Core Insights - The emerging autologous CAR-T therapy significantly reduces costs compared to traditional CAR-T therapies, which can exceed hundreds of thousands of yuan, but it faces high technical barriers [1][4]. Industry Developments - AbbVie announced a $2.1 billion acquisition of Capstan Therapeutics to expand its product line in autoimmune disease therapies, marking the highest transaction record in the cell therapy sector for 2025 [1]. - CloudTop New Horizon (01952.HK) reported advancements in its autologous CAR-T projects, which utilize a proprietary targeted LNP (tLNP) system for treating tumors and autoimmune diseases, achieving effective tumor cell clearance in humanized mouse models and validating T cell transfection in non-human primate models [1]. Advantages of Autologous CAR-T Therapy - Compared to traditional CAR-T therapies, autologous CAR-T therapy offers multiple advantages, including large-scale production capabilities, no need for lymphodepleting chemotherapy prior to treatment, predictable pharmacokinetics/pharmacodynamics, adjustable dosing, and better overall quality control [4]. - The mRNA technology in autologous CAR-T therapy allows for a shift from "molecular screening" to "information design," enabling the body to produce its own drugs, thus marking a new era in biopharmaceuticals [4]. Cost Reduction Potential - The core advantage of in vivo CAR-T cell manufacturing lies in significantly simplifying the process and reducing costs, potentially lowering the cost of a single treatment by an order of magnitude compared to currently commercialized CAR-T therapies [4]. Challenges in Autologous CAR-T Therapy - The main challenge for autologous CAR-T therapy is the precise, efficient, and safe delivery of CAR-T constructs to target T cells [5]. - Two primary technical routes have emerged: lentiviral vectors and RNA delivery. Lentiviral vectors can achieve permanent CAR expression but may lack targeting precision, while RNA delivery offers higher safety but only transient CAR protein synthesis [5]. - The high technical barriers in autologous CAR-T technology limit participation to a few companies, requiring proprietary cationic lipids and stringent delivery technology to target spleen and peripheral T cells while avoiding safety risks associated with liver expression [5].
自体生成CAR-T疗法赛道升温,多家药企入局