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IBI3003(抗GPRC5D/BCMA/CD3三特异性抗体)
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信达生物(1801.HK):信达生物6款创新药新进医保 TCE数据积极
Ge Long Hui· 2025-12-10 18:22
Core Insights - The National Healthcare Security Administration released the 2025 medical insurance negotiation results, with 7 innovative products from Innovent Biologics successfully included in the new national medical insurance drug list, enhancing patient accessibility and affordability for critical diseases like cancer and cardiovascular conditions [1][2][3] Group 1: Medical Insurance Negotiation Results - A total of 127 products participated in the negotiation, with 114 successfully included, marking an 88% success rate for innovative drugs, the highest in seven years, surpassing the 76% success rate of 2024 [2][3] - The updated national medical insurance drug list will officially take effect on January 1, 2026, increasing the total number of drugs in the list to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2][3] Group 2: Innovent Biologics' Product Inclusion - The newly included products cover significant disease areas, including lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, hematological tumors, and metabolic diseases [3][4][5][6][7] - Specific products included are: 1. **Daboshu (Sintilimab)**: New indication for advanced mismatch repair-deficient endometrial cancer [3] 2. **Xinbimin (Tislelizumab)**: Inclusion for moderate to severe thyroid eye disease, a breakthrough therapy after 70 years without effective treatment [3] 3. **Aoyixin (Leratinib)**: First-line treatment for advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations [4] 4. **Dabote (Fuzuloparib)**: Targeting KRAS G12C mutation in advanced NSCLC [5] 5. **Dabole (Entrectinib)**: For ROS1-positive advanced NSCLC [6] 6. **Ruituo (Selpercatinib)**: For RET fusion-positive NSCLC and thyroid cancer [6] 7. **Jiepalai (Pirtobrutinib)**: For relapsed or refractory mantle cell lymphoma [7] Group 3: Clinical Trial Updates - At the 2025 American Society of Hematology (ASH) meeting, Innovent Biologics presented preliminary data on IBI3003, a tri-specific antibody for relapsed or refractory multiple myeloma, showing promising efficacy and manageable safety profiles [9][10] - The trial included 39 patients, with a median follow-up of 3.25 months, demonstrating an overall response rate (ORR) of 83.3% at doses ≥120 μg/kg [11][12] Group 4: Future Prospects and Collaborations - Innovent Biologics has a robust pipeline with 17 commercialized drugs and several in advanced clinical stages, indicating strong growth potential [12][13] - A strategic collaboration with Takeda aims to accelerate the global market entry of next-generation immuno-oncology and antibody-drug conjugate therapies, with a total deal value of $11.4 billion [12][13]