CAR-T Therapies Poised for Breakthrough Era Amid Surging Innovations and Clinical Advances

　　【Pharmaceutical Network Industry Dynamics】Recently, the CAR-T therapy field has achieved significant clinical progress and technological breakthroughs both globally and in China, with continuous good news in areas such as new indications approval and preliminary validation of next-generation technology platforms (e.g., dual-target, in vivo CAR-T).
 

Recently, DeliNova Therapeutics announced that its core product has entered the critical preclinical stage, driven by its self-developed multi-dimensional optimized in vivo CAR-T technology platform. The candidate drug for hematologic tumors will soon initiate its first-in-human clinical trial (IIT), with the potential to break the limitations of traditional CAR-T therapies and benefit more patients.
 

Since its establishment, DeliNova Therapeutics has been committed to in vivo CAR-T. Within just half a year of its founding, it completed seed and angel rounds of financing amounting to nearly 60 million yuan. Notably, the company's Investigator-Initiated Trials (IIT) for solid tumors and autoimmune disease pipelines are also planned to commence in 2026.
 

On December 7, Genscript Biotech announced that its affiliated company, Legend Biotech, released clinical and translational research data on CARVYKTI® in patients with relapsed or refractory multiple myeloma at the American Society of Hematology Annual Meeting on December 6, 2025 (New York time).
 

The announcement mentioned that the long-term data from two pivotal studies of Legend Biotech's CARVYKTI in relapsed or refractory multiple myeloma (RRMM), CARTITUDE-1 and CARTITUDE-4, have set new clinical records for BCMA-targeted CAR-T therapy across several metrics.
 

On December 6, Kite, a subsidiary of Gilead Sciences, announced new clinical data for its core candidate drug anitocabtagene autoleucel (anito-cel), demonstrating "Best-in-class" potential in the treatment of relapsed/refractory multiple myeloma (R/R MM).
 

Anito-cel is an autologous BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy developed using a novel D-domain binder. The properties of the D-domain (including small size, simple structure, and rapid dissociation rate) help achieve high transduction efficiency, stable CAR expression, and reduce the risk of tonic signaling.
 

On December 4, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved its CD19 CAR-T cell therapy Breyanzi (liso-cel) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior systemic therapies.
 

The approval of Breyanzi is based on the results of the MZL cohort in a study named TRANSCEND FL, which was an open-label, multi-center, multi-cohort, single-arm study.
 

In addition, at the 2025 American Society of Hematology Annual Meeting (ASH), Innovent Bio also presented preliminary data from the first-in-human trial of its self-developed anti-GPRC5D/BCMA/CD3 trispecific antibody IBI3003 for patients with relapsed or refractory multiple myeloma (R/R MM) in an oral presentation.
 

IBI3003 demonstrated good tolerability and manageable safety profiles, particularly showing promising efficacy in high-risk patients with extramedullary disease or those previously treated with anti-BCMA and GPRC5D single or dual-targeted therapies.
 

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Overall, as leading pharmaceutical companies both in and outside China are flocking to the CAR-T therapy track, with continuous innovative achievements, this field has become a vast industry characterized by ongoing technological innovation, expanding applications, and an increasingly clear business model. In the future, these new breakthroughs are expected to drive the industry into a boom period, with solid tumor treatments likely achieving greater progress and patients gaining more new options.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.