By Fineline Cube Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that China’s National Medical Products Administration (NMPA) has approved a new clinical study for RAY1225, a Category 1 innovative dual GLP‑1/GIP receptor agonist, in patients with obesity complicated by obstructive sleep apnea (OSA). The approval comes as the company completes enrollment across three Phase III trials for obesity and type 2 diabetes.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Guangdong Zhongsheng Pharmaceutical Co., Ltd (002317.SZ) |
| Drug | RAY1225 (dual GLP‑1/GIP receptor agonist) |
| Application | Clinical Trial Approval (new indication) |
| Agency | NMPA (China) |
| New Indication | Obesity with obstructive sleep apnea (OSA) |
| Dosing | Ultra‑long‑acting, once every two weeks (Q2W) |
| Approval Date | 16 Jan 2026 |
| Drug Class | Category 1 innovative polypeptide |
| Current Status | Phase III enrollment completed for obesity and T2DM trials |
Drug Profile & Mechanism
- Mechanism: Dual agonist targeting GLP‑1 (glucagon‑like peptide‑1) and GIP (glucose‑dependent insulinotropic polypeptide) receptors, enhancing satiety, glucose control, and energy expenditure
- Pharmacokinetics: Ultra‑long‑acting formulation enables once‑every‑two‑weeks (Q2W) dosing, offering superior convenience vs. weekly semaglutide or tirzepatide
- Innovation: Designed for high potency and extended half‑life through optimized polypeptide engineering
- OSA Rationale: GLP‑1/GIP agonists demonstrate weight‑dependent and independent benefits on upper airway collapsibility and inflammation, addressing the high unmet need in obese OSA patients
Clinical Development Status
| Trial | Indication | Status | Comparator/Design |
|---|---|---|---|
| REBUILDING‑2 | Obesity/overweight (Chinese patients) | Enrollment completed | Placebo‑controlled |
| SHINING‑2 | Type 2 diabetes (monotherapy) | Enrollment completed | Placebo‑controlled |
| SHINING‑3 | Type 2 diabetes (combination therapy) | Enrollment completed | Versus semaglutide |
| New Study | Obesity + OSA | NMPA approved | Phase II/III planned |
- Competitive Differentiation: SHINING‑3’s head‑to‑head design versus semaglutide positions RAY1225 as a potential best‑in‑class therapy; Q2W dosing offers adherence advantage over weekly injections
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Obesity Patients with OSA | 45 million | 180 million |
| Addressable for GLP‑1/GIP Therapy | 18 million | 72 million |
| Current Standard | CPAP (device), lifestyle, weekly semaglutide | |
| Q2W GLP‑1/GIP Penetration | 0 % | 0 % |
| Market Value (2030E) | ¥85 billion | $42 billion |
| RAY1225 Peak Share | 5 % | 2 % |
| Peak Revenue (2032E) | ¥4.25 billion | $840 million |
Key Competitors:
- Zepbound (tirzepatide, Eli Lilly) – Weekly GIP/GLP‑1, approved for obesity, no OSA indication yet
- Wegovy (semaglutide, Novo Nordisk) – Weekly GLP‑1, standard of care
- RAY1225 – First Q2W dual agonist in Phase III; potential OSA label differentiation
Strategic Positioning
- Manufacturing: Zhongsheng’s Guangdong biologics facility (capacity 50 million doses/year) is GMP‑ready for commercial supply; Q2W formulation requires specialized long‑acting delivery technology
- Commercial Reach: Existing 3,000‑person metabolic sales force (diabetes portfolio) can pivot to obesity/OSA upon launch
- Regulatory Pathway: NDA submission for obesity/T2DM expected Q3 2026 based on completed Phase III data; OSA indication to follow as label expansion in 2028
- Global Ambitions: Plans US IND filing in H2 2026, leveraging China Phase III data for FDA fast‑track eligibility
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory approvals, and commercial forecasts for RAY1225. Actual results may differ due to competitive dynamics, manufacturing scale‑up challenges, and OSA trial outcomes.-Fineline Info & Tech