Summary
BeOne Medicines Ltd. (ONC) announced a significant disruption to its ABRAXANE® supply in China. On March 25, 2020, the China National Medical Products Administration suspended the importation, sales, and use of ABRAXANE® due to inspection findings at Bristol-Myers Squibb's (BMS) contract manufacturing facility in the United States. Consequently, ABRAXANE® has been removed from the volume-based procurement list by the China National Healthcare Security Administration. This suspension is expected to cause a disruption in BeiGene's supply of ABRAXANE® in China. The company is actively working with BMS to resolve the manufacturing issues and restore supply as quickly as possible. This includes BMS's remediation efforts at the current site and pursuing an alternative manufacturing site qualification for the Chinese market. Investors should monitor the progress of these remediation and qualification efforts as they will directly impact BeiGene's sales and market presence for ABRAXANE® in China.
Key Highlights
- 1ABRAXANE® importation, sales, and use suspended in China by the China National Medical Products Administration.
- 2Suspension is due to inspection findings at BMS's US contract manufacturing facility.
- 3ABRAXANE® removed from the volume-based procurement list by the China National Healthcare Security Administration.
- 4BeiGene expects a disruption in ABRAXANE® supply in China.
- 5BeiGene is working with BMS on remediation efforts and to qualify an alternative manufacturing site.
- 6The company aims to restore supply as soon as possible.