10月9日，药明巨诺（02126）发布公告，中国国家药品监督管理局已正式受理公司倍诺达®使用国产病毒载体的上市后补充申请。
此次申请基于一项II期单臂研究，旨在评估使用新工艺病毒载体（JWLV011）生产的瑞基奥仑赛注射液与现有病毒载体生产的产品可比性。研究结果显示，3个月最佳客观缓解率（ORR）为66.67%，疾病完全缓解率（CR）为41.67%。
公司表示，慢病毒载体是细胞治疗产品的重要生产原材料，现阶段所用的慢病毒载体由国外生产商供货，价格高且供货不稳定，限制了瑞基奥仑赛的商业化生产和临床开发。通过自主研发的JWLV011，预计将优化生产工艺，加强质量控制，确保瑞基奥仑赛注射液的稳定供应，并降低成本，从而提升商业化价值。
（文章来源：财中社）
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