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Genmab (NasdaqGS:GMAB) 2025 Conference Transcript
2025-11-19 13:02
Summary of Genmab's Conference Call Company Overview - **Company**: Genmab - **Event**: Jefferies London Healthcare Conference - **Key Speakers**: CEO Jan van de Winkel, CFO Anthony Pagano Key Focus Areas Late-Stage Programs - Genmab is focusing on late-stage programs including: - **Epkinly** - **Rinatabart sesutecan** - **Acasunlimab** - **Patu Centamab** (acquisition of Merus) [2][3][4] Patu Centamab - **Description**: A bispecific antibody targeting EGFR, showing significant tumor shrinkage in clinical trials. - **Clinical Data**: - In frontline head and neck cancer, a **63% overall response rate** when combined with Pembrolizumab, tripling the benchmark response [9]. - In second-line settings, a **36% overall response rate** with impressive median progression-free survival of **11.4 months** [9]. - **Safety Profile**: New dosing schedules have improved infusion-related reactions, and a subcutaneous version is in development to further mitigate these issues [11]. - **Potential**: Beyond head and neck cancer, Patu Centamab is expected to have applications in other EGFR-positive tumors [6][12]. Epkinly - **Launch Performance**: Launched in May 2023, with potential to become a **$3 billion-plus global brand**. - **Recent Developments**: Positive data in second-line follicular lymphoma, with a significant hazard ratio of **0.21**, indicating a **79% risk reduction** for disease progression [21]. - **Commercial Strategy**: Focus on subcutaneous delivery and maintaining a balance of safety and efficacy [20]. Rinatabart sesutecan - **Characteristics**: Combines a good antibody with a hydrophilic linker, allowing for multiple toxin attachments without compromising pharmacodynamics [23]. - **Clinical Data**: Expected to have a clean safety profile with no ocular toxicity or interstitial lung disease observed [24]. - **Market Potential**: Peak year sales guidance upgraded to **$2 billion**, with a launch expected in **2027** [28]. Acasunlimab - **Clinical Development**: Ongoing studies in second-line plus lung cancer, with follow-up data expected to bolster confidence in its efficacy [30]. - **Sales Guidance**: Projected peak sales of around **$1 billion**, reflecting a conservative approach due to competition in the lung cancer market [31]. Financial Considerations - **Investment Strategy**: 2026 is expected to be an investment year, focusing on late-stage pipeline and commercialization capabilities [14][15]. - **EBITDA Growth**: Anticipated meaningful growth in EBITDA by **2027**, with projections of over **$1 billion** in sales for Patu Centamab by **2029** [16][17]. Other Considerations - **Pipeline Focus**: Genmab remains primarily focused on oncology, with over **90%** of activities in this area, while maintaining some preclinical work in immunology and inflammation [34][35]. - **Future Developments**: Plans to advance two bispecifics and one ADC from the organic pipeline by the end of the year [36]. Conclusion - Genmab is strategically positioned with a robust late-stage pipeline and a clear focus on maximizing the potential of its key assets, particularly Patu Centamab, Epkinly, and Rinatabart sesutecan, while managing investments and operational efficiencies to drive future growth.
礼来(LLY.US)FRα ADC启动III期临床研究
Zhi Tong Cai Jing· 2025-10-10 13:03
Core Insights - Eli Lilly (LLY.US) has initiated the first Phase III clinical trial (FRAmework-01) for its FRαADC drug LY4170156, which is developed by Mablink Bioscience, a company acquired by Eli Lilly [1] - LY4170156 utilizes a payload of the topoisomerase I inhibitor irinotecan, with a drug-to-antibody ratio (DAR) of 8 [1] - According to NextPharma database, there are currently 27 FRαADC drugs in development globally, with 11 in clinical stages [1] - Apart from the already marketed drug somatuzumab, LY4170156, Rinatabart sesutecan (Genmab), and BAT8006 (Baiyoutai) are the three fastest progressing drugs, all having initiated Phase III clinical trials [1]