mufemilast (Hemay005) / Ganzhou Hemay Pharmaceutical - LARVOL DELTA

MUFEMILAST (ORAL PDE4B SELECTIVE EXPRESSION INHIBITOR) FOR ULCERATIVE COLITIS: OPEN-LABEL EXTENSION RESULTS AT 24 WEEKS FROM A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP INDUCTION PHASE II CLINICAL TRIAL (UEGW 2026) - P2 | "The data support mufemilast as a viable treatment option for patients with moderate-to-severe UC, regardless of prior biologic use. Efficacy was maintained to week 24, with remission rates increasing in placebo and 45mg switched subjects. Mufemilast was well tolerated."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Plaque Psoriasis • Psoriasis • Ulcerative Colitis

PALI-2108, a Next-Generation Oral PDE4 Inhibitor Prodrug, Demonstrates Localized Ileocolonic Exposure With Favorable Tolerability in IBD (ACG 2026) - "PK was consistent with delayed enteric release followed by localized ileocolonic bioactivation to PALI-0008, with delayed Tmax and prolonged exposure. Sustained colonic tissue concentrations were achieved while systemic Cmax remained attenuated. In FSCD patients, PK demonstrated favorable steady-state tissue:plasma ratios (Fig."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Behçet disease (EADV 2026) - "In addition to conventional immunomodulatory and immunosuppressive therapies, evidence now supports the efficacy of several biologic agents, particularly TNF-α inhibitors, as well as IL-17 and IL-12/23 inhibitors. Emerging therapeutic approaches with promising results include novel phosphodiesterase-4 inhibitors; roflumilast and mufemilast, Janus kinase inhibitor upadacitinib, IL-1 inhibitors, and low-dose interleukin-2."

Genetic Disorders • Hematological Malignancies • Inflammation • Myelodysplastic Syndrome • Rare Diseases • Vasculitis • IL12A • IL17A • RELA

Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Mufemilast Improves Clinical Remission Rates Among Patients With Moderate to Severe Ulcerative Colitis (DocWire) - "These data were first presented by Laurent Peyrin-Biroulet, MD, McGill University Health Centre, at Digestive Disease Week 2026, in Chicago, Illinois...At week 24, there was improvement in the clinical remission rate among patients who switched from placebo to mufemilast 60 mg (13% to 75%), and those who switched from mufemilast 40 mg to 60 mg (39% to 62%). Of those patients originally randomly assigned to receive mufemilast 60 mg, 25 remained on treatment at 24 weeks with a clinical remission rate of 52%. There was also an increase in the rate of endoscopic improvement among patients who switched from placebo to mufemilast 60 mg (16% to 75%), and (42% to 66%)....'These findings support the initiation of a phase 3 trial in patients with moderate to severe UC.'"

New P3 trial • P2 data • Ulcerative Colitis

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and safety of mufemilast in patients with Behçet's syndrome: a phase 2 randomised clinical trial. (PubMed, Ann Rheum Dis) - P2 | "Among patients with oral ulcers associated with BS, mufemilast significantly reduced the number of oral ulcers, improved pain scores, and induced significantly more ulcer-free remissions compared with placebo, with an acceptable safety profile."

Journal • P2 data • Pain • Rare Diseases

Safety, Tolerability, and Pharmacokinetics of Mufemilast, a PDE4 Inhibitor, in Healthy Participants: A First-in-Human Phase 1 Study. (PubMed, Clin Pharmacol Drug Dev) - "PK analysis revealed that mufemilast exhibited linear PK characteristics. These results support the further evaluation of its efficacy."

Clinical • First-in-human • Journal • P1 data • PK/PD data • Inflammation

A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

Biomarker • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluation the Safety of hemay005 Tablets (clinicaltrials.gov) - P1 | N=468 | Completed | Sponsor: Anhui Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025 | Trial primary completion date: Sep 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • Renal Disease

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jan 2025

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

ORAL MUFEMILAST (A NOVEL SELECTIVE PDE4INHIBITOR) DEMONSTRATES EFFICACY AND SAFETY IN A PHASE II MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION TRIAL IN CHINESE PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (UEGW 2025) - P2 | "Mufemilast efficacy and safety were consistent across subgroups regardless of previous biologic use, suggesting Mufemilast is a viable potential future treatment option in patients with moderate to severe UC that breaks through the current 20% ceiling for clinical remission. A phase 3 study will be conducted to confirm these results."

Clinical • Late-breaking abstract • P2 data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis • IL12A

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease (clinicaltrials.gov) - P3 | N=162 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Mar 2025 ➔ Jun 2026 | Trial primary completion date: Nov 2024 ➔ May 2026

Trial completion date • Trial primary completion date • Rare Diseases

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Evaluation the Safety of hemay005 Tablets (clinicaltrials.gov) - P1 | N=468 | Recruiting | Sponsor: Anhui Hemay Pharmaceutical Co., Ltd

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • Renal Disease

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Bioequivalence Test of Hemay005 Tablets (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed | Trial primary completion date: Dec 2024 ➔ Sep 2024

Trial completion • Trial primary completion date • Dermatology • Immunology • Psoriasis

Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology. (PubMed, Pharmaceutics) - "Apremilast was the first PDE4 inhibitor approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for psoriasis, psoriatic arthritis, and oral ulcers of Behcet's disease. New oral PDE4 inhibitors are being developed, such as orismilast (LEO-32731), mufemilast (Hemay005), difamilast (OPA-15406) or lotamilast (E6005/RVT-501), among others. This narrative review provides a comprehensive synthesis of the pharmacology, clinical efficacy, safety profile, and practical considerations regarding the oral and topical use of PDE4 inhibitors in dermatology."

Journal • Review • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dental Disorders • Dermatitis • Dermatology • Dermatopathology • Discoid Lupus Erythematosus • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Lichen Planus • Lupus • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Sarcoidosis • Seborrheic Dermatitis • Seronegative Spondyloarthropathies • Stomatitis

Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

Bioequivalence Test of Hemay005 Tablets (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis • Renal Disease

To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis