{"id":43603,"date":"2025-10-16T16:59:20","date_gmt":"2025-10-16T08:59:20","guid":{"rendered":"https:\/\/flcube.com\/?p=43603"},"modified":"2025-10-16T16:59:21","modified_gmt":"2025-10-16T08:59:21","slug":"chia-tai-tianqing-secures-nmpa-approval-for-phase-iii-trial-of-tqb2868-anlotinib-in-first%e2%80%91line-mpdac-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43603","title":{"rendered":"Chia Tai Tianqing Secures NMPA Approval for Phase\u202fIII Trial of TQB2868 + Anlotinib in First\u2011Line mPDAC Therapy"},"content":{"rendered":"\n

Chia Tai Tianqing<\/strong>, a wholly\u2011owned subsidiary of Sino Biopharmaceutical<\/strong> (HKG: 1177<\/a>), announced today that the National Medical Products Administration (NMPA)<\/strong> has granted approval for its randomized, double\u2011blind, parallel\u2011controlled, multi\u2011center Phase\u202fIII clinical study. The trial evaluates TQB2868 injection<\/strong> combined with Anlotinib Hydrochloride capsules<\/strong> plus standard chemotherapy versus placebo plus chemotherapy as a first\u2011line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC)<\/strong>. The study has passed central ethics review and is now enrolling patients nationwide.<\/p>\n\n\n\n

Trial Highlights<\/h2>\n\n\n\n
Feature<\/th>Detail<\/th><\/tr><\/thead>
Study Design<\/strong><\/td>Randomized, double\u2011blind, parallel\u2011controlled, multi\u2011center Phase\u202fIII<\/td><\/tr>
Intervention<\/strong><\/td>TQB2868 + Anlotinib + chemotherapy vs. placebo + chemotherapy<\/td><\/tr>
Target Population<\/strong><\/td>First\u2011line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC)<\/td><\/tr>
Regulatory Status<\/strong><\/td>NMPA approval + central ethics clearance<\/td><\/tr>
Recruitment<\/strong><\/td>66 hospitals across China; nationwide enrollment underway<\/td><\/tr>
Key Agent<\/strong><\/td>TQB2868 \u2013 a dual\u2011functional fusion protein targeting PD\u20111 and TGF\u2011\u03b2 (Class\u202f1 therapeutic biologic)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

About TQB2868<\/h2>\n\n\n\n

TQB2868 is a next\u2011generation fusion protein engineered to simultaneously inhibit programmed death\u20111 (PD\u20111)<\/strong> immune checkpoints and transforming growth factor\u2011\u03b2 (TGF\u2011\u03b2)<\/strong> 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\u2011promoting 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.<\/p>\n\n\n\n

Strategic Impact<\/h2>\n\n\n\n