It’s not very often you hear about manufacturing problems at Western facilities slammed by Chinese authorities. But it just happened to a key cancer drug that involves three big industry names, threatening a $100-million-a-year business.
On Wednesday, BeiGene said importation, sales and use of chemotherapy Abraxane—which it licenses from Celgene, now part of Bristol Myers Squibb—in China have been suspended by the country’s National Medical Products Administration (NMPA). The problem? Manufacturing breaches Chinese inspectors found at a BMS contractor facility in the U.S.
In its own statement Thursday, NMPA identified (Chinese) the producer as Fresenius Kabi’s sterile injectables site in Melrose Park, Illinois. The agency said some key production equipment for the med didn’t meet basic quality control requirements, including aseptic management.
As a result of the manufacturing woe, China National Healthcare Security Administration has removed Abraxane from the volume-based procurement program, a BeiGene spokesperson confirmed to FiercePharma.
The incident could give Chinese copycat rivals CSPC and Hengrui Medicine a window to steal market share. After a price negotiation in January, the three companies won tenders to offer their versions of Abraxane through China’s bulk drug procurement program, which is expected to take effect in the second quarter.
The major problem for BeiGene is, the procurement rule asks that manufacturers take responsibility for their products’ quality. Specifically, a supplier shouldn't have been punished by drug regulators at the provincial level or above within two years prior to participating in the bulk offering.
BeiGene obtained Chinese rights to Abraxane through a deal signed in mid-2017 that also secured it rights to blood cancer drugs Revlimid and Vidaza. The deal helped the biotech leapfrog into the commercial stage, bringing it the entire Celgene China commercial team.
For 2019, BeiGene grew product revenue by 70% year over year to $222.6 million, with Abraxane generating half of that haul.
RELATED: Fresenius moves forward with two U.S. expansions after killing Akorn deal
“We are working with BMS to determine corrective actions for this situation as quickly as possible,” BeiGene Chairman and CEO John Oyler said in a statement. While BeiGene is working with Bristol on remedies and preventative measures at the current manufacturing site, the New York pharma has applied for Chinese approval to source the supply from another facility. But before that, BeiGene’s expecting a supply disruption in China.
A Bristol Myers spokesperson said that the halt only applies to the China market and doesn’t impact its ability to supply Abraxane elsewhere.
As for Fresenius Kabi, a company spokesperson told FiercePharma that the findings by NMPA were “general in nature and relate to room classification and process flow/material movement that do not have any impact on product safety,” adding that there's “no field safety corrective action with this product in the Chinese market.”
The German company last April just held a topping out ceremony for a $250 million expansion of the Melrose Park site. That decade-long project includes new buildings for aseptic filing lines, expanded lyophilization capabilities and formulation areas, plus a warehouse. The company didn’t immediately reply to a FiercePharma request for comment.
Editor's Note: The story has been updated with additional comments from BeiGene and Fesnius Kabi.