Chinese Biopharma Advances: Multiple Breakthroughs in TIL Cell Therapy for Solid Tumors

　　【Pharmaceutical Network Industry DynamicsTIL Cell Therapy, or Tumor Infiltrating Lymphocyte Therapy, is an innovative cancer treatment method. After years of research and practice, this technology has gradually matured and will bring new hope to patients with advanced cancer. Recently, several pharmaceutical companies have announced new progress in TIL cell therapy.
 

Sino-cell Biomed announced on March 10 that the kick-off meeting for the pivotal Phase II clinical trial of FAST-TIL (HS-IT101) in the treatment of advanced melanoma was successfully held in Beijing. As a core pipeline product, FAST-TIL received approval from the CDE of the National Medical Products Administration in November 2025 to conduct the pivotal Phase II clinical trial for advanced melanoma. The successful completion of this kick-off meeting marks that FAST-TIL has officially entered a critical period driven by confirmatory clinical trials to realize value transformation.
 

According to relevant sources, FAST-TIL is a next-generation TIL cell therapy product developed by Sino-cell Biomed for solid tumors, addressing 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) 50%, Complete Response Rate (CRR) 20%, Disease Control Rate (DCR) 100%, with several patients achieving sustained deep remission.
 

Juncell Therapeutics' autologous natural tumor-infiltrating lymphocyte injection (acceptance number CXSL2600265) has recently been accepted for clinical review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, becoming the TIL cell therapy new drug accepted in China this year.
 

It is reported that the highlight of the TIL cell therapy submitted by Juncell Therapeutics this time lies in its natural attributes. It does not require genetic editing of immune cells and directly utilizes the naturally occurring TIL cells from the patient's own tumor. Relying on its self-developed DeepTIL™ cell enrichment and expansion technology platform, it has achieved multiple technical breakthroughs: a cell culture success rate exceeding 95%, allowing patients to receive treatment in ordinary wards without high-dose chemotherapy or IL-2 injections. This approach not only reduces the potential risks of genetic modification but also enhances the accuracy of cell recognition of tumors, significantly improving the safety and accessibility of the treatment. It has demonstrated potential in treating difficult solid tumors such as lung cancer, melanoma, and even pancreatic cancer.
 

In addition, at the 2025 ASCO Annual Meeting, Suzhou Lanma Medical Technology Co., Ltd. also announced the Phase I clinical data of its self-developed LM103 TIL therapy in advanced melanoma. This study enrolled a total of 12 evaluable patients. The results showed that the objective response rate (ORR) in the recommended dose group reached an encouraging 50%. This means that half of the patients experienced significant tumor shrinkage. More notably, the disease control rate (DCR) in a specific dose subgroup has reached 100%, with the median progression-free survival (PFS) not yet reached, but the longest observed PFS has exceeded 12 months, and the overall survival (OS) is expected to improve significantly.
 

In recent years, TIL therapy has become a highly regarded anti-cancer breakthrough technology. Unlike CAR-T therapy, which requires genetic modification, its mechanism is closer to the body's own immune system. Looking ahead, as more pharmaceutical companies in China invest in TIL therapy, it is expected to move from the laboratory to clinical applications, becoming a new line of defense for more cancer patients.
 

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