By Fineline Cube 
Allergan Aesthetics, an AbbVie (NYSE: ABBV) company, announced that its SKINVIVE by Juvéderm, an injectable hyaluronic acid gel with lidocaine, has received marketing approval from China’s National Medical Products Administration (NMPA) for the improvement of moderate-to-severe static perioral wrinkles in adults.
Regulatory Milestone
| Agency | Approval Type | Product | Indication | Date | Next Steps |
|---|---|---|---|---|---|
| NMPA (China) | Marketing Approval | SKINVIVE by Juvéderm (injectable hyaluronic acid gel with lidocaine) | Improvement of moderate-to-severe static perioral wrinkles in adults | 02 Sep 2026 | Commercial launch in China’s medical aesthetics market |
Drug Profile & Mechanism of Action
- Product: SKINVIVE by Juvéderm, an injectable hyaluronic acid (HA) gel with lidocaine
- Technology: Developed using Allergan Aesthetics‘ proprietary VYCROSS cross-linking technology
- Formulation characteristics: Soft texture and low cohesiveness, well-suited to the frequently mobile skin environment of the perioral area
- Target area: Static perioral wrinkles — a high-motion facial region where product flexibility matters
- Owner: Allergan Aesthetics, part of AbbVie, extending the established Juvéderm franchise in China
Clinical Evidence – Phase 3 China Registration Trial
| Endpoint | Timepoint | Treatment Group Result |
|---|---|---|
| POLSS responder rate (primary, investigator-assessed on-site) | 2 months post-treatment | 93.4% |
| POLSS responder rate (durability follow-up) | 6 months post-treatment | 89.2% |
The approval is supported by a multicenter, evaluator-blinded, randomized, no-treatment controlled Phase 3 trial conducted in a Chinese population, using the Perioral Wrinkle Static Severity Scale (POLSS) responder rate as the primary efficacy endpoint. Results demonstrated that a single treatment session can deliver durable results for at least 6 months, with the responder rate holding at 89.2% at the 6-month follow-up.
Market Impact & Outlook
- China aesthetics expansion: The NMPA approval broadens the Juvéderm portfolio in China, one of the world’s largest and fastest-growing medical aesthetics markets
- Indication positioning: Moderate-to-severe static perioral wrinkles represent a distinct treatment niche versus volumizing fillers, expanding the addressable patient base for SKINVIVE
- Clinical differentiation: A 93.4% POLSS responder rate at 2 months with durability beyond 6 months from a single session provides a strong efficacy narrative for clinicians and consumers
- Technology edge: The VYCROSS platform’s soft, low-cohesiveness profile addresses the unique biomechanical demands of the perioral area
- Sector signal: The approval underscores continued investment by global aesthetics leaders in China-specific registration studies and local market penetration
Forward‑Looking Statements – This brief contains forward-looking statements regarding the commercialization and market potential of SKINVIVE by Juvéderm in China. Actual results may differ materially due to regulatory, competitive, and market risks. This content is for informational purposes only and does not constitute investment advice.-Fineline Info & Tech