Innogen-B (02591.HK): Two Contract Manufacturing Sites for Isupaglutide α Injection Obtain PIC/S GMP Certificates

NewTimeSpace · 2026/08/03 19:50 · By Boyuan Chen

NewTimeSpace News: Guangzhou Innogen Pharmaceutical Group Co., Limited (02591.HK) announced that two contract manufacturing sites in China for Isupaglutide α Injection have passed compliance inspection conducted by Brazil’s ANVISA in accordance with PIC/S GMP standards and obtained relevant GMP certificates, confirming that the production and quality management systems comply with PIC/S GMP requirements.

NewTimeSpace News: Guangzhou Innogen Pharmaceutical Group Co., Limited (02591.HK) issued a voluntary announcement on 3 August 2026, disclosing that the contract manufacturing sites for Isupaglutide α Injection have been awarded PIC/S GMP certificates.

According to the announcement, on 27 July 2026, two contract manufacturing sites in China for Isupaglutide α Injection (both owned and operated by independent third parties) passed the Good Manufacturing Practice (GMP) compliance inspection carried out by Brazil’s National Health Surveillance Agency (ANVISA) under the standards of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Relevant GMP certificates have been issued by ANVISA.

PIC/S is an internationally recognised authoritative body for pharmaceutical inspection and certification, implementing unified standards for pharmaceutical GMP inspections and certifications. PIC/S member authorities and participating organisations voluntarily recognise each other’s GMP inspection outcomes.

The acquisition of PIC/S GMP certificates verifies that the drug substance and finished dosage form manufacturing as well as quality management systems at the Group’s contract manufacturing sites meet PIC/S GMP standards. This will expand the commercial production capacity of Isupaglutide α and facilitate the drug registration and commercialisation progress in PIC/S member jurisdictions.

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INNOGEN-B 02591.HK GMP