Recently, Hubei JXBio Pharmaceutical Co., Ltd. (“Hubei JXBio”), the peptide manufacturing base of Jianyuan Pharmaceuticals, received the Chemical API Marketing Approval Notification for Icatibant Acetate (Registration No.: Y20240000910) issued by the National Medical Products Administration (NMPA), approving the domestic manufacturing and marketing of the API.

Icatibant Acetate is a selective bradykinin B2 receptor antagonist indicated for the acute treatment of hereditary angioedema (HAE) in adults, adolescents, and pediatric patients aged 2 years and older.

As the registered holder of this API, Hubei JXBio has successfully completed the regulatory review and obtained marketing approval, thereby supporting its client in advancing the commercialization of the corresponding formulation. This approval further validates the Company’s compliance manufacturing capabilities and quality system strengths in the peptide API sector.

To date, the Hubei JXBio peptide manufacturing facility has successfully passed two US FDA cGMP inspections, one EAEU GMP inspection, and multiple NMPA cGMP inspections, earning recurrent international recognition for its quality management system. The Company’s major products have been filed in multiple established markets including the U.S., the EU, and South Korea, positioning it to compete in the global supply chain.

Shenzhen JYMed Technology Co., Ltd.

A leading global peptide solutions provider