By Fineline Cube 
Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris compound nasal spray has received marketing authorization from China’s National Medical Products Administration (NMPA) for the treatment of allergic rhinitis (AR).
Deal & Regulatory Highlights
| Item | Detail |
|---|---|
| Product | Ryaltris – fixed‑dose combination nasal spray (antihistamine + corticosteroid) |
| Indication | Moderate‑to‑severe seasonal AR (adults + children ≥ 6 yr) and moderate‑to‑severe perennial AR (adults + children ≥ 12 yr) |
| Regulatory Milestone | NMPA full approval (11 Nov 2025) |
| Partner | Glenmark Specialty S.A. (global rights holder) |
| Launch Plan | Commercial rollout in China slated for Q1 2026; parallel rollout in Hong Kong and other APAC markets later in 2026 |
| Pricing | To be disclosed; expected to be positioned competitively against existing intranasal steroids and antihistamine monotherapies |
Clinical Evidence
- Phase 3 China Trial: 535 patients across 12 sites; double‑blind, active‑comparator design.
- Efficacy: Ryaltris achieved statistically significant improvements in Total Nasal Symptom Score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) versus single‑agent antihistamine or corticosteroid arms (p < 0.001).
- Onset of Action: Symptom relief observed within 15 minutes of the first dose; sustained efficacy through the 24‑hour dosing interval.
- Safety: Comparable adverse‑event profile to monotherapy comparators; most common events were mild nasal irritation and transient epistaxis (< 2 %).
Market Impact
- Allergic Rhinitis Burden: Over 100 million Chinese adults experience AR; prevalence in children (≥ 6 yr) exceeds 30 %.
- Revenue Potential: Grand Pharmaceutical projects CNY 1.2–1.5 billion in 2027 sales from Ryaltris, assuming 5 % market capture within the first two years.
- Strategic Fit: The combination product differentiates from existing intranasal steroids (e.g., fluticasone) and antihistamine sprays, offering a single‑dose, dual‑action therapy that aligns with patient‑centric treatment trends.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, commercial launch expectations, and revenue projections for Ryaltris. Actual results may differ due to risks including clinical outcomes, regulatory actions, market acceptance, and competitive dynamics.-Fineline Info & Tech