On November 8, 2023 CASI Pharmaceuticals Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported a major milestone in its partnership with Juventas Cell Therapy Ltd. (Juventas) (Press release, CASI Pharmaceuticals, NOV 8, 2023, View Source [SID1234637291]). The China National Medical Products Administration (NMPA) has granted market approval for Juventas’ investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China.
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Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product comprised of a unique CD19 scFv（HI19a）structure and utilizes leading CMC manufacturing techniques. Inaticabtagene Autoleucel has demonstrated a high level of efficacy, with durable remissions, and substantially improved safety profile with reduced CAR-T related toxicities in the pivotal clinical study for the treatment of adults with r/r B-ALL.
This approval is based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China. The 9.3-month follow up data demonstrated very high durable response, overall response rate ("ORR"): 82.1%, complete response rate ("CR"): 66.7% within 3 month after infusion and median duration of response (DoR) has not reached. The safety profile shown the decreased severity of CAR T-Cell related adverse events in patients with r/r B-ALL. Given the currently available treatment options in China, Inaticabtagene Autoleucel will be the first treatment CAR-T therapy option with a positive benefit-risk ratio for adult patients with r/r B-ALL and potentially be a best-in-class CAR-T product.
This pivotal development not only marks a significant achievement for CASI and Juventas but also represents a remarkable advancement in the field of hematology-oncology and cell therapy. CNCT19 is the first CD19-directed CAR-T product with Chinese independent intellectual property rights, making it a trailblazer in the Chinese biopharmaceutical landscape. It is also the first commercialized cell therapy product in China designed to treat B-ALL.
Dr. Wei-Wu He, Chairman and CEO of CASI, expressed his enthusiasm for the commercial and clinical significance of CNCT19. He stated, "The approval of CNCT19 represents a transformative moment not only for CASI and Juventas but for all B-ALL patients in China. We are committed to making this groundbreaking therapy accessible to those in need and aspire to extend its reach globally. CNCT19 offers new hope to patients battling relapsed B-ALL, and this partnership between CASI and Juventas aims to ensure that this innovative therapy reaches those in need across China and beyond."