北京天坛生物制品股份有限公司关于下属企业药品临床试验进展的公告

Group 1 - The core point of the announcement is that Beijing Tiantan Biological Products Co., Ltd. has completed Phase I clinical trials for its "Recombinant Human Coagulation Factor VIII-Fc Fusion Protein" and obtained the clinical trial summary report [1][2]. - The product demonstrated a pharmacokinetic half-life approximately 1.5 to 1.7 times longer than the control drug in adult and adolescent patients with severe hemophilia A, indicating potential clinical benefits [1]. - The product showed a significant reduction in activated partial thromboplastin time (APTT), which is beneficial for clinical hemostasis, and had a low incidence of adverse reactions consistent with similar products [1]. Group 2 - The product still needs to undergo Phase III clinical trials, submit a drug marketing application, and obtain approval from the National Medical Products Administration before it can be marketed [2]. - There are currently no domestic or imported products of this type available in the market, indicating a potential market opportunity for the company [3].