Summary of Key Points from the Conference Call of 科济药业 Company Overview - **Company**: 科济药业 (Kojin Pharmaceutical) - **Focus**: Development of CAR-T cell therapies, particularly CT0,596 and other pipeline projects Core Industry Insights - **CAR-T Cell Therapy**: The company is advancing its CAR-T cell therapy projects, particularly targeting multiple myeloma and other hematological malignancies Key Findings and Arguments 1. **CT0,596 Project Initial Data**: Preliminary data shows promising safety and efficacy, with 3 out of 5 patients achieving strict complete response (CR) and 80% achieving minimal residual disease (MRD) negativity [2][4][5] 2. **Treatment Regimen**: The regimen used is a mild lymphodepletion protocol (Fludarabine 22.5-30 mg/m² and Cyclophosphamide 350-500 mg/m²), with good overall tolerability and no severe adverse reactions reported [2][4][6] 3. **Future Plans for CT0,596**: The company plans to submit an IND application for CT0,596 in the second half of 2025 and explore its application in refractory multiple myeloma and autoimmune diseases [2][5][23] 4. **Comparison with 0,590 Product**: CT0,596 demonstrated CAR-T cell expansion in all dose groups, achieving deep remission at the lowest dose, while 0,590 did not show similar results [2][13] 5. **NDA Submission Timeline**: The company expects to submit an NDA for the 041 project in the first half of 2025, aiming for priority review and potential market entry within a year [2][34] 6. **Market Positioning**: The company aims for a 70% complete response rate, which would position it competitively against existing therapies [18][24] Additional Important Insights 1. **Single Plus Platform**: The first project from the Single Plus platform has shown positive signals, with plans to share data on CD19 and CD20 pipelines [3][39] 2. **Clinical Trial Design**: The company plans to expand trial centers to accelerate patient enrollment and data collection, particularly for the CT0,596 project [11][31] 3. **Cost Comparison**: Autologous CAR-T therapy is more expensive compared to universal CAR-T therapy, which is expected to have lower costs due to earlier production and increased utilization rates [38] 4. **Safety and Efficacy Monitoring**: Ongoing monitoring of safety and efficacy is crucial, with plans to adjust dosing based on patient responses and disease types [6][20][22] Conclusion - 科济药业 is positioned to make significant advancements in CAR-T cell therapy, with promising initial data for CT0,596 and a strategic focus on expanding its pipeline and market presence. The company is actively engaging with investors and stakeholders to communicate progress and updates.