双抗药物

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AK112在CRC的进展将有望再造一个康方
雪球· 2025-04-02 08:14
Core Viewpoint - The article highlights the significant milestone of the company starting the Phase III registration clinical trial for Ivosidenib in colorectal cancer (CRC), suggesting it could lead to a transformative impact for the company [3]. Group 1: Colorectal Cancer Overview - Colorectal cancer is the third most common cancer globally, following lung and breast cancer, and is the second leading cause of cancer-related deaths [4]. - The classification of colorectal cancer primarily includes microsatellite instability-high (MSI-H/dMMR) and microsatellite stable (MSS/pMMR), with the latter accounting for approximately 90% of cases [4]. - Prior to the advent of immunotherapy, treatment for metastatic colorectal cancer did not significantly differ between MSI-H and MSS patients, primarily involving VEGF inhibitors and chemotherapy [4]. Group 2: Immunotherapy Efficacy - Immunotherapy, particularly PD-1 inhibitors, has shown significant efficacy in treating MSI-H colorectal cancer, with a median overall survival (OS) of 77.5 months compared to 36.7 months for chemotherapy [5]. - For MSS colorectal cancer, PD-1 inhibitors have demonstrated poor efficacy, with many trials failing to show significant benefits [5][10]. - The combination of PD-1 inhibitors with standard treatments has shown some improvement in overall response rates (ORR) and duration of response (DoR), but overall survival did not improve significantly [9][10]. Group 3: AK112's Potential - AK112 represents a promising advancement in the treatment of MSS colorectal cancer by combining PD-1 and VEGF targeting, potentially enhancing efficacy while reducing side effects [12]. - Initial clinical data for AK112 shows an ORR of 81.8% and a promising progression-free survival (PFS) rate, indicating its potential to outperform existing therapies [14][15]. - The market potential for AK112 in MSS colorectal cancer is substantial, with estimates suggesting a market size of 350-400 billion CNY in China alone, driven by high patient numbers and treatment duration [20]. Group 4: Market Analysis - The colorectal cancer market is expected to be comparable to that of non-small cell lung cancer (NSCLC), with a significant patient population and treatment duration [19]. - In China, the estimated market size for MSS colorectal cancer could reach 150 billion CNY if the company captures a 50% market share [20]. - In the U.S. and other developed countries, the market potential for AK112 could exceed 300 billion USD, reflecting a significant opportunity for the company [22].
全球制药业洞察 | 霍普金斯大学骨髓瘤专家:双抗药物有望取代CAR-T疗法
彭博Bloomberg· 2025-03-13 01:30
Core Viewpoint - The article discusses the potential of bispecific antibodies to replace CAR-T therapies in the treatment of multiple myeloma, highlighting insights from Dr. Syed Abbas Ali of Johns Hopkins University [3][4][6]. Group 1: Bispecific Antibodies vs. CAR-T Therapies - Dr. Ali emphasizes that bispecific antibodies, particularly those targeting BCMA and CD3, may surpass CAR-T therapies in efficacy and safety, especially as physicians learn to manage toxicity better [6][7]. - The total response rate for Gilead-Arcellx's Anito-cel is reported at 100%, with lower toxicity compared to Johnson & Johnson's Carvykti, which is primarily used for high-risk patients [4][5]. - The safety profile of Anito-cel shows significant advantages, with a median onset of cytokine release syndrome (CRS) at 2 days and a duration of 3 days, compared to Carvykti's 7 days onset and 4 days duration [5]. Group 2: Market Dynamics and Competitive Landscape - The article notes that Blenrep from GlaxoSmithKline faces challenges in regaining market trust after its previous withdrawal, with analysts expressing concerns over its sales growth potential [8]. - Sanofi's Sarclisa is seen as a competitor to Johnson & Johnson's Darzalex, but the latter's ease of use as a monthly subcutaneous injection poses a significant challenge for Sarclisa [9]. - The article highlights the increasing accessibility of blood component apheresis for CAR-T therapy, which has improved patient treatment options [4].