Albumin-bound paclitaxel from Kexing Biopharm receives EU marketing approval

On July 28, 2024, Kexing Biopharm announced the European Commission’s approval of Apexelsin®, the generic to Abraxane® (nab-paclitaxel) from Bristol Myers Squibb and Celgene. Apexelsin® was developed by WhiteOak Pharmaceutical BV and Kexing Biopharm is responsible for marketing this product outside the USA.

Albumin-bound paclitaxel in nanoparticles offers significant advantages for clinical use compared to solvent-based paclitaxel and liposomal paclitaxel, offering higher safety and better patient compliance. It is widely accepted in clinical practice and has high value in oncology. In addition, it is recommended in the European Society of Medical Oncology (ESMO) guidelines as a first-line treatment for metastatic pancreatic cancer and non-small cell lung cancer (NSCLC) and as a second-line option for breast cancer. Breast cancer is one of the most common cancers among women in the EU region, and there is a large market for drugs to treat breast cancer.

In recent years, the Chinese pharmaceutical industry has initiated significant expansion into international markets. But Kexing Biopharm actually began its international ventures 20 years ago with its core products. In recent years, the company has launched more than a dozen high-quality Chinese medicines in emerging markets, improving access to medicines for local patients.

The approval of albumin-bound paclitaxel by the EU will strengthen the company’s competitiveness in the international pharmaceutical market. It also means that Kexing Biopharm is expanding its commercialization efforts into the European market in addition to its long-standing presence in emerging markets. The EU market is an important milestone in the company’s commercialization strategy abroad. To date, Kexing Biopharm has advanced the registration of Apexelsin® in dozens of emerging markets outside of Europe. With the successful launch of this product in the EU, Kexing Biopharm will further expand its global sales reach and serve more patients and healthcare providers.

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