百奥泰生物制药股份有限公司自愿披露关于注射用BAT7111获得药物临床试验批准通知书的公告

Core Viewpoint - Baiotai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of BAT7111, a drug intended for the treatment of advanced solid tumors [2][3] Group 1: Clinical Trial Approval - The drug BAT7111 is a PD-1/4-1BB bispecific antibody developed by the company, aimed at treating advanced solid tumors [3] - The clinical trial application for BAT7111 was accepted on February 12, 2025, and has been approved to proceed with clinical trials [2][3] Group 2: Drug Composition and Mechanism - BAT7111 consists of a recombinant humanized anti-PD-1 antibody and a fully human 4-1BB single-domain antibody, which can block the PD-1/PD-L1 immune suppression pathway and activate immune cells [3] - The design of differential affinity for PD-1 antibodies and 4-1BB antibodies aims to enhance safety and potentially improve the efficacy of existing PD-1 therapies [3] Group 3: Clinical Development Insights - According to data from "Clinical Development Success Rates 2011-2020," the typical duration for Phase I/II clinical trials for anti-tumor drugs is about 2 years, with a 48.8% transition rate from Phase I to II and a 24.6% transition rate from Phase II to III [2][5] - The company will analyze trial data to determine the safety and efficacy of the drug, which will inform the progression of subsequent clinical trials [5]