Regulatory Blessings Helping China CAR-Ts March Closer To Global Cancer Patients?
Cost Advantages May Also Come To Fore
A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.
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AACR highlighted Gracell’s allogeneic CAR-T targeting CD7, Iovance’s TIL therapy in lung cancer, Gilead’s Yescarta/PD-L1 combination and the NCI’s bispecific CAR-T therapy.
2019 was the year that China approved the first new drug for Alzheimer's in nearly two decades and for the first US approval of an original cancer drug from China. While the simmering US trade war has been addressed by a phase one agreement to be signed, other uncertainties marked a year dominated by a large vaccine scandal and resulting bankruptcy, and increasing calls to include China in global clinical development plans.
Phase Ib data at ASH look competitive with new pivotal trial results for Bristol/bluebird’s leading BCMA CAR-T bb2121. The Phase II portion of the CARTITUDE-1 study for JNJ-4528 is fully enrolled.