Yorwida (Inaticabtagene Autoleucel) is an innovative chimeric antigen receptor (CAR) T-cell therapy specifically approved for treating B-cell acute lymphoblastic leukemia (B-ALL). Yorwida has demonstrated exceptional efficacy, durable remissions, and a significantly improved safety profile, with reduced CAR T-cell-related toxicities, as evidenced in its pivotal clinical study.
This cutting-edge CD19 CAR T-cell therapy is engineered with a proprietary CD19 single-chain variable fragment (scFv) known as HI19a and utilizes advanced manufacturing processes. Clinical trials have highlighted its remarkable efficacy and sustained remission in adults with relapsed or refractory B-ALL (r/r B-ALL), alongside its enhanced safety features. YORWIDA represents a groundbreaking achievement as the first CD19-targeted CAR T-cell therapy with proprietary rights developed in China and the first commercially available CAR T-cell therapy for B-ALL in China.
CNCT19 has been approved by the China National Medical Products Administration (NMPA) for indications:
The approval of Yorwida is based on results from a pivotal, single-arm, multi-center study in China involving adults with relapsed/refractory B-ALL. The 9.3-month follow-up data revealed a high and durable response rate, with an overall response rate (ORR) of 82.1% and a complete response rate (CR) of 66.7% within 3 months post-infusion, though the median duration of response (DOR) has not yet been reached. Additionally, the safety profile demonstrated a reduced severity of CAR T-cell related adverse events. CNCT19 has the potential to be a leading CAR-T cell therapy for adult relapsed/refractory B-ALL, addressing a significant unmet clinical need.
23.7 MONTH ANALYSIS
Mean duration of remission (DOR) is 20.7 months, mean recurrence-free survival is 12.4 months.
3 MONTH ANALYSIS
85.4% overall remission rate (ORR) at 3 months, all of which were MRD-negative (n=41/48)
China has experienced remarkable growth in the field of medicine over the past few decades, reflecting its broader advancements in science and technology. The country has made substantial investments in healthcare infrastructure, research, and development, which have significantly improved its medical capabilities. Cutting-edge facilities, increased funding for biomedical research, and a focus on innovation have enabled China to make strides in various areas of medicine, including CAR T-cell therapy.
CAR T-cell therapy has seen substantial progress in China, with several therapies approved for treating blood cancers like large B-cell lymphoma, acute lymphoblastic leukemia and multiple myeloma. The NMPA has streamlined approval processes, and domestic companies are actively developing new therapies and reducing costs. Research and clinical trials are vibrant, focusing on improving efficacy and managing side effects. China is making significant strides in expanding the availability and innovation of CAR T-cell therapies.
China has made significant strides in medical care and research, including advancements in CAR T-cell therapy.
China’s rapid advancements in biotechnologies are establishing it as a leader in CAR T-cell therapy, ensuring effective treatments.
China offers effective CAR T-cell therapies and other medical services with patient-friendly pricing and an accessible approach.
Our devoted service team is with you every step of the way during the CAR T-cell treatment, providing support as you combat cancer.
In China, Yorwida is only provided at certified treatment centers, these centers/hospitals usually are leading hospitals in the region, where the medical staff are highly skilled in managing lymphoma, and are specially trained to take care of you during the entire CAR T-cell therapy process.
You should plan to stay at the certified treatment center for at least one week following the infusion, and you’ll have several appointments before and after the treatment. Your treatment team will advise you on how close you need to be to a certified healthcare facility during the first four weeks after the infusion.
Whether you’re a patient, caregiver, or medical professional, our team can connect you with leading CAR-T treatment centers and clinical experts in China.
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