A domestically developed CAR-T therapy priced at around RMB 200,000 has entered regulatory review in China.

On April 30, the Center for Drug Evaluation (CDE) of the National Medical Products Administration officially accepted the marketing application for Huadao (Shanghai) Biopharma’s Huadao (Shanghai) Biopharma Class 1 CAR-T therapy, wangji orencel injection (HD CD19 CAR-T), for the treatment of relapsed or refractory non-Hodgkin lymphoma, marking its first-ever marketing authorization submission after initiating clinical development in 2018.

Globally, multiple CAR-T therapies have already been approved, with international average prices exceeding $400,000 and China’s marketed products averaging around RMB 1.2 million, highlighting a significant affordability gap for patients. Huadao Biopharma, founded in 2017 with a mission to make cell therapies accessible to broader patient populations, is building a fully automated and closed-loop “unmanned” CAR-T manufacturing facility in Shanghai’s Songjiang district, with Phase I annual capacity reaching 9,000 doses—substantially higher than the sub-300-dose capacity of currently marketed CAR-T products in China.

Leveraging fully in-house R&D and industrialized production capabilities, the company has indicated that the expected post-approval pricing of wangji orencel injection will be in the range of RMB 230,000–250,000, positioning it as one of the most cost-accessible CAR-T therapies globally. In addition to this candidate, Huadao has four other CAR-T programs in clinical development, including two targeting solid tumors, HD004 (CLDN18.2) and HD006 (GUCY2C), reflecting an expanding pipeline beyond hematologic malignancies.