January 23,CDE Official Website Announcement,ImmunityBio, Inc.DepartmentDeclaredOriginal Research Drug“N-803（nogapendekin alfa inbakicept）"Application for Clinical Trial Accepted"。N-803(Product name Anktiva®)Is a First-in-Class IL-15 receptor agonist fusion protein, by activating CD8+ T cells and NK cells, enhancing the body's anti-tumor immune response.Unlike some cytokine-based drugs, Anktiva does not stimulate immunosuppressive Treg cells, creating a differentiated advantage between immune activation and safety.
Recently, ImmunityBio announced the latest data from the QUILT-3.078 Phase 2 clinical study, which is evaluating the IL-15 superagonist.Anktiva (Nogapendekin Alfa Inbakicept) in Combination with CAR-NK Cell Therapy: A Chemotherapy-Free Immunotherapy Regimen, used for treatmentPatients with recurrent or progressive glioblastoma (GBM) in the second line, while also coveringFirst-line to third-line patients treated under single-patient INDs (spINDs)。As of January 22, 2026, the study has enrolled 23 patients with recurrent or progressive GBM who received standard treatments (including surgery, radiotherapy, and temozolomide chemotherapy), among which 19 are still alive. The primary endpoint of the study is overall survival (OS). As of the data update, the median overall survival has not been reached.Showing that the combination regimen releases positive signals in extending patient survival.Anktiva was first introduced in the U.S. in April 2024.Approved for marketing in China,For use in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)。As Close30The third immunotherapy cytokine drug for cancer approved in recent years,AnktivaRepresents an important breakthrough in the field of cytokine therapy.
In 2025, ANKTIVANet product revenue for the year in China was approximately $113 million,Up 700% year-over-year, achieving remarkable results. Currently, the drug is undergoing multiple clinical trials covering bladder cancer, lung cancer, glioblastoma, and more.
January 16, 2026ImmunityBio, Inc. announced that its original drugAnktiva®ObtainApproved for marketing by the Saudi Food and Drug Administration (SFDA), involving two indications:
1）In Combination with Immunotherapy, used forAdult patients with metastatic non-small cell lung cancer (NSCLC) who have failed prior standard therapy。
Notably, the indication is described as "Conditional Approval"Formal approval granted, but subsequent confirmatory clinical trials are still required to further validate its long-term efficacy. Notably,SFDA is the world's first regulatory agency to grant conditional approval to Anktiva for the NSCLC indication.。
2）In combination with BCG, used for treatmentHigh-risk, BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC, with Carcinoma In Situ, CIS)。
In terms of administration, Anktiva inSubcutaneous Injection Adopted in NSCLC Indication, and inIn NMIBC, local drug administration is performed through bladder instillation., reflecting differentiated medication strategies across different tumor types.
Progress of IL-15 Target
IL-15 is considered a promising target for tumor immunotherapy, and currently, only one IL-15 targeted drug has been approved by regulatory agencies worldwide.Anktiva，There are also multiple IL-15 targeted drugs under research, as shown in the table below.。
Among themNKTR-255Progressing rapidly, its clinical trial for the treatment of diffuse large B-cell lymphoma has entered the phase 2/3 stage. Among pharmaceutical companies in China,，Hengrui Medicine's SHR-1501、ASKG315 from Aosaikang, BJ-001 from Boji Bio,ZhiXiang JinTai's GR2301Equally noteworthy.In July last year, Zhi Xiang Jin Tai's IL-15 monoclonal antibody GR2301 injection was accepted for clinical trials by the CDE for the treatment of vitiligo, filling the gap in China for monoclonal antibodies targeting this point in the clinical stage.
Global Part of IL-15 Targeted Drugs in Development (Compiled by PharmaResearch Network | Data Source: New Drug Intelligence Database)
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