89bio lines up China CDMO to build API plant for commercial production of MASH candidate

As it investigates a promising candidate to treat metabolic dysfunction-associated steatohepatitis (MASH), 89bio is laying the bricks to manufacture and commercialize the potential treatment.

Now, the San Francisco-based liver and cardiometabolic disease specialist has struck a deal with a China CDMO to build a plant that will produce the bulk active ingredient for pegozafermin.

89bio will pay BiBo Biopharma Engineering $135 million to construct the facility, with 45% of the payment due in the third quarter of this year and the rest tied to the achievement of certain milestones. 89bio revealed the agreement, which was made in February, in a securities filing this week.

BiBo Pharma, which was established in 2015, operates R&D centers in Boston and Shanghai. Its setup in China includes two manufacturing centers that produce 20-plus commercial-stage projects.

89bio’s plant will be part of BiBo’s third manufacturing center in Shanghai, dubbed the Lin-gang Special Area. BiBo can provide services ranging from DNA sequencing to commercial launch assistance.

Last month, 89bio announced that its first of two phase 3 studies of pegozafermin was underway. A year ago, the company revealed data from a phase 2b trial that indicated its FGF21 analog treatment was in step with another in-class candidate, Akero Therapeutics’ efruxifermin, demonstrating improvement in fibrosis without a worsening of MASH compared to placebo.

Two weeks ago, the European Medicines Agency granted priority medicines status to pegozafermin for the treatment of MASH. The FDA has blessed it with a breakthrough-therapy designation.

Also last month, Madrigal Pharmaceuticals gained FDA approval for its MASH drug Rezdiffra, the first treatment approved in the indication. The oral thyroid receptor beta-agonist has peak sales potential of $5.5 billion, according to analysts at Evercore ISI.