By Fineline Cube 
Chia Tai Tianqing, a wholly‑owned subsidiary of Sino Biopharmaceutical (HKG: 1177), announced today that the National Medical Products Administration (NMPA) has granted approval for its randomized, double‑blind, parallel‑controlled, multi‑center Phase III clinical study. The trial evaluates TQB2868 injection combined with Anlotinib Hydrochloride capsules plus standard chemotherapy versus placebo plus chemotherapy as a first‑line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The study has passed central ethics review and is now enrolling patients nationwide.
Trial Highlights
| Feature | Detail |
|---|---|
| Study Design | Randomized, double‑blind, parallel‑controlled, multi‑center Phase III |
| Intervention | TQB2868 + Anlotinib + chemotherapy vs. placebo + chemotherapy |
| Target Population | First‑line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) |
| Regulatory Status | NMPA approval + central ethics clearance |
| Recruitment | 66 hospitals across China; nationwide enrollment underway |
| Key Agent | TQB2868 – a dual‑functional fusion protein targeting PD‑1 and TGF‑β (Class 1 therapeutic biologic) |
About TQB2868
TQB2868 is a next‑generation fusion protein engineered to simultaneously inhibit programmed death‑1 (PD‑1) immune checkpoints and transforming growth factor‑β (TGF‑β) signaling, pathways known to drive immunosuppression in the pancreatic tumor microenvironment. By combining these two modalities, TQB2868 aims to enhance antitumor immunity while mitigating tumor‑promoting fibrosis. In preclinical models, the agent has shown potent tumor growth inhibition and synergistic effects when paired with vascular endothelial growth factor (VEGF) pathway inhibitors such as Anlotinib.
Strategic Impact
- First‑Mover Advantage – This will be the first large‑scale, head‑to‑head evaluation of a dual PD‑1/TGF‑β inhibitor in combination with a tyrosine‑kinase inhibitor for mPDAC.
- Pipeline Expansion – Successful results could accelerate Chia Tai Tianqing’s expansion into other solid‑tumor indications where immunosuppression limits therapeutic efficacy.
- Commercial Potential – mPDAC remains one of the most lethal cancers; an effective first‑line therapy would address a significant unmet medical need.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech