Chinese regulator rebukes a U.S. drug manufacturer for once
Poor quality control has always dented the reputation of China’s drug manufacturers — domestic companies not infrequently receive FDA warning letters for products that fail to meet stringent requirements. But in a rare reversal of fortunes, Chinese regulators have discovered issues with a drug manufactured by a U.S. pharmaceutical company.
The National Medical Products Administration (NMPA) recently suspended the importation, sales, and use of BeiGene’s cancer chemotherapy Abraxane, in-licensed from BMS subsidiary Celgene in 2017. According to a notice published on the NMPA website, the agency found quality management problems with the manufacturing facility, which is run by Fresenius Kabi. As STAT’s Ed Silverman reports, according to Fresenius Kabi, the issues raised by the NMPA are not related to product safety.
BeiGene, meanwhile, said in a statement that it is “working with BMS to determine corrective actions for this situation as quickly as possible.” Under Chinese regulations, imported drugs can only have one registered manufacturing site at a time. BMS has applied to the NMPA to source its supply of Abraxane from another manufacturing facility.
As for when Abraxane’s supply can resume to normal, the Beijing-based drug developer told STAT that it is unable to comment “given the timing of these events are not in BeiGene’s control.”
Disruption to Abraxane supply is a huge blow to BeiGene, since the cancer chemotherapy represented 50% of the company’s net product revenue for marketed products in China. The suspension of its supply has also resulted in its removal from the country’s volume-based procurement program, giving domestic manufacturers of the generic drug — such as Hengrui Medicine, CSPC Pharma, and Qilu Pharma – opportunities to gain market share.
The National Medical Products Administration (NMPA) recently suspended the importation, sales, and use of BeiGene’s cancer chemotherapy Abraxane, in-licensed from BMS subsidiary Celgene in 2017. According to a notice published on the NMPA website, the agency found quality management problems with the manufacturing facility, which is run by Fresenius Kabi. As STAT’s Ed Silverman reports, according to Fresenius Kabi, the issues raised by the NMPA are not related to product safety.
BeiGene, meanwhile, said in a statement that it is “working with BMS to determine corrective actions for this situation as quickly as possible.” Under Chinese regulations, imported drugs can only have one registered manufacturing site at a time. BMS has applied to the NMPA to source its supply of Abraxane from another manufacturing facility.
As for when Abraxane’s supply can resume to normal, the Beijing-based drug developer told STAT that it is unable to comment “given the timing of these events are not in BeiGene’s control.”
Disruption to Abraxane supply is a huge blow to BeiGene, since the cancer chemotherapy represented 50% of the company’s net product revenue for marketed products in China. The suspension of its supply has also resulted in its removal from the country’s volume-based procurement program, giving domestic manufacturers of the generic drug — such as Hengrui Medicine, CSPC Pharma, and Qilu Pharma – opportunities to gain market share.
A Shenzhen biotech’s test kits deemed unreliable
Chinese companies have been shipping medical supplies to other countries fighting Covid-19, but one biotech is making headlines after the reliability of its test kits were called into question.
Shenzhen Bioeasy Biotechnology’s rapid Covid-19 test kits — which require nasal swabs — had an accuracy rate of only 30%, not 80% as claimed, according to Spain’s Society of Infectious Diseases and Clinical Microbiology.
The Chinese Embassy in Spain said on Twitter that Bioeasy is not on the list of approved suppliers provided to Spain, and the company “has not yet obtained the official license from the China NMPA to sell its products.”
In a statement to Spain’s Ministry of Health, the company said it will replace the test kits. The company said on its WeChat blog that the low accuracy rate could be the result of failure to follow the kit’s operational instructions when performing the nose swab.
Shenzhen Bioeasy Biotechnology’s rapid Covid-19 test kits — which require nasal swabs — had an accuracy rate of only 30%, not 80% as claimed, according to Spain’s Society of Infectious Diseases and Clinical Microbiology.
The Chinese Embassy in Spain said on Twitter that Bioeasy is not on the list of approved suppliers provided to Spain, and the company “has not yet obtained the official license from the China NMPA to sell its products.”
In a statement to Spain’s Ministry of Health, the company said it will replace the test kits. The company said on its WeChat blog that the low accuracy rate could be the result of failure to follow the kit’s operational instructions when performing the nose swab.
Laekna Therapeutics gets rights to Novartis’ investigational PD-L1 molecule
Shanghai biotech startup Laekna Therapeutics has obtained exclusive global rights to Novartis’ PD-L1 drug called FAZ053. While still early in its development, the drug is in a Phase 1 study to test its safety and tolerability, as well as antitumor activity for adults with advanced solid tumors.
