Group 1 - The National Healthcare Security Administration (NHSA) has officially released the "Commercial Health Insurance Innovative Drug Directory," marking a significant step in the accessibility reform of innovative drugs in China [1][6] - The inclusion of Beiduo Da® (Regiokine injection) as the first CAR-T product developed in China is a milestone for the cell therapy industry, with less than 20% of the high-value innovative drugs successfully included in the directory [2][7] - As of June 2025, Beiduo Da® has been included in over 100 city health insurance programs and nearly 100 commercial insurance directories, significantly reducing the financial burden on patients [2][7] Group 2 - Beiduo Da® has benefited approximately 600 patients since its launch in September 2021, showing significant efficacy in treating relapsed or refractory large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma [2][7] - The drug has received priority review qualifications and breakthrough therapy designation, with a new application for a fourth indication submitted in May 2025 [2][7] Group 3 - WuXi AppTec has established three CAR-T production modules approved by the National Medical Products Administration, ensuring product accessibility and safety [3][8] - A new application for using domestically produced viral vectors was accepted in October 2025, which is expected to significantly reduce material costs [3][8] - The production capacity has increased from approximately 100 doses to 1,500 doses per batch, enhancing efficiency and supply capabilities [3][8] Group 4 - WuXi AppTec has developed a diverse pipeline of cell immunotherapy products targeting hematological malignancies, autoimmune diseases, and solid tumors [4][9] - The company is actively expanding its market presence in Asia, with Beiduo Da® undergoing commercialization efforts, including a "Named Patient Program" in Hong Kong and receiving approval in Macau [4][10] - The inclusion of Beiduo Da® in the innovative drug directory provides a reference for the construction of a multi-layered payment guarantee system for high-value innovative drugs in China [5][10]
药明巨诺瑞基奥仑赛纳入国家医保局商保创新药目录（第一版），加速细胞治疗惠及更多中国患者