Shengnuo Biotech announced at noon on September 22 that its wholly-owned subsidiary Shengnuo Pharmaceuticals underwent on-site inspection by the US Food and Drug Administration inspection team in August 2026. On August 27, the FDA inspection team issued the FormFDA 483 observation form to the company in accordance with relevant US regulations, which specified 8 observation items. The company has submitted an initial response to the above 483 and related corrective measures to the FDA. Up to now, after checking the FDA's official website, Shengnuo Pharmaceuticals was added to the 66-40 import ban list on September 19, 2026; however, it has not received the conclusion of the official action instructions issued by the US FDA, nor has it received a warning letter from the FDA. The company achieved sales revenue of 167 million yuan to the US in the first half of 2026, accounting for 32.83% of the company's revenue for the same period. Therefore, this matter may adversely affect the company's operating performance in the future. The company promised to completely stop the sale and shipment of all peptide APIs to the US market until Shengnuo Pharmaceuticals lifts the relevant FDA warning.

Shengnuo Biotech announced at noon on September 22 that its wholly-owned subsidiary Shengnuo Pharmaceuticals underwent on-site inspection by the US Food and Drug Administration inspection team in August 2026. On August 27, the FDA inspection team issued the FormFDA 483 observation form to the company in accordance with relevant US regulations, which specified 8 observation items. The company has submitted an initial response to the above 483 and related corrective measures to the FDA. Up to now, after checking the FDA's official website, Shengnuo Pharmaceuticals was added to the 66-40 import ban list on September 19, 2026; however, it has not received the conclusion of the official action instructions issued by the US FDA, nor has it received a warning letter from the FDA. The company achieved sales revenue of 167 million yuan to the US in the first half of 2026, accounting for 32.83% of the company's revenue for the same period. Therefore, this matter may adversely affect the company's operating performance in the future. The company promised to completely stop the sale and shipment of all peptide APIs to the US market until Shengnuo Pharmaceuticals lifts the relevant FDA warning.