Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has submitted a post-marketing supplementary application to the Chinese National Medical Products Administration for the use of domestically produced viral vectors in its CAR-T cell therapy product, Rikeo Lun Sai (BenoDa) [2] Group 1: Product Development and Approval - Rikeo Lun Sai is a CAR-T cell immunotherapy product targeting CD19, developed based on the CAR-T cell technology platform of WuXi Biologics [2] - The product has received approval for three indications in the blood cancer field in China [2] - Currently, there are seven CAR-T cell therapy products approved in China, but high prices limit accessibility, with Rikeo Lun Sai priced at 1.29 million yuan per injection [2] Group 2: Market Challenges - The high cost of CAR-T cell therapies has led to four failed negotiations with the national medical insurance, attributed to the pricing rules of "no negotiation below 500,000 yuan, and no entry below 300,000 yuan" [2] - Industry insiders indicate that due to production cost constraints, CAR-T drugs need to lower prices to enter insurance coverage, which will take time [2] Group 3: Production and Cost Efficiency - Lentiviral vectors are crucial for gene delivery in cell therapies and are among the most expensive production materials [3] - WuXi Biologics has developed a domestically produced lentiviral vector (JWLV011) to optimize production processes and enhance quality control, aiming to ensure stable supply and reduce costs for Rikeo Lun Sai [3] - The domestic replacement of lentiviral vectors is strategically significant for the company, potentially leading to lower costs and improved competitiveness in commercialization and insurance negotiations [3] Group 4: Clinical Research Findings - The application is based on a Phase II single-arm study assessing the comparability of Rikeo Lun Sai produced with the new JWLV011 vector against the existing product [4] - The study reported a 66.67% overall response rate (ORR) and a 41.67% complete response (CR) after at least three months of follow-up [4] - Common severe adverse events included cytopenia, with CAR-T related toxicities primarily at grade 1, and no grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [4][5]