China is making significant strides in CAR-T innovation. Recently, Chongqing Precision Biotech Co., Ltd. received approval for Priligy (priscabtagene autoleucel) to treat pediatric and adolescent patients aged 3 to 21 years with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). With this approval, Priligy is expected to gain a first-mover advantage as a CAR-T therapy for second-line or later treatment of pediatric r/r B-ALL, according to GlobalData, a leading data and analytics company.

Priligy is reportedly the first domestically developed autologous CAR-T cell product for pediatric patients with r/r B-ALL in China. Its approval was based on Phase II trial results, which showed an objective response rate (ORR) of 90.63% among 64 patients, with a median follow-up of 211 days.

Bobbili Stella Catherin, Pharma Analyst at GlobalData, comments: “With the approval of Priligy, Chongqing Precision Biotech has made a significant advancement in treating pediatric r/r B-ALL patients in China. Its development for this specific patient population addresses a critical unmet medical need in a vulnerable group of children who have long faced limited treatment options, offering new hope to these patients.”

Despite facing significant challenges−such as a heavy bone marrow blast burden and a high risk of genetic variations−Priligy has demonstrated high remission rates, achieved a substantial rate of MRD-negative remission, produced durable responses, and shown a manageable safety profile, establishing it as a new therapeutic option for the pediatric population.

Priligy marks as the first product developed by Chongqing Precision Biotech to receive marketing approval in China, representing the fifth CD19 CAR-T therapy available in the country across all indications. It has also received Breakthrough Therapy Designation in November 2023 and is being evaluated in Phase II trials for lymphoma in China.

According to GlobalData, there are currently eight approved CAR-T drugs across all indications in China, with 211 drugs in clinical development, including six CAR-T therapies in Phase III trials. Specifically, 31 CAR-T drugs are being developed for r/r B-ALL, with five Phase III CAR-T therapies currently in development in China.

Additionally, Yuanruida (inaticabtagene autoleucel) from Juventas Cell Therapy Ltd. is approved for adults and is being developed in Phase I/II trials for pediatric patients with r/r B-ALL in China.

Catherin concludes: “Priligy’s first-to-market position and superior efficacy compared to existing therapies position it strongly in the Chinese pediatric r/r B-ALL market. This approval provides a promising start for Chongqing Precision Biotech and highlights the potential for further innovation in China’s CAR-T cell therapy landscape.”