CGT Therapies Accelerate Into New Blue Ocean: Diversifying Beyond Oncology into Autoimmune, CNS, and Chronic Diseases
Fosun Kairos
Developer of Tumor Immune Cell Therapy Technologies and Products
Rui Therapeutics
A New Generation of Cell-Based Drug Developer
UniXell
Cell Therapy Drug Developer
April 28, 2026
eMedClub News
According to incomplete statistics from the CDE official website and publicly available data, from March 30 to April 26, over 50 Class 1 innovative drugs received clinical implied approval for IND, of which nearly 20 were CGT therapies, covering CAR-T/NK, stem cells, small nucleic acids, gene therapies, etc., accelerating cross-border expansion into non-oncology "new blue oceans" such as autoimmune diseases, neurological disorders, and chronic disease management.
The following are representative CGT therapies approved for clinical use.(In no particular order)
Fosun Kite:
BCMA/CD19 CAR-T
FKC289, developed by Fosun Kite Biotechnology Co., Ltd., is a dual-target autologous CAR-T targeting BCMA/CD19. It has been approved for clinical trials by the CDE and is intended for the development of treatments for relapsed/refractory primary membranous nephropathy and relapsed/refractory primary light chain amyloidosis. Its dual-target design aims to achieve deep clearance of pathogenic plasma cells and B cells through dual targeting of BCMA and CD19, effectively intervening in plasma cell disorders and B cell-mediated autoimmune diseases.
In April 2026, the pivotal clinical research findings of FKC289 were published in the prestigious international nephrology journal, the Journal of the American Society of Nephrology. The studyFor the first timeDual-target CAR-T therapy with both anti-BCMA and anti-CD19 activity was applied in patients with relapsed/refractory AL amyloidosis. The results showed that all six patients achieved100% Complete Hematological Remission and 100% Renal Response Rate。
Rui Therapeutics:
CD19-Targeted Universal CAR-NK
Rui Therapeutics' Targeted CD19 Universal CAR-NK KN5501 Approved for Clinical Trials, Adding Three New Autoimmune Disease Indications: Primary Sjögren's Syndrome, Systemic Sclerosis, and Refractory Lupus Nephritis, to the Already Approved Systemic Lupus Erythematosus Indication.
KN5501 achieves deep remission or even complete remission of the disease by precisely identifying and thoroughly eliminating CD19-positive B cells in patients, blocking abnormal immune responses, and simultaneously inducing the reconstruction of the patient's immune system. Notably, relying on the company's unique...HTAS-RV™ Delivery SystemAndCAR-NK Cell Expansion and CryopreservationTechnology has achieved core breakthroughs in "generalization" and "off-the-shelf" capabilities.
UniXelI BIOTECHNOLOGY:
iPSC-Derived Neural Cell Therapy
UniXelI BIOTECHNOLOGY's UX-GIP001 Injection Approved for Clinical Trials, Aiming to Develop Treatment for Drug-Resistant Unilateral Mesial Temporal Lobe EpilepsyThe World's FirstiPSC cell therapy candidate for epilepsy treatment, achieving dual IND approval in China and the US. As of that time, Neurona was the only company globally to develop a therapy based on human embryonic stem cells.（ESC）Epilepsy cell therapy enters clinical stage.
UX-GIP001 Targets the Core Pathology of Epilepsy —— Functional Loss of Inhibitory GABAergic Interneurons in the Brain, by Directing the Differentiation of iPSCs into Functional Inhibitory Neural Progenitor Cells, Achieves Repair of Neural Circuits and Functional Reconstruction in the Brain, Breaks Through the Limitations of Traditional Symptomatic Treatment, and Pioneers a New Model of Disease-Modifying Therapy.
Starna Therapeutics:
LNP Delivery of mRNA
Xinghe DICE DSL201 Injection Approved for Clinical Trials, Intended Indication for Moderate to Severe Glabellar Lines. Reportedly, this isThe World's FirstAn innovative candidate drug based on mRNA encoding botulinum toxin type A protein.
The active ingredient of DSL201 Injection is mRNA-encoded Type A Botulinum Toxin. Through the targeted delivery system jointly developed by the company's unique local expression platform DScSLOTH and low immunogenicity platform DScBISON, the drug achieves precise and efficient expression at the injection site while demonstrating excellent safety. Preclinical studies have fully confirmed that this mRNA-LNP candidate drug exhibits good safety and long-lasting effects, offering promising new treatment options for those seeking aesthetic improvements.
Ruihongdi Pharmaceuticals:
LNP Delivery of mRNA
Ruihongdi Pharmaceutical's mRNA candidate drug RGL-236 for injection has been approved for clinical trials, intended for the treatment of osteoarthritis, marking another significant breakthrough for the company in the field of LNP-mRNA local delivery and regenerative repair.
RGL-236 utilizes the company's self-developed LNP delivery system, administering the drug via intra-articular injection to efficiently deliver mRNA encoding optimized proteins to target cells within the joint cavity for expression. The expressed target protein promotes the synthesis of type II collagen, thereby achieving the repair and regeneration of hyaline cartilage tissue and reconstructing the joint platform affected by osteoarthritis.
RGL-236 Expected to Become the World's First Osteoarthritis Drug（DMOAD）Type of drugs, while the number of patients with this disease globally is expected to increase to 2025.1.1016 billion。
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