Recent IND Approvals and Filings for Dual-Target CAR-T, NK, and TIL Therapies in China

According to the CDE official website, several companies' candidate pipelines have achieved new IND acceptance/approved clinical progress.

Gracell Bio (a member of AstraZeneca Group):

GC012F Injection

GC012F Injection（AZD0120）Obtained CDE clinical trial implied permission, including4 Indications: Relapsed/refractory multiple myeloma, relapsed or refractory B-cell non-Hodgkin lymphoma, refractory systemic lupus erythematosus, and relapsed or refractory light chain amyloidosis.

GC012F Injection is based on Gracell's proprietaryBCMA and CD19 Dual-Target Autologous CAR-T Candidate Product Developed on the FasTCAR Next-Day Production PlatformCurrently, the candidate product has entered the clinical research stage. At the 2025 ASH Annual Meeting, the clinical research data of three studies on GC012F Injection were officially published.

The advancement of GC012F in clinical trials across multiple indications will further explore the feasibility and potential of CAR-T cell therapy in a broader range of therapeutic areas.

Sai奥斯博生物：SK-NK Injection

On April 4, Sai奥斯博生物's SK-NK Injection IND Application Accepted. According to public information, SK-NK Injection strictly adheres to quality control standards, obtaining higher purity NK cells through specific in vitro production processes. It highly expresses activating receptors such as CD16, NKP46, and NKG2D, while also exhibiting excellent granzyme/perforin expression levels, cytokine secretion function, and powerful anti-tumor killing activity. More importantly, this product achieves large-scale industrial production of NK cells, significantly reducing cell therapy costs.

In December 2025,SK-NK Injection Has Already Obtained IND Approval, for the treatment of advanced or metastatic malignant solid tumors with malignant ascites.

Gracell: GT307 Injection

On April 4, Gracell's GT307 Injection IND application was accepted. GT307 is a CRISPR gene-editing technology-basedNext-Generation Dual-Gene Knockout TIL Product, aiming to solve the key bottleneck issues of traditional TIL, such as susceptibility to functional exhaustion and insufficient persistence in the tumor microenvironment.

Relying on Gracell's independently developed ImmuT Finder^® High-throughput immune regulatory target screening platform systematically discovers and identifies key immune regulators that suppress the anti-tumor function of TILs. Using CRISPR technology for precise knockout of these factors significantly enhances the anti-tumor function and in vivo persistence of TILs. In terms of gene editing strategy, GT307 employs a high-fidelity nuclease system, demonstrating significant advantages in editing safety, product phenotype, expansion, and functionality.

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