Workflow
百奥泰终止帕博利珠单抗生物类似药关键研究,项目已投入逾2亿元

Core Viewpoint - Company plans to adjust the development strategy of BAT3306 (a biosimilar of Pembrolizumab) and terminate the ongoing BAT3306-002 study, with future decisions pending careful evaluation [1][2][3] Development Strategy Adjustment - BAT3306 is currently involved in a Phase I/III study (BAT3306-002) assessing its pharmacokinetics, efficacy, and safety in combination with chemotherapy for stage IV non-small cell lung cancer [2] - The adjustment in development strategy is influenced by recent communications from the FDA and EMA, indicating a reduced necessity for comparative efficacy studies for biosimilars in the approval process [2][3] - Two other companies developing Pembrolizumab biosimilars have also halted their Phase III efficacy studies, opting for submissions based on Phase I and analytical data [2] Financial Implications - The total investment in the BAT3306 project has reached 224 million yuan, with all R&D expenses accounted for in the respective accounting periods, indicating no substantial impact on current or future financial performance [4] - The company has incurred cumulative losses exceeding 1.8 billion yuan since its listing, with only one profitable year in 2021 due to licensing income [5] Revenue and R&D Expenditure - Revenue figures from 2020 to 2024 show fluctuations, with revenues of 185 million yuan, 837 million yuan, 456 million yuan, 705 million yuan, and 743 million yuan respectively, while net profits remained negative [6] - R&D expenses have consistently exceeded revenue, with ratios of R&D expenditure to revenue ranging from 304% to 104.7% over the same period [6] Market Context - Pembrolizumab (Keytruda) is a leading PD-1 inhibitor with over 30 approved indications and sales reaching 25.011 billion USD in 2023, with its key patent expiring in 2028, potentially opening a significant market for biosimilars [4] - The company will continue to monitor regulatory developments and evaluate the future of the BAT3306 project based on the latest policy dynamics [4] Competitive Risks - The company faces risks from centralized procurement policies, as three of its four approved products are biosimilars, which are a major source of revenue [7]