Gelonghui, March 15 | China Biopharmaceutical (01177.HK) announced that “ranilano” (pan-PPAR agonist) and “TQA2225" (recombinant human FGF21-FC fusion protein) jointly developed by the group are currently undergoing phase III and phase II clinical trials in China, respectively, to treat fatty hepatitis with metabolic related dysfunction.

Lanilano is an oral small molecule drug that regulates anti-fibrosis and anti-inflammatory pathways in the body by activating three peroxisomal proliferator-activated receptor (“PPAR”) subtypes. In the NativeIb study, patients treated with F1-F3MASH by La Nilano reached primary and key secondary endpoints, including MASH improvement without worsening fibrosis, improvement in fibrosis, and no worsening of MASH. The results of the study were published in the New England Journal of Medicine. La Nilano is the first oral drug candidate recommended by the US Food and Drug Administration (“FDA”) and the European Medicines Agency (EMA) to achieve statistically significant results at both major clinical endpoints. The FDA has granted La Nilano a breakthrough therapy certification and fast track qualification for MASH.

In March 2023, La Nilano submitted a clinical trial application to the Drug Evaluation Center (“CDE”) of the China National Drug Administration (“CDE”) and was accepted. In July, La Nilano was included in the CDE list of breakthrough treatment varieties. Currently, La Nilano is undergoing phase III clinical trials globally to treat F2/F3MASH patients. The Group's partner, Inventiva, announced the resumption of enrollment of international participants in the La Nilano Phase III clinical trial on March 7, 2024, and is expected to complete enrollment of all subjects in 2024. Lanilano is the first MASH oral drug to enter clinical phase III in China. The Group will accelerate clinical research and development and strive to fill the gap in the Chinese MASH market as soon as possible.

TQA2225 is an all-human long-acting fibroblast growth factor 21 (“FGF21") fusion protein. Compared with other similar target drugs, TQA2225 uses pure natural human FGF21 as the active form, reducing possible immunogenicity and having good safety. Furthermore, TQA2225 uses unique connecting sub-platform technology to extend the half-life of FGF21 in vivo on the basis of preserving human FGF21 biology. It is the world's first all-human long-term FGF21 fusion protein to enter the clinical stage.

Clinical studies have shown that FGF21 signaling can reverse many characteristics of the pathogenesis of MASH, and has the potential to reverse fibrosis, reduce liver fat, and improve blood sugar control. Recently, an overseas biotechnology company published phase IIb clinical data for the same target product. The results showed that FGF21 fusion protein can significantly improve liver fibrosis and has the potential to become the best drug in its class for MASH treatment.

Currently, TQA2225 is undergoing phase II clinical trials in China to treat MASH. TQA2225 is the product with the fastest development progress among same-target drugs in China. It is expected to become the first FGF21 fusion protein to be marketed in China. The Group will accelerate the enrollment of TQA2225 subjects and strive to resolve unmet patient needs as soon as possible.