By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that Ivarmacitinib Tablets and SHR0302 Base Gel received National Medical Products Administration (NMPA) approval to conduct clinical trials for vitiligo, marking the first oral JAK1 inhibitor globally to enter late‑stage development for this skin disease.
Regulatory Milestone
| Item | Detail |
|---|---|
| Products | Ivarmacitinib Tablets; SHR0302 Base Gel |
| Company | Jiangsu Hengrui Pharmaceuticals (600276.SH; 1276.HK) |
| Agency | NMPA (China) |
| Approval Type | Clinical trial approval |
| Indication | Vitiligo (monotherapy or combination) |
| Mechanism | Highly selective JAK1 inhibitor (anti‑inflammatory/immunosuppressive) |
| Global Status | First oral JAK1 inhibitor for vitiligo worldwide; topical ruxolitinib cream (OPZELURA) approved |
Drug Profile
- Mechanism: Highly selective JAK1 inhibitor that blocks JAK1 signal transduction, exerting anti‑inflammatory and immunosuppressive effects
- Innovation: Addresses autoimmune destruction of melanocytes in vitiligo; oral formulation offers systemic treatment vs. topical limitations
- Differentiation: No approved oral drugs of this class for vitiligo globally; positions Hengrui as first‑mover in an underserved indication
- Combination Potential: Trials will explore monotherapy and combination regimens, potentially with phototherapy or topical agents
Market Context & Outlook
| Metric | Value |
|---|---|
| China Vitiligo Patients | ~2.3 million (moderate‑to‑severe) |
| Current Standard | Topical corticosteroids, calcineurin inhibitors; OPZELURA (ruxolitinib cream) approved but limited penetration |
| Oral Therapy Unmet Need | >70% of moderate‑to‑severe patients seek systemic treatment; no approved oral options |
| Market Size (China) | ¥1.8 billion (US$250 million) |
| Growth CAGR | 18% (2024‑2030) |
| Peak Sales Forecast (Ivarmacitinib) | ¥3.5‑4.5 billion (~US$480‑610 million) by 2032 |
| Market Share Target | 30‑35% of systemic therapy segment |
- Competitive Landscape: Incyte/China Medical System’s OPZELURA (topical) is only approved JAK inhibitor; Hengrui’s oral formulation addresses broader disease burden and scalp/genital involvement
- Reimbursement Path: NMPA approval triggers Priority Review; potential NRDL inclusion if Phase II/III demonstrates superiority vs. placebo and non‑inferiority to phototherapy
- Next Catalysts: Phase II dose‑finding study initiation Q1 2026; combination cohort with NB‑UVB phototherapy H2 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Ivarmacitinib’s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in dermatology.-Fineline Info & Tech