Sinovac Biotech and Haichang Bio's Jointly Developed Nab-Paclitaxel Receives MAA Acceptance from EMA

On January 23, Kexing Biopharm announced that its partner, Haichang Biotech, received the "Acceptance Notice" issued by the European Medicines Agency (EMA). The EMA officially confirmed and accepted the Marketing Authorization Application (MAA) for the drug Paclitaxel for Injection (Albumin-Bound), co-developed by Kexing Biopharm and Haichang Biotech, and has entered the technical review process.

Abraxane, the original albumin-bound paclitaxel for injection, was initially developed by Abraxis BioScience and later acquired by Celgene. It is now a wholly-owned subsidiary of Bristol-Myers Squibb. The European Medicines Agency has approved this drug for first-line treatment of breast cancer, metastatic pancreatic adenocarcinoma, and non-small cell lung cancer.

Currently, the manufacturers selling injectable albumin-bound paclitaxel in the EU are only the original patent holder, Bristol-Myers Squibb, and Ratiopharm Gmbh (a subsidiary of Teva Pharmaceutical Industries Limited). The product under review has conducted relevant studies according to the quality requirements for complex injectables in the United States, the EU, and China. Its quality specifications comply with international standards for bioequivalence of complex injectables and are consistent with those of the original reference product.