Zelgen(SH:688266) Shang Hai Zheng Quan Bao·2025-08-20 19:39Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005 combined with JAK inhibitor and chemotherapy for advanced solid tumors [2][5]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized dual-specificity antibody targeting PD-1 and TIGIT, classified as a Category 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]. - ZG005 works by blocking both PD-1 and TIGIT pathways, enhancing T-cell activation and proliferation, thereby improving the immune system's ability to kill tumor cells [3]. - Hydrochloride JAK inhibitor (previously known as JAK inhibitor) is a new dual inhibitor developed by the company, classified as a Category 1 new drug, with independent intellectual property rights. It is the first domestic JAK inhibitor approved for treating myelofibrosis [4]. Group 2: Clinical Trial and Market Impact - The approval for the clinical trial of injectable ZG005 and JAK inhibitor combined with chemotherapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5]. - The JAK inhibitor is also undergoing multiple key clinical studies for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis, and has received support from national major new drug creation projects [4].