INNOGEN-B (02591) announced that as of July 27, 2026, two contract manufacturing sites for its Efesogliptin alfa injection project, both owned and operated by independent third parties, have successfully passed Good Manufacturing Practice compliance inspections conducted by Brazil's National Health Surveillance Agency in accordance with the Pharmaceutical Inspection Co-operation Scheme standards.

The National Health Surveillance Agency has issued the corresponding GMP certificates. The Pharmaceutical Inspection Co-operation Scheme is an internationally recognized authority on drug inspection and certification, covering regulatory bodies from dozens of countries. It enforces unified standards for GMP inspections and certification for human and veterinary medicines.

GMP compliance inspections are a prerequisite for drug registration and approval. PIC/S member states and participating institutions voluntarily recognize each other's GMP inspection results. Obtaining the PIC/S GMP certificates confirms that the company's commissioned sites' drug substance and drug product manufacturing and quality management systems meet PIC/S standards.

This achievement will further expand the commercial manufacturing capacity for Efesogliptin alfa and advance the drug's registration and commercialization process across PIC/S member countries.