SINO BIOPHARM(01177) 格隆汇·2025-05-29 12:30Core Viewpoint - China Biologic Products (01177.HK) announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and AG chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1][2] Group 1: Clinical Study Results - The TQB2868-ALTN-II-01 study evaluated the efficacy and safety of TQB2868 combined with Anlotinib and AG chemotherapy (Gemcitabine + Albumin-bound Paclitaxel) in mPDAC patients [1] - As of January 2025, 40 patients with stage IV mPDAC were enrolled, with 36 being evaluable; the objective response rate (ORR) was 63.9%, significantly higher than the historical data for AG chemotherapy (23%-36%) [1] - The disease control rate (DCR) reached 100%, compared to 62.3% for AG chemotherapy, and the 6-month progression-free survival (PFS) rate was 86%, double that of AG chemotherapy (43.2%) [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The safety profile of the TQB2868 combination therapy was favorable, with a rate of grade 3 or higher adverse reactions at 52.5%, lower than the 68.1%-77% range reported for AG chemotherapy [1] Group 3: Future Developments - The company is in communication with the Chinese National Medical Products Administration (NMPA) regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [2] - This combination therapy is anticipated to become the first-line treatment for pancreatic cancer using immune checkpoint inhibitors, potentially leading to significant improvements in overall survival and quality of life for patients [2]