Clinical Data Reaffirms Therapeutic Potential as Seven Chinese TIL Therapy Companies Advance Development Pipelines
HUASAIBIO
Developer of Stem Cell Therapy Products
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
November 4, 2025
eMedClub News
In China, there are already marketed products in the CAR-T and stem cell sectors. The progress of cell therapies such as TIL, TCR-T, and NK — important components of the overall cell therapy landscape — continues to attract significant industry attention. Globally, TIL therapies already have marketed products, while in China, more than 10 companies are actively involved in this space. Some enterprises have advanced their candidate pipelines to critical clinical stages, raising hopes for new breakthroughs in the near future. This article summarizes the key recent pipeline advancements of some companies in China.(Ranking不分先后)。
Sino-cell Biomed
In October this year, Sino-cell Biomed unveiled FAST-TIL globally for the first time at the ESMO conference.（HS-IT101）Phase I Clinical Trial Data of Melanoma. FAST-TIL has achieved breakthrough innovations addressing the pain points of traditional TIL, featuring lower dependency on IL-2, reduced demand for tumor tissue, shorter production time, and more.
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The data released this time shows: As of October 2025,Four out of 10 subjects with advanced melanoma achieved confirmed disease relief.（1CR、3PR）, ORR reached 40%, DCR reached 100%; Median follow-up was 5 months, mPFS not reached. In addition, most patients achieved deep disease remission, with lesions continuously shrinking during the follow-up period after cell infusion.(More than 1 year at the longest), with overall good safety.
Currently, FAST-TIL（HS-IT101）Melanoma treatment is about to enter the pivotal Phase II clinical trial stage for advanced melanoma treatment. Meanwhile, Sino-cell Biomed is accelerating exploration in TIL clinical trials for non-small cell lung cancer, head and neck tumors, and other highly prevalent cancer types in China.
Juncell Therapeutics
GC101 is in a pivotal Phase II clinical trial.The world's first product that requires no lymphodepletion and no IL-2 injectionNatural TIL therapy. In September this year, Juncell Therapeutics announced a case of a Stage IV endometrial cancer patient who, two months after receiving a single infusion treatment of GC101 TIL,The tumor lesion completely disappeared, achieving CR, and as of the publication, the patient has been disease-free for over 4 years.。
In July, Juncell Therapeutics announced the pivotal Phase II clinical trial of GC101 TIL for malignant melanoma.(MIZAR-003 Project)There are multiple cases where subjects have achieved good efficacy. One subject completed the TIL cell infusion in June this year, and the first efficacy evaluation conducted six weeks after the infusion.Overall target lesion reduction reached 31.9%, with the largest single lesion of 62 mm shrinking by nearly 40%., with an overall efficacy reaching PR.
Gravel Biotech
In September, Grail Biotechnology announced that its joint research with Tianze Cloud Technologies was published in the journal Molecular Therapy under the title "High-Fidelity AaCas12bMAX Enables the Development of an Engineered T Cell Therapy with Enhanced Safety and Functional Fitness," based on their independently developed and validated gene knockout system, KOReTIL.® And Tianzeyuntai's high-fidelity gene editing tool, established a set of sgRNA screening and validation processes, and verified the safety and functionality of this gene editing tool in editing TIL therapy.
In May this year, Juncell Therapeutics presented data on three TIL therapies at the ASCO Annual Meeting, including preliminary efficacy data of GT101 in cervical cancer patients, clinical efficacy data of the next-generation GT201 expressing membrane-bound IL-15 in advanced solid tumor patients, and early clinical data of CRISPR/Cas12b gene-edited GT300 in cold tumors.
The Phase I clinical results of GT101 showed that: among 11 patients with recurrent or metastatic cervical cancer, it achievedORR of 45.5%, DCR reaches 90.9%In the early clinical trial of GT201 for patients with advanced solid tumors who failed multiple lines of treatment,Nine evaluable patients achieved an ORR of 55.6% and a DCR of 77.8%.GT300 is the first CRISPR gene-edited TIL therapy applied in clinical practice.The ORR for 5 patients with gynecological malignant tumors was 60%., with overall good safety.
