Yinnuo Pharmaceutical-B (02591): Two esupaglutide α injections were commissioned to obtain PIC/s GMP certificates at production sites

Zhitongcaijing · 1d ago

According to Zhitong Financial App, Yinnuo Pharmaceutical-B (02591) announced that on July 27, 2026, the Group's two commissioned production sites for the espagrutide alpha injection project in China (both owned and operated by an independent third party) have passed the Good Manufacturing Practice (GMP) compliance inspection carried out by Brazil's National Health Administration (ANVISA) in accordance with the Drug Inspection Cooperation Program (PIC/S) GMP standards, and ANVISA has issued the relevant GMP certificates.

PIC/S is an internationally recognized authority for drug inspection and certification, covering dozens of national drug regulators. It implements uniform standards for GMP inspection and certification of human and veterinary drugs. GMP compliance checks are a prerequisite for drug registration and approval. PIC/S member states and participating agencies voluntarily mutually recognize GMP compliance inspection results.

Obtaining the PIC/S GMP certificate indicates that the liquid and formulation manufacturing and quality management systems at the Group's commissioned production site meet PIC/S GMP standards. This will further expand the Group's commercial production capacity of esupaglutide α and promote the completion of the drug registration and commercialization process in PIC/S member countries.