By Fineline Cube 
China‑based Qilu Pharmaceutical Co., Ltd. announced that it has opened enrollment for its first‑in‑class QLS31905 Phase III study, the company’s registration‑enabling trial for the first‑line treatment of Claudin18.2‑positive advanced pancreatic cancer.
What Is QLS31905?
- Bispecific T‑cell engager that simultaneously binds Claudin18.2 on tumor cells and CD3 on T‑cells.
- Mechanism – Recruits and activates patient T‑cells at the tumor site, driving continuous cancer‑cell lysis without the need for ex vivo cell manipulation.
- In‑house Development – One of the few truly novel bispecific antibodies coming from a domestic Chinese biopharma.
Trial Design
| Feature | Details |
|---|---|
| Phase | III |
| Design | Multicenter, double‑blind, placebo‑controlled, randomized |
| Treatment Arms | QLS31905 + albumin‑bound paclitaxel + gemcitabine vs. placebo + same chemo |
| Population | Adults with Claudin18.2‑positive, unresectable or metastatic pancreatic adenocarcinoma |
| Investigators | Prof. Shen Lin (Beijing Cancer Hospital) & Prof. Hao Jihui (Tianjin Medical University Cancer Institute) |
| Primary Endpoint | Overall survival and progression‑free survival |
| Safety Assessment | Comprehensive AE monitoring, cytokine‑release syndrome surveillance |
Why This Matters
- First‑Ever Claudin18.2/CD3 Bispecific in Phase III – Marks a significant milestone in targeted immunotherapy for a disease historically refractory to treatment.
- Combination Strategy – Leveraging standard chemotherapy (paclitaxel + gemcitabine) may enhance tumor antigen presentation and T‑cell activation, potentially improving clinical outcomes.
- Domestic Innovation – Demonstrates China’s growing capacity to develop sophisticated biologics that can compete on the global stage.
Next Steps
- Recruitment Target – 600–800 patients across > 30 sites in China.
- Data Cut‑off – Scheduled for Q3 2026, with results expected in early 2027.
- Regulatory Filing – Pending positive outcomes, Qilu plans a global submission strategy (FDA/EMA) to expand access.-Fineline Info & Tech