By Fineline Cube 
The National Medical Products Administration (NMPA) announced that Jiangxi Hemei Pharmaceutical Co., Ltd. has received marketing approval for its Class 1 innovative drug, Mufemilast (Hemay005) Tablets. The approval, effective immediately, authorises use in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Product Profile
- Active Ingredient – Mufemilast is a small‑molecule phosphodiesterase 4 (PDE4) inhibitor.
- First Domestic PDE4 Inhibitor – While Amgen’s Apremilast and Pfizer’s Crisaborole ointment have previously entered the Chinese market, Mufemilast is the first domestically‑developed PDE4 inhibitor approved by the NMPA.
- Formulation – Oral tablets, facilitating easier administration than topical or injectable alternatives.
Clinical Indication
- Approved Indication – Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Broader Development Pipeline
Mufemilast is being evaluated in multiple other inflammatory and autoimmune conditions:
| Indication | Trial Phase |
|---|---|
| Behçet’s disease | Phase III |
| Atopic dermatitis | Phase II |
| Ankylosing spondylitis | Phase II |
| Ulcerative colitis | Phase II |
| Chronic Obstructive Pulmonary Disease (COPD) | Phase I |
| Crohn’s disease | Clinical‑trial approval |
| Psoriatic arthritis | Clinical‑trial approval |
Market Impact
The approval positions Hemei as a key player in China’s expanding biologics and small‑molecule arena, offering a new oral alternative for psoriasis treatment. The company’s ongoing trials could broaden the drug’s therapeutic portfolio, potentially capturing significant market share in multiple inflammatory disorders.-Fineline Info & Tech