Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the commencement of Phase III and Phase II clinical studies for two of its drug candidates. Lanifibranor, a PPAR agonist, and TQA2225, an FGF21-Fc fusion protein, are both being evaluated as potential treatments for metabolic dysfunction-associated steatohepatitis (MASH).
Lanifibranor is designed to target all three PPAR isoforms with a balanced activation profile, moderately potently activating PPARα and PPARδ, and partially activating PPARγ. In the NATIVE Phase IIb study for MASH, lanifibranor achieved both primary and key secondary endpoints, demonstrating effective improvement in subjects without worsening of fibrosis, amelioration of fibrosis, and no deterioration of MASH. The drug has been granted breakthrough therapy designation (BTD) and fast-track status in the US, as well as BTD status in China. Lanifibranor is currently undergoing a global Phase III study for F2/F3 stage MASH.
TQA2225, in comparison to other drugs targeting the same pathway, utilizes pure natural human FGF21, which minimizes potential immunogenicity and offers a good safety profile. The drug employs a unique linker platform technology that extends the in vivo half-life of FGF21 while maintaining its biological activity. Clinical studies have indicated that FGF21 signaling can reverse many pathogenic characteristics of MASH, potentially reversing fibrosis, reducing liver fat, and improving blood sugar control.- Flcube.com
