CASI Pharmaceuticals and Juventas Cell Therapy recently received approval from China’s National Medical Products Administration (NMPA) for Yuanruida (Inaticabtagene Autoleucel/CNCT19), a domestic CD19-targeting CAR-T therapy for relapsed/refractory B-Cell Acute Lymphocytic Leukemia (r/r B-Cell ALL). The approval positions both companies as trailblazers in China’s dynamic oncology landscape and cell therapy.  As the first homegrown CAR-T to get approval for this indication, Yuanruida will have a first-mover advantage for r/r B-cell ALL treatment in China, says GlobalData, a leading data and analytics company.

The approval is based on data from a Phase II, multi-center, pivotal trial involving 39 adults with r/r B-cell ALL. Trial results showed an overall response rate of 82.1% and a complete response rate of 66.7% within 3 months after infusion as second- or third-line of therapy, making Yuanruida a treatment with a promising benefit-risk ratio for adult patients.

Srija Chilamula, Pharma Analyst at GlobalData, comments: “CAR-T therapy revolutionized patient treatment, especially in relapsed and refractory hemato-oncology. Unlike conventional therapies, these have remarkably high response rates and prolonged remissions in a substantial proportion. Yuanruida has a long remission with reduced adverse events, addressing the potential need where patients in China were largely dependent on Blincyto (blinatumomab), a monoclonal CD19-targeted antibody, besides other cytotoxic agents.”

According to GlobalData’s Pharmaceutical Intelligence Center, the diagnosed prevalent cases of ALL in China are estimated to increase from 48,081 cases in 2023 to 52,525 cases in 2029, with an annual growth rate of 2.05%, which is the highest among the major markets*. Currently, ten CD19-targeting CAR-T therapies for ALL are in Phase II. Of them, Chongqing Precision Biotech’s pCAR-19B is expected to announce its Phase II results by December 2023.

As of December 2023, four CAR-T therapies are on the market for B-cell ALL globally, including Yuanruida and all have CD19-expressing cancer cells as a target. Notably, Kymriah (tisagenlecleucel) by Novartis and Tecartus (brexucabtagene autoleucel) by Gilead Sciences are well-established therapy options in multiple countries, including the US and EU, while actalycabtagene autoleucel by ImmunoACT is a recent approval in India.

Chilamula concludes: “Yuanruida could emerge as a preferable option with better market access in China. Moreover, this has also received investigational new drug (IND) approval to conduct clinical trials in the US. Based on the successful completion of clinical trials in the US for regulatory filing and probable approval, it can further expand into the US market. However, it is expected to compete with pCAR-19B in China.”

*Major markets include Australia, Canada, Germany, India, Japan, United Kingdom, United States, Urban China, Spain, South Korea, South Africa, Russia, Mexico, Italy, France, and Brazil.