Pharma Focus Asia

CASI Pharmaceuticals Receives Regulatory Approval for CNCT19 from China's NMPA

Thursday, November 09, 2023

CASI Pharmaceuticals Inc. (Nasdaq: CASI), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics and pharmaceutical products, is excited to announce a significant milestone in its partnership with Juventas Cell Therapy Ltd. (Juventas). 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.

Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product featuring a unique CD19 scFv (HI19a) structure and utilizing advanced CMC manufacturing techniques. Inaticabtagene Autoleucel has demonstrated a high level of effectiveness, delivering long-lasting remissions and a significantly improved safety profile with reduced CAR-T-related toxicities in a pivotal clinical study for the treatment of adults with r/r B-ALL.

This approval is based on clinical results from a single-arm, multi-center, pivotal study involving 39 adult patients with r/r B-ALL in China. The 9.3-month follow-up data demonstrated a very high durable response, with an overall response rate ("ORR") of 82.1% and a complete response rate ("CR") of 66.7% within 3 months after infusion. The median duration of response (DoR) has not been reached. The safety profile showed reduced 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 CAR-T therapy option with a positive benefit-risk ratio for adult patients with r/r B-ALL, potentially becoming a best-in-class CAR-T product.

This pivotal development is not only 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 pioneer in the Chinese biopharmaceutical landscape. It is also the first commercially available cell therapy product in China designed to treat B-ALL.

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."

Established in June 2018, Juventas Cell Therapy Ltd., a biopharmaceutical company powered by cutting-edge cell and gene technologies, has become the leader of innovative CGT drug development in China. Juventas' innovation is rooted in its integrated R&D platforms, including CAR, iPSCs, and gene-editing technologies. With more than 10 drug candidates in its pipeline, featuring solo, dual, or multiple target autologous CAR-T and universal cellular products, Juventas is well on its way to fulfilling its mission - providing novel solutions to unmet clinical needs in the treatment of blood cancers, solid tumors, and other diseases. In November 2023, Juventas' first core product - Inaticabtagene Autoleucel (CNCT19) was approved by NMPA for the treatment of adult B-cell relapsed and refractory acute lymphoblastic leukemia (B-ALL).



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