By Fineline Cube Marubeni Pharmaceuticals (China) Co., Ltd. (formerly Sumitomo Pharma China) announced the initiation of commercialization for Xenleta (lefamulin acetate) in China, with a market launch slated for April 2026. The first‑in‑class pleuromutilin antibiotic for community‑acquired pneumonia (CAP) concludes a multi‑year licensing journey involving Nabriva, Sinovant Sciences, and Sumitomo Pharma.
Licensing History Evolution
| Year | Milestone | Parties Involved |
|---|---|---|
| 2018 | Nabriva licenses Greater China rights to Sinovant Sciences | Nabriva → Sinovant (CITIC/Roivant JV) |
| May 2021 | Sinovant assigns license to Sumitomo (Suzhou) | Sinovant → Sumitomo (terms unchanged) |
| 2023 | Sumitomo Pharma acquires full rights from Nabriva | Sumitomo ← Nabriva (Mainland China, HK, Macau, Taiwan) |
| Nov 2023 | Category 5.1 lefamulin approved for marketing | Sumitomo Pharma (Suzhou) submission |
| Jun 2025 | Category 4 chemical drug approval (local transfer) | Sumitomo Pharma Group submission |
| Apr 2026 | Commercial launch (planned) | Marubeni Pharmaceuticals (China) |
Product Profile & Market Position
| Item | Detail |
|---|---|
| Drug | Xenleta (lefamulin acetate) |
| Originator | Nabriva Therapeutics |
| Mechanism | First‑in‑class pleuromutilin antibiotic |
| Indication | Community‑acquired pneumonia (CAP) |
| US Approval | FDA approved 2019 |
| China Regulatory Status | Category 4 chemical drug (locally transferred) |
| Launch Timeline | April 2026 |
Market Impact & Commercial Outlook
- China CAP Market: Valued at ¥15 billion : (~US$2.1 billion) in 2025; novel antibiotics represent ~8% : of market but growing due to resistance concerns
- Competitive Landscape: Competes with fluoroquinolones and macrolides; Xenleta’s novel mechanism offers advantage against resistant pathogens
- Strategic Value: Marubeni’s launch completes the licensing circle, leveraging Sumitomo’s established China infrastructure; positions company as a credible player in anti‑infectives
- Revenue Potential: Analysts project ¥200–350 million (US$28–49 million) peak annual sales by 2028, assuming 5% share of premium CAP segment
- Next Steps: Distribution agreements with major hospital groups to be finalized Q1 2026; medical affairs team to conduct physician education programs
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for Xenleta. Actual results may differ due to competitive dynamics, hospital formulary access, and reimbursement negotiations.-Fineline Info & Tech