Summary of the Conference Call for Maiwei Biotech Company Overview - **Company**: Maiwei Biotech - **Date**: November 4, 2025 Key Points Financial Performance - As of September 30, the company reported cash and cash equivalents of 1.439 billion RMB, an increase of over 200 million RMB compared to the end of last year [5] - Revenue for the first three quarters reached 566 million RMB, a year-on-year increase of 300%, driven by growth in technical service fees and a 70% increase in the sales of Dizu monoclonal antibody [5] - The loss for the third quarter significantly reduced to 49 million RMB, a year-on-year decrease of 200 million RMB, marking the first substantial reduction in losses [5] Business Development (BD) Achievements - The company achieved multiple breakthroughs in BD, including collaborations on Bai Jie 11, small nucleic acids, and long-acting Shengmai injections, resulting in over 800 million RMB in cash inflow [6][7] - Several BD pipelines are in progress, including 94 ADR BTC, CDED, and STE U monoclonal antibodies, with expectations for more results in the future [7] Core Projects and Pipeline Progress - The core pipeline includes 9KT 4 ADC, B713 ADC, and CD17 ADC, with multiple products expected to be approved and initiate patient enrollment in both China and the U.S. [8] - The SE2 monoclonal antibody for COPD has completed enrollment of 80 patients in the EB27 clinical trial, with expectations to complete follow-up by the end of the year [3] - The company is also advancing the CDH17 ADC project, which has received overseas authorization with a total amount exceeding 1 billion USD for liver delivery exploration [3][4] Market Expansion and Product Launches - Dizu monoclonal antibody sales approached 100 million RMB in the first half of the year, ranking first among domestic products [16] - The company has signed agreements with over 10 countries to expand biosimilars into emerging markets, with the first launch in Pakistan in August [16] - A supplemental application for bone metastasis indications is expected to be approved in the first half of next year, which could significantly increase revenue [16] Future Development Plans - The company is focusing on four key platforms: antibody discovery, ADC, TCE, and small nucleic acids, with plans to launch more TCE products into clinical trials next year [8] - The company is also developing treatments for age-related diseases, such as the SE2 monoclonal antibody for COPD, with plans for larger sample size trials [8] Clinical Trials and Regulatory Approvals - The company is actively communicating with the FDA regarding clinical trial designs and endpoints, particularly for the Bai Jie 11 project targeting pathological scars [9][28] - The 2,821 project is expected to focus on single endpoint PFS (Progression-Free Survival) to shorten clinical cycles and sample sizes [18][25] Innovations in Drug Development - The siRNA platform has been authorized to Editas, with ongoing development of dual-target siRNA and exploration of liver and CNS delivery systems [12][33] - The company is also developing a new oral small molecule drug for osteoarthritis, which is currently advancing to phase II clinical trials [14] Market Outlook - The company anticipates significant revenue growth from traditional products like Dizu and Adalimumab, with a complete transition to Maiwei's invoicing by 2026 [22] - The aging population in China is expected to drive demand for ophthalmic preparations, particularly for age-related macular degeneration [38] Conclusion - Maiwei Biotech is positioned for growth with a robust pipeline, significant financial improvements, and strategic collaborations, aiming to expand its market presence and enhance its product offerings in the coming years [39]