B · Normal
[Sirnaomics: Subsidiaries have been included in the 66-40 list by the FDA, which may have a certain adverse impact on performance] On September 22, Sirnaomics announced at noon that its wholly-owned subsidiary Sirnaomics Pharmaceuticals will accept an on-site inspection by the U.S. Food and Drug Administration ("FDA") inspection team in August 2026. On August 27, the FDA inspection team issued a FormFDA 483 observation form to the company in accordance with relevant U.S. regulations, stating 8 observation items. The company has submitted its initial response to the above 483 and related corrective measures to the FDA. Up to now, after checking the official website of the FDA, Sirnaomics has been included in the import ban list No. 66-40 on September 19, 2026; however, it has not yet received the official action instruction conclusion from the US FDA, nor has it received an FDA warning letter. The company achieved sales revenue of 167 million yuan in the United States in the first half of 2026, accounting for 32.83% of the company's operating revenue in the same period. Therefore, this matter may have a certain adverse impact on the company's operating performance in the future. The company promises to completely stop the sales and shipment of all peptide APIs to the U.S. market before Sirnaomics lifts the relevant FDA warning.
Futures Market Intelligence 🕐 2026-09-22 12:43

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