Chinese Regulators Examine Xinxing's Blood Products for HIV

(Bloomberg) -- The National Medical Products Administration has demanded Shanghai regulators conduct on-site inspections at Shanghai Xinxing Medicine after receiving a report that an Intravenous Human Immunoglobulin lot made by the company tested positive for HIV antibodies, the regulator says in a statement.

• The agency asked Shanghai regulators to check products made from the same lot of plasma, and from lots made before and after that one
  • Has sent inspection and supervision groups to Shanghai and Jiangxi province to investigate, handle issues
• In Shanghai, regulators tested the batch in question for HIV, Hepatitis B + C antibodies and the results were negative; in Jiangxi, patient tests for HIV were negative
• The agency says it continues to investigate the situation
• The agency and National Health Commission have jointly ordered an immediate halt to use of the co.’s related products, and ordered product sealing and storage measures
• Separately, Shanghai’s medical product regulator said it had controlled all of the company’s relevant production and test records and sent samples for tests per the notice from national regulators
  • Shanghai has sent law enforcement personnel, experts to co., has ordered production halt, started an urgent product recall, ordered city’s medical institutions to halt use of related products
• Xinxing representatives weren’t available for comment during the annual Lunar New Year holidays

To contact the reporter on this story: Belinda Cao in New York at lcao4@bloomberg.net

To contact the editors responsible for this story: Clementine Fletcher at cfletcher5@bloomberg.net, Jim Silver

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