By Fineline Cube Guangzhou BeBetter Medicine Technology Co., Ltd. (SHA: 688759) announced that the National Medical Products Administration (NMPA) has approved a Phase I/II clinical study for BEBT-701 in patients with mild‑to‑moderate hypertension combined with elevated LDL‑C. BEBT-701 is a first‑in‑class siRNA drug targeting both AGT and PCSK9, leveraging BeBetter Med’s proprietary GalNAc dual oligonucleotide conjugate (GDOC) technology platform.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Guangzhou BeBetter Medicine Technology Co., Ltd. (688759.SH) |
| Drug | BEBT-701 |
| Mechanism | siRNA targeting AGT and PCSK9 |
| Technology | GalNAc dual oligonucleotide conjugate (GDOC) platform |
| Indication | Mild‑to‑moderate hypertension with elevated LDL‑C |
| Approval | NMPA Phase I/II clinical trial authorization |
| Innovation | “Single administration, dual‑pathway action” for blood pressure and lipids |
| Stage | Preclinical studies completed |
Technology & Clinical Rationale
- Dual Targeting: Silences AGT (angiotensinogen) to reduce blood pressure and PCSK9 to lower LDL-C simultaneously
- GDOC Platform: Enables efficient delivery of siRNA to hepatocytes via GalNAc conjugation, achieving durable gene silencing
- Preclinical Results: Demonstrated efficient and durable silencing of both targets in humanized mouse models and non‑human primates, with synergistic efficacy in lowering blood pressure and lipids and a favorable safety profile
Market Impact & Commercial Outlook
- China Hypertension Market: Affects 300 million adults; dyslipidemia market valued at ¥50 billion : (~US$7 billion) in 2025
- Unmet Need: No approved therapy addresses both conditions simultaneously; BEBT-701 could simplify treatment regimens
- Competitive Landscape: Competes with PCSK9 antibodies (alirocumab, evolocumab) and siRNA inclisiran; dual mechanism offers differentiation
- Revenue Potential: Analysts project ¥3–5 billion (US$420–700 million) peak annual sales if approved, based on dual‑indication pricing advantage
- Strategic Value: Positions BeBetter Med as a leader in next‑generation siRNA technology; validates GDOC platform for future multi‑target candidates
- Next Steps: Phase I/II trial initiation expected Q2 2026; dose‑escalation and proof‑of‑concept data anticipated H1 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for BEBT-701. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech