TIL cell therapy, also known as tumor-infiltrating lymphocyte therapy, is an innovative cancer treatment method. After years of research and practice, this technology has gradually matured, bringing new hope to patients with advanced cancer. Recently, several pharmaceutical companies have announced new progress in TIL cell therapy.
On March 10th, Huasaiberman announced that the launch meeting for the key Phase II clinical trial of Huasaiberman FAST-TIL (HS-IT101) for the treatment of advanced melanoma was successfully held in Beijing. As the company's core pipeline, FAST-TIL has been approved by the China Food and Drug Administration's Center for Drug Evaluation (CDE) in November 2025 to conduct key Phase II clinical trials for advanced melanoma. The successful completion of this launch meeting marks the official entry of FAST-TIL into a critical period of value transformation driven by confirmatory clinical data.
According to relevant sources, FAST-TIL is a new generation of TIL cell therapy product developed by Huasaiberman specifically for solid tumors, which breaks through the pain points of the traditional cell therapy industry. It has demonstrated excellent efficacy and safety in Phase I clinical trials: objective response rate (ORR) of 50%, complete response rate (CRR) of 20%, disease control rate (DCR) of 100%, with multiple patients achieving sustained deep remissions.
The autologous natural tumor-infiltrating lymphocyte injection (application number CXSL2600265) submitted by Junsaibio has recently been clinically accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, becoming the first new TIL cell therapy drug to be accepted domestically this year.
It is reported that the highlight of the TIL cell therapy declared by JUNSAI Biologics lies in its natural property, which eliminates the need for gene editing of immune cells and directly utilizes the naturally occurring TIL cells in the patient's own tumor. Relying on its proprietary DeepTIL™ cell enrichment and expansion technology platform, it has achieved multiple technological breakthroughs: the success rate of cell culture exceeds 95%, and patients can receive treatment in general wards without the need for high-dose chemotherapy lymphodepletion and IL-2 injection. This not only reduces the potential risks of genetic modification but also enhances the cell's ability to recognize tumors more accurately, significantly improving the safety and accessibility of treatment. It has demonstrated potential in the treatment of refractory solid tumors such as lung cancer, melanoma, and even pancreatic cancer.
In addition, at the ASCO Annual Meeting in 2025, Blue Horse Medical also announced the Phase I clinical data of its self-developed LM103 TIL therapy in advanced melanoma. A total of 12 patients with evaluable efficacy were included in this study. The results showed that the objective response rate (ORR) in the recommended dose group reached an encouraging 50%. This means that the tumors of half of the patients had significantly shrunk. More notably, the disease control rate (DCR) in a specific dose subgroup had reached 100%, and the median progression-free survival (PFS) had not yet been reached, but the observed longest PFS had exceeded 12 months, and the overall survival (OS) was expected to be significantly improved.
In recent years, TIL therapy has emerged as a highly anticipated cutting-edge anti-cancer technology. Unlike CAR-T therapy, which requires genetic modification, its principle is more closely aligned with the body's own immune mechanism. Looking ahead, as more and more domestic pharmaceutical companies invest in TIL therapy, it is expected to move from the laboratory to the clinic, becoming a new line of defense for more cancer patients.