By Fineline Cube 
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary GenSci (GeneScience Pharmaceutical) received clinical trial approval from the National Medical Products Administration (NMPA) for GenSci142 Capsule, a Category 1 biological product for the treatment of bacterial vaginosis (BV), leveraging an AI‑optimized molecular structure that selectively kills pathogens while preserving protective lactobacilli.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | GenSci142 Capsule |
| Company | GenSci (GeneScience Pharmaceutical), subsidiary of Changchun High‑Tech (000661.SZ) |
| Agency | NMPA (China) |
| Approval Type | Clinical trial approval (Category 1 biological product) |
| Indication | Bacterial vaginosis (BV) |
| Innovation | AI‑optimized antimicrobial; preserves lactobacilli; penetrates biofilms |
| Next Step | Initiate Phase I/II study Q2 2026 |
Drug Profile
- Mechanism: Directly disrupts bacterial cell wall, selectively and rapidly killing primary BV pathogens while fully preserving protective lactobacilli
- Biofilm Penetration: Can penetrate and dismantle biofilms, eliminating pathogen reservoirs and reducing recurrence risk
- Clinical Response: Potential to significantly alleviate symptoms within 12 hours
- Resistance Profile: Remains effective against metronidazole‑resistant infections (90% resistance rate)
- Administration: Local vaginal delivery, no systemic exposure, safe for use
- AI Optimization: Utilizes bioinformatics screening and AI‑driven molecular structure optimization
Market Context & Outlook
| Metric | Value |
|---|---|
| China BV Patients | ~30 million women annually (2024) |
| Current Standard | Metronidazole/clindamycin (80% share); 30‑50% recurrence rate |
| Metronidazole Resistance | 90% in some regions |
| BV Treatment Market Size (China) | ¥4.2 billion (US$580 million) |
| Growth CAGR | 9% (2024‑2030) |
| Peak Sales Forecast (GenSci142) | ¥2.0‑2.8 billion (~US$270‑380 million) by 2032 |
| Market Share Target | 15‑20% of metronidazole‑resistant or recurrent BV segment |
- Competitive Landscape: No approved non‑antibiotic BV therapies in China; GenSci142’s lactobacillus‑sparing and biofilm‑penetrating mechanism offers first‑in‑class differentiation
- Reimbursement Path: NMPA Category 1 status qualifies for Priority Review; potential NRDL inclusion based on superior efficacy vs. standard of care
- Strategic Value: Expands Changchun High‑Tech’s biologics portfolio beyond growth hormone; validates AI‑driven drug discovery platform
Forward‑Looking Statements
This brief contains forward‑looking statements regarding GenSci142’s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the women’s health market.-Fineline Info & Tech