By Fineline Cube 
SciClone Pharmaceuticals Inc. announced that Meropenem/Vaborbactam for Injection has been approved under the “Hong Kong-Macau Drug and Device Access” policy for use in designated medical institutions across the Greater Bay Area (GBA) mainland cities, marking the first antibiotic introduced through the GBA Medical Connect scheme and offering a breakthrough treatment for Carbapenem-resistant Enterobacterales (CRE) infections.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Meropenem/Vaborbactam for Injection |
| Company | SciClone Pharmaceuticals Inc. |
| Agency | NMPA (via GBA Medical Connect policy) |
| Approval Type | Access approval for designated GBA medical institutions |
| Indications | Serious infections caused by CRE and other resistant bacteria |
| Significance | First antibiotic approved under GBA Medical Connect |
| Global Status | Approved in EU (cUTI, cIAI, HAP/VAP, bacteremia) and US (cUTI); HK/Macau approved Apr 2024 |
Drug Profile
- Mechanism: Novel β‑lactam/β‑lactamase inhibitor combination (carbapenem meropenem + cyclic boronic acid vaborbactam)
- Innovation: Blocks Class A and Class C serine carbapenemases, restoring meropenem activity against resistant strains
- Administration: Intravenous injection
- Strategic Value: Addresses unmet need in China’s growing CRE infection burden
Market Context & Outlook
| Metric | Value |
|---|---|
| China CRE Infection Incidence | ~80,000‑100,000 cases annually |
| Current Treatment Gap | Limited options; polymyxins and tigecycline have toxicity concerns |
| Market Size (CRE Antibiotics) | ¥1.2 billion (US$165 million) in 2024 |
| Growth CAGR | 18% (2024‑2030) |
| Pricing | Expected ¥3,000‑4,000 per treatment course |
| Peak Sales Forecast | ¥400‑600 million (US$55‑82 million) by 2028 |
| Competitive Edge: First novel CRE therapy accessible in mainland China via GBA pathway; potential for national approval within 24 months | |
| Partnership: Exclusive mainland China rights from Menarini Asia-Pacific (licensed Aug 2022) |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Meropenem/Vaborbactam’s GBA market penetration, national approval timeline, and sales potential. Actual results may differ materially due to risks including regulatory pathway changes, competitive entry, and hospital adoption rates.-Fineline Info & Tech