百奥泰(688177) - 百奥泰2023年11月投资者活动记录表

Group 1: Product Development and Approval - Bevacizumab and tocilizumab have completed on-site inspections by the FDA and EMA, with tocilizumab (brand name: TOFIDENCE) receiving FDA approval in September 2023, marking it as the first monoclonal antibody drug developed and produced by a Chinese company to gain FDA approval [2] - BAT2506 (golimumab) is currently in global Phase III clinical trials, with patient enrollment expected to be completed in 2023. The company plans to pursue commercialization through global and regional partnerships, having already established cooperation with Pharmapark LLC for the drug in Russia and other CIS countries [2][3] Group 2: Global Market Strategy - The company recognizes the necessity of entering the global biopharmaceutical market, particularly in Europe and the U.S., which hold a significant share of the market. It will analyze trial data and market conditions while maintaining effective communication with global regulatory agencies [3] - The company is actively exploring opportunities for global commercialization of its innovative drugs, with a focus on maintaining compliance with international regulations [3] Group 3: Innovative Drug Pipeline - BAT2094 (batifiban) is a peptide β3 integrin receptor inhibitor for perioperative antithrombotic therapy, with a marketing authorization application submitted to the National Medical Products Administration [3] - BAT5906 is a monoclonal antibody designed for treating retinal diseases, currently in Phase III clinical trials for wet age-related macular degeneration (wAMD) [3] - BAT4406F is a next-generation glyco-optimized fully human anti-CD20 antibody, also in Phase III clinical trials for neuromyelitis optica spectrum disorders [3] Group 4: Technology Platforms - The company has established seven leading core technology platforms covering the entire drug development and production process, including antibody library and display technology, antibody structure and engineering design, and ADC technology [3] - The new ADC platform features three main characteristics: fully human or humanized monoclonal antibodies, PEG-modified cleavable linkers with strong stability and low off-target toxicity, and potent payloads with strong membrane permeability [3] Group 5: Financial Planning and Risks - The company adjusts R&D expenses based on product development progress and is exploring other financing channels as needed. Currently, there are no financial constraints affecting R&D and operations [4] - Investors are advised to be aware of investment risks related to industry forecasts and company development strategies, as these do not constitute commitments or guarantees from the company [4]