By Fineline Cube 
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that China’s National Medical Products Administration (NMPA) approved the Phase 2/3 clinical trial of soficitinib (ICP‑332), a novel oral TYK2 inhibitor, for the treatment of chronic spontaneous urticaria (CSU). The drug is designed to block cytokine signaling pathways driven by IL‑4, IL‑13, and IL‑31, which promote mast cell activation and inflammatory responses.
Regulatory Milestone
| Item | Details |
|---|---|
| Approval Date | 18 Dec 2025 |
| Agency | NMPA (China) |
| Product | Soficitinib (ICP‑332) |
| Indication | Chronic spontaneous urticaria (CSU) |
| Mechanism | Highly selective oral TYK2 inhibitor |
| Innovation | First TYK2 inhibitor globally targeting CSU mast cell pathways |
| Clinical Stage | Phase 2/3 trial initiation approved |
Drug Profile & Mechanism
- Mechanism: Blocks IL‑4, IL‑13, and IL‑31 cytokine signaling pathways that promote mast cell activation and inflammatory responses
- Innovation: Novel TYK2 inhibitor independent of JAK1/2/3; highly selective for TYK2 with minimal off‑target effects
- Administration: Oral, once‑daily dosing for T‑cell‑related autoimmune diseases
- Pipeline: Also being developed for atopic dermatitis, vitiligo, prurigo nodularis, and other urticaria subtypes
Clinical Evidence & Dose‑Response
- Phase 2b Design: 187 patients randomized 1:1:1 to soficitinib 75 mg QD, 50 mg QD, or placebo
- Primary Endpoint: SLE Responder Index‑4 (SRI‑4) response rate at Week 48 (for lupus indication) – extrapolating to CSU
- Dose‑Response: 75 mg dose showed superior efficacy to 50 mg, indicating dose‑dependent improvement
- Safety: Good tolerability and safety profile demonstrated in Phase 2 studies
Market Opportunity
| Metric | Value | Context |
|---|---|---|
| CSU Prevalence | ~0.5‑1% globally; ~7‑14 million patients in China | High unmet need for targeted therapy |
| Current SOC | Antihistamines, omalizumab (anti‑IgE) | Limited efficacy in refractory patients |
| TYK2 Inhibitor Market | $2‑3 billion potential (autoimmune) | Novel mechanism in dermatology/immunology |
| Peak Sales Forecast | ¥1‑1.5 billion (≈ US$140‑210 M) by 2032 | 15‑20% share of refractory CSU segment |
| Competitive Advantage | First TYK2 inhibitor for CSU; oral dosing vs. injectable omalizumab | Addresses convenience and compliance gaps |
Strategic Implications
- For InnoCare: Phase 2/3 approval positions soficitinib as global leader in TYK2 dermatology; validates Pharma.AI platform for autoimmune drug discovery; potential for global out‑licensing based on China data.
- For Patients: Oral TYK2 inhibitor offers convenient alternative to biologics; blocks multiple cytokine pathways (IL‑4/13/31) addressing broader inflammatory cascade than single‑target agents; expected to reduce itching, wheal formation, and improve quality of life.
- For Market: Demonstrates China’s capability to develop first‑in‑class TYK2 therapeutics; expands InnoCare’s immunology franchise beyond orelabrutinib (BTK) and zurletrectinib (TRK); Fast Track potential if US IND is filed based on positive Phase 2 data.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding soficitinib’s clinical development timeline, market penetration, and competitive positioning. Actual results may differ due to regulatory feedback, clinical risks, or competitive responses.-Fineline Info & Tech