本次申请是基于一项II期单臂研究，目的是评估和论证使用新工艺病毒载体 (JWLV011)生产的瑞基奥仑 赛注射液，与使用现有病毒载体生产的瑞基奥仑赛注射液产品可比。目前本研究已完成至少3个月随 访：观察到的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%。最常见的严重不 良事件为血细胞减少;CAR-T相关毒性如细胞因子释放综合征(CRS)，多为1级，无≥3级CRS发生，无任 何级别免疫效应细胞相关神经毒性综合征(ICANS)发生。综合有效性、安全性结果，本研究的临床资料 表明，由国产慢病毒载体(JWLV011)生产的瑞基奥仑赛注射液，与现有慢病毒载体生产的产品具有临床 可比性。 （原标题：药明巨诺-B(02126)：国家药监局正式受理倍诺达®使用国产病毒载体的上市后补充申请） 智通财经APP讯，药明巨诺-B(02126)发布公告，中国国家药品监督管理局(NMPA)已正式受理其倍诺达 新增使用国产病毒载体的上市后补充申请。 慢病毒载体作为目的基因递送工具，在细胞治疗产品中起着重要的作用，可以实现嵌合抗原受体基因的 转导和整合。慢病毒载体是瑞基奥仑赛注射液的重要的生产原材料之 ...

Summary of Weekly Review on Pharmaceutical Sector Industry Overview - The pharmaceutical sector in A-shares showed a positive performance with the index (CITIC) increasing by 2.21% while the CSI 300 index decreased by 1.08% and the ChiNext index fell by 1.40% [1][2] - In H-shares, the Hang Seng Index for healthcare increased by 3.43%, contrasting with a decline of 1.32% in the Hang Seng Index and a drop of 1.46% in the Hang Seng Technology Index [1][2] Market Performance - The CSI 300 pharmaceutical index rose by 0.61% and the CSI 500 pharmaceutical index increased by 1.83% [3] - The overall daily trading volume for the market remained between 9,900 million and 12,000 million, with the pharmaceutical sector's market trading share fluctuating between 7.3% and 10.1% [3] - The pharmaceutical sector outperformed both the CSI 300 index and the ChiNext index during the week [3] Key Announcements and News - **WuXi AppTec**: The NMPA has accepted the application for the new indication of its cell immunotherapy product, Beiduo® (Regorafenib Injection), for second-line treatment of relapsed or refractory adult B-cell lymphoma patients [4] - **Hengrui Medicine**: The company received approval from the National Medical Products Administration for the clinical trial of SHR-4712 injection, which targets tumor-associated antigens and activates immune cells in the tumor microenvironment [4] - **Junshi Biosciences**: The company's HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) has been granted orphan drug designation for gastric cancer treatment by the European Commission [4] - **Kejia Pharmaceutical**: The candidate product targeting Claudin18.2 protein, "Shu Rui Ji Ao Lun Sai Injection," has been included in priority review by the NMPA for treating Claudin18.2 positive patients with advanced gastric and gastroesophageal junction adenocarcinoma who have failed at least second-line treatment [4] - **Rongchang Biologics**: The company announced that its dual-target fusion protein, Tai Ta Xi Pu, has been approved for listing in China for the treatment of acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG), showing significant improvement in patient symptoms after 24 weeks of treatment [5]

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received acceptance from the National Medical Products Administration (NMPA) for its cell immunotherapy product, Brexucabtagene Autoleucel (Ruxolitinib Injection), for a new indication in the second-line treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) patients [1][2] Group 1 - The application for Brexucabtagene Autoleucel is the fourth submission for this product by WuXi Biologics [1] - The NMPA granted breakthrough therapy designation for Brexucabtagene Autoleucel in January 2025 for the second-line treatment of r/r LBCL [1] - LBCL is a highly aggressive form of non-Hodgkin lymphoma and is the most common subtype of lymphoma in adults, with 30-40% of patients experiencing relapse or refractory disease after first-line treatment [1] Group 2 - The sBLA is based on a pivotal, single-arm, multi-center clinical study that evaluated Brexucabtagene Autoleucel in adult r/r LBCL patients who were not suitable for autologous stem cell transplantation (ASCT) after first-line treatment failure [2] - The Phase II open-label study in China included patients who had failed prior treatment with targeted CD20 antibodies and anthracycline-based regimens [2] - As of January 21, 2025, 49 patients had undergone cell infusion with at least 3 months of follow-up, showing significant clinical efficacy with an overall response rate (ORR) of 81.3% and a complete response rate (CRR) of 54.2% [2]