T-Cell Lymphoma Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "T-Cell Lymphoma Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the T-Cell Lymphoma market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging T-cell lymphoma drugs, the T-cell lymphoma pipeline analysis report provides a 360-degree view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The T-cell lymphoma market is rapidly evolving with targeted therapies and immuno-oncology agents spearheaded by companies like Astex Pharmaceuticals, Corvus Pharmaceuticals, ViGenCell Inc., Affimed GmbH, and MediSix Therapeutics. With increasing focus on antibody-drug conjugates, bispecific antibodies, and CAR-T cell therapies, these players are addressing unmet needs across subtypes such as PTCL and CTCL. The innovation surge is aimed at improving survival outcomes in relapsed or refractory settings, where traditional chemotherapies have shown limited success.

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Key Takeaways from the T-Cell Lymphoma Pipeline Report
• DelveInsight's T-cell lymphoma pipeline analysis depicts a robust space with 90+ active players working to develop 90+ pipeline drugs for T-cell lymphoma treatment.
• The leading T-cell lymphoma companies include Soligenix, CStone Pharmaceuticals, Genor Biopharma, Innate Pharma, ImmuneOncia Therapeutics, Astex Pharmaceuticals, Corvus Pharmaceuticals, ViGenCell Inc., Affimed GmbH, MediSix Therapeutics, Dialectic Therapeutics, Artiva Biotherapeutics, Inc., and others are evaluating their lead assets to improve the T-cell lymphoma treatment landscape.
• Key T-cell lymphoma pipeline therapies in various stages of development include SGX 301, Sugemalimab, Geptanolimab, Lacutamab, IMC-001, Tolinapant, CPI-818, VT-EBV-N, AFM-13, PCART3, DT2216, AB-101, and others.
• In April 2025, Shanghai Yingli Pharmaceutical Co., Ltd. received FDA clearance to begin a global Phase III study of linperlisib versus standard care for relapsed/refractory peripheral T-cell lymphoma (PTCL).
• In January 2025, March Biosciences announced that the FDA granted orphan drug designation to MB-105, a first-in-class CD5-targeted CAR-T cell therapy for relapsed/refractory CD5-positive T-cell lymphoma.
• In February 2024, Corvus Pharmaceuticals announced that the FDA granted Orphan Drug Designation for soquelitinib for the treatment of T-cell lymphoma.

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T-Cell Lymphoma Overview
T-cell lymphomas are a rare subtype of non-Hodgkin lymphomas that can develop in lymphoid tissues, such as lymph nodes and the spleen, or outside of these tissues, including the gastrointestinal tract, liver, nasal cavity, and skin. These lymphomas, more common in men and typically affecting individuals in their mid-60s, generally have a poorer prognosis than B-cell lymphomas. T-cell lymphomas may stem from mature or, less commonly, immature T cells, with the latter leading to T-cell lymphoblastic lymphoma, which often affects children and young adults. Symptoms vary depending on the lymphoma type and location but can include swollen lymph nodes, skin rashes, fatigue, loss of appetite, bone pain, and liver enlargement. Diagnosis typically requires biopsy and imaging such as PET/CT or MRI scans. Treatment depends on the lymphoma subtype and aggressiveness, with options like chemotherapy, monoclonal antibodies, targeted therapies, and radiotherapy.

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T-Cell Lymphoma Treatment Analysis: Drug Profile
SGX 301: Soligenix
SGX301 (HyBryteTM/synthetic hypericin) is an innovative, first-in-class photodynamic therapy that utilizes safe visible light for activation. It is a topical treatment in the form of a hypericin ointment activated by visible light, designed for patients with early-stage cutaneous T-cell lymphoma (CTCL). HyBryteTM has received Orphan Drug and Fast Track designations in the US, Orphan Drug designation in Europe, and Promising Innovative Medicine designation from the UK Health Authority. Soligenix has also submitted a new drug application (NDA) for HyBryteTM to the US FDA for the treatment of early-stage CTCL.

Sugemalimab: CStone Pharmaceuticals
Sugemalimab is an investigational anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals. As a fully human, full-length monoclonal antibody, sugemalimab mimics the natural G-type immunoglobulin 4 (IgG4), reducing the risk of immunogenicity and toxicities compared to similar drugs. In September 2022, China's National Medical Products Administration (NMPA) accepted the supplemental new drug application (sNDA) for sugemalimab, granting it priority review for the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL).

Key T-Cell Lymphoma Therapies and Companies
• SGX 301: Soligenix
• Sugemalimab: CStone Pharmaceuticals
• IMC-001: ImmuneOncia Therapeutics
• Tolinapant: Astex Pharmaceuticals
• CPI-818: Corvus Pharmaceuticals
• COPIKTRA (duvelisib): Secura Bio
• Linperlisib (YY-20394): Shanghai YingLi Pharmaceutical
• Golidocitinib (DZD4205): Dizal Pharmaceuticals
• Sugemalimab (CS1001): CStone Pharmaceuticals
• AFM13: Affimed
• Tolinapant (ASTX660): Otsuka Pharmaceutical/Astex Pharmaceuticals

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T-Cell Lymphoma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the T-Cell Lymphoma Pipeline Report
• Coverage: Global
• Key T-Cell Lymphoma Companies: Soligenix, CStone Pharmaceuticals, Genor Biopharma, Innate Pharma, ImmuneOncia Therapeutics, Astex Pharmaceuticals, Corvus Pharmaceuticals, ViGenCell Inc., Affimed GmbH, MediSix Therapeutics, Dialectic Therapeutics, Artiva Biotherapeutics, Inc., and others.
• Key T-Cell Lymphoma Pipeline Therapies: SGX 301, Sugemalimab, Geptanolimab, Lacutamab, IMC-001, Tolinapant, CPI-818, VT-EBV-N, AFM-13, PCART3, DT2216, AB-101, and others.

Dive deep into rich insights for drugs used for T-Cell Lymphoma treatment; visit @ https://www.delveinsight.com/sample-request/t-cell-lymphoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. T-Cell Lymphoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. T-Cell Lymphoma Pipeline Therapeutics
6. T-Cell Lymphoma Pipeline: Late-Stage Products (Phase III)
7. T-Cell Lymphoma Pipeline: Mid-Stage Products (Phase II)
8. T-Cell Lymphoma Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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