $4.54 billion for Skyrizi and $2.16 billion for Rinvoq [3] Expansion into Other Therapeutic Areas - AbbVie is diversifying its portfolio beyond immunology, with significant growth in neuroscience driven by the uptake of migraine treatments, Ubrelvy and Qulipta [4] - The oncology segment has also expanded, moving beyond hematologic cancers into solid tumors, supported by new drugs like Elahere and Emrelis [4] Competitive Landscape - The immunology market is highly competitive, with Johnson & Johnson (JNJ) as a key player, marketing Stelara and Tremfya for multiple indications, including UC and CD [5] - Eli Lilly (LLY) is also increasing its presence in immunology with the recent FDA approval of Omvoh for UC, marking its first immunology drug for IBD in the U.S. [6] Financial Performance and Valuation - AbbVie shares have outperformed the industry year-to-date, reflecting strong demand for Skyrizi and Rinvoq, which have restored top-line growth following Humira's patent loss [7][8] - AbbVie is currently trading at a premium valuation, with a price/earnings (P/E) ratio of 16.72, above the industry average of 15.70 and its five-year mean of 13.16 [10] - The bottom-line estimate per share for 2025 has slightly decreased from $12.02 to $11.93, while estimates for 2026 have increased from $14.32 to $14.42 over the past month [11]
3 Exceptional Stocks to Build Long-Term Wealth
MarketBeat· 2025-10-06 21:25
Group 1: Long-term Investment Considerations - Long-term investors should consider the time horizon and the stock's characteristics before selling, as time is often an ally for them [1][7] - Blue-chip stocks are highlighted for their maturity and significant profits, often returning value to shareholders through buybacks and dividends, with many being Dividend Aristocrats or Kings [2] - Growth-oriented companies in emerging industries can also provide durable value, potentially evolving into blue-chip stocks over time [3] Group 2: Rocket Lab Overview - Rocket Lab USA Inc. is considered a speculative investment with revenue in the hundreds of millions and no current profitability [4] - The company primarily generates revenue from its launch business but plans to expand its services to become a comprehensive space business [5] - Rocket Lab's stock has increased by 473% in the last 12 months, trading about 25% above analysts' consensus price target, leading to high short interest [6][8] Group 3: Costco Wholesale Profile - Costco Wholesale is characterized as a mature and profitable business with a membership-based model that delivers recurring revenue and a high retention rate near 90% [9][10] - The company recently raised its membership fee for the first time in seven years without a drop in retention, indicating strong customer loyalty [9] - Costco's stock trades at a high valuation near 50x earnings, and it has a history of returning capital to shareholders through buybacks and special dividends [10] Group 4: AbbVie Insights - AbbVie Inc. is a biopharmaceutical company with a strong portfolio of blockbuster drugs and a recent FDA approval for its oncology drug, Emrelis [13][14] - The stock has shown a total return of over 225% in the last five years, with a dividend yield of 2.85% and a history of increasing dividends for 53 consecutive years [14][15] - AbbVie has over 90 drug candidates in clinical trials, with more than 50 in late-stage trials, indicating significant growth potential alongside defensive income [15] Group 5: Investment Strategy Summary - The article emphasizes that a mix of established dividend payers and emerging innovators can provide stability and growth for long-term investors [16]
ABBV's Improving Oncology Sales Poise It Well for Long-Term Growth
ZACKS· 2025-08-22 13:46
Core Insights - AbbVie has a strong immunology franchise with blockbuster drugs and has also developed a substantial oncology franchise with key products like Imbruvica and Venclexta [1] Oncology Franchise Development - AbbVie and Genmab's Epkinly was approved for relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, while Emrelis was approved for non-squamous non-small cell lung cancer [2] - The acquisition of Immunogen added Elahere to AbbVie's oncology portfolio, contributing to double-digit revenue growth for Elahere and Epkinly in the first half of 2025 [2] - AbbVie's oncology segment generated $3.3 billion in revenue in the first half of 2025, a 4.2% increase year over year, driven by Venclexta and new drugs [3] Innovation in Oncology - AbbVie is enhancing its oncology portfolio with antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [4] - The company has two ADCs in its commercial portfolio and two additional next-generation ADCs in late-stage development, along with others in early-stage development [4] Pipeline and Growth Potential - A key candidate in AbbVie's oncology pipeline is etentamig/ABBV-383, targeting relapsed/refractory multiple myeloma [5] - Despite competitive pressure on Imbruvica, AbbVie's oncology business is well-positioned for growth in the coming years [5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, Bristol-Myers, and Pfizer, with AstraZeneca's oncology sales comprising around 43% of total revenues and growing 16% in the first half of 2025 [6] - Merck's Keytruda accounts for about 50% of its pharmaceutical sales, with a 6.6% sales increase to $15.1 billion in the first half of 2025 [7] - Pfizer's oncology revenues grew 9% in the first half of 2025, driven by various drugs, while AbbVie's oncology revenues rose 4.2% to $3.3 billion [8] Financial Performance and Valuation - AbbVie's stock has increased by 21.2% this year, outperforming the industry [10] - The company's shares trade at a price/earnings ratio of 15.54, higher than the industry average of 14.64 [13] - The Zacks Consensus Estimate for 2025 earnings has slightly decreased to $12.02 per share, while the estimate for 2026 has increased to $14.31 per share [16]
Pre-Q2 Earnings: Is AbbVie Stock a Portfolio Must-Have?
ZACKS· 2025-07-28 16:21
Core Viewpoint - AbbVie is expected to report second-quarter 2025 earnings on July 31, with sales estimated at $15.07 billion and earnings per share (EPS) at $2.89, although earnings estimates have declined recently [1][4][5] Financial Performance - AbbVie has consistently exceeded earnings expectations in the past four quarters, with an average earnings surprise of 2.93% [2][3] - The company anticipates adjusted earnings between $2.84 and $2.88 per share for Q2 2025, with net revenues around $15.0 billion [5] Product Performance - Growth is expected to be driven by newer immunology drugs, Skyrizi and Rinvoq, with sales estimates of $4.12 billion and $1.98 billion respectively [6] - Humira, which lost patent protection in January 2023, is projected to generate $1.41 billion in sales, reflecting ongoing sales erosion [7] - Sales for Imbruvica are expected to decline due to competition, with estimates at $704 million [8] - Venclexta sales are likely to rise, estimated at $668 million, driven by strong demand [9] - Neuroscience product sales are projected at $2.47 billion, supported by strong growth in drugs like Botox and Vraylar [10][11] Market Position and Valuation - AbbVie shares have outperformed the industry this year, trading at a price/earnings ratio of 14.44, slightly below the industry average of 15.34 [13][16] - Despite challenges from Humira biosimilars, AbbVie expects robust revenue growth in 2025, with a projected high single-digit revenue CAGR through 2029 [18] Strategic Outlook - AbbVie is investing in its future pipeline through collaborations, including a recent licensing deal for an investigational antibody targeting oncology and autoimmune diseases [20] - The company’s diverse portfolio, including drugs like Venclexta, Vraylar, and others, is expected to offset losses from declining sales in certain areas [19]