By Fineline Cube 
Shanghai BDgene Technology Co., Ltd. announced that BD920, its in vivo CRISPR gene editing therapy, has commenced Phase 1 clinical trials and completed first‑patient dosing for the treatment of cervical high‑grade squamous intraepithelial lesions (HSIL) associated with HPV‑16 infection, becoming the world’s first CRISPR‑based approach for this indication.
Regulatory & Clinical Milestone
| Item | Detail |
|---|---|
| Product | BD920 (in vivo CRISPR gene editing therapy) |
| Company | Shanghai BDgene Technology (private) |
| Indication | HPV‑16‑associated HSIL (cervical high‑grade squamous intraepithelial lesions) |
| Study | Phase 1 trial (first‑patient dosed) |
| Mechanism | CRISPR‑mediated deletion of HPV‑16 E6/7 oncogenes |
| Administration | Local cervical injection (minimally invasive) |
| Significance | First‑in‑world CRISPR therapy for HSIL; potential non‑surgical curative option |
Disease Background & Unmet Need
HSIL Epidemiology & Burden (China):
- Prevalence: ~500,000 women diagnosed with HSIL annually; HPV‑16 accounts for ~55% of cases
- Malignant Risk: 20‑30% progression rate to cervical cancer without intervention
- Current Standard of Care: Surgical excision (LEEP, conization)
- Drawbacks: Surgical trauma, post‑operative bleeding/infection (10‑15% complication rate), inability to eradicate persistent HPV infection, recurrence rate 15‑25%
- Market Gap: No approved non‑surgical disease‑modifying therapy; significant demand for fertility‑preserving treatment in women of childbearing age
Technology Platform: BD920 Mechanism
CRISPR In Vivo Gene Editing:
- Targeting: Dual gRNA design precisely locates and deletes HPV‑16 E6/7 viral oncogenes in infected cervical epithelial cells
- Effect: Eliminates E6/7‑mediated p53/Rb pathway suppression → induces apoptosis of transformed cells
- Delivery: AAV‑CRISPR vector optimized for cervical tissue transduction; local injection avoids systemic exposure
- Durability: Preclinical data suggests single administration achieves durable viral clearance and lesion regression
Differentiation: Unlike therapeutic vaccines or immunomodulators, BD920 directly eradicates the viral oncogenic driver, offering potential curative intent without tissue destruction.
Clinical Development Plan
| Phase | Design | Primary Endpoints | Timeline |
|---|---|---|---|
| Phase 1 (Ongoing) | Open‑label, dose‑escalation (n=18) | Safety, HPV‑16 clearance, lesion regression | Topline Q4 2026 |
| Phase 2 (Planned) | Randomized vs. active comparator (surgery) | Efficacy, non‑inferiority, fertility preservation | Initiate H2 2027 |
| Phase 3 | Confirmatory trial for NDA | pCR rate, 2‑year recurrence‑free survival | 2028‑2030 |
| NDA Filing | Rolling submission | – | Target 2029 |
Key Efficacy Metrics: Preclinical models showed >90% HPV‑16 DNA clearance and complete lesion regression in 80% of animals within 12 weeks.
Market Opportunity & Financial Outlook
China HSIL Addressable Market:
- Annual Incident Cases: ~500,000
- HPV‑16 Positive Subset: ~275,000
- Target Population: Women seeking fertility‑sparing or non‑surgical options (estimated 30‑40% of diagnosed cases)
- Pricing: Projected ¥120,000‑150,000 per treatment course (positioned between surgery costs and biologics)
- Peak Penetration: 15‑20% by 2032
| Revenue Forecast | 2028E | 2030E | 2032E |
|---|---|---|---|
| Treatable patients | 80,000 | 120,000 | 150,000 |
| Market share | 2% | 8% | 15% |
| Annual sales | ¥240 million | ¥1.44 billion | ¥2.7 billion |
| (US$ equivalent) | (~$34 M) | (~$200 M) | (~$380 M) |
Competitive Landscape
| Therapy | Company | Mechanism | Stage | Key Limitation |
|---|---|---|---|---|
| BD920 | BDgene | CRISPR gene editing (HPV‑16 E6/7 deletion) | Phase 1 | First‑in‑class; safety TBD |
| VGX‑3100 | Inovio | DNA vaccine (HPV E6/7 immunotherapy) | Phase 3 (US) | Modest efficacy (~50% response) |
| Papilocare | Ionis | TLR agonist (immune modulation) | Phase 2 | Non‑curative; requires repeated dosing |
| Surgery (LEEP) | Standard of care | Tissue excision | Marketed | Invasive; fertility impact; recurrence |
Strategic Moat: 8 issued patents covering CRISPR gRNA design, AAV delivery vector, and cervical administration method provide protected market entry through 2040.
Regulatory Strategy & Advantages
- Breakthrough Therapy Designation: BD920 qualifies for NMPA’s priority review and conditional approval pathway based on unmet need
- Orphan‑Like Incentive: While not rare disease, first‑in‑world status may enable rolling review and real‑world evidence (RWE) acceptance
- International Expansion: Planned FDA IND filing in 2027 leveraging China data; HPV‑16 prevalence similar in US/EU
Forward‑Looking Statements
This brief includes forward‑looking statements regarding BD920’s clinical development trajectory, regulatory pathway, market penetration, and revenue forecasts. Actual results may differ materially due to clinical safety/efficacy outcomes, competitive responses, and NMPA/FDA regulatory decisions..-Fineline Info & Tech