BMS partners with Repertoire and Scenic, plus deals involving: G1/Pepper, Harmony/Epygenix, Biodexa/Emtora, Regeneron/Mammoth, Vertex/Treefrog and Immedica/KKR/Impilo.

Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.

Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.

With the success of the partnership between J&J and partner Legend, more Chinese cell therapy developers are now looking to enter the US market. But for a complex product like a CAR-T therapy, the journey to the West is not short of challenges. Nasdaq-listed Gracell Bio wants to give it a shot based on quicker delivery and cost-effectiveness advantages.