By Fineline Cube 
The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced by Hefei Amvite Biotechnology Co., Ltd. for the treatment of moderate‑to‑severe Alzheimer’s disease in adult patients.
Product Overview
| Attribute | Details |
|---|---|
| Drug name | Memristin™ (Memantine Hydrochloride ODT) |
| Manufacturer | Hefei Amvite Biotechnology Co., Ltd. |
| Regulatory status | NMPA marketing authorisation (effective 4 Nov 2025) |
| Indication | Moderate‑to‑severe Alzheimer’s disease in adults |
| Dosage form | Orally disintegrating tablet, 10 mg per tablet |
| Mechanism | NMDA‑receptor antagonist that protects neurons and supports cognitive recovery |
| Reference product | Ebixa® (Memantine Hydrochloride) – originally developed by H. Lundbeck A/S (EU approval 15 May 2002; China launch July 2012) |
Clinical & Commercial Significance
- Therapeutic value: Memantine is the only approved N‑methyl‑D‑aspartate (NMDA) receptor antagonist for Alzheimer’s, offering a neuroprotective approach distinct from cholinesterase inhibitors.
- Market impact: China’s Alzheimer’s patient pool exceeds 10 million and is projected to grow > 30 % by 2030, creating a ¥30‑¥45 billion market for disease‑modifying therapies.
- Pricing advantage: The ODT formulation provides a convenient, swallow‑free option for elderly patients with dysphagia, potentially capturing market share from existing tablet and liquid formulations.
Timeline & Outlook
| Milestone | Date |
|---|---|
| NMPA approval announcement | 4 Nov 2025 |
| Commercial launch in mainland China | Q1 2026 |
| Expected inclusion in provincial reimbursement lists | H2 2026 |
| Expansion to Hong Kong & Taiwan (regulatory filing) | 2027 |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercial launch, pricing, and market adoption of Memristin™ in China. Actual results may differ due to regulatory, competitive, reimbursement, and clinical‑trial outcomes.-Fineline Info & Tech