China’s drugs regulator has suspended the import and sale of Bristol Myers Squibb’s cancer drug Abraxane, citing findings from an inspection of a U.S. contract manufacturing facility that produces the therapy for the pharma.Beigene, a Chinese biotech which markets the drug in the country, disclosed the decision, saying in a Mar. 25 statement that it’s bracing for a disruption in supply of the chemotherapy.The Chinese drugmaker said it’s working with Bristol Myers to fix the situation as “quickly as possible.” Bristol Myers is also applying to the China National Medical Products Administration for permission to source Abraxane from an alternate drug plant.
The import alert from the NMPA is a twist in the usual story of the U.S.-China supply chain for medicines.
The Food and Drug Administration has repeatedly flagged Chinese plants for failing to meet regulatory standards as they worked to make drug ingredients for the U.S. market. This time, it is China’s regulator that’s warning of manufacturing questions about a U.S.-produced drug sold in China.
BeiGene didn’t give any details about the flaws discovered at the U.S. manufacturing facility and referred questions about the inspection to Bristol Myers.
“We are working closely with the Chinese health authorities and the manufacturing site to implement corrective actions and preventive measures to address their findings,” a spokesperson for Bristol Myers said in a statement to BioPharma Dive. “In parallel, we are pursuing licensure of an alternate manufacturing site as part of the path forward in China.”
Bristol Myers makes Abraxane for the U.S. market at a former Celgene site in Arizona, while outsourcing production for China to Fresenius Kabi, according to Wall Street analysts who follow the company.
The biotech Celgene originally developed Abraxane, which is used to treat lung, breast and pancreatic cancers. Bristol Myers acquired the medicine as part of its $74 billion acquisition of Celgene last year.
Celgene and BeiGene partnered in 2017, with BeiGene securing rights in China to Abraxane and two other cancer medicines. BeiGene promotes and distributes Abraxane, while Bristol Myers is responsible for manufacturing the drug.
BeiGene, which recently inked a major deal with Amgen, is a leading Chinese biotech and last year won U.S. approval for Brukinsa, a cancer drug it developed.
BeiGene said the NMPA findings don’t affect any other products that it markets.
Celgene reported third-quarter sales of Abraxane reached $318 million, before its acquisition by Bristol Myers. The medicine had sales of $166 million between the deal’s closing date of Nov. 20, 2019 and the end of the year, Bristol Myers said.
