Kexing Biopharm Facility Secures EU GMP for Paclitaxel Injection

SHENZHEN, China, May 10, 2024 - On May 5, Kexing Biopharm (stock code: 688136) announced that it had received a "Certificate of GMP Compliance of a Manufacturer" from the Norwegian Medical Products Agency. This certification adheres to the regulations set by the European Medicines Agency (EMA).

This certification is a significant milestone for Kexing Biopharm. It allows their first cancer therapy drug, Paclitaxel for Injection (Albumin Bound), to be registered in the European Union (EU). With this certification, the company has overcome a major hurdle and can now officially enter the EU pharmaceutical market.

Since its initial public offering, Kexing Biopharm has been implementing international strategies. These strategies include focusing on drugs with high clinical value, employing advanced technical expertise, adhering to stringent international quality management and registration standards, and ensuring rapid commercialization. So far, the company has expanded its portfolio to 13 products. Paclitaxel for Injection (Albumin Bound) is the company's first cancer therapy drug. Its manufacturing process demands high-level production equipment, advanced technical expertise, strict aseptic management, and complex pharmaceutical processes. Recognizing the drug's potential in the EU market, Kexing Biopharm established a new production line compliant with EU cGMP standards. This new production line allows for the integration of research, production, and marketing, helping the company to better capitalize on market opportunities.

Paclitaxel for Injection (Albumin Bound) is characterized by its slight side effects, high efficacy, and convenient administration. As a result, it is considered an ideal first-line treatment for metastatic pancreatic cancer and non-small cell lung cancer according to the guidelines of the European Society for Medical Oncology. The decision to introduce this product was driven by its effectiveness and significant market potential. This drug is a collaborative effort between Kexing Biopharm and Haichang Biotech and has been submitted for marketing authorization in both China and the EU simultaneously. According to IQVIA data, the market penetration rate of this drug is currently only 15% in the EU.

The certification under the EU's GMP mutual recognition signifies compliance with EU GMP standards for the Paclitaxel for Injection (Albumin Bound) production line. Once Kexing Biopharm receives approval for its EU Marketing Authorisation Application (MAA) for this drug, it will mark a pivotal success in its entry into EU regulatory markets. This achievement will represent a major advancement in the company's international development strategy.