瑞基奥仑赛注射液(倍诺达)
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过百万的CAR-T药物,价格有望大幅下降?
第一财经· 2025-10-10 07:10
Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has submitted a supplementary application for the domestic production of a viral vector for its CAR-T cell therapy product, Rikeolunai Injection, which targets blood cancers. This move aims to enhance the stability of supply and reduce production costs, thereby improving the product's market competitiveness and potential for insurance negotiations [3][6][7]. Group 1: Product Development and Approval - WuXi Biologics' Rikeolunai Injection has received approval for three indications in the domestic market, focusing on hematological malignancies [3]. - The number of CAR-T cell therapy products approved in China has reached seven, but high prices, such as Rikeolunai Injection's price of 1.29 million yuan per dose, limit accessibility [6]. Group 2: Cost and Supply Chain Challenges - The high cost of viral vectors, which are crucial for CAR-T cell therapy production, has been a significant barrier to market entry and insurance negotiations. The industry has faced multiple failures in price negotiations with national insurance [6][7]. - The company has developed a domestically produced viral vector (JWLV011) to mitigate supply chain issues and reduce costs associated with foreign suppliers [6][8]. Group 3: Clinical Research and Efficacy - A Phase II study has shown that the Rikeolunai Injection produced with the new domestic viral vector has comparable clinical efficacy to that produced with existing foreign vectors, with an overall response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% observed after three months [8].