ChengDu Sheng Nuo Biotec (688117.SH) Subsidiary Shengnuo Pharmaceutical Included by FDA in the 66-40 List Explanation

ChengDu Sheng Nuo Biotec (688117.SH) announced that its wholly-owned subsidiary, ChengDu Sheng Nuo Biotec Pharmaceutical Co., Ltd. (hereinafter referred to as "Shengnuo Pharmaceutical"), underwent on-site inspections by a U.S. Food and Drug Administration (hereinafter referred to as "FDA") inspection team from August 20, 2026 to August 22, 2026, as well as on August 24, 2026 and August 27, 2026. On August 27, 2026, the FDA inspection team issued a Form FDA 483 observation form (hereinafter referred to as the "483") to the company pursuant to Section 704(b) of the U.S. Federal Food, Drug, and Cosmetic Act, documenting 8 observations, primarily concerning the same group of products and the same production and packaging process, at levels including identification of critical quality attributes, contamination control capability, detection and result acceptance capability, and quality system governance. On September 17, 2026, the company submitted an Initial Response to the above 483 and related corrective measures to the Office of Manufacturing Quality (OMQ) of the FDA's Center for Drug Evaluation and Research (CDER) via email. As of now, according to a search of the FDA's official website, Shengnuo Pharmaceutical was placed on the Import Alert List No. 66-40 on September 19, 2026; however, apart from having received the above Form FDA 483 issued by the FDA, the company has not yet received an Official Action Indicated (OAI) conclusion from the U.S. FDA, nor has it received an FDA Warning Letter.