JunSai Bio's TIL Therapy GC101 Becomes First Solid Tumor Cell Therapy to Be Featured in ASCO LBA with Pivotal Phase II Data

Next week,The Highest-Level Global Oncology Event —— American Society of Clinical Oncology (ASCO) WillPublish2026Annual Meeting Report Content.

Juncell Therapeutics independently developedGC101（Nolgileucel, Nuoji Lun Sai), asWorld's First Product Without Intensive Lymphodepletion Chemotherapy、WithoutIL-2Drug AdministrationTheTILCell Therapy, with its key to treating advanced melanomaIIPhase Clinical Study (MIZAR-003) Excellent data, selectedASCO 2026Annual MeetingLatest Breakthrough Abstract（Late-Breaking Abstract, LBA）and was invited to give an oral presentation, which will take place at the local time in Chicago.6Month1DayGlobal First Release of Efficacy and Safety Data。

ASCO LBA Heavyweight Study Value

Original Research Strength Recognized by International Top Authorities

LBAOnly accept changes in clinical practice (practice-changing) Clinical data, requirementsII/IIIExpected to reach hard endpoints, that is,Reached Pre-set Primary Endpoint、Statistically Significant、Must be randomized controlled, andWith better efficacy than existing treatments and addressing unmet clinical needs, is a highly valuable and authoritative certification.

This TimeGC101 TILKeyIIPhase Clinical SelectionASCO LBAHeavyweight Research,Not only this yearASCO 63ItemLBAIn ChinaThe only cell therapy clinical research, alsoASCOThe First in History to Be SelectedLBAClinical research on实体瘤细胞治疗, Juncell Therapeutics has开创了实体瘤细胞治疗的历史.

This is a milestone in China's cell therapy field and a watershed moment for global cell therapy—Chinese innovative drug companies are increasingly occupying an important position in the global cell therapy competitive landscape with their original superior technology and hardcore clinical data.。

ASCO LBA Endorsement

Three Pillars Accelerate the Commercialization Process of GC101

The data to be announced this timeMIZAR-003The study is an open-label, randomized controlled, multi-center pivotal trial in China.IIPhase clinical trial, by Deputy Dean of Peking University Cancer Hospital, Director of the Department of Melanoma and Sarcoma Medicine, Director of the Department of Urological Oncology MedicineLed by Professor Guo Jun, carried out in 25 top-tier cancer centers across China`, aiming to`ConfirmationGC101Used forPD-1Efficacy and Safety in Advanced Late-line Melanoma Patients with Antibody Therapy Failure。

Although melanoma is a rare type of cancer in China, the demand for treatment is extremely urgent. Unlike in Europe and America, acral and mucosal melanomas are the predominant subtypes in China and East Asia, with targeted therapies and immune checkpoint inhibitors (ICI) The proportion and degree of benefit in treatment are significantly inferior to those of the cutaneous type, and the treatment difficulty is high. This selectionLBA, meansGC101 TILA significant breakthrough has been achieved in this refractory tumor, and its clinical efficacy is highly anticipated.

Currently the world's only approvedTILThe therapy is from the United States.IovanceCompanyDevelopedAmtagvi®(lifileucel)`, for treatment`PD-1Advanced Melanoma with Failed Antibody Therapy. Despite theTILThe therapy can bring deep and lasting clinical benefits to patients, but it must be combined with high-intensity lymphodepletion chemotherapy and high doses.IL-2Repeated injections triggered numerous adverse reactions, beingFDAGiven the black box warning, there are more restrictions in clinical application. In contrast,GC101Without high-intensity lymphodepletion chemotherapy, withoutIL-2Administration,Significantly improved safety gives patients peace of mind and makes healthcare providers' jobs easier.

In terms of accessibility, compared with conventionalTILTherapy,GC101Optimized clinical protocols can benefit more patients.No Longer DependentICU, which can cover more hospitals, meaning thatInnovationTILTreatment no longer relies on high-specification special medical care, significantly reducing the clinical use threshold and medical resource occupation, which will provide security assurance for large-scale commercial implementation.

InTILCell Preparation Level, with a total area exceeding16000Square meters ofJuncell Therapeutics New QualityTILCell Industrialization BaseAlready in use.It is reported that,Juncell Therapeutics has already2Month obtainedThe First in ChinaTILManufacturing License for Cellular Medicines。Prior to this, Juncell Therapeutics also led the formulation of the first in China...TILIndustry standards, continuously providing high-quality services/products for patientsTILProducts, and lead the high-quality development of the industry.

This timeASCO LBAThe selection is a true reflection of Juncell Therapeutics' team persistence in doing "difficult but right things," continuously breaking through barriers and utilizing original breakthroughs in foundational technology to unlock the high value of potentially curative therapies.TILMedicines Become“"Safer, more effective, and more accessible" to benefit more cancer patients; leveraging the dividends of engineering innovation to steadily advance the industry towards a more universal industrialization direction, allowing the once out-of-reach dream of solid tumor cell therapy to gradually become a reality.

Deep Cultivation in the Long Slope Track with Accumulated Snow

TIL Leads the Industrialization Wave of Solid Tumor Immunotherapy

Globally, there remains a significant unmet clinical need for solid tumors, withPD-(L)1Antibody-based immunotherapy has reshaped the treatment landscape for solid tumors, becoming one of the most promising long-term mainstays in global biopharmaceutical innovation. The market size for solid tumor immunotherapy in China has reached the billion-dollar level, and the industry is expected to maintain a high compound growth rate over the next five years, with a clear and robust growth trajectory.

Looking at the various technical pathways in cell therapy,CAR-T Focus on Hematologic Tumors,TCR-T Deep Cultivation of Intracellular Antigens,NK Cells emphasize safety and broad-spectrum; and TIL With no fixed target limitations, natural tumor specificity and polyclonal composition, excellent tumor homing ability and in vivo adaptive capacity, adaptable to multiple tumor types and compatible with different disease stages, integrating the advantages of traditional and emerging therapies, it possesses the typical characteristics of a long-term valuable track.

TIL The track possesses three core traits: First, it covers a wide range of indications with significant clinical potential, and cutting-edge clinical data has already validated its efficacy and safety value across more than ten types of solid tumors; Second, it features high technical barriers, spanning tumor specificity.TMultiple core processes such as cell enrichment, reversal of exhaustion state, large-scale expansion, and standardized production technology are not challenges that can be overcome by simple process development; thirdly, the product lifecycle is long, global commercial supply is still in its early stages, and a differentiated technology platform with comprehensive patent coverage will build a formidable technological moat that is difficult to replicate.

In the face of the urgent need for a breakthrough in solid tumor cell therapy, cell therapy2.0As the times call for it, Juncell Therapeutics is not the lone breakthrough. In the future, an increasing number of Chinese cell therapy companies will achieve success.First-in-ClassBreakthroughs, multiple products entering pivotal clinical trials, achieving the successful commercialization of cell therapies for solid tumors with unstoppable momentum, and setting Chinese standards through globally leading academic outputs.

The Future is Now: The Rise of China's Strength in Cell Therapy.

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