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

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.