PD1xIL2双抗IBI363

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科伦博泰SKB264大样本疗效数据有所下滑 肺癌细分适应症仍占据优势 | 2025ASCO
Xin Lang Zheng Quan· 2025-06-06 05:37
Core Insights - The 2025 ASCO Annual Meeting will showcase significant research results from domestic innovative drugs, highlighting their potential in oncology treatments [1] Group 1: Clinical Data and Drug Performance - The TROP2 ADC SKB264 from Kelun-Biotech reported a 59.3% overall response rate (ORR) and a 91.4% disease control rate (DCR) in a Phase II trial for non-small cell lung cancer (NSCLC) [2] - The median progression-free survival (mPFS) for the same patient group was 15.0 months, with ORR varying by PD-L1 expression levels: 47.1% for TPS<1%, 68.1% for TPS≥1%, and 77.8% for TPS≥50% [2] - Compared to previous data, the ORR decreased from 72.7% to 59.3% in a larger sample size [2] - SKB264 demonstrated superior efficacy over other PD-1/VEGF dual antibodies, with ORR of 54.5% for SSGJ-707 and 47% for Ivosidenib [3] Group 2: Safety and Adverse Effects - The incidence of grade 3 or higher adverse reactions for SKB264 was 40%, higher than SSGJ-707's 24.1% and Ivosidenib's 29% [3] - However, the discontinuation rate due to adverse effects for SKB264 was 0%, lower than Ivosidenib's 2% and SSGJ-707's 6% [3] Group 3: Comparative Efficacy in EGFR Mutant NSCLC - In a separate study for EGFR mutant NSCLC, SKB264 showed a 45.1% ORR and mPFS of 6.9 months, statistically significant compared to Docetaxel [4] - Despite a decrease in ORR and mPFS in larger sample sizes, SKB264 still outperformed Dato-DXd (43%) and HER3-DXd (35.2%) in efficacy [4] - Other domestic competitors also showed promising results, with Ivosidenib achieving an ORR of 50.6% and BL-B01D1 reaching 52.5% in their respective trials [4][5]
信达生物IBI363多项数据入选口头报告 后线治疗肺癌、结直肠癌疗效优于现有竞品 | 2025ASCO
Xin Lang Zheng Quan· 2025-06-06 05:37
Core Viewpoint - The 2025 ASCO Annual Meeting will showcase significant research achievements of domestic innovative drugs, highlighting their potential in oncology treatment [1] Group 1: Innovative Drug Highlights - Several innovative drug molecules with first-in-class or best-in-class potential will present data, including IBI363 from Innovent Biologics, SKB264 from Kelun-Biotech, and others [1] - IBI363 is the world's first next-generation IO dual antibody designed with IL 2α bias, showing promising efficacy in treating IO-resistant tumors such as NSCLC, melanoma, and CRC [2] Group 2: Clinical Data and Efficacy - In a Phase I clinical study, IBI363 demonstrated an overall response rate (ORR) of 43.3% and a disease control rate (DCR) of 90.0% in squamous NSCLC patients at a 3 mg/kg dosage, with a median progression-free survival (mPFS) of 7.3 months [2] - For adenocarcinoma patients previously treated with PD-(L)1 therapy, the 3 mg/kg group showed an ORR of 76.0% and a DCR of 90.0%, with an mPFS of 4.2 months [2] Group 3: Comparative Efficacy - IBI363 exhibited significant clinical activity in IO-resistant lung squamous and adenocarcinoma patients, outperforming existing therapies such as docetaxel and various immune combination treatments [3] Group 4: Colorectal Cancer Potential - IBI363 also shows promise in late-line CRC treatment, with clinical studies indicating an overall survival (OS) of 16.1 months for patients treated with IBI363 monotherapy [5][6] - Compared to standard treatments like TAS-102 combined with bevacizumab, IBI363 demonstrated superior survival outcomes in patients with worse baseline characteristics [6]
国信证券:关注国产双抗、ADC等创新分子 看好差异化创新出海
智通财经网· 2025-06-03 08:48
Group 1 - The core viewpoint is that domestic innovative drugs are increasingly gaining global value, with a trend of going overseas for development [1][2] - The ASCO annual meeting is highlighted as a significant platform for showcasing high-quality research results of domestic innovative drugs, with several promising drug candidates expected to present data [1] - Companies such as Innovent Biologics, Kelun-Biotech, and others are mentioned as having innovative drugs with potential for first-in-class or best-in-class status [1] Group 2 - The report indicates that the collaboration between Innovent Biologics and Pfizer for the PD-1xVEGF bispecific antibody 707, with an upfront payment of $1.25 billion, sets a new record for domestic innovative drugs [2] - There is a noted increase in the number and value of licensing agreements for domestic innovative drugs since the beginning of the year [2] - The release of clinical data is crucial for determining the drug development potential and subsequent global commercialization of these innovative drugs [2]
医药生物行业周报(24年第17周):ASCO摘要标题整理,25Q1公募基金医药持仓分析
Guoxin Securities· 2025-04-30 12:25
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5][44]. Core Insights - The pharmaceutical sector has shown strong performance compared to the overall market, with a 1.16% increase in the biopharmaceutical sector [1][33]. - Multiple domestic innovative drug molecules are set to present important clinical data at the ASCO annual meeting, highlighting the growing global competitiveness of Chinese pharmaceutical companies [2][12]. - The report suggests focusing on companies with high-quality innovation capabilities, such as Innovent Biologics, Kelun Biotech, and others [2][12]. Summary by Sections Market Performance - The overall A-share market increased by 0.95%, with the biopharmaceutical sector outperforming the market [1][33]. - The TTM P/E ratio for the biopharmaceutical sector is 30.67x, which is at the 61.96% percentile of the past five years [1][40]. Fund Holdings Analysis - In Q1 2025, the total fund holdings in the pharmaceutical sector increased to 9.05%, up by 0.47 percentage points [3][20]. - The largest sub-sectors in terms of holdings are chemical preparations and CXO, with significant increases in their holdings compared to Q4 2024 [3][22]. Key Company Forecasts and Ratings - Major companies such as Mindray Medical, WuXi AppTec, and Innovent Biologics are rated as "Outperform" with projected net profits increasing over the next few years [4][46]. - For instance, Mindray Medical is expected to achieve a net profit of 115.8 billion in 2023, growing to 176.4 billion by 2026 [4]. Investment Strategy - The report emphasizes the acceleration of outbound licensing transactions for innovative drugs, suggesting that companies like Kelun Biotech and Innovent Biologics are well-positioned for growth [44][46]. - It also highlights the potential of the medical services sector, particularly in light of new policies supporting reproductive health and elderly care [45][46].