Summary of Conference Call Notes Company Overview - The company discussed its performance and developments related to its products, particularly focusing on CM310 (Sikukiyu monoclonal antibody), CM512 (TSLP/IL-13 dual antibody), and CMG901 (Claudin 18.2 ADC) [2][3][4][8]. Key Points Industry and Product Performance - **CM310 (Sikukiyu monoclonal antibody)**: - Achieved sales of 310 million RMB in 2025, a 77.2% increase year-on-year [3]. - Entered the national medical insurance list in January 2026, significantly boosting hospital access [4][5]. - Expected to be available in nearly 1,000 hospitals by the end of 2026, with over 40% access achieved [5]. - **CM512 (TSLP/IL-13 dual antibody)**: - Positioned as an upgraded version of CM310, with a reduced administration frequency of 2-4 injections per year [2][8]. - Clinical data for nasal polyps expected to be read out ahead of schedule in June-July 2026 [8][16]. - **CMG901 (Claudin 18.2 ADC)**: - Licensed to AstraZeneca, with global filing for second-line gastric cancer expected in H2 2026 [2][8]. - The project has entered first-line combination therapy trials, with over 2,500 patients planned for global clinical trials [10][17]. Financial Performance - Total revenue for 2025 was 720 million RMB, a 67% increase year-on-year, with product sales contributing 310 million RMB [3][11]. - The company raised 860 million HKD through H-share placement, maintaining a cash reserve of nearly 2 billion RMB by the end of 2025 [3][11]. - R&D investment remained stable at 720 million RMB, with a net loss of 500 million RMB for 2025 [11]. Production Capacity and Cost Management - The company is expanding its production capacity with the ND4 stainless steel production line, set to be operational by March 2026, which will significantly reduce costs [6][11]. R&D Pipeline and Strategic Initiatives - The company is diversifying its R&D beyond antibody drugs, with advancements in ADC, small nucleic acids, and PROTAC platforms [7][19]. - CM336 (BCMAxCD3) has shown over 90% overall response rate (ORR) and 75% complete response (CR) in multiple myeloma, with a strategic partnership with Gilead to enhance global market access [9][12]. Future Milestones - Key R&D milestones for 2026 include: - Submission of CM310 for adolescent moderate to severe atopic dermatitis [11]. - Data readout for CM512 in nasal polyps expected in mid-2026 [11]. - Initiation of clinical trials for CM313 and CMG901 [11][17]. Market Strategy and Competitive Positioning - The company aims to leverage its first-mover advantage in the dermatology field while expanding into respiratory and nasal indications [23][24]. - CM512 is not expected to be the first approved indication; instead, the focus will be on asthma and COPD to avoid pricing pressures from a large patient population [24][25]. Clinical Data and Academic Engagement - The company plans to present key clinical data at major academic conferences in 2026, including results for CM-518 and CM-310 [27]. Patient Engagement and Market Dynamics - Following the inclusion of CM310 in the national insurance list, patient adherence (DOT) has increased, with potential for over 15 treatment cycles observed in chronic patients [28]. Conclusion The company is positioned for significant growth with a robust pipeline, strategic partnerships, and a focus on expanding its market presence while maintaining financial stability and operational efficiency.

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]