Precision Bio Announces NMPA Acceptance of New Drug Application for Pujilunsa Injection, China's First CD19 CAR-T Therapy for Pediatric and Adolescent Leukemia

▎Armstrong

On July 20, 2024, the marketing application for Chongqing Precision Biotech Co., Ltd.'s CD19 CAR-T therapy, Pucilencercept Injection, was accepted by the NMPA.

Pukilun RaceScheduled for priority review at the end of June, this is China's first CAR-T therapy to enter Phase II clinical trials for the treatment of acute leukemia in children and adolescents.

Chongqing Precision Biotech Co., Ltd. was founded in 2016 by Professor Qian Cheng's technical team in collaboration with Zhifei Biological (Zhirui Investment), focusing on CAR-T/CAR-NK therapies.

Zhirui Investment is the largest shareholder, with a stake of 39.714%.

Summary

In China, several CAR-T therapies have entered the commercialization stage, including CD19 CAR-T from Wuxi Jounce, Fosun Kite, and AcroBiotech, as well as BCMA CAR-T from CARsgen Therapeutics and Iaso Biotherapeutics. The BCMA CAR-T from Legend Biotech has already been launched in the United States, with sales of 500 million US dollars in 2023 and 343 million US dollars in the first half of this year.