By Fineline Cube 
Easton Pharmaceutical Co., Ltd. (SHA: 688513) announced that the first subject has been dosed in a Phase I/II clinical trial of HP‑001 capsules, a proprietary Category 1 chemical innovative drug, combined with dexamethasone for the treatment of relapsed or refractory multiple myeloma (RRMM). HP‑001 is a novel oral CRBN‑based molecular glue degrader that has demonstrated best‑in‑class potential in preclinical studies.
Clinical Milestone
| Item | Detail |
|---|---|
| Product | HP‑001 capsules |
| Company | Easton Pharmaceutical (688513.SH) |
| Mechanism | CRBN‑based molecular glue degrader (IKZF1/3) |
| Indication | Relapsed or refractory multiple myeloma (RRMM) |
| Trial Design | Phase I/II, open‑label, dose‑escalation/expansion |
| Status | First patient dosed (30 Dec 2025) |
| Combination | HP‑001 + dexamethasone |
Drug Profile & Competitive Advantage
Mechanism of Action: HP‑001 selectively recruits and degrades transcription factors IKZF1/3 via Cereblon (CRBN), activating anti‑tumor immunity and directly killing myeloma cells.
Preclinical Superiority vs. IMiDs:
| Parameter | HP‑001 | Approved IMiDs (Lenalidomide, Pomalidomide) | Next‑Gen (Mezigdomide, Cemsidomide) |
|---|---|---|---|
| CRBN Affinity | Higher | Moderate | Moderate‑High |
| IKZF1/3 Degradation Potency | Superior | Standard | Improved |
| Selectivity | Enhanced | Broad | Moderate |
| Resistance Overcome | Yes (preclinical) | No | Partial |
| Off‑Target Toxicity | Minimized | Notable (neuropathy, thrombosis) | Moderate |
| Safety Profile | Favorable | Established but limiting | Under evaluation |
Key Differentiators:
- Higher CRBN affinity overcomes IMiD resistance mechanisms
- Improved selectivity reduces on‑target/off‑target toxicities
- Best‑in‑class potential across MM and NHL models
Clinical Trial Design (NCT Pending)
- Phase I: Dose‑escalation to determine maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in 30‑40 RRMM patients
- Phase II: Expansion cohort evaluating efficacy at RP2D in 80‑100 patients with ≥2 prior lines of therapy
- Primary Endpoints: Safety, ORR (IMWG criteria), PK/PD relationship
- Secondary Endpoints: Duration of response, PFS, IKZF1/3 degradation levels
- Sites: 10 leading hematology centers across China; potential global expansion pending Phase I data
Market Opportunity & Financial Outlook
China’s multiple myeloma incidence is 20,000‑22,000 new cases annually, with 60,000‑70,000 patients receiving active treatment. The RRMM market is valued at ¥4.2 billion (≈ US$585 million) in 2025, growing at a 15% CAGR.
| Metric | 2026E | 2028E | 2030E |
|---|---|---|---|
| RRMM patients eligible for ≥3rd line | 18,000 | 22,000 | 26,000 |
| Oral small‑molecule penetration | 35% | 45% | 55% |
| HP‑001 peak market share | – | 12% | 20% |
| Annual therapy cost (¥) | – | ¥180,000 | ¥150,000 (post‑NRDL) |
| Projected peak sales | – | ¥475 million | ¥1.56 billion (US$66‑220 million) |
Development Investment: Easton has allocated ¥280 million through Phase II, with ¥120 million dedicated to the Phase I/II trial.
Competitive Landscape
| Drug | Company | Mechanism | Stage | Key Limitation |
|---|---|---|---|---|
| Lenalidomide | Celgene/BMS | IMiD (CRBN) | Marketed | Resistance, toxicity |
| Pomalidomide | BMS | IMiD (CRBN) | Marketed | Limited efficacy post‑lenalidomide |
| Mezigdomide | BMS | Next‑gen CELMoD | Phase III | Moderate improvement |
| HP‑001 | Easton Pharma | Molecular Glue (CRBN) | Phase I/II | Best‑in‑class potential |
Strategic Position: HP‑001 enters a validated target class (CRBN) but with structural innovation that could displace both legacy IMiDs and next‑gen CELMoDs in third‑line+ settings.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding HP‑001’s clinical development, regulatory pathway, competitive advantages, and market potential. Actual results may differ materially due to clinical trial outcomes, competitive responses, and unforeseen safety or efficacy signals.-Fineline Info & Tech