Kexing Biopharm's Albumin-bound Paclitaxel Approved by EU

SHENZHEN, China, July 31, 2024 -- On July 28, 2024, Kexing Biopharm announced that it has received European Commission approval for Apexelsin®, the generic version of Bristol Myers Squibb's and Celgene's Abraxane® (Nab-paclitaxel). Developed by WhiteOak Pharmaceutical B.V., Kexing Biopharm is responsible for commercializing Apexelsin® outside the United States.

Nanoparticle albumin-bound paclitaxel, the primary component of Apexelsin®, provides notable clinical benefits. It offers improved safety and higher patient compliance compared to its solvent-based and liposomal paclitaxel counterparts. This formulation is widely accepted in clinical practice and holds significant value in oncology. According to guidelines from the European Society for Medical Oncology (ESMO), albumin-bound paclitaxel is recommended as a first-line treatment for metastatic pancreatic cancer and non-small cell lung cancer (NSCLC), as well as a second-line treatment for breast cancer. Breast cancer is a prevalent cancer type among women in the European Union, presenting a significant market opportunity for treatment drugs.

The Chinese pharmaceutical industry has increasingly expanded into international markets in recent years. However, Kexing Biopharm began its global ventures two decades ago with its core products. Recently, the company has introduced over a dozen high-quality Chinese medications to emerging markets, enhancing local patients' access to essential medicines.

The European Commission's approval of albumin-bound paclitaxel will bolster Kexing Biopharm's competitiveness in the international pharmaceutical market. It also marks the company's entry into the European market, complementing its established presence in emerging markets. The EU market is a significant milestone in Kexing Biopharm's global commercialization strategy. The company is currently proceeding with the registration of Apexelsin® in various emerging markets outside Europe. With the successful launch of this product in the EU, Kexing Biopharm aims to expand its global sales reach, serving a broader range of patients and healthcare providers.

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