Kexing Biopharm's Licensed-In Product, Liraglutide Injection, Successfully Passed Brazil's ANVISA GMP On-Site Audit

Article source：Kexing BiopharmNov 26,2025View： 588

Recently, Kexing Biopharm Co., Ltd. (688136.SH), in collaboration with Tonghua Dongbao Pharmaceutical Co., Ltd. (600867.SH), achieved a significant milestone in its overseas expansion with the blockbuster product Liraglutide Injection. The product passed the Good Manufacturing Practice (GMP) on-site audit conducted by Brazil's National Health Surveillance Agency (ANVISA)—a PIC/S member country—with "zero deficiencies." This represents one of the core review stages prior to the product's entry into the Brazilian pharmaceutical market.

The audit was rigorously conducted in accordance with the PIC/S (Pharmaceutical Inspection Co-operation Scheme) GMP Guide, encompassing a comprehensive scope that covered the full chain, including production, testing, warehousing, and quality management systems.

The joint teams from Kexing Biopharm and Tonghua Dongbao collaborated closely, with thorough pre-audit preparations and efficient on-site coordination ensuring the orderly execution of all audit processes. The product passed the on-site audit with no deficiencies identified.

Since joining the PIC/S organization in 2021, Brazil's pharmaceutical GMP regulatory standards and rigorous enforcement have gained global acclaim, establishing it as a benchmark for emerging pharmaceutical markets.

This zero-deficiency passage of the GMP on-site audit for Liraglutide Injection marks another critical breakthrough in Kexing Biopharm's overseas commercialization strategy, providing strong endorsement for the product's swift entry into the Brazilian market and further expansion across South America. Moving forward, Kexing Biopharm will accelerate the introduction of more high-quality medicines into Brazil, offering superior treatment options to local patients.

About Kexing

Kexing Biopharm (Stock Code: 688136.SH) is a multinational biopharmaceutical enterprise that engages in the R&D, manufacture and sales of innovative medicines of distinct modalities including recombinant proteins, antibodies, and targeted delivery therapies.

Through building cutting-edge technology platforms to advance the development of novel targeted therapies and drug delivery systems, Kexing strives to address unmet clinical needs in the areas of oncology, autoimmune and antiviral treatment, creating a significant and meaningful positive impact on patients' lives.

By adhering to the platform development model driven by the twin engines of “Innovation & Internationalization”, Kexing is committed to becoming a world leader in high-quality biopharmaceuticals, improving the health of patients worldwide.