By Fineline Cube 
Cutia Therapeutics (HKG: 2487) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for CU‑40105, a topical finasteride spray for the treatment of androgenetic alopecia, positioning it as the first and only topical finasteride product in China.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | CU‑40105 (topical finasteride spray) |
| Company | Cutia Therapeutics |
| Agency | NMPA (China) |
| Approval Type | NDA acceptance |
| Indication | Androgenetic alopecia (male pattern hair loss) |
| Market Status | First and only topical finasteride in China |
| Global Status | Approved in overseas markets; imported original product |
| Next Steps | Technical review process; potential approval H2 2026 |
Drug Profile
- Mechanism: Competitive inhibitor of Type II 5‑alpha reductase, blocking conversion of testosterone to dihydrotestosterone (DHT) in scalp tissue
- Differentiation: Topical spray administration directly to scalp reduces systemic exposure by ~90% compared to oral finasteride, potentially minimizing systemic side effects
- Formulation: Ready‑to‑use spray for targeted delivery to affected scalp areas
- Patient Convenience: Avoids daily oral dosing and associated concerns about sexual dysfunction and mood changes (reported in 3‑5% of oral finasteride users)
Market Context & Outlook
| Metric | Value |
|---|---|
| China Alopecia Market (2024) | ¥8.5 billion (US$1.2 billion) |
| Male Androgenetic Alopecia Patients | >30 million men in China |
| Oral Finasteride Market Share | ~35% of prescription alopecia treatments |
| Peak Sales Forecast (CU‑40105) | ¥1.5‑2.0 billion (US$200‑270 million) by 2030 |
| Market Capture Assumption | 15‑20% of finasteride‑eligible patients switching to topical |
| Price Premium | Expected 30‑40% premium vs. oral generic finasteride |
- Competitive Landscape: Oral finasteride generics dominate; topical minoxidil is the only other topical prescription option. CU‑40105 offers a first‑in‑class topical anti‑androgen alternative.
- Physician Adoption: Dermatologists report strong interest in topical options to address patient concerns about systemic side effects; key opinion leader endorsements expected post‑launch.
- Reimbursement: Likely self‑pay category initially; potential for inclusion in outpatient pharmacy benefits if real‑world safety data demonstrate clear advantage.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding CU‑40105’s regulatory review timeline, market adoption, and revenue potential. Actual results may differ materially due to risks including NMPA approval outcomes, competitive responses, and physician uptake rates.-Fineline Info & Tech