BeiGene scrambles to find new Abraxane supplier as Chinese inspectors order halt on imports, citing Bristol Myers failure
In a slap in the face aimed right at one of the world’s largest drugmakers, BeiGene $BGNE said today that it is being forced by Chinese officials to halt imports of the cancer drug Abraxane.
According to the China-based BeiGene, the China National Medical Products Administration — or NMPA — ordered the halt following an inspection of one of Bristol Myers’ US facilities used to make the drug. That’s a rare event in the global drug making world, where the FDA is known for its regular citations for overseas drug manufacturers.
BeiGene did not explain what the Chinese officials found in the inspection that caused the problems for Abraxane. But the company said it’s scrambling to find another supplier for the drug, which it licensed from Celgene, as they try to resolve the issues raised by Chinese inspectors.
According to a Bristol Myers spokesman:
A recent inspection of the Chinese governmental body at a third-party manufacturing site that produces Abraxane for the China market identified opportunities for improvement. We are working closely with the Chinese health authorities and the manufacturing site to implement corrective actions and preventive measures to address their findings. In parallel, we are pursuing licensure of an alternate manufacturing site as part of the path forward in China.
Analysts were quick to seize on this as a possible issue for investors who own some of Bristol Myers’ $9 CVRs from the Celgene buyout. The CVR is based on a schedule of FDA approvals on 3 drugs over the next year.
Relations between China and the US have been fraught with tension ever since Donald Trump became president and began to pressure China to make some fundamental changes in the way they handle exports to the US. Recently, that pressure has watched up during the pandemic. But China, which was hit first by the outbreak, has been the first to declare victory over the coronavirus.