By Fineline Cube Ascletis Pharma Inc. (HKG: 1672) announced it has selected ASC37, a next‑generation once‑monthly subcutaneous GLP‑1R/GIPR/GCGR triple‑agonist peptide, as its clinical development candidate, positioning the company at the forefront of ultra‑long‑acting metabolic disease therapies.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Ascletis Pharma Inc. (HKEX: 1672) |
| Drug | ASC37 (GLP‑1R/GIPR/GCGR triple‑agonist peptide) |
| Application | Clinical candidate selection |
| Dosing | Once‑monthly subcutaneous injection (≤1 mL volume) |
| Technology | AISBDD platform + ULAP (ultra‑long‑acting platform) |
| Differentiation | Monthly vs. weekly competitors (e.g., retatrutide) |
| Indication | Metabolic diseases (obesity, diabetes, metabolic syndrome) |
| Selection Date | 16 Jan 2026 |
Drug Profile & Mechanism of Action
- Triple Agonist: Simultaneously activates GLP‑1R (glucagon‑like peptide‑1), GIPR (gastric inhibitory polypeptide), and GCGR (glucagon) receptors to achieve superior weight loss, glycemic control, and metabolic benefits
- AI‑Driven Discovery: Developed using Ascletis’ proprietary AI‑assisted structure‑based drug discovery (AISBDD) platform, optimizing receptor binding affinity and selectivity
- Ultra‑Long‑Acting Technology: ULAP technology enables monthly dosing with low injection volume (≤1 mL), improving patient convenience vs. retatrutide (weekly) and semaglutide (weekly)
- Market Position: First monthly triple agonist in China; potential best‑in‑class metabolic therapy
Market Opportunity & Competitive Landscape
| Parameter | China Market | Global Market |
|---|---|---|
| Obesity/Type 2 Diabetes Patients (2026E) | 180 million / 142 million | 650 million / 537 million |
| GLP‑1/GIP/GCGR Market (2030E) | ¥85 billion | $62 billion |
| Triple Agonist Penetration | 0% | <1% |
| ASC37 Peak Market Share | 8% | 2% |
| Peak Revenue (2032E) | ¥6.8 billion | $1.24 billion |
| Annual Cost (Est.) | – | $8,000‑12,000 |
Key Competitors:
- Retatrutide (Eli Lilly) – Weekly triple agonist, Phase III, not yet monthly
- Semaglutide (Novo Nordisk) – Weekly GLP‑1, market leader
- Tirzepatide (Eli Lilly) – Weekly GIP/GLP‑1 dual agonist
- ASC37 – First monthly triple agonist; differentiated convenience and AI‑optimized design
Strategic Positioning
- Manufacturing: Ascletis’ Hangzhou facility (capacity 5,000 L) will produce ASC37 for Phase I; scale‑up to 20,000 L planned for commercial launch
- Clinical Development: Phase I initiation expected Q2 2026; primary endpoint: safety, PK, PD markers; Phase II to evaluate weight loss and HbA1c reduction
- Regulatory Pathway: Eligible for fast‑track designation given monthly dosing innovation and obesity epidemic priority
- Commercial Strategy: Position as premium therapy for patients seeking convenience; NRDL negotiation planned for 2029
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for ASC37. Actual results may differ due to competitive dynamics, clinical trial outcomes, and manufacturing challenges.-Fineline Info & Tech