Zelgen(SH:688266) Shang Hai Zheng Quan Bao·2025-08-21 20:09Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005, ZGGS18, and JAK inhibitor Jika Xini tablets in combination for advanced solid tumors [2][3]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 1 innovative tumor immunotherapy product, with potential applications for various solid tumors. It is one of the first drugs globally to enter clinical research targeting the same mechanism [3][4]. - Injectable ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF and TGF-β, also classified as a Class 1 therapeutic biological product, expected to be an innovative treatment for solid tumors [4][5]. - JAK inhibitor Jika Xini tablets, developed by the company, are a new Class 1 drug with independent intellectual property rights. They have received NDA approval for treating high-risk myelofibrosis and are undergoing clinical trials for other indications [5][6]. Group 2: Clinical Trial Approval Impact - The approval for the clinical trial of the combination therapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development and approval processes [2][7]. - The company will actively promote the research projects in accordance with national regulations and fulfill information disclosure obligations regarding subsequent project developments [7][8].