Summary of Key Points from the Conference Call Company and Industry Overview - **Company**: 科济药业 (Kojin Pharmaceutical) - **Industry**: Biotechnology, specifically focusing on CAR-T cell therapy and cancer treatment Core Insights and Arguments - **Clinical Trials and Efficacy**: - The Phase I clinical trial of Shurijiaolun's adjuvant therapy for pancreatic cancer showed preliminary efficacy, with 83.3% of patients experiencing a significant decrease in CA199 levels, although longer follow-up is needed to assess long-term disease-free survival (DFS) and overall survival (OS) [2][3] - CT0,596, a universal CAR-T therapy, demonstrated rapid tumor clearance in relapsed/refractory multiple myeloma, with two patients achieving stringent complete response (SCR) and negative minimal residual disease (MRD) detection [2][4] - The CD041 project for pancreatic cancer indicated that CAR-T therapy may extend DFS for high-risk patients, but final data requires further clinical validation [2][3] - **Technological Developments**: - The Enma LNP technology showed excellent performance in B-cell clearance but faces challenges in T CAR-T expansion time and antibody level recovery [2][9] - The company is exploring CT0,596 for other plasma cell tumor indications, such as amyloidosis affecting organs like the heart, to expand its clinical application and market potential [2][5] - **Market Position and Future Plans**: - The company is optimistic about returning to the Hong Kong Stock Connect, with a significant market cap recovery providing a safety cushion for this transition [2][24] - Plans to submit IND applications for multiple myeloma by the end of the year and to continue expanding the clinical application of its CAR-T therapies [2][4][19] Additional Important Insights - **Patient Data and Safety**: - In the CD041 project, 6 patients were enrolled, with a median follow-up of 6.05 months; only one patient experienced disease recurrence, indicating a positive trend in DFS [3][20] - All patients in the trials experienced mild to moderate cytokine release syndrome (CRS), with one case of grade 3 CRS managed effectively [3] - **Competitive Landscape**: - The pancreatic cancer treatment landscape is becoming competitive with various emerging drugs, including small molecule inhibitors and ADCs, necessitating exploration of combination therapies for improved efficacy [2][15][17] - **Intellectual Property**: - The company has a strong patent portfolio, including European patent grants for GP10 CAR-T and broad coverage for NK cell technology, ensuring comprehensive protection for its technology platforms [2][21] - **Financial and R&D Progress**: - The company has made progress in its funding chain and plans to disclose more data on universal products by the end of the year [2][25] - Focus remains on challenging projects in solid tumors, leveraging a less competitive environment to concentrate resources [2][26] - **Viral Vector Technology**: - Viral vectors are a core technology for the company, enabling self-production and modification for potential future relapses, with ongoing efforts to innovate in this area [2][27]

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.