The marketing agent for China, BeiGene, announced the China National Medical Products Administration (NMPA) suspended the importation, sales and use of ABRAXANE.
The marketing agent for ABRAXANE® (nanoparticle albumin-bound paclitaxel), an immuno-oncology medication, in China has announced that the China National Medical Products Administration (NMPA) suspended the importation, sales and use of ABRAXANE in China.
BeiGene Ltd., who is supplied the medication by Celgene Corporation, a Bristol Myers Squibb (BMS) company, stated that the suspension is based on inspection findings at BMS’s contract manufacturing facility in the United States. BeiGene revealed they expect disruptions to the ABRAXANE supply in China and are working closely with BMS to restore supply.
Currently BMS is working on remedying the situation at the present manufacturing site but has also applied for NMPA approval to source its ABRAXANE supply for the China market from an alternative manufacturing facility.
“As the marketing agent for ABRAXANE in China, we are extremely disappointed by this interruption in drug supply,” said John Oyler, Chairman, Co-Founder and Chief Executive Officer of BeiGene. “At BeiGene, the quality of our medicines is of the utmost importance and we hold ourselves and our partners to the highest global industry standards. We are working with BMS to determine corrective actions for this situation as quickly as possible. We remain focused on the ongoing launches of our other products in China and the US and the development of potential new treatments for patients worldwide.”
BeiGene and Celgene is now a BMS company, the two entered into an exclusive license and supply agreement for ABRAXANE and two other cancer medicines in 2017 as part of a broader strategic collaboration. Under the terms of the agreement, BeiGene is responsible for promoting and distributing ABRAXANE in China and BMS is responsible for manufacturing the drug in compliance with regulatory requirements, maintaining the drug registration and import license and supplying packaged drug product for the China market.
No other BeiGene products are affected as they are not manufactured at the same BMS site.