SHENZHEN, China, May 10, 2024 /PRNewswire/ -- On the evening of May 5, Kexing Biopharm (stock code: 688136) announced it had obtained a "Certificate of GMP Compliance of a Manufacturer" granted by the Norwegian Medical Products Agency in accordance with the European Medicines Agency (EMA) regulations.
The certification is a milestone for Kexing Biopharm, whose first drug for cancer therapy, Paclitaxel for Injection (Albumin Bound) , can now be registered in the EU as the company overcomes the primary obstacle and officially embarks on its journey into the EU pharmaceutical market.
Since its initial public offering, Kexing Biopharm has actualized international strategies, focusing on high clinical value, a high technical level, high international quality management and registration standards, and fast commercialization to expand its portfolio to 13 products. Paclitaxel for Injection (Albumin Bound) is Kexing Biopharm's first drug for cancer therapy. The manufacturing of the drug requires production equipment of a higher level, technical expertise of an advanced level, incredibly stringent aseptic management of the lean manufacturing process, and pharmaceutical processes of great complexity. The potential of the drug on the EU market prompted Kexing Biopharm to establish an EU cGMP-compliant brand-new production line that would enable the company to integrate research, production and marketing to capitalize more effectively on market opportunities.
The characteristics of slight side effects, high efficacy and convenient injection make Paclitaxel for Injection (Albumin Bound) an ideal mainstream first-line treatment for metastatic pancreatic cancer and non-small cell lung cancer recommended by the European Society for Medical Oncology guidelines. Kexing Biopharm's decision to introduce this product was influenced by its efficacy and great market potential. Paclitaxel for Injection (Albumin Bound) is a collaborative effort between Kexing Biopharm and Haichang Biotech and has been submitted for marketing authorization simultaneously both in China and the EU. IQVIA data reveals the market penetration rate of the drug to stand at a mere 15% in the EU.
Under the GMP mutual recognition among EU members, the certification signifies the compliance with EU GMP of the Paclitaxel for Injection (Albumin Bound) production line. Once Kexing Biopharm obtains the approval of an EU Marketing Authorisation Application (MAA) for this drug, it will be a pivotal success in its entry into the EU regulatory markets, marking a major step forward in its international development strategy.