Possibility of shortened approval review… Product approval targeted for 2026
[by Jin, Yu Jeong] AbClon announced on September 24 that its next-generation chimeric antigen receptor T-cell (CAR-T) treatment candidate, ‘Nespe-cel (development code AT101),’ has officially received designation as an ‘advanced biopharmaceutical fast-track treatment.’ The designation was conferred approximately two months following the company’s submission of a fast-track application on July 23.
The ‘fast-track 에볼루션 바카라 사이트 designation system’ enables the Ministry of Food and Drug Safety (MFDS) to prioritize the approval review of 에볼루션 바카라 사이트s aimed at addressing serious or life-threatening conditions that currently lack effective 에볼루션 바카라 사이트 options, or where meaningful medical advancement is possible. With this designation, AbClon becomes eligible for key regulatory advantages, including the assignment of a dedicated review team, an accelerated evaluation timeline, and partial exemption from clinical trial data requirements, significantly shortening the time to product approval.
Nespe-cel, a CAR-T 에볼루션 바카라 사이트 developed in Korea, is targeting product approval in 2026. The candidate is currently under development with the backing of the Korea Drug Development Fund (KDDF).