On June 6th, Gelunhui reported that according to The Paper, there were market rumors that Jiangsu Hengrui Pharmaceuticals had received the FDA Form 483. In response, Jiangsu Hengrui Pharmaceuticals stated that this FDA inspection involved a pharmaceutical production site in the Lianyungang area of the company. The company has submitted a corrective response and completion tracking report in response to the defects raised during the inspection and has remained in active communication with the FDA. Jiangsu Hengrui Pharmaceuticals emphasized that the production exported to the United States has not been affected, and the inspection results are not related to the company's PD-1 combination therapy application for listing in the US.
恒瑞收FDA现场观察报告，称与PD-1在美申报上市无关联
Hengrui has received an FDA on-site inspection report, stating that it has no association with the PD-1 in the US market application for listing.
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