8-KRegulation FDOther EventsExhibits & Filings

BeOne Medicines Ltd. 8-K Report, Regulation FD Disclosure (Mar 25, 2020)

Filed March 25, 2020For Securities:ONCBEIGF

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.

Frequently Asked Questions

The immediate impact is the suspension of importation, sales, and use of ABRAXANE® in China, and its removal from the volume-based procurement list. This will lead to a disruption in BeiGene's supply of the drug in the Chinese market.

The suspension was triggered by inspection findings at Bristol-Myers Squibb's (BMS) contract manufacturing facility located in the United States, which supplies ABRAXANE® to BeiGene.

BeiGene is collaborating with BMS. BMS is undertaking remediation efforts at its current manufacturing site and is also applying to qualify an alternative manufacturing site specifically for the Chinese market. BeiGene's goal is to restore supply as soon as possible.

While the extent of the impact is not quantified in this filing, ABRAXANE® is a key product. A prolonged suspension or significant delays in restoring supply could materially affect BeiGene's revenue from the Chinese market.