China suspends imports of Bristol Myers Squibb's cancer drug Abraxane over findings at US plant

China's National Medical Products Administration (NMPA) suspended the importation, sales and use of Bristol Myers Squibb's Abraxane (nab-paclitaxel) in the country based on "inspection findings" at the drugmaker's contract manufacturing facility in the US. BeiGene, which disclosed the ban on Wednesday, said that as the marketing agent for Abraxane in China, it is working with Bristol Myers Squibb to restore supply in China "as soon as possible."

Meanwhile, the US drugmaker noted that "this decision only applies to the China market and does not impact our ability to supply Abraxane outside of China."

BeiGene did not elaborate on what specifically prompted the NMPA to issue the order, but indicated that actions being done to reinstate Abraxane include "remediation efforts" at the current facility. In addition, Bristol Myers Squibb is also seeking NMPA approval to source its supply for the China market from an alternative manufacturing site, with that application currently under review by the regulator.

"We are extremely disappointed by this interruption in drug supply" in China, commented BeiGene CEO John Oyler. He added that his company is working with Bristol Myers Squibb "to determine corrective actions for this situation as quickly as possible." In the meantime, Oyler said BeiGene "remains focused on the ongoing launches of our other products in China and the US." The Beijing-based drugmaker said the NMPA inspection findings do not impact any other drugs marketed by BeiGene, noting that none of its other products are made at the US facility in question.

Abraxane generated sales of $1.2 billion for Bristol Myers Squibb in 2019. BeiGene and Celgene, which has since been acquired by Bristol Myers Squibb, entered into an exclusive license and supply agreement for Abraxane and two other cancer medicines in China in 2017 as part of a broader strategic collaboration.

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