U.S. biotechnology company 89bio (NASDAQ: ETNB) has secured the services of China-based Contract Development and Manufacturing Organization (CDMO) BiBio Biopharma Engineering to construct an API facility in China. The facility will supply the active pharmaceutical ingredient (API) for 89bio’s lead pipeline candidate, pegozafermin, an investigational FGF21 analog currently in Phase III development for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
According to an SEC filing from 89bio, BiBio will receive a payment of USD 135 million for the construction of the new facility dedicated to the commercial supply of pegozafermin. Under the terms of the deal signed in February this year, 45% of the payment is due in Q3 2024, with the remaining amount structured against milestones. BiBio, which operates in both Shanghai and Boston, U.S., will establish the facility in Shanghai’s Lin-gang Special Area, a free-trade zone.
Last month, 89bio announced the commencement of a Phase III study for pegozafermin targeting non-cirrhotic MASH patients with fibrosis. Additionally, the drug candidate has been granted Priority Medicines (PRIME) status by the European Medicines Agency, indicating its potential to address unmet medical needs.- Flcube.com
