Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that separate clinical trial filings for its Category 1 product candidates ZG2001 and ZG0895 have both been accepted for review by the National Medical Products Administration (NMPA) in China. This marks a significant milestone in the development of these innovative drug candidates.
ZG2001: KRAS Mutation Inhibitor
ZG2001 is an in-house developed oral pan-KRAS mutation inhibitor being developed to treat KRAS mutant tumors. The molecule has demonstrated good anti-tumor effects in both in vivo and in vitro tests and has shown significant synergistic anti-tumor effects when combined with KRAS G12C, MEK, and other inhibitors. Notably, there are no drugs with the same mechanism of action currently marketed anywhere in the world.
ZG0895: TLR8 Agonist
ZG0895 is a self-developed highly selective toll-like receptor (TLR8) agonist designed to treat advanced solid tumors. The drug has shown excellent TLR8 agonist activity in both in vivo and in vitro pharmacological and pharmacodynamic studies. It can selectively activate TLR8, stimulate the secretion of TLR8-related cytokines, and induce the apoptosis of bone marrow-derived inhibitory cells (MDSCs). This mechanism helps reverse immunosuppression, inhibit tumor growth, and enhance anti-tumor immunity. ZG0895 has demonstrated excellent anti-tumor activity in various in vivo models and can cause tumor regression. After subcutaneous injection, ZG0895 exhibits unique pharmacokinetic characteristics, reducing the risk of continuous activation of the systemic immune system once the drug enters the circulatory system, and has shown good safety. There is no similar product approved for marketing anywhere around the world.-Fineline Info & Tech
