药闻丨百余家企业竞速体内CAR-T技术“新赛道”

Core Insights - The launch of the first "Commercial Health Insurance Innovative Drug Directory" has brought CAR-T therapy back into focus, despite its high costs and complex manufacturing processes [1] - The industry is shifting attention to In Vivo CAR-T technology, which is expected to see significant investment and acquisitions from multinational corporations (MNCs) by 2025 [2][3] Industry Overview - Traditional CAR-T therapy is limited by its complex "autologous preparation" process, which involves extracting T cells from patients, modifying them in a lab for 2-4 weeks, and then reinfusing them, leading to high costs of approximately 1 million to 1.2 million RMB in China [2] - In Vivo CAR-T technology aims to eliminate the need for external cell preparation, potentially reducing costs and wait times, making it a strategic focus for global pharmaceutical giants [2][3] Market Dynamics - MNCs are making substantial investments in In Vivo CAR-T, with notable acquisitions including AstraZeneca's $1 billion purchase of EsoBiotec, AbbVie's $2.1 billion acquisition of Capstan Therapeutics, and BMS's $1.5 billion acquisition of Orbital Therapeutics [2] - The investment community views these acquisitions as not just supplementary to existing pipelines but as a strategic shift towards a complete replacement of traditional CAR-T therapies [3] Competitive Landscape - The In Vivo CAR-T sector is crowded, with over 100 domestic companies entering the field, raising concerns about potential homogenization and profit dilution similar to the PD-1 inhibitor market [4] - However, the exploration of In Vivo CAR-T is seen as fundamentally different from previous market entries, as it involves pioneering technology rather than following established paths [4] Technological Development - The In Vivo CAR-T industry is still in its early stages, with significant differentiation in technology routes, including viral vector-based frameworks and lipid nanoparticle (LNP) delivery systems [5] - Companies must focus on core technological differentiation, clinical data quality, and development speed to maintain competitive positioning [5] Future Outlook - The next 1-2 years are critical for validating In Vivo CAR-T technologies, with companies like Fengxun Bio preparing for initial human clinical trials [5][6] - The favorable policy environment in China is expected to accelerate the transition of technologies from the lab to clinical validation, with anticipated clarity in the technological roadmap as clinical data emerges [6]