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China faces its latest medical scandal after the discovery of a major batch of HIV-infected human blood plasma treatment.
The batch of intravenous immunoglobulin – an antibody-based immunotherapy treatment derived from blood plasma – was produced by the second largest manufacturer of blood products for medical use in China, the company's Shanghai State Xinxing Pharmaceutical Company.
As of Tuesday, a statement from the National Health Commission (NHC) has asked hospitals to immediately suspend the use of the lot after the Jiangxi Provincial Health Committee and the disease control center, in East of China, have detected traces of HIV.
A representative of the Jiangxi Province Disease Control Center told the Beijing News newspaper that the Shanghai Xinxing contaminated lot had been reported to NHC and that he had yet to find any cases of patients having contracted HIV.
<! – The defective batch included 12,229 50-ml plasma bottles that were due to expire in June 2021, said a source of the state's food and drug regulator at the China Business Journal.
Immunoglobulins are antibodies produced by white blood cells used to treat immune deficiencies caused by diseases such as leukemia, hepatitis and rabies.
The NHC statement advised hospitals to report any treatment stock and closely monitor the condition of patients who had previously been treated with the defective lot.
The Health Commission of Shaanxi Province in northwestern China issued a statement on Tuesday confirming the receipt of the National Health Commission's notification. She added that she would hunt down the lot for it to be tested again. A staff member told Beijing News that 10 hospitals had reported that they had not found any HIV-positive patients yet.
Hospital staff in central China's Henan Province and Shanghai confirmed receiving the information on Tuesday, the Daily Economic News reported.
A hematology officer from a Shanghai hospital told the newspaper that they had not yet received the notice.
"If this is true, it would be a very serious mistake," said the doctor, whose name is unknown. "For now, the crucial point is whether it was caused by a blood donor or a problem with the product.
"We need to know where the defective lot was delivered and proceed with a recall and a new review."
He told the paper that patients treated with defective blood plasma are not necessarily infected with HIV because there is anti-virus treatment in the preparation process.
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"[Patients] would need to be retested to see if they were specifically infected, "he said.
Founded in 2000, Shanghai Xinxing is a biotechnology company specializing in the production and sale of blood-based medical products, according to its official website.
It is controlled by the Chinese group Meheco, one of the largest pharmaceutical companies in China, which in turn belongs to the Chinese group General Technology, a public company.
Shanghai Xinxing did not respond to requests for comments.
<! – The incident occurred less than a month after the revelation that 145 children from Jiangsu Province, in eastern China, had been treated with the expired polio vaccine, which caused the many protests from their parents and the investigation of 17 local officials.
In July, 252,600 defective rabies vaccines manufactured by Changchun Changsheng Bio-technology, one of the largest vaccine manufacturing companies in China, were administered to thousands of toddlers.
In November, the government consulted the first vaccine management bill, which would allow citizens to sue drug makers for punitive damages in the event of death or serious illness caused by defective vaccines.
This article was first published in South China Morning Post.
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