Again, not a stem cell therapy, but an autologous cellular therapy which has blatant medical procedure similarities with Ortho ATI (it too involves a biopsy; autologous cell culturing; reinjection [more arduous infusion in this case]) that I have mentioned before, J&J's CARVYKTI has been accepted in application in China:
https://www.precisiononcologynews.com/regulatory-news-fda-approvals/chinas-nmpa-accepts-new-drug-application-legend-biotech-janssens#.Y7ZkiHZBxPY
J&J has made considerable investment in a number of CAR T-cell ventures including Fate Therapeutics induced pluripotent stem cell approach, but has only had regulatory approval success with a simple autologous procedure that has already made $55 million in revenue in Q3 23 (likely pushing $100 million in Q4) after only gaining approval in February.
Oooh look, as Legend and collaborators reported in the Journal of Clinical Oncology in October, nearly 90 percent of 48 patients on Carvykti responded and 77 percent achieved a complete response. Sounding at all similar to the trial results reported from the J&J/OCC trial collaboration on Ortho ATI?
For all the super advanced approaches to CAR T-cell therapies out there (and billions are being spent), J&J made a simple, (relatively) easy, regulatory and emerging commercial win on an autologous therapy. I know its slowly losing plausibility/probability with time, but an JNJ/OCC Ortho ATI partnership is still very much a possibility IMO. Its a similarly easier regulatory route and easily applicable procedure (via ambulatory/outpatient centres) that could be a quick revenue growth area for JNJ that recently named Carvykti as one of its core growth brands:
https://www.fiercepharma.com/financials/johnson-johnson-sticks-2025-projection-60-billion-pharma-sales-relying-eight-key-brands
Disappointed we've heard nothing from the company, but too many obvious analogies to ignore and far too early to dismiss yet, given JNJ's recent success in this autologous cellular therapy with many analogies to Ortho ATI.
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