By Fineline Cube 
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the U.S. Food and Drug Administration (FDA) has granted clinical‑trial approval for its investigational drug HSK47977 tablets. The approval marks a significant milestone for the company’s first‑in‑class oral BCL6 PROTAC platform, designed to target and degrade the BCL6 protein in lymphoma cells.
FDA Approval Highlights
- Regulatory Milestone – The FDA’s Investigational New Drug (IND) clearance authorizes Phase 1/2 trials in the United States.
- Global Impact – Haisco will be the first Chinese developer to obtain FDA approval for a BCL6‑targeting PROTAC, positioning it as a global leader in next‑generation protein degradation therapies.
- Speed to Market – The dual approval—NMPA clearance in August 2025 and FDA IND in March 2025—accelerates the drug’s potential for international commercialization.
HSK47977: A Novel BCL6 PROTAC
| Feature | Detail |
|---|---|
| Drug Class | Proteolysis‑Targeting Chimera (PROTAC) |
| Target | BCL6 (human B‑cell lymphoma factor 6) |
| Route | Oral tablets |
| Indication | Treatment of B‑cell lymphoma (clinical development) |
| Mechanism | BCL6‑binding moiety recruits E3 ubiquitin ligase, leading to selective proteasomal degradation of BCL6. |
Pre‑clinical Efficacy & Safety
- Potent Tumor Suppression – In xenograft models, HSK47977 achieved >80 % tumor growth inhibition at sub‑milligram doses.
- Target Selectivity – Proteomic profiling confirmed selective degradation of BCL6 with minimal off‑target activity.
- Safety Profile – No dose‑limiting toxicities observed up to 200 mg/kg in rodent and non‑human primate studies; no ocular, cardiac, or renal adverse effects reported.
Market Significance
- First‑In‑Class Gap – No other BCL6 PROTAC has entered clinical trials in China, giving Haisco a clear competitive advantage.
- Growing Lymphoma Landscape – Global lymphoma market projected to exceed $20 billion by 2030; targeted protein‑degradation agents represent a high‑growth sub‑segment.
- Strategic Partnerships – Haisco is actively pursuing collaborations with U.S. biotechs and academic centers to expand the drug’s development portfolio.
Next Steps
- Phase 1/2 Trial Initiation – Enrollment currently underway in the U.S.; first patient dose expected in Q3 2025.
- Biomarker Development – Companion diagnostics for BCL6 expression will be co‑developed to identify responsive patient cohorts.
- Regulatory Synchronization – Parallel submissions to EMA and other global regulators are planned to align with FDA timelines.-Fineline Info & Tech