89bio’s $135M Deal with BiBo Biopharma for Pegozafermin Production

• 89bio, a San Francisco-based liver and cardiometabolic disease specialist, has partnered with China’s BiBo Biopharma Engineering to construct a facility for producing pegozafermin, a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH).

• The new plant will be part of BiBo’s third manufacturing center in Shanghai, known as the Lin-gang Special Area.

89bio, a San Francisco-based liver and cardiometabolic disease specialist, is making strides in the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The company has recently partnered with China’s BiBo Biopharma Engineering to construct a facility that will produce the bulk active ingredient for pegozafermin, a promising candidate for MASH treatment.

The deal, which was struck in February and revealed in a securities filing this week, involves a payment of $135 million by 89bio to BiBo. The payment schedule is structured such that 45% is due in the third quarter of this year, with the remainder tied to the achievement of certain milestones.

The new plant will be part of BiBo’s third manufacturing center in Shanghai, known as the Lin-gang Special Area. BiBo, established in 2015, operates R&D centers in Boston and Shanghai and has two manufacturing centers in China that produce over 20 commercial-stage projects. The company offers a range of services from DNA sequencing to commercial launch assistance.

In a statement, 89bio announced, “Our first of two phase 3 studies of pegozafermin is underway.” This follows data from a phase 2b trial a year ago that showed its FGF21 analog treatment demonstrated improvement in fibrosis without a worsening of MASH compared to placebo.

The European Medicines Agency granted priority medicines status to pegozafermin for the treatment of MASH two weeks ago, and the FDA has given it a breakthrough-therapy designation. This comes as Madrigal Pharmaceuticals gained FDA approval for its MASH drug Rezdiffra, the first treatment approved in the indication, last month.