Delving into the Latest Updates on Mufemilast with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HEMAY 005, HEMAY-005, HEMAY005

Target

PDE4 x PDE4B

Action

inhibitors

Mechanism

PDE4 inhibitors(Phosphodieterase 4 inhibitors), PDE4B inhibitors(Phosphodiesterase 4B inhibitors)

Therapeutic Areas

Immune System DiseasesCardiovascular DiseasesCongenital Disorders+ [7]

Active Indication

Plaque psoriasisBehcet SyndromeBronchitis, Chronic+ [5]

Inactive Indication-

Originator Organization

Tianjin Hemei Biological Technology Co.,Ltd.

Active Organization

Ganzhou Hemei Pharmaceutical Co LtdTianjin Hemei Biological Technology Co.,Ltd.

Inactive Organization

Hainan Hailing Chemipharma Corp. Ltd.

Tianjin Hemay Pharmaceutical Technology Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (30 Sep 2025),

Plaque psoriasis

RegulationOrphan Drug (United States), Priority Review (China), Special Review Project (China)

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Structure/Sequence

Molecular FormulaC20H22N2O7S2

InChIKeyPRSNGWLHNWGOKD-CQSZACIVSA-N

CAS Registry1255909-03-5

Aim: Hemay005 is a novel small-molecule inhibitor of phosphodiesterase-4 developed for the treatment of psoriasis. Measurement of Hemay005 in biological samples is critical for evaluation of its pharmacokinetics in clinical studies. Methodology & results: Plasma and urine samples were extracted and then chromatographed on an Acquity UPLC HSS T3 column with a gradient elution. Detection was performed on a Xevo TQ-S tandem mass spectrometer using negative ESI. Conclusion: For the first time, a sensitive and robust ultra-high performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) method was established and validated for the quantitative determination of Hemay005 in human plasma and urine, and it was successfully applied to evaluate the pharmacokinetics of Hemay005 in healthy subjects in a first-in-human study.

100 Deals associated with Mufemilast

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Plaque psoriasis	China	Ganzhou Hemei Pharmaceutical Co Ltd	30 Sep 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Behcet Syndrome	Phase 3	China	Ganzhou Hemei Pharmaceutical Co Ltd	16 Oct 2023
Bronchitis, Chronic	Phase 2	China	Ganzhou Hemei Pharmaceutical Co Ltd	13 Nov 2025
Moderate Atopic Dermatitis	Phase 2	China	Ganzhou Hemei Pharmaceutical Co Ltd	24 Nov 2022
Severe Atopic Dermatitis	Phase 2	China	Ganzhou Hemei Pharmaceutical Co Ltd	24 Nov 2022
Colitis, Ulcerative	Phase 2	China	Ganzhou Hemei Pharmaceutical Co Ltd	08 Nov 2022
Ankylosing Spondylitis	Phase 2	China	Tianjin Hemei Biological Technology Co.,Ltd.	05 Aug 2022
Psoriasis	Phase 1	-	Tianjin Hemay Pharmaceutical Technology Co., Ltd.	10 Oct 2018
Crohn Disease	IND Approval	China	Ganzhou Hemei Pharmaceutical Co Ltd	21 Nov 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2023	Phase 2	-	90	Hemay005 60 mg BID	ooqigplzty(vkawdlvtsv) = tjqejkgnfa izdgqnupbb (fzjkzrfpxx )	Positive	14 Nov 2023
NCT04839328 (ACR2023) Manual	Phase 3	Plaque psoriasis	-	Hemay005	ljrbizliig(ukeckatkfs) = gibehhtvfg bvzqgjnwfw (pecxoovutr ) View more	Positive	13 Nov 2023
NCT04839328 (ACR2023) Manual	Phase 3	Plaque psoriasis	-	Placebo	ljrbizliig(ukeckatkfs) = lxipszvggm bvzqgjnwfw (pecxoovutr ) View more	Positive	13 Nov 2023