Blue Horse Medical
In October this year, Lanma Medical received the final round of feedback from NMPA.LM103 Injection, a Self-developed TIL Therapy, Enters Pivotal Clinical ResearchThis is a TIL therapy for the single-agent treatment of malignant melanoma, which has entered the pivotal Phase II trial without the need to be combined with anti-tumor drugs such as PD1.
At the 2025 ASCO Annual Meeting, Professor Guo Jun's team from Peking University Cancer Hospital reported the Phase I clinical study results of LM103: As of April 2025, among 12 evaluable melanoma patients,ORR was 41.7%, DCR reached 83.3%, where the ORR of the recommended dose group reached 50%, and the DCR of a specific dose subgroup reached 100%.
Baiji Bio
BST02 is the world's first TIL therapy for liver cancer developed by Juncell Therapeutics, characterized by its ability to be cryopreserved and not requiring high-dose IL-2. In March this year, BST02 made progress in a Phase I clinical trial targeting advanced liver cancer patients who had failed at least one line of systemic treatment and had no other effective treatment options.A subject achieved complete regression of target lesions 18 weeks after receiving BST02 injection.。
At the AACR Annual Meeting this April, Juncell Therapeutics presented two research findings in a poster session, one of which was "the world's first gene-edited CAR-TIL for liver cancer." The research team developed TILs co-expressing CAR and a membrane-bound protein structure, enabling TILs to target hepatocellular carcinoma.（HCC）The glycoprotein GPC3 on the cell surface, and enhanced the targeting and in vivo expansion capability of TILs for tumor cells without relying on IL-2 co-administration, representing an innovative exploration of TILs.
Carti Healthcare
This September, "CELL》Sub-issue《Cell Reports Medicine》published a proof-of-concept clinical study, in humansFor the first timeIsolating TIL-like cells from peripheral blood for genetic modification and validating their clinical efficacy on biliary tract tumors. Sino-cell Biomed provides ScTIL cell preparation and corresponding technology.
ScTIL Has Three Major Innovative Advantages: The Effective Overcoming of Heterogeneity by Sorted TIL Cells; The Use of a "Enhanced Receptor" Gene Modification to Address Microenvironment Challenges; The Use of CAR Gene Modification Targeting CD19 to Achieve ScTIL Expansion In Vivo. Moreover, No Chemotherapy Lymphodepletion or IL-2 Is Required.
Research data shows,Compared with the control group, the DCR of the treatment group was 100% and 0%, respectively, with a median overall survival.（mOS）18.3 months and 3.2 months, respectively. This study preliminarily verified the scientificity and feasibility of the ScTIL technology route, while further confirmatory studies with larger sample sizes are still needed.
CircuLife Medicine
Shengxun Medicine's main R&D pipelines are Re-TIL tumor cell immunotherapy and HPV therapeutic nucleic acid vaccines. In July this year, Shengxun Medicine's official website published an article stating that "Tumor-Infiltrating Lymphocytes（TIL）The release ceremony of the "Guidelines for Preparation and Quality Control of Formulations" and the key technology training course for tumor-infiltrating lymphocytes were successfully held. Sino-cell Biomed was one of the two companies involved in drafting the guidelines.
Summary
In addition, there are several companies in the TIL field actively advancing, and this article will not list them one by one. Overall, compared to before, the significant breakthrough for TIL cell therapy in China lies inProgress in Clinical Trials and Disclosure of Clinical DataIn terms of clinical progress, the faster companies have already advanced to the pivotal Phase II clinical trials, which is a milestone for the field; in terms of clinical data disclosure, an increasing number of companies have disclosed the desired treatment data, verifying the efficacy and safety of TIL therapy. Moreover, many companies have implemented optimized designs in the development of TIL therapy, making it more promising compared to traditional TIL therapy.
Editor-in-Chief: Xun
Proofread by Xun
References:
1.Official Websites of Various Enterprises
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