Ignis Therapeutics announced that Solriamfetol Hydrochloride Tablets received approval from China’s National Medical Products Administration (NMPA) for improving wakefulness in adult patients with obstructive sleep apnea (OSA) accompanied by excessive daytime sleepiness (EDS).
Regulatory Approval & Product Profile
Attribute
Details
Company
Ignis Therapeutics
Product
Solriamfetol Hydrochloride Tablets
Approval
NMPA (China)
Indication
OSA with EDS in adult patients
Mechanism
Dual dopamine (DA) and norepinephrine (NE) reuptake inhibition
Global Status
Already approved in Europe and US for OSA-EDS and narcolepsy
Clinical Efficacy: TONES Studies & Chinese Phase 3
Efficacy Parameter
Result
Clinical Significance
Onset of Action
Within 1 hour
Rapid wakefulness improvement
Duration
9 hours
Covers full daytime/work period
MWT Improvement
Significant enhancement
Objective measure of wakefulness maintenance
ESS Score (12 weeks)
-7.7 points (150mg group)
Clinically meaningful reduction in sleepiness
Symptom Improvement
~90% of patients reported improvement
High responder rate
Long-term Efficacy (1 year)
>96% sustained improvement
Durable benefit with continued treatment
Safety & Tolerability Profile
Adverse Events: Mostly mild-to-moderate, occurring within first week, subsiding over time
Nighttime Sleep: Does not affect nighttime sleep architecture
Cardiovascular: Minimal impact on blood pressure in OSA patients
Discontinuation: No rebound sleepiness after treatment cessation
Validation: Positive conclusions confirmed by Chinese Phase 3 clinical study
Commercial Rights & Partnership
Agreement
Details
Partner
SK Biopharmaceuticals
Deal Signed
November 2021
Territory
Greater China (Mainland, Hong Kong, Macau, Taiwan)
Rights
Exclusive development, registration, local production, and commercialization
Strategic Value
Leverages SK’s global development data for accelerated China entry
Market Opportunity & Strategic Outlook
OSA Prevalence: 180 million adults in China affected by OSA; 60 million experience EDS
Market Gap: Limited pharmacologic options for OSA‑related EDS; solriamfetol offers first oral non‑stimulant alternative
Competitive Positioning: Differentiated from modafinil/armodafinil through dual mechanism and longer duration
Revenue Forecast: Analysts project ¥500‑800 million (US$70‑110 million) peak China sales by 2029
Next Steps: Pricing negotiations with NHSA; hospital listing campaign Q1 2026
Forward‑Looking Statements This brief contains forward‑looking statements regarding solriamfetol commercialization timelines, market penetration, and revenue projections. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.-Fineline Info & Tech
By Fineline Cube 