In December 2017, Johnson & Johnson Innovative Pharmaceuticals, a subsidiary of Johnson & Johnson, signed an exclusive global license and cooperation agreement with Legendary Biotech to develop and commercialize Sidakiolene.
The Zhitong Finance App learned that Legend Biotech announced that the European Commission (EC) has approved cilta-cel (cilta-cel, trade name Carvykti) to treat adult patients with recurrent and refractory multiple myeloma. These patients have received at least first-line treatment (including a proteasome inhibitor and an immunomodulator), progressed in the last treatment and became resistant to lenalidomide. Sidakiolenol is a CAR-T therapy targeting B-cell maturation antigen (BCMA). In December 2017, Johnson & Johnson Innovative Medicine (Johnson & Johnson Innovative Medicine), a subsidiary of Johnson & Johnson (Johnson & Johnson), signed an exclusive global license and cooperation agreement with Legendary Biotech to develop and commercialize Sidakion.
In February 2022, Sidakiolens was approved for marketing by the US FDA, and in May, it obtained a conditional marketing license granted by the EC to treat adult patients with recurrent or refractory multiple myeloma. These patients have received at least 3 types of early treatment. The FDA also approved Sidakiolenol on April 5 this year to treat adult patients with recurrent or refractory multiple myeloma who have received at least one treatment (including a proteasome inhibitor and an immunomodulator) and are resistant to lenalidomide.
In China, the marketing application for Sidakiolensis injection's new drug has been prioritized by the NMPA. The proposed indication is to treat adult patients with recurrent or refractory multiple myeloma (R/R MM) after previous treatment with a proteasome inhibitor and an immunomodulator.