Sino Biopharm Introduces Lanifibranor, a Potential BIC NASH Oral Treatment

Release time:2022-09-22

On September 22, Sino Biopharm announced that on September 21, 2022, a subsidiary of the Group, ChiaTai Tianqing Pharmaceutical Group Company Limited (CTTQ), entered into a formal license agreement with Inventiva S. A. (Inventiva) to develop, manufacture and commercialize lanifibranor in mainland China, Hong Kong, Macau and Taiwan (Greater China region). Lanifibranor, Inventiva's core product for the treatment of non-alcoholic steatohepatitis (NASH) and other underlying metabolic diseases.



Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule drugs in the areas of NASH, mucopolysaccharidosis and other areas of unmet clinical need. CTTQ will make an initial payment of US$12 million and potential clinical and registration milestone payments of up to US$40 million to Inventiva for the exclusive license of the product in Greater China. Upon approval of the product in Greater China, CTTQ will pay additional commercialization milestone payments and a tiered commission based on net sales in Greater China.


Reasons for Collaboration


The introduction of this product by Sino Biopharm will further enrich the Group's innovation pipeline, improve the Group's presence in NASH and provide better treatment options for liver disease patients in China. NASH is an area of significant unmet clinical need and one of the fastest growing causes of cirrhosis and liver cancer globally. By 2025, the number of new cases of NASH in China may reach 2 million per year, with no approved treatment modalities available. This product is a late-stage development asset currently in Phase III clinical trials in the U.S. and is expected to be the first FDA-approved oral drug for NASH with potential best-in-class efficacy, filling a gap in the global NASH market.


About lanifibranor


Lanifibranor is an orally administered small molecule drug that benefits vascular and metabolic changes by activating three peroxisome proliferator-activated receptor (PPAR) subtypes that modulate antifibrotic, anti-inflammatory pathways in human. PPARs are nucleotide receptors that regulate multiple processes related to lipid metabolism, glucose homeostasis and insulin signaling. As a PPAR agonist, it targets all three PPAR subtypes with moderate potency, including balanced activation of PPARα and PPARδ, and partial activation of PPARγ. It is the most advanced pan-PPAR agonist in clinical development for the treatment of NASH compared to other PPAR agonists that target only one or two PPAR subtypes. Inventiva believes that lanifibranor's moderate and balanced pan-PPAR binding profile will result in a well-tolerated drug, as evidenced in both clinical trials and preclinical studies to date.


In the NATIVE Phase IIb study, lanifibranor met the primary and key secondary endpoints of NASH improvement with no worsening of fibrosis and fibrosis improvement with no worsening of NASH in patients with F1-F3 NASH, which was published in the New England Journal of Medicine. lanifibranor is the first oral drug candidate to achieve statistically significant results in both of the primary clinical endpoints recommended by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which facilitated its application for accelerated U.S. approval and conditional EU approval in Phase III clinical development. NatiV3 is the pivotal Phase III trial for lanifibranor in F2/F3 NASH and the FDA has granted Breakthrough Therapy Designation and Fast Track status to lanifibranor for NASH.