▎药明康德/报道

JNJ-4528是一款结构上具有差异性的CAR-T疗法。它的抗体片段中携带两个靶向BCMA的蛋白域。JNJ-4528最初由南京传奇公司设计和开发。在2017年12月,杨森公司与南京传奇达成全球性合作,共同开发和推广JNJ-4528治疗MM患者。在中国,南京传奇与杨森合作开展的2期临床试验CARTIFAN-1,正在招募患者,进一步评估JNJ-4528在治疗晚期复发/难治性MM患者时的疗效。这一疗法已经获得FDA授予的孤儿药资格,以及欧盟EMA授予的PRIME药品认定。

参考资料:
[1] Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma. Retrieved December 6, 2019, from https://www.prnewswire.com/news-releases/janssen-announces-bcma-car-t-therapy-jnj-4528-granted-us-fda-breakthrough-therapy-designation-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma-300970825.html
[2] Results from CARTITUDE-1: A Phase 1b/2 Study of JNJ-4528, a CAR-T Cell Therapy Directed Against B-Cell Maturation Antigen (BCMA), in Patients with Relapsed and/or Refractory Multiple Myeloma (R/R MM). Retrieved December 6, 2019, from https://ash.confex.com/ash/2019/webprogram/Paper121731.html
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