这款过百万的CAR-T药物要使用国产病毒载体了，价格有望大幅下降？

Core Viewpoint - The approval of the domestic viral vector for the production of the CAR-T cell therapy product, Brexucabtagene Autoleucel (brand name: Beinuoda), by WuXi AppTec is a significant step towards reducing production costs and improving supply stability, which may enhance the product's commercial viability and competitiveness in the market [1][4]. Group 1: Product Development and Approval - WuXi AppTec announced that the China National Medical Products Administration has officially accepted its supplementary application for the use of domestically produced viral vectors in the post-marketing phase for Beinuoda [1]. - Beinuoda is a CAR-T cell immunotherapy product targeting CD19, developed based on the CAR-T cell technology platform of WuXi AppTec's subsidiary, and has received approval for three indications in the blood cancer field [1]. Group 2: Market Context and Challenges - Currently, there are seven CAR-T cell therapy products approved in China, but their high prices, often exceeding one million yuan (approximately 129 million), limit accessibility [3]. - Previous attempts to negotiate inclusion in the national medical insurance have failed, attributed to strict pricing rules [3]. Group 3: Production Cost and Strategy - The use of lentiviral vectors is crucial in CAR-T cell therapy, being one of the most expensive raw materials, which has hindered the commercial production and clinical development of Beinuoda [3]. - The company has developed a new lentiviral vector (JWLV011) to optimize production processes and enhance quality control, aiming to ensure stable supply and reduce costs [3][4]. Group 4: Clinical Research and Efficacy - A Phase II study has been conducted to evaluate the comparability of Beinuoda produced with the new JWLV011 vector against the existing product, showing a 66.67% overall response rate and a 41.67% complete response rate after three months of follow-up [4][5]. - The study indicated that the safety profile of the JWLV011-produced product is comparable to that of the existing product, with no severe adverse events reported [5].