Laekna plans to start trials on combination therapies as soon as possible.
Since its founding in 2016, the cancer-focused Chinese biotech has already in-licensed several molecules from Novartis, which holds an equity stake in the startup. Led by ex-Novartis scientist Chris Lu, Laekna is also developing treatments for liver diseases.
Laekna plans to start trials on combination therapies as soon as possible.
Since its founding in 2016, the cancer-focused Chinese biotech has already in-licensed several molecules from Novartis, which holds an equity stake in the startup. Led by ex-Novartis scientist Chris Lu, Laekna is also developing treatments for liver diseases.
Innovent to develop Alector’s novel cancer therapy in China
Suzhou-based Innovent Biologics has partnered with Alector to develop the California-based biotech’s cancer therapy, AL008, for the China market. The licensing agreement will allow Innovent to develop, manufacture, and commercialize the molecule in China, while Alector will lead the development for the rest of the world.
“We believe that AL008 will complement perfectly with our current pipeline, further solidifying our position in this promising space while providing more options to patients in need,” said Michael Yu, Innovent’s founder, chairman, and CEO.
AL008 is an anti-SIRP-alpha antibody, a type of drug that acts against the CD47-SIRP-alpha pathway. This pathway is commonly overexpressed in cancers, sending “don’t eat me” signals so that immune cells don’t attack the tumors. The drug works by blocking the cancer’s suppression of the immune system, while promoting immune-activating signals to drive anti-tumor activity.
Partnering with Innovent makes a lot of sense for Alector. The maker of PD-1 drug Tyvyt has a huge pipeline of cancer therapies. Hiding in plain sight is the Phase 1 molecule IBI188, an anti-CD47 monoclonal antibody that works in the same signaling pathway as AL008.
“We believe that AL008 will complement perfectly with our current pipeline, further solidifying our position in this promising space while providing more options to patients in need,” said Michael Yu, Innovent’s founder, chairman, and CEO.
AL008 is an anti-SIRP-alpha antibody, a type of drug that acts against the CD47-SIRP-alpha pathway. This pathway is commonly overexpressed in cancers, sending “don’t eat me” signals so that immune cells don’t attack the tumors. The drug works by blocking the cancer’s suppression of the immune system, while promoting immune-activating signals to drive anti-tumor activity.
Partnering with Innovent makes a lot of sense for Alector. The maker of PD-1 drug Tyvyt has a huge pipeline of cancer therapies. Hiding in plain sight is the Phase 1 molecule IBI188, an anti-CD47 monoclonal antibody that works in the same signaling pathway as AL008.
Can China keep its coronavirus cases at bay?
China is well past its peak of the coronavirus outbreak, but the threat of new infections is not over, local experts tell Science.
"China is addressing an issue every country and location in the world will eventually face: how to normalize and restore societal activities, while at the same time minimizing disease-related dangers from the outbreak," University of Hong Kong epidemiologist Keiji Fukuda said.
Locally transmitted cases may remain low on paper. But the numbers don’t include people who test positive for the virus but have no symptoms.
To prevent new outbreaks, investigators are tracking and quarantining close contacts of every newly confirmed case, Wu Zunyou, an epidemiologist at the Chinese Center for Disease Control and Prevention, told China Daily.
Ding Sheng, director of Tsinghua University’s Global Health Drug
Discovery Institute, believes China can keep its guard up until vaccines and drugs are available. Large-scale reemergence of Covid-19 "is very unlikely given what we have learned," Ding said.
"China is addressing an issue every country and location in the world will eventually face: how to normalize and restore societal activities, while at the same time minimizing disease-related dangers from the outbreak," University of Hong Kong epidemiologist Keiji Fukuda said.
Locally transmitted cases may remain low on paper. But the numbers don’t include people who test positive for the virus but have no symptoms.
To prevent new outbreaks, investigators are tracking and quarantining close contacts of every newly confirmed case, Wu Zunyou, an epidemiologist at the Chinese Center for Disease Control and Prevention, told China Daily.
Ding Sheng, director of Tsinghua University’s Global Health Drug
Discovery Institute, believes China can keep its guard up until vaccines and drugs are available. Large-scale reemergence of Covid-19 "is very unlikely given what we have learned," Ding said.
More reads:
- Shanghai’s Abbisko Therapeutics raises $70 million to develop novel cancer immunotherapies (DealStreetAsia)
- How have China's clinical plans for Covid-19 improved? (China Daily)
- Zhejiang-based Mabpharm partners with Sorrento Therapeutics to develop Covid-19 treatment (Yahoo Finance)
- Top Chinese scientist says not wearing masks is ‘a big mistake’ (Science)
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