Abclon announced on February 7 that it is accelerating its efforts to obtain fast-track approval for its CAR-T therapy, AT101, as Phase 2 clinical trials progress smoothly.

AT101 is an advanced biopharmaceutical being developed for patients with relapsed or refractory B-cell lymphoma (BCL). The company is currently conducting an interim analysis based on partial patient data and plans to apply for the Designation of Advanced Biopharmaceuticals for Rapid Processing. 

This designation shortens the approval review process for treatments targeting life-threatening diseases once safety and efficacy are demonstrated, offering benefits such as tailored reviews and partial clinical data exemptions.

Abclon emphasized that AT101, based on its proprietary CD19-targeting antibody h1218, is expected to be highly competitive compared to existing CD19 CAR-T therapies. The company previously confirmed AT101’s efficacy and safety in Phase 1 trials.

A company representative stated, “With the fast-testing method approval from the Ministry of Food and Drug Safety (MFDS) last August, we have reduced the treatment timeline for AT101, allowing faster patient access to the therapy. We are optimistic about the interim analysis results and plan to apply for fast-track designation in the first half of this year.”

To expedite the market launch of AT101, Abclon is collaborating with a consulting firm experienced in GMP (Good Manufacturing Practice) evaluations to prepare the necessary documentation.