Breakthroughs in Kexing Biopharm's Overseas Efforts: Qualification of Two licensed Products for GMP Audits in Egypt

Article source：Kexing BiopharmApr 07,2024View： 288

Kexing Biopharm's licensed products infliximab and bevacizumab were officially notified of their qualification for site GMP inspections in Egypt after the completion of site GMP audits by the Egyptian Drug Authority (EDA) in September last year. This signifies EDA's full approval of these two products across all production, inspection, warehousing, and quality management system aspects, highlighting that the company's international commercialization efforts in Egypt have significantly enhanced the introduction of these two new products.

Specifically, infliximab is primarily utilized for treating rheumatoid arthritis, Crohn's disease in adults and children aged 6 and above, fistulizing Crohn's disease, ankylosing spondylitis, psoriasis, and ulcerative colitis in adults. In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents. The product underwent GMP audits in Egypt, Brazil, and Indonesia respectively in September 2023, February 2024, and March 2024.

Another product bevacizumab is mainly prescribed for advanced, metastatic, or recurrent non-squamous non-small cell lung cancer and metastatic colorectal cancer. In 2022, Kexing Biopharm swiftly reached agreements with 23 overseas market customers, initiating the submission of drug access registration documents. The product underwent a GMP audit in Egypt in September 2023.

In recent years, the pharmaceutical market in Egypt has experienced booming growth and is now considered by Kexing as a primary international market. By establishing local subsidiaries, Kexing Biopharm strives to accelerate product registration processes and enhance competitiveness in overseas markets.