By Fineline Cube 
Sinclair (Hangzhou) Medical Technology Co., Ltd., a wholly‑owned subsidiary of Huadong Medicine (SHE: 000963), announced that it has received an Acceptance Notice from the National Medical Products Administration (NMPA) for the registration application of MaiLi Precise, a Class III medical device. The product is a cross‑linked sodium hyaluronate gel formulated with lidocaine for injection, designed to provide an immediate correction of infra‑orbital hollows.
Product Highlights
| Feature | Detail |
|---|---|
| Device Class | Class III medical device |
| Active Ingredient | Cross‑linked sodium hyaluronate gel + lidocaine |
| Concentration | Lowest sodium hyaluronate concentration in the MaiLi series |
| Clinical Benefit | Immediate correction of infra‑orbital hollows post‑injection |
| Regulatory Status | Acceptance Notice from NMPA (Oct 16 2025) |
MaiLi Series Overview
- Global Lineage – The MaiLi series originates from Kylane Laboratoires SA, a Swiss R&D leader in medical aesthetics.
- Sinclair’s Stake – Sinclair holds an equity position in Kylane and possesses the global exclusive license for the MaiLi product line.
- UK Presence – Sinclair Pharmaceuticals Limited, Sinclair’s UK subsidiary, markets the series worldwide.
- European Success – The products received CE certification in June 2020 and launched in the EU market in early 2021, garnering strong market feedback.
Strategic Implications for Huadong Medicine
- Portfolio Expansion – The acceptance of MaiLi Precise adds a high‑margin aesthetic device to Huadong’s product mix.
- Market Penetration – The Class III classification positions the product for premium pricing and broader clinical adoption.
- Synergy with Existing Offerings – Sinclair’s expertise in hyaluronic acid gels complements Huadong’s existing medical device pipeline, creating cross‑selling opportunities.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech