Follicular Lymphoma Pipeline 2025

Follicular Lymphoma Pipeline 2025: In-Depth Analysis of Mechanisms of Action, Routes of Administration, and Clinical Trial Progress | DelveInsight

(Las Vegas, Nevada, United States) According to DelveInsight’s latest assessment, the global follicular lymphoma (FL) pipeline features 45+ leading pharmaceutical and biotechnology companies actively developing 50+ therapeutic candidates. The analysis provides a comprehensive evaluation of ongoing clinical trials, therapeutic approaches, mechanisms of action, routes of administration, and recent developmental milestones shaping the follicular lymphoma treatment landscape.

The “Follicular Lymphoma Pipeline Insight, 2025” report by DelveInsight delivers a detailed overview of the current clinical development environment and future growth potential across the global follicular lymphoma market.

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This pipeline report offers an in-depth commercial and clinical assessment of investigational therapies ranging from preclinical and early-stage development to late-stage and marketed products. Each therapy is profiled with detailed insights into its mechanism of action, clinical trial status, regulatory approvals (where applicable), and product development activities, including technological platforms, collaborations, licensing agreements, mergers and acquisitions, funding activities, and special regulatory designations.

Key Highlights from the Follicular Lymphoma Pipeline Report

• Pharmaceutical and biotechnology companies worldwide continue to advance innovative follicular lymphoma therapies, achieving notable clinical progress over recent years.
• Key companies actively developing FL therapies include InnoCare Pharma, Allogene Therapeutics, HUTCHMED, Sound Biologics, Xynomic Pharmaceuticals, ADC Therapeutics, AstraZeneca, Dr. Reddy’s Laboratories, MAB WORKS, among others.
• Prominent pipeline candidates across various stages of development include ICP 248, ALLO-501, HMPL-689, PSB 202, Abexinostat, Loncastuximab tesirine, Acalabrutinib, DRL_RI, and MIL62, all of which are expected to significantly influence the follicular lymphoma treatment landscape in the coming years.

DelveInsight’s analysis highlights Japan as a key Asia–Pacific hub for follicular lymphoma clinical development, with domestic and regionally affiliated companies actively sponsoring Phase 1–3 studies. In contrast, Korean and Taiwanese companies currently have limited sponsor-led clinical activity in FL, with participation primarily occurring through multinational trials sponsored by global pharmaceutical players.

Further Follicular Lymphoma product details are provided in the report. Download the Follicular Lymphoma pipeline report to learn more about the emerging Follicular Lymphoma therapies

• Chugai Pharmaceutical 
  • Drug Candidate: Mosunetuzumab (LUNSUMIO®)
  • MOA: CD20 × CD3 bispecific antibody that redirects T cells to eliminate malignant B cells
  • Clinical Development: Phase I expansion studies (FLMOON-1; jRCT2080223801) in relapsed/refractory FL demonstrated high complete response rates and a manageable safety profile
  • Regulatory Status: Approved in Japan for relapsed/refractory follicular lymphoma after ≥2 prior therapies
• AbbVie G.K. / Genmab (Japan co-sponsorship)
  • Drug Candidate: Epcoritamab (EPKINLY®)
  • MOA: Subcutaneous CD20 × CD3 T-cell–engaging bispecific antibody
  • Clinical Development: Phase 1/2 and Phase 3 EPCORE FL-1 trial (jRCT2021230024) evaluating epcoritamab in combination with rituximab and lenalidomide versus R² alone
  • Regulatory Status: Approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for relapsed/refractory FL (Grades 1–3A), becoming the first subcutaneous bispecific antibody approved for FL in Japan
•  While Korea serves as a clinical trial site for several global follicular lymphoma studies, no Korean biopharmaceutical company is currently sponsoring or co-sponsoring a dedicated FL therapy in Phase 1–3 development.
•  Taiwanese biotechnology companies remain active in oncology; however, no sponsor-led follicular lymphoma clinical programs have been identified in Phase 1–3 trials as of the current assessment period.

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Follicular Lymphoma Recent Regulatory and Clinical Developments

• June 2025: The U.S. FDA approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for relapsed or refractory FL, based on the Phase III inMIND trial (NCT04680052) involving 548 patients.

• March 2025: The European Commission approved lisocabtagene maraleucel (Breyanzi), a CD19-directed CAR T-cell therapy, for adult patients with relapsed or refractory FL after at least two prior systemic therapies.

• February 2025: Japan’s MHLW approved EPKINLY® (epcoritamab) for relapsed or refractory FL (Grades 1–3A).

• December 2024: At ASH 2024, AstraZeneca presented interim first-in-human data for AZD0486, a novel bispecific T-cell engager, in relapsed or refractory FL.

• August 2024: Favorable Phase III data supported plans to submit a supplemental BLA for tafasitamab in FL.

• June 2024: A consortium led by Eugene Private Equity and Korea Development Bank Private Equity announced plans to acquire an 80% stake in Boryung Biopharma for approximately ~USD 231 million.

Follicular Lymphoma Overview

Follicular lymphoma is an indolent form of non-Hodgkin lymphoma originating from B lymphocytes. It primarily affects lymph nodes but may also involve the bone marrow and spleen. Common clinical manifestations include painless lymphadenopathy, fatigue, and night sweats. While generally not curable, follicular lymphoma can often be managed long term using immunotherapies, chemotherapies, and targeted agents.

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Follicular Lymphoma - Epidemiology Forecast - 2034

DelveInsight’s “Follicular lymphoma – Epidemiology Forecast – 2034” report delivers an in-depth understanding of Follicular Lymphoma, historical and forecasted epidemiology in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Follicular Lymphoma - Pipeline Insight, 2025

DelveInsight’s, “Follicular Lymphoma - Pipeline Insight, 2025” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Follicular Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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