By Fineline Cube 
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with disitamab vedotin for the treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC). The approval encompasses patients with HER2 immunohistochemistry results of 1+, 2+, or 3+.
Regulatory Approval & Clinical Evidence
| Parameter | Detail |
|---|---|
| Regulatory Agency | National Medical Products Administration (NMPA), China |
| Drug Combination | Toripalimab + disitamab vedotin |
| Indication | HER2-expressing (IHC 1+/2+/3+) locally advanced or metastatic urothelial carcinoma |
| Trial Design | Phase III RC48-C016: multi-center, randomized, open-label, positive-controlled |
| Patient Population | First-line treatment for HER2-expressing advanced UC |
| Primary Endpoints | Progression-free survival (PFS) and overall survival (OS) – dual-primary endpoint positive results |
Pivotal Phase III Results
| Endpoint | Toripalimab + Disitamab Vedotin | Conventional Chemotherapy | Benefit |
|---|---|---|---|
| Median PFS | 13.1 months | 6.5 months | HR=0.36 (95% CI: 0.28-0.46; p<0.0001) |
| Median OS | 31.5 months | 16.9 months | HR=0.54 (95% CI: 0.41-0.73; p<0.0001) |
| Objective Response Rate (ORR) | 76.1% | 50.2% | +25.9 percentage points |
| Median Duration of Response | 14.6 months | 5.6 months | 2.6-fold improvement |
| Safety Profile | Significantly improved compared to conventional chemotherapy | Standard chemotherapy toxicity profile | Enhanced tolerability |
Strategic Significance & Market Impact
- Therapeutic Innovation: This approval represents the first combination regimen of a PD-1 inhibitor with an antibody-drug conjugate specifically for HER2-expressing urothelial carcinoma in China
- Broad HER2 Definition: Inclusion of HER2 IHC 1+, 2+, and 3+ patients significantly expands the treatable population beyond traditional HER2-positive definitions
- Clinical Leadership: Loqtorzi (toripalimab) continues its expansion as China’s first domestically developed PD-1 inhibitor, now with multiple approved indications across various tumor types
- Global Development Platform: With over 40 clinical studies initiated globally covering more than 15 indications, toripalimab demonstrates robust development momentum and international recognition
- Commercial Opportunity: Urothelial carcinoma represents a significant market segment with high unmet need, particularly in the first-line metastatic setting where this combination demonstrates unprecedented survival benefits
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, clinical outcomes, and commercial expectations for Loqtorzi. Actual results may differ due to risks including market competition, pricing dynamics, and evolving treatment guidelines.-Fineline Info & Tech