By Fineline Cube 
Ignis Therapeutics announced that cenobamate tablets received marketing approval from China’s National Medical Products Administration (NMPA) for the treatment of partial seizures in adult patients with epilepsy.
Regulatory Approval & Product Profile
| Attribute | Details |
|---|---|
| Company | Ignis Therapeutics |
| Product | Cenobamate tablets |
| Approval | NMPA (China) |
| Indication | Partial seizures in adult epilepsy patients |
| Mechanism | Dual action: sodium channel blocker + GABAA receptor agonist |
| Drug Generation | Third-generation anti-seizure medication |
Global Presence & China Licensing
Geographic Reach:
- Approved in 24 countries including US, UK, Germany
- Trade names: Xcopri (US) / Ontozry (EU)
- Approved in Hong Kong SAR of China
Licensing Agreement:
- Partner: SK Biopharmaceuticals
- Deal Signed: November 2021
- Territory: Greater China (Mainland China, Hong Kong, Macau, Taiwan)
- Rights: Exclusive development and commercialization
Clinical Basis: Phase 3 C035 Study
| Study Parameter | Detail |
|---|---|
| Study Design | Multi-center, randomized, double-blind, placebo-controlled Phase 3 |
| Study Name | C035 |
| Global Centers | 70 centers across China, Japan, South Korea |
| Total Patients | 519 |
| Chinese Patients | 227 (43.7% of total) |
| Baseline | Median 10 seizures per 28 days; 92% had ≥2 prior anti-seizure medications |
Primary Efficacy Results (400mg dose group)
| Endpoint | Result | Comparison |
|---|---|---|
| Median seizure reduction | 100% | Significantly superior to placebo |
| Seizure-free rate | 59.6% | Significantly superior to placebo |
| Safety profile | Good overall safety and tolerability | Mild-to-moderate adverse events |
Market Context & Strategic Outlook
- Epilepsy Prevalence: 9 million patients in China; partial seizures account for ~60% of cases
- Market Gap: Limited third-generation options; cenobamate offers dual mechanism with proven efficacy
- Competitive Positioning: Differentiated from traditional sodium channel blockers through GABA-A agonism
- Revenue Forecast: Analysts project ¥300-500 million (US$42-70 million) peak China sales by 2029
- Launch Timeline: Commercial launch expected Q2 2026 following pricing negotiations
Forward‑Looking Statements
This brief contains forward‑looking statements regarding cenobamate commercialization timelines and market potential. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.-Fineline Info & Tech