The board of directors (the "Board") of Sino Biopharmaceutical Limited (the "Company", together with its subsidiaries, the "Group") announces that TQB3454 tablet "IDH1 inhibitor", a national Category 1 innovative drug independently developed by Chia Tai Tianqing Pharmaceutical Group Co. Ltd. ("CTTQ"), a subsidiary of the Group, has been included in the priority review and approval procedures by the Center for Drug Evaluation (the "CDE") of the China's National Medical Products Administration for the treatment of patients with locally advanced, recurrent and/or metastatic biliary tract cancer (BTC) harbouring IDH1 mutations, who have failed treatment with gemcitabine- and fluorouracil-based regimens. TQB3454 is an IDH1 inhibitor that specifically targets and inhibits the IDH1 mutant enzyme, thereby reducing downstream 2-HG levels and alleviating the DNA and histones hypermethylation caused by abnormally elevated 2-HG. This restores normal chromatin structure, prompting mutated cells to return to normal differentiation and development processes, thereby achieving an anti-tumour effect. In March 2026, the Group announced that the Phase III clinical trial of TQB3454 (TQB3454-III-01) in patients with advanced BTC harbouring IDH1 mutations had met its primary endpoints in a pre-specified interim analysis, with both progression-free survival (PFS) and overall survival (OS) reaching the protocol-specified superiority thresholds. The interim analysis results demonstrated that, compared with the control group, TQB3454 significantly reduced the risk of disease progression or death in patients with advanced BTC, and significantly prolonged PFS and OS. The safety profile was consistent with known risks, and no new safety signals were identified. The Group plans to present the detailed data at a major international academic conference within this year. This is the second successful Phase III clinical study of an IDH1 inhibitor for the BTC in the world, and the first one in China. TQB3454 is also the
first domestically developed IDH1 inhibitor to complete a Phase III clinical trial, and is expected to fill the clinical gap in precision targeted therapy for IDH1-mutated BTC in China. BTC accounts for approximately 3% of all gastrointestinal tumours. Most cases are adenocarcinomas, characterised by high invasiveness and poor prognosis, with a five-year survival rate of less than 5%. The global incidence of BTC is on the rise, with the highest incidence observed in Asian countries. Among patients with intrahepatic BTC, the incidence of IDH1 mutations ranges from 13% to 17%. TQB3454 was granted breakthrough therapy designation by the CDE in April 2023. Its inclusion in the priority review and approval process marks a pivotal milestone for the drug's progression from the clinical stage towards marketing approval stage. Currently, no drugs targeting the same pathway have been approved for the treatment of BTC in China, and there remains a significant unmet clinical need in this field. Furthermore, TQB3454 has demonstrated promising clinical development potential in various solid tumours, including glioma and chondrosarcoma, and is expected to provide a novel precision targeted therapy for patients harbouring IDH1 mutations.