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 ...

Key Takeaways GSK secures FDA approval for Blujepa to treat uncomplicated urogenital gonorrhea.The approval is based on EAGLE-1 data showing non-inferiority to standard combination therapy.Study results also highlighted Blujepa's favorable safety and tolerability profile.GSK plc (GSK) announced that the FDA has approved its supplemental new drug application (sNDA) seeking approval for its oral antibiotic Blujepa (gepotidacin) for treating uncomplicated urogenital gonorrhea (uGC) in adult and pediatric patie ...

Summary of Corbus Pharmaceuticals Holdings Conference Call Company Overview - Corbus Pharmaceuticals is a small biotech company based in Norwood, Massachusetts, with approximately 40 employees - The company has a diverse pipeline with two main assets: a Nectin-4 ADC targeting solid tumors (head and neck and cervical cancers) and a small molecule oral CB1 inverse agonist targeting obesity [3][4] Oncology Asset Development - The Nectin-4 ADC is developed in partnership with CSPC, the third largest pharmaceutical company in China - The development programs for the ADC are independent, with separate data sets for U.S./European and Chinese sites [4][5] - Recent data presented at ISMO showed a 48% overall response rate (ORR) at 3.6 mg/kg and 33% at 2.7 mg/kg for head and neck and cervical cancers [7][10] Efficacy and Safety - The company is optimistic about the durability of responses, with data expected to mature by mid-next year [10][11] - Safety profile shows low rates of peripheral neuropathy, a significant advantage over competitors like Padcev, which has higher rates of this adverse effect [12][13] - Ocular toxicity remains a concern, with a noted 44% incidence in Padcev, while Corbus's ADC has a manageable profile [14][15] Market Opportunity - The second-line treatment space for head and neck cancer is currently limited, with an ORR of about 10% or lower, making Corbus's asset attractive [20][21] - The U.S. second-line therapy market for head and neck cancer is estimated at around 24,000 patients, potentially increasing to 36,000 due to improved survival rates from front-line therapies [21][22] Competitive Landscape - Other ADCs in the second-line space are limited, with Pfizer's attempts not progressing [22] - Corbus's Nectin-4 ADC is positioned well due to its unique safety profile, making it less likely for competitors to enter the same market segment [22][23] Obesity Asset Development - The CB1 inverse agonist is currently in SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) studies, with data expected before the end of the year [34][35] - The upcoming 90-day study in obese non-diabetic patients aims to assess safety and weight loss efficacy [35][36] - Historical data from Rimonabant suggests that CB1 inverse agonists can lead to significant weight loss, although the exact efficacy of Corbus's asset remains to be determined [36][38] Financial Position and Future Catalysts - Corbus has approximately $180 million in cash, which supports ongoing and upcoming studies [53] - Key data catalysts for the next year include results from the 701 program and the 90-day dose range finding study for the 913 asset [53][54] Conclusion - Corbus Pharmaceuticals is strategically positioned in the oncology and obesity markets with promising assets and a solid financial foundation, making it an interesting prospect for investors looking for opportunities in biotech [53][54]

Core Insights - GSK reported strong third-quarter earnings, with earnings per share of approximately 73 cents and sales of $11.35 billion, surpassing forecasts of 61 cents and $10.93 billion respectively [1][2] - The company raised its full-year sales growth outlook to 6% to 7%, up from a previous range of 3% to 5%, and core earnings per share growth guidance to 10% to 12%, increased from 6% to 8% [2] Financial Performance - GSK's earnings per share increased from 65 cents in the same period last year, with sales rising from $10.42 billion [1] - Analysts had projected earnings per share of $2.18 on sales of $42.68 billion, reflecting a respective increase of 10% and 9% [2] Market Reaction - Following the earnings report and raised guidance, GSK's stock rose more than 3% to $45.11 [2]

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]

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 ...

Core Viewpoint - GSK's stock fell over 5% to $43.10 following the FDA's approval of its blood cancer drug Blenrep, which has limited indications and a narrow commercial opportunity despite the positive regulatory outcome [1] Group 1: FDA Approval - GSK received FDA approval for Blenrep as a third-line therapy for adult patients who have undergone at least two prior treatments, contrary to GSK's expectation for it to be approved as a second-line therapy [1] - The approval is seen as a positive development, but the limited indication may dampen its commercial prospects [1] Group 2: Market Impact - UBS analysts noted that the requirement for patients to undergo ophthalmic examinations before each dose could further disappoint GSK [1] - The combination of a smaller indication range and strict risk evaluation and mitigation strategies may reduce the drug's market potential [1]

Core Viewpoint - GSK's stock fell over 5% to $43.10 following the FDA's approval of its blood cancer drug Blenrep, which has limited indications and a narrower commercial opportunity than anticipated [1] Summary by Relevant Sections FDA Approval - GSK received FDA approval for Blenrep as a third-line therapy for adult patients who have undergone at least two prior treatments, contrary to the company's expectation for it to be approved as a second-line therapy [1] Market Impact - The approval is seen as a positive outcome amidst previous uncertainties, but the limited indication and the requirement for ophthalmic examinations before each dose may dampen its commercial prospects [1]

Group 1 - GSK's stock fell over 6% to 43.60 after the FDA granted a narrower-than-expected approval for its blood cancer treatment, Blenrep [1][2] - Blenrep had previously received accelerated approval in 2020 but was pulled from the market in 2022 after failing its confirmatory study [2] - The company was seeking approval for second-line treatment, which would allow patients to use Blenrep after only one prior therapy [2] Group 2 - Other pharmaceutical stocks are experiencing positive movements, with Sanofi's third-quarter Dupixent sales nearing $5 billion [3] - GSK's ADR shows improved relative strength but remains below benchmark levels [4] - GSK's stock performance is influenced by broader market dynamics, including potential tariffs on pharmaceutical imports [4]

Core Viewpoint - The approval of GSK's Blenrep by U.S. regulators marks a significant opportunity for the company to re-enter the largest pharmaceutical market after previously withdrawing the drug due to efficacy concerns [1][2] Group 1: Drug Approval and Market Potential - The U.S. FDA has approved GSK's Blenrep for use in combination with two other drugs for treating relapsed or treatment-resistant multiple myeloma patients [1] - This approval is accompanied by a risk mitigation plan to ensure proper usage and coordination among healthcare providers [1] - Industry research estimates that the sales potential for Blenrep could reach up to $2.6 billion following its approval [1] Group 2: Previous Withdrawal and New Research - GSK withdrew Blenrep from the market in 2022 due to its inability to demonstrate superiority over existing therapies [2] - The company subsequently explored combination therapies and found that the new regimen could reduce the risk of death by 42% compared to a drug sold by Johnson & Johnson [2]